Publications by authors named "Roberto Bergamaschi"

258 Publications

Long-term outcomes in patients presenting with optic neuritis: Analyses of the MSBase registry.

J Neurol Sci 2021 Sep 3;430:118067. Epub 2021 Sep 3.

Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA. Electronic address:

Background: Short-term outcomes of optic neuritis (ON) have been well characterized. Limited data exists on longer-term visual outcomes in patients who present with ON. The large MSBase registry allows for characterization of long-term visual outcomes after ON.

Methods: Via the MSBase Registry, data on patients from 41 centers was collected during routine clinical and research visits. Physical and visual disability were measured using the expanded disability status scale (EDSS) and the visual function score (VFS). Inclusion criteria for this analysis included age ≥ 18 years, clinically isolated syndrome (CIS), ON-onset, baseline visit within 6 months of onset, and at least one follow-up visit. Survival analysis was used to evaluate the association of disease-modifying treatment with time to conversion to clinically definite MS or sustained EDSS/VFS progression.

Results: Data from 60,933 patients were obtained from the MSBase registry in July 2019. Of these, 1317 patients met inclusion criteria; 935 were treated at some point in disease course, while 382 were never treated. At baseline, mean age was 32.3 ± 8.8 years, 74% were female, median EDSS was 2 (IQR 1-2), and median VFS was 1 (IQR 0-2). Median follow-up time was 5.2 years (IQR 2.4-9.3). Treatment was associated with reduced risk and delayed conversion to clinically definite MS (HR = 0.70, p < 0.001), sustained EDSS progression (HR = 0.46, p < 0.0001) and sustained VFS (HR = 0.41, p < 0.001) progression.

Conclusions: In the MSBase cohort, treatment after ON was associated with better visual and neurological outcomes compared to no treatment. These results support early treatment for patients presenting with ON as the first manifestation of MS.
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http://dx.doi.org/10.1016/j.jns.2021.118067DOI Listing
September 2021

Rectal prolapse and pelvic descent.

Curr Probl Surg 2021 Sep 29;58(9):100952. Epub 2020 Dec 29.

Section of Colorectal Surgery, New York Medical College, Westchester Medical Center, Valhalla, NY. Electronic address:

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http://dx.doi.org/10.1016/j.cpsurg.2020.100952DOI Listing
September 2021

Effects of Combined Endurance and Resistance Training in Women With Multiple Sclerosis: A Randomized Controlled Study.

Front Neurol 2021 5;12:698460. Epub 2021 Aug 5.

Inter-Department Multiple Sclerosis Research Centre, National Neurological Institute Casimiro Mondino, Pavia, Italy.

To test the hypothesis that combined resistance and endurance training would improve muscle strength, fatigue, depression, and quality of life in persons with MS. Twenty-seven women with MS were randomly assigned to either control (CON, = 13) or the experimental (EXP, = 14) group. The participants in the EXP group trained twice a week for 12 weeks, followed by 12 weeks of detraining. Both CON and EXP groups were tested before and after 12 weeks of the intervention period, as well as 12 weeks after training cessation (follow-up), where measures of muscle strength, fatigue, depression, and quality of life were evaluated. There were significant changes in maximal voluntary isometric contraction (MVIC), 1RM leg extension, and 1RM chest press following the intervention period in the EXP group ( < 0.05), but not in the CON group ( > 0.05). These changes persisted after 12 weeks of detraining. Similar findings were found for fatigue, depression, and physical and mental composites of quality of life. These results suggest that combined exercise training, at a minimum, prevents the disease-related deterioration of muscular performance and quality of life and well-being in persons with MS.
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http://dx.doi.org/10.3389/fneur.2021.698460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8374042PMC
August 2021

PML risk is the main factor driving the choice of discontinuing natalizumab in a large multiple sclerosis population: results from an Italian multicenter retrospective study.

J Neurol 2021 Jun 28. Epub 2021 Jun 28.

Neurosciences Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.

Background: Natalizumab (NTZ) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). However, patients and physicians may consider discontinuing NTZ therapy due to safety or efficacy issues. The aim of our study was to evaluate the NTZ discontinuation rate and reasons of discontinuation in a large Italian population of RRMS patients.

Materials And Methods: The data were extracted from the Italian MS registry in May 2018 and were collected from 51,845 patients in 69 Italian multiple sclerosis centers. MS patients with at least one NTZ infusion in the period between June 1st 2012 to May 15th 2018 were included. Discontinuation rates at each time point were calculated. Reasons for NTZ discontinuation were classified as "lack of efficacy", "progressive multifocal leukoencephalopathy (PML) risk" or "other".

Results: Out of 51,845, 5151 patients, 3019 (58.6%) females, with a mean age of 43.6 ± 10.1 years (median 40), were analyzed. Out of 2037 (39.5%) who discontinued NTZ, a significantly higher percentage suspended NTZ because of PML risk compared to lack of efficacy [1682 (32.7% of 5151) vs 221 (4.3%), p < 0.001]; other reasons were identified for 99 (1.9%) patients. Patients discontinuing treatment were older, had longer disease duration and worse EDSS at the time of NTZ initiation and at last follow-up on NTZ treatment. The JCV index and EDSS at baseline were predictors for stopping therapy (HR 2.94, 95% CI 1.22-4.75; p = 0.02; HR 1.36, 95% CI 1.18-5.41; p = 0.04).

Conclusions: Roughly 60% of MS patients stayed on NTZ treatment during the observation period. For those patients in whom NTZ discontinuation was required, it was mainly due to PML concerns.
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http://dx.doi.org/10.1007/s00415-021-10676-6DOI Listing
June 2021

Longitudinal machine learning modeling of MS patient trajectories improves predictions of disability progression.

Comput Methods Programs Biomed 2021 Sep 18;208:106180. Epub 2021 May 18.

19 Mayis University, Samsun, Turkey.

Background And Objectives: Research in Multiple Sclerosis (MS) has recently focused on extracting knowledge from real-world clinical data sources. This type of data is more abundant than data produced during clinical trials and potentially more informative about real-world clinical practice. However, this comes at the cost of less curated and controlled data sets. In this work we aim to predict disability progression by optimally extracting information from longitudinal patient data in the real-world setting, with a special focus on the sporadic sampling problem.

Methods: We use machine learning methods suited for patient trajectories modeling, such as recurrent neural networks and tensor factorization. A subset of 6682 patients from the MSBase registry is used.

Results: We can predict disability progression of patients in a two-year horizon with an ROC-AUC of 0.85, which represents a 32% decrease in the ranking pair error (1-AUC) compared to reference methods using static clinical features.

Conclusions: Compared to the models available in the literature, this work uses the most complete patient history for MS disease progression prediction and represents a step forward towards AI-assisted precision medicine in MS.
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http://dx.doi.org/10.1016/j.cmpb.2021.106180DOI Listing
September 2021

Description and preliminary experience with Virtual Visit Assessment (ViVA) during the COVID-19 pandemic, a structured virtual management protocol for patients with multiple sclerosis.

Neurol Sci 2021 Jun 15. Epub 2021 Jun 15.

Multiple Sclerosis Center, IRCCS Mondino Foundation, via Mondino 2, 27100, Pavia, Italy.

In people with multiple sclerosis (PwMS), strict follow-up is essential. Telemedicine has the potential to overcome many of the difficulties in routine management. Herein, we present a structured protocol that can be used to remotely manage patients with MS, describing in detail the steps to be taken and exams needed at each stage. A working group was established which developed a tailored protocol that can be adapted to a variety of settings. The overall protocol consisted of 5 phases: enrolment, document sharing phase, pre-evaluation, virtual visit, and post-visit phase, which was divided into 14 individual steps. As of October 2020, 25 virtual visits have been carried out, all via Skype. The patient's caregiver was present during visits and had an active role. The average duration of the virtual visit was 24 min, and that of the pre-visit and post-visit were around 15 min each. Overall satisfaction as rated by physicians was considered high (8.0 ± 0.5). Using the system usability scale (SUS), patients also favorably rated the virtual visit (96.6 ± 6.1). In 20% of cases, the virtual visit was not sufficient to provide adequate information and an in-person clinical visit was recommended. The described protocol has the potential to provide benefits for the healthcare system as well as patients and their caregivers both during and beyond COVID-19 pandemic.
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http://dx.doi.org/10.1007/s10072-021-05371-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8205205PMC
June 2021

Long-term disability trajectories in relapsing multiple sclerosis patients treated with early intensive or escalation treatment strategies.

Ther Adv Neurol Disord 2021 31;14:17562864211019574. Epub 2021 May 31.

Dipartimento di Neurologia, Neurofisiologia e Neuroriabilitazione, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.

Background And Aims: No consensus exists on how aggressively to treat relapsing-remitting multiple sclerosis (RRMS) nor on the timing of the treatment. The objective of this study was to evaluate disability trajectories in RRMS patients treated with an early intensive treatment (EIT) or with a moderate-efficacy treatment followed by escalation to higher-efficacy disease modifying therapy (ESC).

Methods: RRMS patients with ⩾5-year follow-up and ⩾3 visits after disease modifying therapy (DMT) start were selected from the Italian MS Registry. EIT group included patients who received as first DMT fingolimod, natalizumab, mitoxantrone, alemtuzumab, ocrelizumab, cladribine. ESC group patients received the high efficacy DMT after ⩾1 year of glatiramer acetate, interferons, azathioprine, teriflunomide or dimethylfumarate treatment. Patients were 1:1 propensity score (PS) matched for characteristics at the first DMT. The disability trajectories were evaluated by applying a longitudinal model for repeated measures. The effect of early late start of high-efficacy DMT was assessed by the mean annual Expanded Disability Status Scale (EDSS) changes compared with baseline values (delta-EDSS) in EIT and ESC groups.

Results: The study cohort included 2702 RRMS patients. The PS matching procedure produced 363 pairs, followed for a median (interquartile range) of 8.5 (6.5-11.7) years. Mean annual delta-EDSS values were all significantly ( < 0.02) higher in the ESC group compared with the EIT group. In particular, the mean delta-EDSS differences between the two groups tended to increase from 0.1 (0.01-0.19,  = 0.03) at 1 year to 0.30 (0.07-0.53,  = 0.009) at 5 years and to 0.67 (0.31-1.03,  = 0.0003) at 10 years.

Conclusion: Our results indicate that EIT strategy is more effective than ESC strategy in controlling disability progression over time.
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http://dx.doi.org/10.1177/17562864211019574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8170278PMC
May 2021

Superior mesenteric vessel anatomy features differ in Russian and Chinese patients with right colon cancer: computed tomography-based study.

Chin Med J (Engl) 2021 Jun 7. Epub 2021 Jun 7.

Department of Surgery, Clinic of Colorectal and Minimally Invasive Surgery, I.M. Sechenov First Moscow State Medical University, Moscow 119991, Russia Department of Diagnostic Radiology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China Department of Colorectal Surgery, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China.

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http://dx.doi.org/10.1097/CM9.0000000000001566DOI Listing
June 2021

Clostridium septicum liver abscess following colonoscopic stenting of transverse colon cancer.

Eur J Gastroenterol Hepatol 2021 07;33(7):1032-1033

Department of Surgery, Section of Colorectal Surgery.

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http://dx.doi.org/10.1097/MEG.0000000000002090DOI Listing
July 2021

Robotic TAMIS: A Technical Note Comparing Si® versus Xi®.

Surg Technol Int 2021 May;38:169-172

Department of Surgery, New York Medical College, Colorectal Surgery, Valhalla, New York.

Transanal minimally invasive surgery (TAMIS) can be performed robotically assisted (R-TAMIS) for easier rectal defect suture closure particularly on the anterior rectal wall. The surgical technique described in this technical note emphasizes three safety points: 1) decreased likelihood for rectal injury when the ports are inserted into the GelPOINT® Path Transanal Access Platform (Applied Medical, Rancho Santa Margarita, California) on the back table rather than being inserted into the rectum; 2) decreased external collision between ports when using ports of different length; and 3) increased stabilization of pneumorectum when insufflating with an AirSeal™ port (Intelligent Flow System, ConMed, Utica, New York). Although R-TAMIS can be safely performed with the da Vinci® Si® or Xi® (Intuitive Surgical Inc., Sunnyvale, California) patient cart, the following differences are noteworthy: a) the Si® vertically-mounted arms design forces the patient in an uncomfortable position with asymmetrical hip flexion as opposed to the Xi® boom-mounted horizontal arm design; b) the 28cm circumference of each Si® patient cart arms operating between the patient's legs offer decreased maneuvering freedom as opposed to the 19cm circumference of the Xi® counterparts; and c) the abduction pattern of movement of the Si® arms potentially increases the risk of external collision with the patient's legs as opposed to the Xi® "jack-knife" pattern of movement.
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May 2021

Statistical, Clinical, Methodological Evaluation of Local Recurrence Following Transanal Total Mesorectal Excision for Rectal Cancer: A Systematic Review.

Dis Colon Rectum 2021 07;64(7):899-914

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York.

Background: A recent Norwegian moratorium challenged the status quo of transanal total mesorectal excision for rectal cancer by reporting increased early multifocal local recurrences.

Objective: The aim of this systematic review and meta-analysis was to evaluate the local recurrence rates following transanal total mesorectal excision as well as to assess statistical, clinical, and methodological bias in reports published to date.

Data Sources: The PubMed and MEDLINE (via Ovid) databases were systematically searched.

Study Selection: Descriptive or comparative studies reporting rates of local recurrence at a median follow-up of 6 months (or more) after transanal total mesorectal excision were included.

Interventions: Patients underwent transanal total mesorectal excision.

Main Outcome Measures: Local recurrence was any recurrence located in the pelvic surgery site. The untransformed proportion method of 1-arm meta-analysis was utilized. Untransformed percent proportion with 95% confidence interval was reported. Ad hoc meta-regression with the Omnibus test was utilized to assess risk factors for local recurrence. Among-study heterogeneity was evaluated: statistically by I2 and τ2, clinically by summary tables, and methodologically by a 33-item questionnaire.

Results: Twenty-nine studies totaling 2906 patients were included. The pooled rate of local recurrence was 3.4% (2.7%-4.0%) at an average of 20.1 months with low statistical heterogeneity (I2 = 0%). Meta-regression yielded no correlation between complete total mesorectal excision quality (p = 0.855), circumferential resection margin (p = 0.268), distal margin (p = 0.886), and local recurrence rates. Clinical heterogeneity was substantial. Methodological heterogeneity was linked to the excitement of novelty, loss aversion, reactivity to criticism, indication for transanal total mesorectal excision, nonprobability sampling, circular reasoning, misclassification, inadequate follow-up, reporting bias, conflict of interest, and self-licensing.

Limitations: The studies included had an observational design and limited sample and follow-up.

Conclusion: This systematic review found a pooled rate of local recurrence of 3.4% at 20 months. However, given the substantial clinical and methodological heterogeneity across the studies, the evidence for or against transanal total mesorectal excision is inconclusive at this time.
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http://dx.doi.org/10.1097/DCR.0000000000002110DOI Listing
July 2021

Natalizumab, Fingolimod and Dimethyl Fumarate Use and Pregnancy-Related Relapse and Disability in Women With Multiple Sclerosis.

Neurology 2021 Apr 20. Epub 2021 Apr 20.

Liverpool Hospital, Australia.

Objective: To investigate pregnancy-related disease activity in a contemporary multiple sclerosis (MS) cohort.

Methods: Using data from the MSBase Registry, we included pregnancies conceived after 31 Dec 2010 from women with relapsing-remitting MS or clinically isolated syndrome. Predictors of intrapartum relapse, and postpartum relapse and disability progression were determined by clustered logistic regression or Cox regression analyses.

Results: We included 1998 pregnancies from 1619 women with MS. Preconception annualized relapse rate (ARR) was 0.29 (95% CI 0.27-0.32), fell to 0.19 (0.14-0.24) in third trimester, and increased to 0.59 (0.51-0.67) in early postpartum. Among women who used fingolimod or natalizumab, ARR before pregnancy was 0.37 (0.28-0.49) and 0.29 (0.22-0.37), respectively, and increased during pregnancy. Intrapartum ARR decreased with preconception dimethyl fumarate use. ARR spiked after delivery across all DMT groups. Natalizumab continuation into pregnancy reduced the odds of relapse during pregnancy (OR 0.76 per month [0.60-0.95], p=0.017). DMT re-initiation with natalizumab protected against postpartum relapse (HR 0.11 [0.04-0.32], p<0.0001). Breastfeeding women were less likely to relapse (HR 0.61 [0.41-0.91], p=0.016). 5.6% of pregnancies were followed by confirmed disability progression, predicted by higher relapse activity in pregnancy and postpartum.

Conclusion: Intrapartum and postpartum relapse probabilities increased among women with MS after natalizumab or fingolimod cessation. In women considered to be at high relapse risk, use of natalizumab before pregnancy and continued up to 34 weeks gestation, with early re-initiation after delivery is an effective option to minimize relapse risks. Strategies of DMT use have to be balanced against potential fetal/neonatal complications.
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http://dx.doi.org/10.1212/WNL.0000000000012084DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8253565PMC
April 2021

Current Robotic Platforms in Surgery and the Road Ahead.

Surg Technol Int 2021 May;38:39-46

New York Medical College, School of Medicine, Department of Surgery, Westchester Medical Center Health, Valhalla, New York.

Minimally invasive surgery has rapidly evolved from the once novel laparoscopic approach to advanced robotic surgery. In the past few decades alone, robotic systems have gone from systems which were significantly limited to full-fledged platforms featuring 3D vision, articulated instruments, integrated ultrasound and fluorescence capabilities, and even the latest wireless connectivity, as is now standard. In this review, we aimed to summarize features of currently commercialized and utilized robotic surgical systems as well as currently unfolding platforms. The pros and cons of different robotic surgical systems were discussed. In addition, we discussed the future perspectives of robotic platforms used in general surgery. In this regard, we emphasized that the market, once dominated by Intuitive Surgical Inc., has become occupied by several worthy competitors with new technological giants such as Google. Eventually, the question facing hospital systems will not be of whether or not to invest in robotic surgery, but instead of how they will strike balance between price, features, and availability when choosing robots from the growing market to best equip their surgeons.
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May 2021

Robotic-Assisted Surgery Training (RAST) Program: An Educational Research Protocol.

Surg Technol Int 2021 May;38:52-55

Section of Colorectal Surgery, Department of Surgery, New York Medical College, Westchester Medical Center, Valhalla, New York.

Technology has had a dramatic impact on how diseases are diagnosed and treated. Although cut, sew, and tie remain the staples of surgical craft, new technical skills are required. While there is no replacement for live operative experience, training outside the operating room offers structured educational opportunities and stress modulation. A stepwise program for acquiring new technical skills required in robotic surgery involves three modules: ergonomic, psychomotor, and procedural. This is a prospective, educational research protocol aiming at evaluating the responsiveness of general surgery residents in Robotic-Assisted Surgery Training (RAST). Responsiveness is defined as change in performance over time. Performance is measured by the following content-valid metrics for each module. Module 1 proficiency in ergonomics includes: cart deploy, boom control, cart driving, camera port docking, targeting anatomy, flex joint, clearance joint and port nozzle adjusting, and routine and emergent undocking. Module 2 proficiency in psychomotor skills includes tissue handling, accuracy error, knot quality, and operating time. Module 3 proficiency in procedural skills prevents deviations from standardized sequential procedural steps in order to test length of specimen resection, angle for transection, vessel stump length post ligation, distance of anastomosis from critical landmarks, and proximal and distal resection margins. Resident responsiveness over time will be assessed comparing the results of baseline testing with final testing. Educational interventions will include viewing one instructional video prior to module commencement, response to module-specific multiple-choice questions, and individual weekly training sessions with a robotic instructor in the operating room. Residents will progress through modules upon successful final testing and will evaluate the educational environment with the Dundee Ready Educational Environment Measure (DREEM) inventory. The RAST program protocol outlined herein is an educational challenge with the primary endpoint to provide evidence that formal instruction has an impact on proficiency and safety in executing robotic skills.
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May 2021

Failure of nonoperative management in patients with acute diverticulitis complicated by abscess: a systematic review.

Int J Colorectal Dis 2021 Jul 7;36(7):1367-1383. Epub 2021 Mar 7.

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Suite D-361, Taylor Pavilion, 100 Woods Rd, Valhalla, NY, 10595, USA.

Background: The aim of this study was to assess failure rates following nonoperative management of acute diverticulitis complicated by abscess and trends thereof.

Method: Pubmed, MEDLINE, EMBASE, CINAHL, Cochrane Library, and Web of Science were systematically searched. Nonoperative management was defined as a combination of nil per os, IV fluids, IV antibiotics, CT scan-guided percutaneous drainage, and total parenteral nutrition. The primary endpoint was failure of nonoperative management defined as persistent or worsening abscess and/or sepsis, development of new complications, such as peritonitis, ileus, or colocutaneous fistula, and urgent surgery within 30-90 days of index admission. Data were stratified by three arbitrary time intervals: 1986-2000, 2000-2010, and after 2010. The primary outcome was calculated for those groups and compared.

Results: Thirty-eight of forty-four eligible studies published between 1986 and 2019 were included in the quantitative synthesis of data (n = 2598). The pooled rate of failed nonoperative management was 16.4% (12.6%, 20.2%) at 90 days. In studies published in 2000-2010 (n = 405), the pooled failure rate was 18.6% (10.5%, 26.7%). After 2000 (n = 2140), the pooled failure rate was 15.3% (10.7%, 20%). The difference was not statistically significant (p = 0.725). After controlling for heterogeneity in the definition of failure of nonoperative management, subgroup analysis yielded the pooled rate of failure of 21.8% (16.1%, 27.4%).

Conclusion: This meta-analysis found that failure rates following nonoperative management of acute diverticulitis complicated by abscess did not significantly decrease over the past three decades. The general quality of published data and the level and certainty of evidence produced were low.
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http://dx.doi.org/10.1007/s00384-021-03899-6DOI Listing
July 2021

A meta-analysis of DaVinci Si versus Xi in colorectal surgery.

Int J Med Robot 2021 Jun 8;17(3):e2222. Epub 2021 Feb 8.

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York, USA.

Background: The aim of this meta-analysis was to evaluate whether adoption of DaVinci Xi had any impact upon intra- and postoperative metrics in colorectal surgery.

Methods: The Pubmed, CINAHL, Cochrane Library and MEDLINE (Ovid) databases were systematically searched. Operating time as well as docking and surgeon console times were the primary endpoints. Conversion and postoperative complication rates were the secondary endpoints.

Results: Six studies totaling 610 patients (320 Si and 290 Xi) were included. Total operating time [MD (95% CI) = 30.553 (15.071, 46.035); p < 0.001], docking time [MD (95% CI) = 4.178 (2.120, 6.235); p < 0.001] and surgeon console time [MD (95% CI) = 17.246 (-0.479, 34.971); p = 0.056] were longer in DaVinci Si as compared to DaVinci Xi . No significant difference was found in conversion (p = 0.816) and postoperative complication rates (p = 0.405).

Conclusion: This meta-analysis found that the adoption of DaVinci Xi was associated with significantly decreased total operating time as well as docking and surgeon console times. Conversion and complication rates were similar.
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http://dx.doi.org/10.1002/rcs.2222DOI Listing
June 2021

Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study.

J Neurol 2021 Aug 22;268(8):2922-2932. Epub 2021 Feb 22.

Clinica Neurologica, Centro Sclerosi Multipla, Azienda Ospedaliera di Padova, Padova, Italy.

Objective: To identify baseline factors associated with disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) under teriflunomide treatment.

Methods: This was an independent, multi-centre, retrospective post-marketing study. We analysed data of 1,507 patients who started teriflunomide since October 2014 and were regularly followed in 28 Centres in Italy. We reported the proportions of patients who discontinued treatment (after excluding 32 lost to follow-up) and who experienced clinical disease activity, i.e., relapse(s) and/or confirmed disability worsening, as assessed by the Expanded Disability Status Scale (EDSS). Decision tree-based analysis was performed to identify baseline factors associated with clinical disease activity during teriflunomide treatment.

Results: At database lock (September 2020), approximately 29% of patients (430 out of 1,475) discontinued teriflunomide because of disease activity (~ 46%), adverse events (~ 37%), poor tolerability (~ 15%), pregnancy planning (~ 2%). Approximately 28% of patients experienced disease activity over a median follow-up of 2.75 years: ~ 9% had relapses but not disability worsening; ~ 13% had isolated disability worsening; ~ 6% had both relapses and disability worsening. The most important baseline factor associated with disease activity (especially disability worsening) was an EDSS > 4.0 (p < 0.001). In patients with moderate disability level (EDSS 2.0-4.0), disease activity occurred more frequently in case of ≥ 1 pre-treatment relapses (p = 0.025). In patients with milder disability level (EDSS < 2.0), disease activity occurred more frequently after previous exposure to ≥ 2 disease-modifying treatments (p = 0.007).

Conclusions: Our study suggests a place-in-therapy for teriflunomide in naïve patients with mild disability level or in those who switched their initial treatment for poor tolerability. Adverse events related with teriflunomide were consistent with literature data, without any new safety concern.
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http://dx.doi.org/10.1007/s00415-021-10455-3DOI Listing
August 2021

Safety of disease-modifying treatments in SARS-CoV-2 antibody-positive multiple sclerosis patients.

Mult Scler Relat Disord 2021 Apr 13;49:102754. Epub 2021 Jan 13.

Multiple Sclerosis Centre, IRCCS Mondino Foundation, Pavia, Italy.

Background: Coronavirus disease 2019 (COVID-19) raises particular concerns for people with multiple sclerosis (PwMS) on disease-modifying treatments (DMTs), and for physicians caring for them. The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on PwMS receiving DMTs that inhibit immune cell trafficking, such as natalizumab (NTZ) and fingolimod (FTY), remains to be determined, as do the possible effects of these drugs on both the infection and the related disease.

Aims: To describe self-reported COVID-19 symptoms and disease severity in PwMS on NTZ or FTY who received serology confirmation of SARS-CoV-2 infection.

Methods: From 27th April to 3rd May 2020, telephone interviews were conducted with 140 PwMS under treatment with NTZ or FTY in order to collect structured data on multiple sclerosis (MS) and COVID-19. The patients, all followed at our center, were classified as symptomatic, paucisymptomatic or asymptomatic on the basis of their self-reported clinical characteristics. COVID-19 severity was rated on a 7-point ordinal scale. In addition, in the period 4th May to 3rd June 2020 SARS-CoV-2 serology testing, using the Roche SARS-CoV-2 IgG assay (Elecsys), was performed in 104/140 (74.2%) of the interviewed PwMS (50 treated with NTZ and 54 with FTY).

Results: 14/104 (13.4%) PwMS on NTZ or FTY had anti-SARS-CoV-2 antibodies: 8 met the criteria for asymptomatic, 3 for paucisymptomatic and 3 for symptomatic COVID-19 (COVID-19 severity score lower than 3). None of them required hospitalization or showed severe COVID-19 complications.

Conclusions: Despite the relatively high SARS CoV-2 seroprevalence found in this sample of PwMS, all the positive cases showed either no or only mild COVID-19 symptoms. These reassuring findings indicate a lack of COVID-19 complications in PwMS on DMTs and support the hypothesis that it is safe to maintain ongoing treatment with these drugs in the current setting.
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http://dx.doi.org/10.1016/j.msard.2021.102754DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7836789PMC
April 2021

Delayed urinary bladder perforation in a hostile post-radiation pelvis.

Acta Chir Belg 2021 Apr 8;121(2):152-153. Epub 2021 Feb 8.

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, NY, USA.

The radiation-induced injury to normal tissue is a well-described phenomenon that incites tissue hypoxia, vascular damage, and parenchymal cell death. In addition to the morbidity caused by the radiation-induced injury itself, surgical management adds to the overall morbidity in these patients. We herein present a case demonstrating challenges of surgical management of urological complications in a radiated pelvis including delayed bladder perforation, recurrence of vesicovaginal fistula, and ureteral stricture. Nonoperative management strategies should be exhausted prior to surgical intervention.
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http://dx.doi.org/10.1080/00015458.2020.1871288DOI Listing
April 2021

Determinants of therapeutic lag in multiple sclerosis.

Mult Scler 2021 Jan 11:1352458520981300. Epub 2021 Jan 11.

CHU de Caen, MS Expert Centre, Department of Neurology, avenue de la Côte-de-Nacre, Normandy University, Caen, France.

Background: A delayed onset of treatment effect, termed therapeutic lag, may influence the assessment of treatment response in some patient subgroups.

Objectives: The objective of this study is to explore the associations of patient and disease characteristics with therapeutic lag on relapses and disability accumulation.

Methods: Data from MSBase, a multinational multiple sclerosis (MS) registry, and OFSEP, the French MS registry, were used. Patients diagnosed with MS, minimum 1 year of exposure to MS treatment and 3 years of pre-treatment follow-up, were included in the analysis. Studied outcomes were incidence of relapses and disability accumulation. Therapeutic lag was calculated using an objective, validated method in subgroups stratified by patient and disease characteristics. Therapeutic lag under specific circumstances was then estimated in subgroups defined by combinations of clinical and demographic determinants.

Results: High baseline disability scores, annualised relapse rate (ARR) ⩾ 1 and male sex were associated with longer therapeutic lag on disability progression in sufficiently populated groups: females with expanded disability status scale (EDSS) < 6 and ARR < 1 had mean lag of 26.6 weeks (95% CI = 18.2-34.9), males with EDSS < 6 and ARR < 1 31.0 weeks (95% CI = 25.3-36.8), females with EDSS < 6 and ARR ⩾ 1 44.8 weeks (95% CI = 24.5-65.1), and females with EDSS ⩾ 6 and ARR < 1 54.3 weeks (95% CI = 47.2-61.5).

Conclusions: Pre-treatment EDSS and ARR are the most important determinants of therapeutic lag.
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http://dx.doi.org/10.1177/1352458520981300DOI Listing
January 2021

Performance evaluation of stool DNA methylation tests in colorectal cancer screening: a systematic review and meta-analysis.

Colorectal Dis 2021 05 25;23(5):1030-1042. Epub 2021 Jan 25.

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, NY, USA.

Aim: There is not sufficient evidence about whether stool DNA methylation tests allow prioritizing patients to colonoscopy. Due to the COVID-19 pandemic, there will be a wait-list for rescheduling colonoscopies once the mitigation is lifted. The aim of this meta-analysis was to evaluate the accuracy of stool DNA methylation tests in detecting colorectal cancer.

Methods: The PubMed, Cochrane Library and MEDLINE via Ovid were searched. Studies reporting the accuracy (Sackett phase 2 or 3) of stool DNA methylation tests to detect sporadic colorectal cancer were included. The DerSimonian-Laird method with random-effects model was utilized for meta-analysis.

Results: Forty-six studies totaling 16 149 patients were included in the meta-analysis. The pooled sensitivity and specificity of all single genes and combinations was 62.7% (57.7%, 67.4%) and 91% (89.5%, 92.2%), respectively. Combinations of genes provided higher sensitivity compared to single genes (80.8% [75.1%, 85.4%] vs. 57.8% [52.3%, 63.1%]) with no significant decrease in specificity (87.8% [84.1%, 90.7%] vs. 92.1% [90.4%, 93.5%]). The most accurate single gene was found to be SDC2 with a sensitivity of 83.1% (72.6%, 90.2%) and a specificity of 91.2% (88.6%, 93.2%).

Conclusions: Stool DNA methylation tests have high specificity (92%) with relatively lower sensitivity (81%). Combining genes increases sensitivity compared to single gene tests. The single most accurate gene is SDC2, which should be considered for further research.
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http://dx.doi.org/10.1111/codi.15521DOI Listing
May 2021

Effect of Disease-Modifying Therapy on Disability in Relapsing-Remitting Multiple Sclerosis Over 15 Years.

Neurology 2021 02 28;96(5):e783-e797. Epub 2020 Dec 28.

From CORe (T.K., I.D., S.S., C.M.), Department of Medicine, University of Melbourne; MS Centre (T.K., I.D., S.S., C.M.), Department of Neurology, Royal Melbourne Hospital, Australia; Karolinska Institute (T.S.), Stockholm, Sweden; Department of Neuroscience (T.S., V.J., A.v.d.W., O.S., H.B.), Central Clinical School, Monash University, Melbourne; Burnet Institute (T.S.), Melbourne, Australia; Department of Neurology and Center of Clinical Neuroscience (D.H., E.K.H.), General University Hospital and Charles University in Prague, Czech Republic; Department of Basic Medical Sciences, Neuroscience and Sense Organs (M. Trojano), University of Bari, Italy; Hospital Universitario Virgen Macarena (G.I.), Sevilla, Spain; Department of Neuroscience, Imaging and Clinical Sciences (A.L.), University "G. d'Annunzio," Chieti; Department of Biomedical and Neuromotor Sciences (A.L.), University of Bologna, IRCCS Istituto delle Scienze Neurologiche di Bologna, Italy; Hopital Notre Dame (A.P., M.G., P.D.), Montreal; CHUM and Universite de Montreal (A.P., M.G., P.D.); CISSS Chaudière-Appalache (P.G.), Levis, Canada; Department of Neurology (V.J., A.v.d.W., O.S., H.B.), Alfred Hospital, Melbourne, Australia; Neuro Rive-Sud (F. Grand'Maison), Quebec, Canada; Department of Neuroscience (P.S., D.F.), Azienda Ospedaliera Universitaria, Modena, Italy; Isfahan University of Medical Sciences (V.S.), Isfahan, Iran; Amiri Hospital (R. Alroughani), Kuwait City, Kuwait; Zuyderland Ziekenhuis (R.H.), Sittard, the Netherlands; Medical Faculty (M. Terzi), 19 Mayis University, Samsun; KTU Medical Faculty Farabi Hospital (C.B.), Karadeniz Technical University, Trabzon, Turkey; School of Medicine and Public Health (J.L.-S.), University Newcastle; Department of Neurology (J.L.-S.), John Hunter Hospital, Newcastle, Australia; UOC Neurologia (E.P.), Azienda Sanitaria Unica Regionale Marche-AV3, Macerata, Italy; Cliniques Universitaires Saint-Luc (V.V.P.), Brussels, Belgium; University of Parma (F. Granella); C. Mondino National Neurological Institute (R.B.), Pavia; Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino (D.S.), Italy; Flinders University (M. Slee), Adelaide; Westmead Hospital (S.V.), Sydney, Australia; Nemocnice Jihlava (R. Ampapa), Czech Republic; University of Queensland (P.M.), Brisbane; Royal Brisbane and Women's Hospital (P.M.), Brisbane, Australia; Hospital Germans Trias i Pujol (C.R.-T.), Badalona, Spain; CSSS Saint-Jérôme (J.P.), Canada; Hospital Universitario Donostia (J.O.), Paseo de Begiristain, San Sebastián, Spain; Hospital Italiano (E.C.), Buenos Aires, Argentina; Brain and Mind Centre (M.B.), University of Sydney, Australia; INEBA-Institute of Neuroscience Buenos Aires (M.L.S.), Argentina; Hospital de Galdakao-Usansolo (J.L.S.-M.), Galdakao, Spain; Liverpool Hospital (S. Hodgkinson), Sydney, Australia; Jahn Ferenc Teaching Hospital (C.R.), Budapest, Hungary; Craigavon Area Hospital (S. Hughes), UK; Jewish General Hospital (F.M.), Montreal, Canada; Deakin University (C.S.), Geelong; Monash Medical Centre (E.B.), Melbourne, Australia; South East Trust (O.G.), Belfast, UK; Perron Institute (A.K.), University of Western Australia, Nedlands; Institute of Immunology and Infectious Diseases (A.K.), Murdoch University; Sir Charles Gairdner Hospital (A.K.), Perth, Australia; Department of Neurology (T.C.), Faculty of Medicine, University of Debrecen, Hungary; Bombay Hospital Institute of Medical Sciences (B.S.), Mumbai, India; St Vincents Hospital (N.S.), Fitzroy, Melbourne, Australia; Veszprém Megyei Csolnoky Ferenc Kórház zrt (I.P.), Veszprem, Hungary; Royal Hobart Hospital (B.T.), Australia; Semmelweis University Budapest (M. Simo), Hungary; Central Military Emergency University Hospital (C.-A.S.), Bucharest; Titu Maiorescu University (C.-A.S.), Bucharest, Romania; BAZ County Hospital (A.S.), Miskolc, Hungary; and Box Hill Hospital (H.B.), Melbourne, Australia.

Objective: To test the hypothesis that immunotherapy prevents long-term disability in relapsing-remitting multiple sclerosis (MS), we modeled disability outcomes in 14,717 patients.

Methods: We studied patients from MSBase followed for ≥1 year, with ≥3 visits, ≥1 visit per year, and exposed to MS therapy, and a subset of patients with ≥15-year follow-up. Marginal structural models were used to compare the cumulative hazards of 12-month confirmed increase and decrease in disability, Expanded Disability Status Scale (EDSS) step 6, and the incidence of relapses between treated and untreated periods. Marginal structural models were continuously readjusted for patient age, sex, pregnancy, date, disease course, time from first symptom, prior relapse history, disability, and MRI activity.

Results: A total of 14,717 patients were studied. During the treated periods, patients were less likely to experience relapses (hazard ratio 0.60, 95% confidence interval [CI] 0.43-0.82, = 0.0016), worsening of disability (0.56, 0.38-0.82, = 0.0026), and progress to EDSS step 6 (0.33, 0.19-0.59, = 0.00019). Among 1,085 patients with ≥15-year follow-up, the treated patients were less likely to experience relapses (0.59, 0.50-0.70, = 10) and worsening of disability (0.81, 0.67-0.99, = 0.043).

Conclusion: Continued treatment with MS immunotherapies reduces disability accrual by 19%-44% (95% CI 1%-62%), the risk of need of a walking aid by 67% (95% CI 41%-81%), and the frequency of relapses by 40-41% (95% CI 18%-57%) over 15 years. This study provides evidence that disease-modifying therapies are effective in improving disability outcomes in relapsing-remitting MS over the long term.

Classification Of Evidence: This study provides Class IV evidence that, for patients with relapsing-remitting MS, long-term exposure to immunotherapy prevents neurologic disability.
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http://dx.doi.org/10.1212/WNL.0000000000011242DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7884998PMC
February 2021

Evolution of the Circular Stapler in Rectal Cancer Surgery.

Surg Technol Int 2020 Nov;37:99-101

Westchester Medical Center, Valhalla, NY,New York Medical College, School of Medicine, Valhalla, NY.

The circular stapler has played a critical role in fashioning colorectal anastomoses following low anterior resection for rectal cancer. One of the greatest benefits of the circular stapler has been the feasibility of constructing ultra-low anastomoses, thereby decreasing permanent colostomy rates. A notable US innovation to the original design was the addition of disposable cartridges of various sizes, which greatly decreased assembly time and made the instrument more versatile. Another important modification was the ability to detach the anvil from the stapler shaft. This markedly simplified the construction of anastomoses by negating the need for a double purse-string and avoiding an open rectal stump. An additional modification to facilitate transanal stapler extraction was the tilted-top anvil, which flipped parallel to the shaft once the stapler was fired. The circular stapler continues to evolve while maintaining the basic elements of Hültl's brilliant concept from over a century ago.
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November 2020

A Multicenter Prospective Non-Randomized Study Comparing Ferguson Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization for Prolapsed, Nonincarcerated, Reducible Hemorrhoids: A Study Protocol.

Surg Technol Int 2020 Nov;37:109-112

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, NY.

Introduction: Current evidence suggests that transanal hemorrhoidal dearterialization (THD) is associated with less postoperative pain and faster recovery than Ferguson hemorrhoidectomy. However, there is some uncertainty regarding the durability of the therapeutic effect in terms of recurrent disease. Objective and significance: The aim of this study will be to evaluate the outcome of THD compared to Ferguson hemorrhoidectomy in terms of recurrence rate at 1-year follow-up.

Methods: This is a multicenter, parallel-arm, non-randomized prospective study comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rate at one year. The primary endpoint is recurrence rate at one year defined as prolapsing internal hemorrhoids at physical examination. Secondary endpoints include the following postoperative complications: urinary retention, constipation (requiring laxative or emergency room visit), dysuria, pruritis ani, anal pain, anal stenosis, unhealed wound, fissure, fecal urgency, and flatus or stool incontinence. Adults older than 18 years with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination will be included in one of the study arms: Ferguson hemorrhoidectomy and THD. Surgeons with proven expertise in hemorrhoids surgery will enroll patients undergoing Ferguson hemorrhoidectomy and THD (not both). Each participating surgeon will enroll a maximum of 10 patients. Ethics and Dissemination: This study was approved by the Institutional Review Boards of Stony Brook University (previously) and New York Medical College (currently), and registered in ClinicalTrials.gov (NCT03245086). The findings of the study will be published in a peer-reviewed journal.
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November 2020

Combined intra- and extra-peritoneal bladder perforation following rectal impalement injury.

Urol Case Rep 2021 Jan 7;34:101489. Epub 2020 Nov 7.

Department of Urology, New York Medical College/Westchester Medical Center, 100 Woods Rd, Valhalla, NY, 10595, USA.

A 62-year-old male presented with abdominal pain and hematuria following impalement of the rectum with a wooden foreign object. CT imaging showed air and fluid in the peritoneum prompting the patient to undergo abdominal exploration. An anterior rectal perforation was discovered along with dual bladder lacerations of the posterior wall and dome. The patient underwent a diverting colostomy and primary bladder repair. Post-operative course was uncomplicated and bladder repair was followed via cystograms with catheter removal 2 months post-operatively. Four months after the injury the patient underwent colostomy closure and remains with normal bladder and bowel function at 21-month follow-up.
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http://dx.doi.org/10.1016/j.eucr.2020.101489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7662846PMC
January 2021

Right Colon Resection: Evolution and Surgical Technique.

Surg Technol Int 2020 Nov;37:87-92

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, NY.

This review aims to provide succinct insight into the past, present and near-future of right colon resection. The history of right colon resection as well as the evolution of a laparoscopic approach are described. Standardization of the surgical technique, indications for medial-to-lateral and lateral-to medial mobilization, D2 and D3 lymphadenectomy, iso-peristaltic and antiperistaltic anastomotic configurations, intracorporeal and extracorporeal anastomosis, totally stapled and stapled handsewn techniques, laparoscopic and robotic suturing, mucosa eversion and inversion, and specimen extraction sites are discussed. In addition, totally intracorporeal robotic right colectomy for cancer is described. This review concludes that, whether it is hindered or assisted, gasless or "con gas", multiple- or single-port, extra- or intracorporeal, iso- or anti-peristaltic, right colon resection is still evolving.
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November 2020

Transition to secondary progression in relapsing-onset multiple sclerosis: Definitions and risk factors.

Mult Scler 2021 03 19;27(3):430-438. Epub 2020 Nov 19.

Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari "Aldo Moro," Bari, Italy.

Background: No uniform criteria for a sensitive identification of the transition from relapsing-remitting multiple sclerosis (MS) to secondary-progressive multiple sclerosis (SPMS) are available.

Objective: To compare risk factors of SPMS using two definitions: one based on the neurologist judgment (ND) and an objective data-driven algorithm (DDA).

Methods: Relapsing-onset MS patients ( = 19,318) were extracted from the Italian MS Registry. Risk factors for SPMS and for reaching irreversible Expanded Disability Status Scale (EDSS) 6.0, after SP transition, were estimated using multivariable Cox regression models.

Results: SPMS identified by the DDA ( = 2343, 12.1%) were older, more disabled and with a faster progression to severe disability ( < 0.0001), than those identified by the ND ( = 3868, 20.0%). In both groups, the most consistent risk factors ( < 0.05) for SPMS were a multifocal onset, an age at onset >40 years, higher baseline EDSS score and a higher number of relapses; the most consistent protective factor was the disease-modifying therapy (DMT) exposure. DMT exposure during SP did not impact the risk of reaching irreversible EDSS 6.0.

Conclusion: A DDA definition of SPMS identifies more aggressive progressive patients. DMT exposure reduces the risk of SPMS conversion, but it does not prevent the disability accumulation after the SP transition.
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http://dx.doi.org/10.1177/1352458520974366DOI Listing
March 2021

Does the learning curve in robotic rectal cancer surgery impact circumferential resection margin involvement and reoperation rates? A risk-adjusted cumulative sum analysis.

Minerva Surg 2021 Apr 9;76(2):124-128. Epub 2020 Nov 9.

Section of Colorectal Surgery, Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, NY, USA -

Background: The aim of this study was to evaluate the impact of surgeons' learning curve in robotic surgery for rectal cancer on circumferential resection margin (CRM) involvement and reoperation rates.

Methods: Learning curve data were prospectively collected from four centers. Patients undergoing robotic proctectomy for resectable rectal cancer were included. CRM was involved when ≥1 mm. TME quality was classified as complete, nearly complete, or incomplete. T-test and χ tests were used to compare continuous and categorical variables, respectively. Risk-adjusted cumulative sum (RA-CUSUM) analysis was utilized to evaluate the effect of the learning curve on primary endpoints. Univariate analysis of potential risk factors for CRM involvement and reoperation was performed. Factors with the P value ≤0.2 were included in the multivariate logistic regression model for further RA-CUSUM analysis.

Results: A total of 221 patients (80, 36, 62, and 43 patients operated on by surgeons 1, 2, 3, and 4, respectively) who underwent robotic surgery for rectal cancer during the surgeons' learning curves were included. CRM involvement rate was 0%, 11%, 3%, and 5% in surgeons 1, 2, 3, and 4, respectively. Reoperation rate was 3.7%, 8.3%, 4.8%, and 11.6%, respectively. RA-CUSUM analysis of CRM involvement (R=0.9886) and reoperation (R=0.9891) found a statistically significant decreasing trend in aggregate CUSUM values throughout the learning curve.

Conclusions: This study found a continued significant decrease in CRM involvement and reoperation rates throughout the learning curve in robotic rectal cancer surgery.
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http://dx.doi.org/10.23736/S0026-4733.20.08491-6DOI Listing
April 2021

Air pollution as a contributor to the inflammatory activity of multiple sclerosis.

J Neuroinflammation 2020 Nov 6;17(1):334. Epub 2020 Nov 6.

IRCCS Mondino Foundation, Pavia, Italy.

Objective: Air pollution has been recently identified as a risk factor for multiple sclerosis. Aim of this study was to investigate the immunological mechanism underlying the clinical association between air pollution, namely exposure to particulate matter 10 (PM10), and inflammatory activity of multiple sclerosis (MS) METHODS: Daily recording of PM10 was obtained by monitors depending on the residence of subjects. Expression of molecules involved in activation, adhesion, and migration of T lymphocytes were tested by flow cytometry in 57 MS patients and 19 healthy controls. We next assessed in vitro the effect of PM10 on expression of C-C chemokine receptors 6 (CCR6) by peripheral blood mononuclear cells (PBMCs), on cytokine production by monocyte-derived dendritic cells (mdDC), and on T cell polarization in PBMC/mdDC mixed cultures.

Results: We identified a significant correlation between mean PM10 levels and expression of CCR6 CD4+ T circulating cells in MS patients. This was paralleled by the observation in vitro of a higher level of CCR6 expression on PBMC following treatment with increased doses of particulate matter. Moreover, in mdDC cultures, particulate matter induced the secretion by mdDC of Th17 polarizing IL1 beta, IL6, and IL23 and, in mdDC/PBMC mixed cultures, enhanced generation of IL17-producing T cells.

Conclusions: Ex vivo and in vitro studies support the pro-inflammatory role of PM in MS, by upregulating expression of CCR6 on circulating CD4+ T cells and inducing in innate immune cells the production of Th17 polarizing cytokines. Therefore, we speculate that in MS respiratory exposure to PM10 may induce the production in the lung of autoreactive Th17 lymphocytes and boost their migratory properties through the blood-brain barrier.
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http://dx.doi.org/10.1186/s12974-020-01977-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645903PMC
November 2020

Meta-analysis of Postoperative Mortality and Morbidity After Total Abdominal Colectomy Versus Loop Ileostomy With Colonic Lavage for Fulminant Clostridium Difficile Colitis.

Dis Colon Rectum 2020 09;63(9):1317-1326

Department of Surgery, Westchester Medical Center, New York Medical College, Valhalla, New York.

Background: Emergency surgery is often required for fulminant Clostridium difficile colitis. Total abdominal colectomy has been the treatment of choice despite high morbidity and mortality.

Objective: The aim of this meta-analysis was to evaluate postoperative mortality and morbidity after total abdominal colectomy and loop ileostomy with colonic lavage in patients with fulminant C difficile colitis.

Data Sources: Studies comparing total abdominal colectomy to loop ileostomy for fulminant C difficile colitis were identified by a systematic search of PubMed, Cochrane Library, MEDLINE, and CINAHL.

Study Selection: Relevant records were detected and screened using a cascade system (title, abstract, and/or full text article).

Intervention(s): Total abdominal colectomy (rectal-sparing resection of the entire colon with end ileostomy) was compared to loop ileostomy (exteriorization of an ileal loop not far from the ileocecal junction for colonic lavage).

Main Outcomes Measures: This meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Guidelines. Primary outcome was postoperative mortality, defined as death occurring within 30 days after the intervention. Secondary end points were the rates of ostomy reversal, deep venous thrombosis/embolism, surgical site infection, urinary tract infection, respiratory complications, reoperations, and adverse events. Mantel-Haenszel method with random-effects model was used for meta-analysis.

Results: Five observational studies (3 cohort and 2 database analysis studies) totaling 3683 patients were included. Postoperative mortality rate was 31.3% after total abdominal colectomy and 26.2% after loop ileostomy (OR = 1.36 (95% CI, 0.83-2.24); p = 0.22; number needed to treat/harm = 20; I = 55%). Ostomy reversal rate was both statistically and clinically significantly higher after loop ileostomy as compared with total abdominal colectomy (80% vs 25%; OR = 0.08 (95% CI, 0.02-0.30); p = 0.002; number needed to treat/harm = 2) with low heterogeneity (I = 0%).

Limitations: A limitation is the observational nature of the included studies introducing an overall high risk of selection bias.

Conclusions: This meta-analysis suggests that loop ileostomy with colonic lavage for fulminant C difficile colitis may be associated with similar survival and decreased surgical site infection rates as compared with total abdominal colectomy. Although loop ileostomy with colonic lavage was associated with higher ostomy reversal rates, this finding was based on the data from only 2 studies.
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http://dx.doi.org/10.1097/DCR.0000000000001764DOI Listing
September 2020
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