Publications by authors named "Susan van Dieren"

80 Publications

Performance with robotic surgery versus 3D- and 2D-laparoscopy during pancreatic and biliary anastomoses in a biotissue model: pooled analysis of two randomized trials.

Surg Endosc 2021 Nov 19. Epub 2021 Nov 19.

Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, De Boelelaan 1117 (ZH-7F), 1081 HV, Amsterdam, The Netherlands.

Background: Robotic surgery may improve surgical performance during minimally invasive pancreatoduodenectomy as compared to 3D- and 2D-laparoscopy but comparative studies are lacking. This study assessed the impact of robotic surgery versus 3D- and 2D-laparoscopy on surgical performance and operative time using a standardized biotissue model for pancreatico- and hepatico-jejunostomy using pooled data from two randomized controlled crossover trials (RCTs).

Methods: Pooled analysis of data from two RCTs with 60 participants (36 surgeons, 24 residents) from 11 countries (December 2017-July 2019) was conducted. Each included participant completed two pancreatico- and two hepatico-jejunostomies in biotissue using 3D-robotic surgery, 3D-laparoscopy, or 2D-laparoscopy. Primary outcomes were the objective structured assessment of technical skills (OSATS: 12-60) rating, scored by observers blinded for 3D/2D and the operative time required to complete both anastomoses. Sensitivity analysis excluded participants with excess experience compared to others.

Results: A total of 220 anastomoses were completed (robotic 80, 3D-laparoscopy 70, 2D-laparoscopy 70). Participants in the robotic group had less surgical experience [median 1 (0-2) versus 6 years (4-12), p < 0.001], as compared to the laparoscopic group. Robotic surgery resulted in higher OSATS ratings (50, 43, 39 points, p = .021 and p < .001) and shorter operative time (56.5, 65.0, 81.5 min, p = .055 and p < .001), as compared to 3D- and 2D-laparoscopy, respectively, which remained in the sensitivity analysis.

Conclusion: In a pooled analysis of two RCTs in a biotissue model, robotic surgery resulted in better surgical performance scores and shorter operative time for biotissue pancreatic and biliary anastomoses, as compared to 3D- and 2D-laparoscopy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00464-021-08805-3DOI Listing
November 2021

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair.

Trials 2021 Sep 19;22(1):639. Epub 2021 Sep 19.

Department of Vascular Surgery, Dijklander ziekenhuis, Maelsonstraat 3, 1624, NP, Hoorn, The Netherlands.

Background: Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200-220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe.

Methods: Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200-220 s. If the ACT after 5 min is < 180 s, 60 IU/kg will be administered; if the ACT is between 180 and 200 s, 30 IU/kg. If the ACT is > 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group.

Discussion: The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. TRIAL REGISTRATION {2A}: NTR NL8421 ClinicalTrials.gov NCT04061798 . Registered on 20 August 2019 EudraCT 2018-003393-27 TRIAL REGISTRATION: DATA SET {2B}: Data category Information Primary registry and trial identifying number ClinicalTrials.gov : NCT04061798 Date of registration in primary registry 20-08-2019 Secondary identifying numbers NTR: NL8421 EudraCT: 2018-003393-27 Source(s) of monetary or material support ZonMw: The Netherlands Organisation for Health Research and Development Dijklander Ziekenhuis Amsterdam UMC Primary sponsor Dijklander Ziekenhuis Secondary sponsor(s) N/A Contact for public queries A.M. Wiersema, MD, PhD [email protected] 0031-229 208 206 Contact for scientific queries A.M. Wiersema, MD, PhD [email protected] 0031-229 208 206 Public title ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair (ACTION-1) Scientific title ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial Countries of recruitment The Netherlands. Soon the recruitment will start in Germany Health condition(s) or problem(s) studied Abdominal aortic aneurysm, arterial disease, surgery Intervention(s) ACT-guided heparinization 5000 IU of heparin Key inclusion and exclusion criteria Ages eligible for the study: ≥18 years Sexes eligible for the study: both Accepts healthy volunteers: no Inclusion criteria: Study type Interventional Allocation: randomized Intervention model: parallel assignment Masking: single blind (patient) Primary purpose: treatment Phase IV Date of first enrolment March 2020 Target sample size 750 Recruitment status Recruiting Primary outcome(s) The primary efficacy endpoint is 30-day mortality and in-hospital mortality during the same admission. The primary safety endpoint is the incidence of bleeding complications according to E-CABG classification, grade 1 and higher. Key secondary outcomes Serious complications as depicted in the Suggested Standards for Reports on Aneurysmal disease: all complications requiring re-operation, longer hospital stay, all complications.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-021-05552-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8449992PMC
September 2021

Local Recurrence and Disease-Free Survival After Transanal Total Mesorectal Excision: Results From the International TaTME Registry.

J Natl Compr Canc Netw 2021 08 17. Epub 2021 Aug 17.

Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.

Background: The oncologic safety of transanal total mesorectal excision (TaTME) for rectal cancer has recently been questioned, with high local recurrence (LR) rates reported in Dutch and Norwegian experiences. The objective of this study was to evaluate the oncologic safety of TaTME in a large cohort of patients with primary rectal cancer, primarily in terms of LR, disease-free survival (DFS), and overall survival (OS).

Patients And Methods: This was a prospective international registry cohort study, including all patients who underwent TaTME for primary rectal adenocarcinoma from February 2010 through December 2018. The main endpoints were 2-year LR rate, pattern of LR, and independent risk factors for LR. Secondary endpoints included 2-year DFS and OS rates. Kaplan-Meier survival analysis was used to calculate actuarial LR, DFS, and OS rates.

Results: A total of 2,803 patients receiving primary TaTME were included, predominantly men (71%) with a median age of 65 years (interquartile ratio, 57-73 years). After a median follow-up of 24 months (interquartile ratio, 12-38 months), the 2-year LR rate was 4.8% (95% CI, 3.8%-5.8%) with a unifocal LR pattern in 99 of 103 patients (96%). Independent risk factors for LR were male sex, threatened resection margin on baseline MRI, pathologic stage III cancer, and a positive circumferential resection margin on final histopathology. The 2-year DFS and OS rates were 77% (95% CI, 75%-79%) and 92% (95% CI, 91%-93%), respectively.

Conclusions: This largest TaTME cohort to date supports the oncologic safety of the TaTME technique for rectal cancer in patients treated in units that contributed to an international registry, with an acceptable 2-year LR rate and a predominantly unifocal LR pattern.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.6004/jnccn.2021.7012DOI Listing
August 2021

Right-sided resection with standard or selective portal vein resection in patients with perihilar cholangiocarcinoma: a propensity score analysis.

HPB (Oxford) 2021 Jul 7. Epub 2021 Jul 7.

Department of Surgery, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Campus Virchow-Klinikum, Berlin, Germany.

Background: Standard portal vein resection (PVR) has been proposed to improve oncological outcomes in patients with perihilar cholangiocarcinoma (PHC), however it potentially introduces an increased risk of morbidity. The policy in Amsterdam UMC(AMC) is to resect the portal vein bifurcation selectively when involved, while in Charité-Universitätsmedizin Berlin, standard PVR is performed with right trisectionectomy. The objective of this study was to analyze postoperative outcomes and survival after standard or selective PVR for PHC.

Methods: A retrospective study was performed including PHC-patients undergoing right-sided resection in Amsterdam (2000-2018) and Berlin (2005-2015). Primary outcomes were 90-day mortality, severe morbidity (Clavien-Dindo≥3), and overall survival (OS). A propensity score comparison (1:1 ratio) was performed corrected for age/sex/ASA/jaundice/tumor diameter/N-stage/Bismuth-Corlette type-IV.

Results: A total of 251 patients who underwent right-sided resection for PHC were evaluated: 87 in the selective (Amsterdam) and 164 in the standard PVR-group (Berlin). Major differences in baseline characteristics were observed, with higher ASA and AJCC-stage in the standard PVR-group (Berlin). Severe morbidity and 90-day mortality were comparable before matching (selective/Amsterdam:68% and 19%, standard/Berlin:61% and 17%,p = 0.284 and p = 0.746, respectively). After propensity score matching, both short term outcomes and OS were comparable (selective/Amsterdam (n = 45) 33 months (95%CI:20-45), standard/Berlin (n = 45) 31 months (95%CI:24-38,p = 0.747)).

Conclusion: In this combined cohort, standard PVR was not associated with increased severe morbidity or mortality. After propensity score matching, survival was comparable after selective (Amsterdam) and standard PVR (Berlin).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hpb.2021.06.429DOI Listing
July 2021

Analysis of Outcomes After Endovascular Abdominal Aortic Aneurysm Repair in Patients With Abnormal Findings on the First Postoperative Computed Tomography Angiography.

J Endovasc Ther 2021 12 28;28(6):878-887. Epub 2021 Jul 28.

Department of Surgery, Amsterdam University Medical Centres, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.

Purpose: Lifelong follow-up after endovascular abdominal aortic aneurysm repair (EVAR) is recommended due to a continued risk of complications, especially if the first postoperative imaging shows abnormal findings. We studied the long-term outcomes in patients with abnormalities on the first postoperative computed tomography angiography (CTA) following EVAR.

Materials And Methods: This is a retrospective study of all consecutive patients who underwent elective EVAR for nonruptured abdominal aortic aneurysm (AAA) between January 2007 and January 2012 in 16 Dutch hospitals with follow-up until December 2018. Patients were included if the first postoperative CTA showed one of the following abnormal findings: endoleak type I-IV, endograft kinking, infection, or limb occlusion. AAA diameter, complications, and secondary interventions during follow-up were registered. Primary endpoint was overall survival, and other endpoints were secondary interventions and intervention-free survival. Kaplan-Meier analyses were used to estimate overall and intervention-free survival. Cox regression analyses were used to identify the association of independent determinants with survival and secondary interventions.

Results: A total of 502 patients had abnormal findings on the first postoperative CTA after EVAR and had a median follow-up (interquartile range IQR) of 83.0 months (59.0). The estimated overall survival rate at 1, 5, and 10 years was 84.7%, 51.0%, and 30.8%, respectively. Age [hazard ratio (HR) 1.06, 95% confidence interval (CI) 1.05 to 1.10] and American Society of Anesthesiologists (ASA) classification (ASA IV HR 3.20, 95% CI 1.99 to 5.15) were significantly associated with all-cause mortality. Overall, 167 of the 502 patients (33.3%) underwent 238 secondary interventions in total. Fifty-eight patients (12%) underwent an intervention based on a finding on the first postoperative CTA. Overall survival was 38.4% for patients with secondary interventions and 44.5% for patients without (log rank; p=0.166). The intervention-free survival rate at 1, 5, and 10 years was 82.9%, 61.3%, and 45.6%, respectively.

Conclusions: Patients with abnormalities on the first postoperative CTA after elective EVAR for infrarenal AAA cannot be discharged from regular imaging follow-up due to a high risk of secondary interventions. Patients who had a secondary intervention had similar overall survival as those without secondary interventions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/15266028211030539DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573614PMC
December 2021

Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial.

BMJ Open 2021 03 30;11(3):e042629. Epub 2021 Mar 30.

Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC Location AMC, Amsterdam, The Netherlands

Introduction: Distal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy.

Methods And Analysis: To test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment.Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model.Patients are randomised between using the wearable-controlled mobile serious game (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group).

Ethics And Dissemination: The protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences.

Trial Registration Number: Dutch Trial Registry (NTR), NL6140, protocol V.2.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-042629DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8030479PMC
March 2021

The use and clinical outcome of total pancreatectomy in the United States, Germany, the Netherlands, and Sweden.

Surgery 2021 08 16;170(2):563-570. Epub 2021 Mar 16.

Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address:

Background: Total pancreatectomy has high morbidity and mortality and differences among countries are currently unknown. This study compared the use and postoperative outcomes of total pancreatectomy among 4 Western countries.

Methods: Patients who underwent one-stage total pancreatectomy were included from registries in the United States, Germany, the Netherlands, and Sweden (2014-2018). Use of total pancreatectomy was assessed by calculating the ratio total pancreatectomy to pancreatoduodenectomy. Primary outcomes were major morbidity (Clavien Dindo ≥3) and in-hospital mortality. Predictors for the primary outcomes were assessed in multivariable logistic regression analyses. Sensitivity analysis assessed the impact of volume (low-volume <40 or high-volume ≥40 pancreatoduodenectomies annually; data available for the Netherlands and Germany).

Results: In total, 1,579 patients underwent one-stage total pancreatectomy. The relative use of total pancreatectomy to pancreatoduodenectomy varied up to fivefold (United States 0.03, Germany 0.15, the Netherlands 0.03, and Sweden 0.15; P < .001). Both the indication and several baseline characteristics differed significantly among countries. Major morbidity occurred in 423 patients (26.8%) and differed (22.3%, 34.9%, 38.3%, and 15.9%, respectively; P < .001). In-hospital mortality occurred in 85 patients (5.4%) and also differed (1.8%, 10.2%, 10.8%, 1.9%, respectively; P < .001). Country, age ≥75, and vascular resection were predictors for in-hospital mortality. In-hospital mortality was lower in high-volume centers in the Netherlands (4.9% vs 23.1%; P = .002), but not in Germany (9.8% vs 10.6%; P = .733).

Conclusion: Considerable differences in the use of total pancreatectomy, patient characteristics, and postoperative outcome were noted among 4 Western countries with better outcomes in the United States and Sweden. These large, yet unexplained, differences require further research to ultimately improve patient outcome.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.surg.2021.02.001DOI Listing
August 2021

Axial slicing versus bivalving in the pathological examination of pancreatoduodenectomy specimens (APOLLO): a multicentre randomized controlled trial.

HPB (Oxford) 2021 Sep 21;23(9):1349-1359. Epub 2021 Jan 21.

Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address:

Background: In pancreatoduodenectomy specimens, dissection method may affect the assessment of primary tumour origin (i.e. pancreatic, distal bile duct or ampullary adenocarcinoma), which is primarily determined macroscopically. This is the first study to prospectively compare the two commonly used techniques, i.e. axial slicing and bivalving.

Methods: In four centres, a randomized controlled trial was performed in specimens of patients with a suspected (pre)malignant tumour in the pancreatic head. Primary outcome measure was the level of certainty (scale 0-100) regarding tumour origin by four independent gastrointestinal pathologists based on macroscopic assessment. Secondary outcomes were inter-observer agreement and R1 rate.

Results: In total, 128 pancreatoduodenectomy specimens were randomized. The level of certainty in determining the primary tumour origin did not differ between axial slicing and bivalving (mean score 72 [sd 13] vs. 68 [sd 16], p = 0.21), nor did inter-observer agreement, both being moderate (kappa 0.45 vs. 0.47). In pancreatic cancer specimens, R1 rate (60% vs. 55%, p = 0.71) and the number of harvested lymph nodes (median 16 vs. 17, p = 0.58) were similar.

Conclusion: This study demonstrated no differences in determining the tumour origin between axial slicing and bivalving. Both techniques performed similarly regarding inter-observer agreement, R1 rate, and lymph node harvest.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hpb.2021.01.005DOI Listing
September 2021

Wound infection following implant removal of foot, ankle, lower leg or patella; a protocol for a multicenter randomized controlled trial investigating the (cost-)effectiveness of 2 g of prophylactic cefazolin compared to placebo (WIFI-2 trial).

BMC Surg 2021 Feb 1;21(1):69. Epub 2021 Feb 1.

Trauma Surgery, Amsterdam UMC, Loc. AMC, G4-137, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.

Background: Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures.

Methods: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups.

Discussion: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12893-020-01024-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7849087PMC
February 2021

Gastrectomy Versus Esophagectomy For Gastroesophageal Junction Tumors: Short- And Long-term Outcomes From the Dutch Upper GI Cancer Audit.

Ann Surg 2020 Nov 17. Epub 2020 Nov 17.

Amsterdam UMC, location AMC, University of Amsterdam, Department of Surgery, Cancer Center Amsterdam, Amsterdam, The Netherlands.

Objective: Investigate long-term survival, morbidity, mortality and pathology results in patients following esophagectomy or total gastrectomy for GEJ cancer.

Background: Both a total gastrectomy and an esophagectomy may be valid treatment options in patients with gastroesophageal junction (GEJ) cancer. Which procedure results in the most optimal patient outcome is not well studied. The aim of this study was to investigate the long-term survival, morbidity, mortality and pathology results in patients following esophagectomy or total gastrectomy for GEJ cancer.

Methods: A retrospective comparative cohort study of prospectively collected data from the Dutch Upper GI Cancer Audit combined with survival data of the Dutch medical insurance database was performed. Patients with GEJ cancer in whom a total gastrectomy or an esophagectomy was performed between 2011-2016 were compared. The primary outcome was 3-year overall survival. Postoperative morbidity, mortality, 3-year conditional survival, radicality of resection and lymph node yield were secondary endpoints.

Results: A total of 871 patients were included: 790 following esophagectomy and 81 following gastrectomy. The 3-year overall survival was 35.8% after esophagectomy and 28.4% after gastrectomy (HR 1.2, 95%CI 0.721-1.836, p = 0.557). Postoperative morbidity, mortality, radicality of resection, lymph node yield and 3-year conditional survival did not differ significantly between groups.

Conclusion: A total gastrectomy and an esophagectomy for GEJ cancer show largely comparable results with regard to long-term survival, postoperative morbidity, mortality and pathology results. If both procedures are feasible other parameters such as surgeon's experience and quality of life should be considered when planning for surgery.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/SLA.0000000000004610DOI Listing
November 2020

Pain patterns in chronic pancreatitis: a nationwide longitudinal cohort study.

Gut 2021 Sep 6;70(9):1724-1733. Epub 2020 Nov 6.

Department of Surgery, University Medical Centre, Utrecht, The Netherlands

Objective: Pain in chronic pancreatitis is subdivided in a continuous or intermittent pattern, each thought to represent a different entity, requiring specific treatment. Because evidence is missing, we studied pain patterns in a prospective longitudinal nationwide study.

Design: 1131 patients with chronic pancreatitis (fulfilling M-ANNHEIM criteria) were included between 2011 and 2018 in 30 Dutch hospitals. Patients with continuous or intermittent pain were compared for demographics, pain characteristics, quality of life (Short-Form 36), imaging findings, disease duration and treatment. Alternation of pain pattern and associated variables were longitudinally assessed using a multivariable multinomial logistic regression model.

Results: At inclusion, 589 patients (52%) had continuous pain, 231 patients (20%) had intermittent pain and 311 patients (28%) had no pain. Patients with continuous pain had more severe pain, used more opioids and neuropathic pain medication, and had a lower quality of life. There were no differences between pain patterns for morphological findings on imaging, disease duration and treatment. During a median follow-up of 47 months, 552 of 905 patients (61%) alternated at least once between pain patterns. All alternations were associated with the Visual Analogue Scale pain intensity score and surgery was only associated with the change from pain to no pain.

Conclusion: Continuous and intermittent pain patterns in chronic pancreatitis do not seem to be the result of distinctly different pathophysiological entities. The subjectively reported character of pain is not related to imaging findings or disease duration. Pain patterns often change over time and are merely a feature of how severity of pain is experienced.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/gutjnl-2020-322117DOI Listing
September 2021

Relationship Between Quality of Life and Survival in Patients With Pancreatic and Periampullary Cancer: A Multicenter Cohort Analysis.

J Natl Compr Canc Netw 2020 10 1;18(10):1354-1363. Epub 2020 Oct 1.

Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Background: A relationship between quality of life (QoL) and survival has been shown for several types of cancer, mostly in clinical trials with highly selected patient groups. The relationship between QoL and survival for patients with pancreatic or periampullary cancer is unclear.

Methods: This study analyzed QoL data from a prospective multicenter patient-reported outcome registry in patients with pancreatic or periampullary carcinoma registered in the nationwide Netherlands Cancer Registry (2015-2018). Baseline and delta QoL, between baseline and 3-month follow-up, were assessed with the Happiness, EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30), and QLQ-PAN26 questionnaires. The relationship between QoL and survival was assessed using Cox regression models, and additional prognostic value of separate items was assessed using Nagelkerke R2 (explained variance).

Results: For the baseline and delta analyses, 233 and 148 patients were available, respectively. Most were diagnosed with pancreatic adenocarcinoma (n=194; 83.3%) and had stage III disease (n=77; 33.0%), with a median overall survival of 13.6 months. Multivariate analysis using baseline scores indicated several scales to be of prognostic value for the total cohort (ie, happiness today, role functioning, diarrhea, pancreatic pain, and body image; hazard ratios all P<.05) and for patients without resection (ie, overall satisfaction with life, physical and cognitive functioning, QLQ-C30 summary score, fatigue, pain, constipation, diarrhea, and body image; hazard ratios all P<.05). Except for diarrhea, all QoL items accounted for >5% of the additional explained variance and were of added prognostic value. Multivariate analysis using delta QoL revealed that only constipation was of prognostic value for the total cohort, whereas no association with survival was found for subgroups with or without resection.

Conclusions: In a multicenter cohort of patients with pancreatic or periampullary carcinoma, QoL scores predicted survival regardless of patient, tumor, and treatment characteristics. QoL scores may thus be used for shared decision-making regarding disease management and treatment choice.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.6004/jnccn.2020.7579DOI Listing
October 2020

Yield of Screening for COVID-19 in Asymptomatic Patients Before Elective or Emergency Surgery Using Chest CT and RT-PCR (SCOUT): Multicenter Study.

Ann Surg 2020 12;272(6):919-924

Department of Surgery, Sint Antonius Hospital, Nieuwegein, the Netherlands.

Objective: To determine the yield of preoperative screening for COVID-19 with chest CT and RT-PCR in patients without COVID-19 symptoms.

Summary Of Background Data: Many centers are currently screening surgical patients for COVID-19 using either chest CT, RT-PCR or both, due to the risk for worsened surgical outcomes and nosocomial spread. The optimal design and yield of such a strategy are currently unknown.

Methods: This multicenter study included consecutive adult patients without COVID-19 symptoms who underwent preoperative screening using chest CT and RT-PCR before elective or emergency surgery under general anesthesia.

Results: A total of 2093 patients without COVID-19 symptoms were included in 14 participating centers; 1224 were screened by CT and RT-PCR and 869 by chest CT only. The positive yield of screening using a combination of chest CT and RT-PCR was 1.5% [95% confidence interval (CI): 0.8-2.1]. Individual yields were 0.7% (95% CI: 0.2-1.1) for chest CT and 1.1% (95% CI: 0.6-1.7) for RT-PCR; the incremental yield of chest CT was 0.4%. In relation to COVID-19 community prevalence, up to ∼6% positive RT-PCR was found for a daily hospital admission rate >1.5 per 100,000 inhabitants, and around 1.0% for lower prevalence.

Conclusions: One in every 100 patients without COVID-19 symptoms tested positive for SARS-CoV-2 with RT-PCR; this yield increased in conjunction with community prevalence. The added value of chest CT was limited. Preoperative screening allowed us to take adequate precautions for SARS-CoV-2 positive patients in a surgical population, whereas negative patients needed only routine procedures.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/SLA.0000000000004218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668335PMC
December 2020

Choledochoduodenostomy versus hepaticojejunostomy - a matched case-control analysis.

HPB (Oxford) 2021 Apr 13;23(4):560-565. Epub 2020 Sep 13.

Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.

Background: Choledochoduodenostomy (CD) is believed to cause certain long-term complications, such as sump syndrome and reflux gastritis. Therefore, CD is considered inferior to a Roux-and-Y hepaticojejunostomy (HJ). The aim of this study was to compare short- and long-term outcomes following CD and HJ for benign biliary diseases.

Methods: This was a retrospective, matched case-control study of patients undergoing biliary-digestive anastomosis for benign diseases between 2000 and 2016 in a tertiary centre. Patients undergoing CD and HJ were matched 1:1 based on age, sex, ASA-classification, indication, history of abdominal surgery or acute cholecystitis/pancreatitis. Short- and long-term outcomes were compared.

Results: Of 336 patients undergoing biliary-digestive anastomoses, 27 patients underwent CD. Matching resulted in two comparable groups of 26 patients each. Overall morbidity after HJ and CD was comparable: 30.8% versus 26.9% (p>0.999). Long-term complications occurred in 23.1% after HJ, and in 50% after CD (p=0.118). After CD, 2 patients (7.7%) developed sump syndrome. Both patients with an anastomotic stricture after HJ could be managed by endoscopic/radiological re-intervention, whilst all six patients with a stricture after CD required surgical re-intervention (p=0.016).

Conclusion: Although short-term complications were comparable, the number of anastomotic strictures was higher in patients undergoing CD. We therefore conclude that HJ is the biliary bypass of choice while CD should be performed in selected patients only.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hpb.2020.08.014DOI Listing
April 2021

Indications and outcomes of enucleation versus formal pancreatectomy for pancreatic neuroendocrine tumors.

HPB (Oxford) 2021 Mar 6;23(3):413-421. Epub 2020 Aug 6.

Department of Surgery, The Ohio State University, Wexner Medical Center, 410 W 10th Ave, OH 43210, Columbus, USA. Electronic address:

Background: Pancreatoduodenectomy (PD) or distal pancreatectomy (DP) are common procedures for patients with a pancreatic neuroendocrine tumor (pNET). Nevertheless, certain patients may benefit from a pancreas-preserving resection such as enucleation (EN). The aim of this study was to define the indications and differences in long-term outcomes among patients undergoing EN and PD/DP.

Methods: Patients undergoing resection of a pNET between 1992 and 2016 were identified. Indications and outcomes were evaluated, and propensity score matching (PSM) analysis was performed to compare long-term outcomes between patients who underwent EN versus PD/DP.

Results: Among 1034 patients, 143 (13.8%) underwent EN, 304 (29.4%) PD, and 587 (56.8%) DP. Indications for EN were small size (1.5 cm, IQR:1.0-1.9), functional tumors (58.0%) that were mainly insulinomas (51.7%). After PSM (n = 109 per group), incidence of postoperative pancreatic fistula (POPF) grade B/C was higher after EN (24.5%) compared with PD/DP (14.0%) (p = 0.049). Median recurrence-free survival (RFS) was comparable among patients who underwent EN (47 months, 95% CI:23-71) versus PD/DP (37 months, 95% CI: 33-47, p = 0.480).

Conclusion: Comparable long-term outcomes were noted among patients who underwent EN versus PD/DP for pNET. The incidence of clinically significant POPF was higher after EN.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hpb.2020.06.015DOI Listing
March 2021

Routine histopathologic examination of the appendix after appendectomy for presumed appendicitis: Is it really necessary? A systematic review and meta-analysis.

Surgery 2020 08 27;168(2):305-312. Epub 2020 May 27.

Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address:

Background: Owing to substantial costs and increasing interest in the nonoperative management of appendicitis, the necessity of routine histopathologic examination of appendectomy specimens is being questioned. The aim of this study was to determine whether routine histopathologic examination after appendectomy for suspected appendicitis should still be performed.

Methods: PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies listing the histopathologic diagnoses after appendectomy for suspected appendicitis. Main outcomes were the incidence of histopathologically proven aberrant findings, the ability of surgeons to recognize unexpected appendiceal pathology intraoperatively, and the percentage of aberrant findings resulting in a change of postoperative management. A meta-analysis was performed using a random-effects model.

Results: Twenty-five studies with 57,357 patients were included. The pooled percentage of aberrant findings was 2.52% (95% confidence interval 1.81-3.51). Neoplasms were found in 0.71% (95% confidence interval 0.54-0.94). Findings of the intraoperative assessment by the surgeon were reported for 82 of the 2,718 (3.0%) unexpected diagnoses, with great variation between studies. The impact on postoperative management was described for 237 of 2,718 (8.7%) aberrant findings. Of these, 166 (70.0%) resulted in a change of postoperative management.

Conclusion: Based on current evidence, it remains unclear how many of the unexpected appendiceal pathologies with clinical consequences can be identified intraoperatively by the surgeon. Until reliable data on the safety and potential cost savings of a selective policy becomes available, we advise sending appendectomy specimens routinely for histopathologic examination.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.surg.2020.03.032DOI Listing
August 2020

Volar Plate Fixation in Adults with a Displaced Extra-Articular Distal Radial Fracture Is Cost-Effective.

J Bone Joint Surg Am 2020 04;102(7):609-616

Department of Trauma and Hand Surgery, Maasstad Hospital, Rotterdam, the Netherlands.

Background: To our knowledge, a health economic evaluation of volar plate fixation compared with plaster immobilization in patients with a displaced extra-articular distal radial fracture has not been previously conducted.

Methods: A cost-effectiveness analysis of a multicenter randomized controlled trial was performed. Ninety patients were randomly assigned to volar plate fixation or plaster immobilization. The use of resources per patient was documented prospectively for up to 12 months after randomization and included direct medical, direct non-medical, and indirect non-medical costs due to the distal radial fracture and the received treatment.

Results: The mean quality-adjusted life-years (QALYs) at 12 months were higher in patients treated with volar plate fixation (mean QALY difference, 0.16 [bias-corrected and accelerated 95% confidence interval (CI), 0.07 to 0.27]). (The 95% CIs throughout are bias-corrected and accelerated.) In addition, the mean total costs per patient were lower in patients treated with volar plate fixation (mean difference, -$299 [95% CI, -$1,880 to $1,024]). The difference in costs per QALY was -$1,838 (95% CI, -$12,604 to $9,787), in favor of volar plate fixation. In a subgroup analysis of patients who had paid employment, the difference in costs per QALY favored volar plate fixation by -$7,459 (95% CI, -$23,919 to $3,233).

Conclusions: In adults with a displaced extra-articular distal radial fracture, volar plate fixation is a cost-effective intervention, especially in patients who had paid employment. Besides its better functional results, volar plate fixation is less expensive and provides a better quality of life than plaster immobilization.

Level Of Evidence: Economic Level I. See Instructions for Authors for a complete description of levels of evidence.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2106/JBJS.19.00597DOI Listing
April 2020

Predictive Factors and Risk Model for Positive Circumferential Resection Margin Rate After Transanal Total Mesorectal Excision in 2653 Patients With Rectal Cancer.

Ann Surg 2019 11;270(5):884-891

Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands.

Objective: The aim of this study was to determine the incidence of, and preoperative risk factors for, positive circumferential resection margin (CRM) after transanal total mesorectal excision (TaTME).

Background: TaTME has the potential to further reduce the rate of positive CRM for patients with low rectal cancer, thereby improving oncological outcome.

Methods: A prospective registry-based study including all cases recorded on the international TaTME registry between July 2014 and January 2018 was performed. Endpoints were the incidence of, and predictive factors for, positive CRM. Univariate and multivariate logistic regressions were performed, and factors for positive CRM were then assessed by formulating a predictive model.

Results: In total, 2653 patients undergoing TaTME for rectal cancer were included. The incidence of positive CRM was 107 (4.0%). In multivariate logistic regression analysis, a positive CRM after TaTME was significantly associated with tumors located up to 1 cm from the anorectal junction, anterior tumors, cT4 tumors, extra-mural venous invasion (EMVI), and threatened or involved CRM on baseline MRI (odds ratios 2.09, 1.66, 1.93, 1.94, and 1.72, respectively). The predictive model showed adequate discrimination (area under the receiver-operating characteristic curve >0.70), and predicted a 28% risk of positive CRM if all risk factors were present.

Conclusion: Five preoperative tumor-related characteristics had an adverse effect on CRM involvement after TaTME. The predicted risk of positive CRM after TaTME for a specific patient can be calculated preoperatively with the proposed model and may help guide patient selection for optimal treatment and enhance a tailored treatment approach to further optimize oncological outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/SLA.0000000000003516DOI Listing
November 2019

Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses.

BMJ Open 2019 10 16;9(10):e031151. Epub 2019 Oct 16.

Department of Surgery, Amsterdam UMC-Location AMC, Amsterdam, Netherlands.

Objective: Randomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients' preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.

Design: Systematic review and meta-analyses.

Data Sources: MEDLINE, Embase, PsycINFO and the Cochrane Library.

Eligibility Criteria For Selecting Studies: RPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.

Data Extraction And Synthesis: Two independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.

Results: In total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%-100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%-99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI -0.178 to 0.364, p0.502).

Conclusions: Patients' preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.

Prospero Registration Number: CRD42019094438.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2019-031151DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797441PMC
October 2019

The relationship between patient factors and the refusal of analgesics in adult Emergency Department patients with extremity injuries, a case-control study.

Scand J Pain 2019 12;20(1):87-94

Department of Anaesthesiology, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.

Background and aims Previous studies have described the phenomenon of oligo-analgesia in Emergency Department patients with traumatic injuries, despite the high prevalence of pain among these patients. Besides aspects related to health care staff, patient related factors might also play a role in suboptimal pain treatment, however evidence is scarce. Therefore, the objective of the current study was to evaluate patient related factors in adult patients refusing offered analgesics during an Emergency Department presentation with extremity injuries. Methods This was a case control study in the Emergency Department of a level 1 Trauma Centre. Cases were defined as adult patients with an extremity injury who declined analgesia, when offered. They were matched to controls from the same population, who accepted analgesics, in a 1:2 ratio using gender as matching variable. Primary outcome was difference in NRS pain score. Secondary outcomes were the relationship between categorical severity of pain scores and refusal of analgesics, exploration of independent predictors of analgesia refusal utilizing multivariate logistic regression and the evaluation of eight beliefs among patients who refuse analgesics. Results Between August 1st and 31st 2016, a total of 253 patients were eligible for inclusion of whom 55 declined analgesic treatment. They were included as cases and matched to 110 controls. Difference in median NRS pain score was significant between the groups: 5.0 (IQR 3.0-8.0) vs. 8.0 (IQR 6.0-9.0), respectively (p < 0.01). Nearly 20% of patients with severe pain declined analgesics, compared to 41% with moderate and 69% with mild pain (p < 0.01). The NRS pain score was the only independent predictor of refusal of analgesic treatment with a mean Odds Ratio of 0.67 (95%-CI 0.54-0.83). Most common patients' beliefs were that pain medication should be used in extreme pain only, fear of decreasing the doctor's ability to judge the injury and fear of addiction to analgesics. Conclusions Pain severity is the single independent predictor of refusal of analgesia, however the following patient beliefs are important as well: pain medication should be used in extreme pain only; fear of decreasing the doctor's ability to judge the injury and the fear of becoming addicted to pain medication. Implications In case patients refuse offered analgesics, the health care provider should actively address patient beliefs that might exist and lead to suboptimal pain treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1515/sjpain-2019-0077DOI Listing
December 2019

Laparoscopic surgery facilitates administration of adjuvant chemotherapy in locally advanced colon cancer: propensity score analyses.

Cancer Manag Res 2019 29;11:7141-7157. Epub 2019 Jul 29.

Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, AZ 1105, Amsterdam, The Netherlands.

Purpose: The aim of this study was to evaluate the impact of a laparoscopic approach on long-term oncological outcomes in curative intent surgery for pT4 colon cancer, in both overall and stratified subgroups with distinct clinical entities.

Patients And Methods: Patients with a pT4N0-2M0 colon cancer from four centers between 2000 and 2014 were included. Laparoscopic and open approaches were compared according to the intention-to-treat principle. Propensity scores were used to adjust for baseline differences between the groups in three manners: i) as a linear predictor in a Cox regression model, ii) to create a 1:1 matched cohort, and iii) to stratify patients into four groups with an increasing chance of receiving laparoscopy.

Results: In total, 424 patients were included. After 1:1 matching, a laparoscopic approach correlated with higher rates of radical resection, lower morbidity, and a higher percentage of patients receiving adjuvant chemotherapy. This translated into better 5-year disease-free survival (52% vs 40%, HR 0.70; 95% CI 0.50-0.96) and 5-year overall survival (68% vs 57%, HR 0.66; 95% CI 0.43-0.99). These results were confirmed in the other two propensity score analyses. In the multivariable models, adjuvant chemotherapy remained independently associated with better survival, whereas surgical approach lost significance.

Conclusions: In locally advanced colon cancer, an intentional laparoscopic approach in experienced hands seems to decrease morbidity and to increase the proportion of patients receiving adjuvant chemotherapy. Receiving adjuvant chemotherapy was independently associated with improved survival.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2147/CMAR.S205906DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681076PMC
July 2019

Systematic review of published literature on oxaliplatin and mitomycin C as chemotherapeutic agents for hyperthermic intraperitoneal chemotherapy in patients with peritoneal metastases from colorectal cancer.

Crit Rev Oncol Hematol 2019 Oct 9;142:119-129. Epub 2019 Jul 9.

Department of surgery, Catharina hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands. Electronic address:

Background: The role of hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin in addition to cytoreductive surgery (CRS) has recently been questioned in peritoneal metastases of colorectal cancer. Whether this applies to all published CRS/HIPEC regimens is unclear.

Methods: A systematic literature search identified 46 studies on CRS/HIPEC using either oxaliplatin of mitomycin C with at least one oncological outcome parameter RESULTS: Oxaliplatin and mitomycin C studies were comparable regarding extent of disease, but differed substantially regarding synchronous versus metachronous presentation, application of neo-adjuvant systemic chemotherapy, duration of HIPEC, and completeness of cytoreduction for at least one of the oncological endpoints. Severe postoperative complication rate seemed significantly higher after oxaliplatin-based CRS/HIPEC.

Conclusion: Published cohorts on oxaliplatin-based CRS/HIPEC differed essentially from MMC-based procedures, especially considering the application of oxaliplatin-containing neo-adjuvant systemic therapy and shorter exposure time to intraperitoneal chemotherapy in oxaliplatin studies. No meaningful comparison could be made regarding DFS and OS.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.critrevonc.2019.06.014DOI Listing
October 2019

Active involvement of family members in postoperative care after esophageal or pancreatic resection: A feasibility study.

Surgery 2019 11 6;166(5):769-777. Epub 2019 Jul 6.

Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address:

Background: Active involvement of relatives has the potential to improve postoperative patient outcomes by prevention of complications sensitive to basic care and unplanned readmissions. The aim of this study was to assess the feasibility of a program in which relatives participated in postoperative care.

Methods: A pragmatic feasibility trial conducted at the surgical ward of a University hospital in the Netherlands. Patients undergoing esophageal or pancreatic resection with a relative who was willing and able to participate formed the intervention group (n = 20). A control group (n = 20) received usual postoperative care. The program consisted of the following: (1) information; (2) shared goal setting; (3) task-oriented training; (4) participation in basic care, focusing on mobilization, breathing exercises, cognitive activities and oral hygiene; (5) presence of relatives during ward rounds; and (6) rooming-in. Feasibility criteria were adherence to basic care, caregiver burden, and satisfaction of patients, family, and healthcare professionals.

Results: All participants completed the program. Patients in the intervention group mobilized more (estimated difference for walking 170 meters per day, P = .037, and for sitting 109 minutes per day, P < .001), and showed more adherence to breathing exercises (estimated difference per day 1.4, P = .003), oral hygiene (estimated difference 1.52, P = .001), and cognitive activities (estimated difference 2.6, P < .001). Relatives'Care-Related Quality of Life instrument score did not deteriorate over time (P = .64); 96% of relatives would recommend the program and 92% felt better prepared for discharge. Patients in the intervention group were more satisfied with hospital admission. Healthcare professionals valued the program positively.

Conclusion: This program is feasible and is positively appreciated by patients, family, and healthcare professionals. Patients following the program showed more adherence to basic care activities.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.surg.2019.05.032DOI Listing
November 2019

Textbook Outcome: Nationwide Analysis of a Novel Quality Measure in Pancreatic Surgery.

Ann Surg 2020 01;271(1):155-162

Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Background: Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome.

Methods: Post-hoc analysis of patients who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) for all indications between 2014 and 2017, queried from the nationwide prospective Dutch Pancreatic Cancer Audit. An international survey was conducted among 24 experts from 10 countries to reach consensus on the requirements for TO in pancreatic surgery. Univariable and multivariable logistic regression was performed to identify TO predictors. Between-hospital variation in TO rates was compared using observed-versus-expected rates.

Results: Based on the survey (92% response rate), TO was defined by the absence of postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage (all ISGPS grade B/C), severe complications (Clavien-Dindo ≥III), readmission, and in-hospital mortality. Overall, 3341 patients were included (2633 (79%) PD and 708 (21%) DP) of whom 60.3% achieved TO; 58.3% for PD and 67.4% for DP. On multivariable analysis, ASA class 3 predicted a worse TO rate after PD (ASA 3 OR 0.59 [0.44-0.80]), whereas a dilated pancreatic duct (>3 mm) and pancreatic ductal adenocarcinoma (PDAC) were associated with a better TO rate (OR 2.22 [2.05-3.57] and OR 1.36 [1.14-1.63], respectively). For DP, female sex and the absence of neoadjuvant therapy predicted better TO rates (OR 1.38 [1.01-1.90] and OR 2.53 [1.20-5.31], respectively). When comparing institutions, the observed-versus-expected rate for achieving TO varied from 0.71 to 1.46 per hospital after casemix-adjustment.

Conclusions: TO is a novel quality measure in pancreatic surgery. TO varies considerably between pancreatic centers, demonstrating the potential benefit of quality assurance programs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/SLA.0000000000003451DOI Listing
January 2020

Paracetamol versus other analgesia in adult patients with minor musculoskeletal injuries: a systematic review.

Emerg Med J 2019 Aug 22;36(8):493-500. Epub 2019 Jun 22.

Department of Anaesthesiology, Amsterdam UMC - Locatie AMC, Amsterdam, The Netherlands.

Objectives: Pain treatment in acute musculoskeletal injuries usually consists of paracetamol, non-steroidal antiinflammatory drugs (NSAIDs) or opioids. It would be beneficial to determine whether paracetamol is as effective as other analgesics. The objective of this study was to evaluate available evidence regarding efficacy of paracetamol in these patients.

Methods: Embase, MEDLINE, Cochrane and relevant trial registers were searched from inception to 14 February 2018 by two independent reviewers to detect all randomised studies with adult patients with acute minor musculoskeletal injuries treated with paracetamol as compared with other analgesics. There were no language or date restrictions. Two independent reviewers evaluated risk of bias and quality of evidence. Primary outcome was decrease in pain scores during the first 24 hours, and secondary outcomes included pain decrease beyond 24 hours, need for additional analgesia and occurrence of adverse events.

Results: Seven trials were included, evaluating 2100 patients who were treated with paracetamol or NSAIDs or the combination of both as comparisons, of which only four studies addressed the primary outcome. No studies were found comparing paracetamol with opioids. There were no differences in analgesic effectiveness within and beyond 24 hours, nor in need for additional analgesia and occurrence of adverse events. Overall, quality of evidence was low. Because of methodological inconsistencies, a meta-analysis was not possible.

Conclusions: Based on available evidence, paracetamol is as effective as NSAIDs or the combination of both in treating pain in adult patients with minor musculoskeletal injuries in the acute setting. The quality of evidence is low.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/emermed-2019-208439DOI Listing
August 2019

Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or faecal peritonitis (LADIES): a multicentre, parallel-group, randomised, open-label, superiority trial.

Lancet Gastroenterol Hepatol 2019 08 6;4(8):599-610. Epub 2019 Jun 6.

Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, Netherlands.

Background: Previous studies have suggested that sigmoidectomy with primary anastomosis is superior to Hartmann's procedure. The likelihood of stoma reversal after primary anastomosis has been reported to be higher and reversal seems to be associated with lower morbidity and mortality. Although promising, results from these previous studies remain uncertain because of potential selection bias. Therefore, this study aimed to assess outcomes after Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease) in a randomised trial.

Methods: A multicentre, randomised, open-label, superiority trial was done in eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands. Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid. Patients with Hinchey I or II diverticulitis were not eligible for inclusion. Patients were allocated (1:1) to Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy. Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone. Random and concealed block sizes of two, four, or six were used, and randomisation was stratified by age (<60 and ≥60 years). The primary endpoint was 12-month stoma-free survival. Patients were analysed according to a modified intention-to-treat principle. The trial is registered with the Netherlands Trial Register, number NTR2037, and ClinicalTrials.gov, number NCT01317485.

Findings: Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016, 133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease) were randomly assigned to Hartmann's procedure (68 patients) or primary anastomosis (65 patients). Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease). In 17 (27%) of 64 patients assigned to primary anastomosis, no stoma was constructed. 12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001). There were no significant differences in short-term morbidity and mortality after the index procedure for Hartmann's procedure compared with primary anastomosis (morbidity: 29 [44%] of 66 patients vs 25 [39%] of 64, p=0·60; mortality: two [3%] vs four [6%], p=0·44).

Interpretation: In haemodynamically stable, immunocompetent patients younger than 85 years, primary anastomosis is preferable to Hartmann's procedure as a treatment for perforated diverticulitis (Hinchey III or Hinchey IV disease).

Funding: Netherlands Organisation for Health Research and Development.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S2468-1253(19)30174-8DOI Listing
August 2019

Added value of 3D-vision during laparoscopic biotissue pancreatico- and hepaticojejunostomy (LAELAPS 3D2D): an international randomized cross-over trial.

HPB (Oxford) 2019 08 10;21(8):1087-1094. Epub 2019 May 10.

Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address:

Background: It is currently unclear what the added value is of 3D-laparoscopy during pancreatic and biliary surgery. 3D-laparoscopy could improve procedure time and/or surgical performance, for instance in demanding anastomoses such as pancreatico- and hepaticojejunostomy. The impact of 3D-laparoscopy could be negligible in more experienced surgeons.

Methods: We conducted a randomized controlled cross-over trial including 20 expert laparoscopic surgeons and 20 surgical residents from 9 countries (Argentina, Estonia, Israel, Italy, the Netherlands, South Africa, Spain, UK, USA). All participants performed a pancreaticojejunostomy (PJ) and a hepaticojejunostomy (HJ) using 3D- and 2D-laparoscopy on biotissue organ models according to the Pittsburgh method. Primary endpoint was the time required to complete both anastomoses. Secondary endpoint was the objective structured assessment of technical skill (OSATS; range 12-60) rating. Observers were blinded for 3D/2D and expertise.

Results: A total of 40 participants completed 144 PJs and HJs. 3D-laparoscopy reduced the operative time with 15.5 min (95%CI 10.2-24.5 min), from 81.0 to 64.4 min, p = 0.001. This reduction was observed for both experts and residents (13.0 vs 22.2 min, intergroup significance p = 0.354). The OSATS improved with 5.1 points, SD ± 6.3, with 3D-laparoscopy, p = 0.001. This improvement was observed for both experts and residents (4.6 vs 5.6 points, p = 0.519). Of all participants, 37/39 participants stated to prefer 3D laparoscopy whereas 14/39 reported side effects. Minor side effects were reported by 10/39 participants whereas 2/39 participants reported severe side effects (both severe eye strain).

Conclusion: 3D-laparoscopy, as compared to 2D-laparoscopy, reduced the operative time and improved surgical performance for PJ and HJ anastomoses in both experts and residents with mostly minor side effects.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.hpb.2019.04.012DOI Listing
August 2019

Volar Plate Fixation Versus Plaster Immobilization in Acceptably Reduced Extra-Articular Distal Radial Fractures: A Multicenter Randomized Controlled Trial.

J Bone Joint Surg Am 2019 May;101(9):787-796

Department of Hand and Trauma Surgery, Maasstad Hospital, Rotterdam, the Netherlands.

Background: There is no consensus as to whether displaced extra-articular distal radial fractures should be treated operatively or nonoperatively. We compared the outcomes of open reduction and volar plate fixation with closed reduction and plaster immobilization in adults with an acceptably reduced extra-articular distal radial fracture.

Methods: In this multicenter randomized controlled trial, patients 18 to 75 years old with an acceptably reduced extra-articular distal radial fracture were randomly assigned to open reduction and volar plate fixation or plaster immobilization. The primary outcome was function as measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire after 12 months. Follow-up was conducted at 1, 3, and 6 weeks and at 3, 6, and 12 months. Analyses were performed according to the intention-to-treat principle.

Results: Ninety-two patients were randomized, 48 to open reduction and volar plate fixation and 44 to plaster immobilization; 1 patient in each group was excluded for withdrawing informed consent. At all follow-up time points, operatively treated patients had significantly better functional outcomes, as indicated by significantly lower DASH scores, than patients treated nonoperatively (all p values < 0.05). Twelve nonoperatively managed patients (28%) had fracture redisplacement within 6 weeks and underwent subsequent open reduction and internal fixation, and 6 patients (14%) had a symptomatic malunion treated with corrective osteotomy.

Conclusions: Patients with an acceptably reduced extra-articular distal radial fracture treated with open reduction and volar plate fixation have better functional outcomes after 12 months compared with nonoperatively managed patients. Additionally, 42% of nonoperatively managed patients had a subsequent surgical procedure. Open reduction and volar plate fixation should be considered for patients who experience this common injury.

Level Of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2106/JBJS.18.00693DOI Listing
May 2019
-->