Publications by authors named "Pedro T Ramirez"

267 Publications

Impact of a tiered discharge opioid algorithm on prescriptions and patient-reported outcomes after open gynecologic surgery.

Int J Gynecol Cancer 2021 Jun 16. Epub 2021 Jun 16.

Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Objective: To compare discharge opioid refills, prescribed morphine equivalent dose and quantity, and longitudinal patient-reported outcomes before and after implementation of a tiered opioid prescribing algorithm among women undergoing open gynecologic surgery within an enhanced recovery after surgery program.

Methods: We compared opioid prescriptions, clinical outcomes, and patient-reported outcomes among 273 women. Post-discharge symptom burden was collected up to 42 days after discharge using the validated 27-item MD Anderson Symptom Inventory and analyzed using linear mixed effects models and Kaplan-Meier curves for symptom recovery.

Results: Among 113 pre-implementation and 160 post-implementation patients there was no difference in opioid refills (9.7% vs 11.3%, p=0.84). The post-implementation cohort had a significant reduction in median morphine equivalent dose (112.5 mg vs 225 mg, p<0.01), with no difference in median hospital length of stay (3 days vs 3 days, p=1.0) or 30-day readmission rate (9.4% vs 7.1%, p=0.66). There was no difference in patient-reported pain between the pre- and post-implementation cohorts on the day of discharge (severity 4.93 vs 5.14, p=0.53) or in any patient-reported symptoms, interference measures, or composite scores by post-discharge day 7. The median recovery time for most symptoms was 7 days, except for pain (14 days), fatigue (18 days), and physical interference (21 days), with no differences between cohorts.

Conclusions: After implementation of a tiered opioid prescribing algorithm, the quantity and dose of discharge opioids prescribed decreased with no change in post-operative refills and without negatively impacting patient-reported symptom burden or interference, which can be used to educate and reassure patients and providers.
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http://dx.doi.org/10.1136/ijgc-2021-002674DOI Listing
June 2021

Effectiveness of Perioperative Opioid Educational Initiatives: A Systematic Review and Meta-Analysis.

Anesth Analg 2021 Jun 11. Epub 2021 Jun 11.

Department of Anesthesiology, Hospital for Special Surgery, New York, New York.

Background: Opioids are the most commonly prescribed analgesics in the United States. Current guidelines have proposed education initiatives to reduce the risk of chronic opioid consumption, yet there is lack of efficacy data on such interventions. Our study evaluates the impact of perioperative opioid education on postoperative opioid consumption patterns including opioid cessation, number of pills consumed, and opioid prescription refills.

Methods: The MEDLINE/PubMed, Embase, Cochrane Library, Scopus, and Google Scholar databases were systematically searched for randomized controlled trials (RCTs) assessing the impact of perioperative educational interventions (using either paper- or video-based instruments regarding pain management and drug-induced side effects) on postoperative opioid patterns compared to standard preoperative care among patients undergoing elective surgery. Our end points were opioid consumption (number of pills used), appropriate disposal of unused opioids, opioid cessation (defined as no use of opioids), and opioid refills within 15 days, 6 weeks, and 3 months.

Results: In total, 11 RCTs fulfilled the inclusion criteria, totaling 1604 patients (804 received opioid education, while 800 received standard care). Six trials followed patients for 15 days after surgery, and 5 trials followed patients up to 3 months. After 15 days, the opioid education group consumed a lower number of opioid pills than those in the control group (weighted mean difference [WMD], -3.39 pills; 95% confidence interval [CI], -6.40 to -0.37; P =.03; I2 = 69%) with no significant difference in overall opioid cessation (odds ratio [OR], 0.25; 95% CI, 0.04-1.56; P = .14; I2 = 83%). Likewise, perioperative opioid education did not have significant effects on opioid cessation at 6 weeks (OR, 0.69; 95% CI, 0.45-1.05; P = .10; I2 = 0%) and 3 months (OR, 0.59; 95% CI,0.17-2.01; P = .10; I2 = 0%) after surgery, neither reduced the need for opioid refills at 15 days (OR, 0.57; 95% CI, 0.28-1.15; P = .12; I2 = 20%) and 6 weeks (OR, 1.08; 95% CI, 0.59-1.98; P = .80; I2 = 37%). There was no statistically significant difference in the rate of appropriate disposal of unused opioids between both groups (OR, 1.99; 95% CI, 0.66-6.00; P = .22; I2 = 71%). Subgroup analysis by type of educational intervention showed a statistical reduction of opioid consumption at 15 days when implementing multimedia/audiovisual strategies (4 trials: WMD, -4.05 pills; 95% CI, -6.59 to -1.50; P = .002; I2 = 45%), but there was no apparent decrease when using only paper-based strategies (2 trials: WMD, -2.31 pills; 95% CI, -12.21 to 7.59; P = .65; I2 = 80%).

Conclusions: Perioperative educational interventions reduced the number of opioid pills consumed at 15 days but did not demonstrate a significant effect on opioid cessation or opioid refills at 15 days, 6 weeks, and 3 months. Further randomized trials should focus on evidence-based educational interventions with strict homogeneity of material to draw a more definitive recommendation.
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http://dx.doi.org/10.1213/ANE.0000000000005634DOI Listing
June 2021

Technique for inguino-femoral lymph node dissection in vulvar cancer: an international survey.

Int J Gynecol Cancer 2021 Jun 14;31(6):817-823. Epub 2021 May 14.

Department of Obstetrics and Gynaecology, University Hospital of Wales, Cardiff, UK.

Background: Vulvar cancer is a rare disease and despite broad adoption of sentinel lymph node mapping to assess groin metastases, inguino-femoral lymph node dissection still plays a role in the management of this disease. Inguino-femoral lymph node dissection is associated with high morbidity, and limited research exists to guide the best surgical approach.

Objective: To determine international practice patterns in key aspects of the inguino-femoral lymph node dissection technique and provide data to guide future research.

Methods: A survey addressing six key domains of practice patterns in performing inguino-femoral lymph node dissection was distributed internationally to gynecologic oncology surgeons between April and October 2020. The survey was distributed using the British Gynecological Cancer Society, the Society of Gynecologic Oncology, authors' direct links, the UK Audit and Research in Gynecology Oncology group, and Twitter.

Results: A total of 259 responses were received from 18 countries. The majority (236/259, 91.1%) of respondents reported performing a modified oblique incision, routinely dissecting the superficial and deep inguino-femoral lymph nodes (137/185, 74.1%) with sparing of the saphenous vein (227/258, 88%). Most respondents did not routinely use compression dressings/underwear (169/252 (67.1%), used prophylactic antibiotics at the time of surgery only (167/257, 65%), and closed the skin with sutures (192 74.4%). Also, a drain is placed at the time of surgery by 243/259 (93.8%) surgeons, with most practitioners (144/243, 59.3%) waiting for drainage to be less than 30-50 mL in 24 hours before removal; most respondents (66.3%) routinely discharge patients with drain(s) in situ.

Conclusion: Our study showed that most surgeons perform a modified oblique incision, dissect the superficial and deep inguino-femoral lymph nodes, and spare the saphenous vein when performing groin lymphadenectomy. This survey has demonstrated significant variability in inguino-femoral lymph node dissection in cases of vulvar cancer among gynecologic oncology surgeons internationally.
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http://dx.doi.org/10.1136/ijgc-2021-002452DOI Listing
June 2021

Outcomes of the First Pregnancy After Fertility-Sparing Surgery for Early-Stage Ovarian Cancer.

Obstet Gynecol 2021 06;137(6):1109-1118

Department of Gynecologic Oncology and Reproductive Medicine, the Department of Health Services Research, Division of Cancer Prevention and Population Sciences, and the Department of Breast Medical Oncology, the University of Texas MD Anderson Cancer Center, Houston, Texas; the Department of Obstetrics and Gynecology, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; the Department of Obstetrics and Gynecology, the University of Texas Medical Branch at Galveston, Galveston, Texas; and the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, and the Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, New York.

Objective: To evaluate the outcomes of the first pregnancy after fertility-sparing surgery in patients treated for early-stage ovarian cancer.

Methods: We performed a retrospective study of women aged 18-45 years with a history of stage IA or IC ovarian cancer reported to the California Cancer Registry for the years 2000-2012. These data were linked to the 2000-2012 California Office of Statewide Health Planning and Development birth and discharge data sets to ascertain oncologic characteristics and obstetric outcomes. We included in the case group ovarian cancer patients who conceived at least 3 months after fertility-sparing surgery. The primary outcome was preterm birth, and only the first pregnancy after cancer diagnosis was considered. Secondary outcomes included small-for-gestational-age (SGA) neonates, neonatal morbidity (respiratory support within 72 hours after birth, hypoxic-ischemic encephalopathy, seizures, infection, meconium aspiration syndrome, birth trauma, and intracranial or subgaleal hemorrhage), and severe maternal morbidity as defined by the Centers for Disease Control and Prevention. Propensity scores were used to match women in a 1:2 ratio for the case group and the control group. Wald statistics and logistic regressions were used to evaluate outcomes.

Results: A total of 153 patients who conceived after fertility-sparing surgery were matched to 306 women in a control group. Histologic types included epithelial (55%), germ-cell (37%), and sex-cord stromal (7%). Treatment for ovarian cancer was not associated with preterm birth before 37 weeks of gestation (13.7% vs 11.4%; odds ratio [OR] 1.23, 95% CI 0.69-2.20), SGA neonates (birth weight less than the 10th percentile: 11.8% vs 12.7%; OR 0.91, 95% CI 0.50-1.66), severe maternal morbidity (2.6% vs 1.3%; OR 2.03, 95% CI 0.50-8.25), or neonatal morbidity (both 5.9% OR 1.00, 95% CI 0.44-2.28).

Conclusion: Patients who conceived at least 3 months after surgery for early-stage ovarian cancer did not have an increased risk of adverse obstetric outcomes.
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http://dx.doi.org/10.1097/AOG.0000000000004394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141030PMC
June 2021

Minimally invasive radical trachelectomy: Considerations on surgical approach.

Best Pract Res Clin Obstet Gynaecol 2021 Feb 20. Epub 2021 Feb 20.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Current evidence supports that radical trachelectomy is a safe and feasible alternative to patients with early-stage cervical cancer who wish to preserve fertility. In addition, published retrospective literature supports that oncologic outcomes are equivalent to those of radical hysterectomy. First published as a vaginal approach, a number of other approaches have been reported including laparotomic, laparoscopic, and robotic. In 2018, the first ever prospective randomized trial (LACC) comparing open vs. minimally invasive radical hysterectomy showed worse disease-free and overall survival for the minimally invasive (both laparoscopic and robotic) approach than the open approach. This landmark publication raised concerns regarding the oncologic safety of minimally invasive radical trachelectomy. In the United States, minimally invasive became the dominant approach by 2011 for radical trachelectomy. Given that radical trachelectomy is an infrequent performed procedure, only small retrospective studies, systematic reviews, and large database studies have been published. These studies are limited by their retrospective nature, small sample size, patient selection bias, unbalanced groups, and sequential surgical approach comparisons. However, the available evidence thus far shows that oncologic outcomes for both open and minimally invasive radical trachelectomy are equivalent. Given the rarity of the procedure and the low recurrence and death rates of patients with early-stage cervical cancer undergoing radical trachelectomy, a prospective randomized trial seems unlikely. A multi-institutional international registry study (International Radical Trachelectomy Assessment - IRTA - study) has been recently completed evaluating open vs. minimally invasive radical trachelectomy. There are three ongoing prospective studies evaluating the possibility of less radical surgery in a low-risk early-stage cervical cancer population, ConCerv, SHAPE, and GOG 278. We look forward to the final results of these studies that will hopefully shed light on the optimal treatment option for patients with early-stage cervical cancer wishing to preserve fertility. This article will review the most impacting publications comparing open vs. minimally invasive radical trachelectomy and analyze the limitations of the current available literature.
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http://dx.doi.org/10.1016/j.bpobgyn.2021.01.009DOI Listing
February 2021

Tumor Staging of Endocervical Adenocarcinoma: Recommendations From the International Society of Gynecological Pathologists.

Int J Gynecol Pathol 2021 Mar;40(Suppl 1):S92-S101

The International Federation of Gynecology and Obstetrics (FIGO) updated its staging system for cervical cancer in 2018 with changes that affect size criteria for early stage disease, as well as including pathology and radiology in addition to clinical assessment to be used in staging. Lymph node involvement was also included in the staging system. In early stage disease, pathologic findings are crucial in determining stage, which in turn determine treatment and prognosis for the patient. Therefore, it is imperative that there are unified and consistent methods and recommendations for assessing and reporting pathologic parameters for accurate staging. We describe the changes in the revised FIGO staging scheme and discuss controversial issues in cervical cancer staging from a pathologic perspective. We also provide practical recommendations regarding these parameters based on literature review and/or expert opinion/consensus.
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http://dx.doi.org/10.1097/PGP.0000000000000758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969160PMC
March 2021

Endocervical Adenocarcinoma, Gross Examination, and Processing, Including Intraoperative Evaluation: Recommendations From the International Society of Gynecological Pathologists.

Int J Gynecol Pathol 2021 Mar;40(Suppl 1):S24-S47

The International Society of Gynecological Pathologists (ISGyP) Endocervical Adenocarcinoma Project aims to provide evidence-based guidance for the pathologic evaluation, classification, and reporting of endocervical adenocarcinoma. This review presents the recommendations pertaining to gross evaluation and intraoperative consultation of specimens obtained from patients in the setting of cervical cancer. The recommendations are the product of review of published peer-reviewed evidence, international guidelines and institutional grossing manuals, as well as deliberation within this working group. The discussion presented herein details the approach to the different specimen types encountered in practice: loop electrosurgical excision procedure, cone, trachelectomy, radical hysterectomy, pelvic exenteration, and lymphadenectomy specimens. Guidelines for intraoperative evaluation of trachelectomy and sentinel lymph node specimens are also addressed. Correlation with ISGyP recommendations on cancer staging, which appear as a separate review in this issue, is also included when appropriate. While conceived in the framework of endocervical adenocarcinoma, most of the discussion and recommendations can also be applied to other cervical malignancies.
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http://dx.doi.org/10.1097/PGP.0000000000000745DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969178PMC
March 2021

Dasatinib, paclitaxel, and carboplatin in women with advanced-stage or recurrent endometrial cancer: A pilot clinical and translational study.

Gynecol Oncol 2021 Apr 4;161(1):104-112. Epub 2021 Feb 4.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America; Department of Cancer Biology, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America.

Purpose: To evaluate the effect of dasatinib therapy on EphA2 signaling in cancers of women with measurable (biopsy amenable) advanced-stage, chemo-naïve primary or recurrent endometrial cancer. Preliminary efficacy was also assessed.

Patients And Methods: We performed a pilot study of single-agent dasatinib lead-in, followed by triplet dasatinib, paclitaxel, and carboplatin. We measured the downstream effectors of EphA2 signaling in pre- and post-dasatinib treatment biopsy tissue samples; we also determined the severity of adverse events and patients' progression-free survival and overall survival durations.

Results: Eighteen patients were recruited and given dasatinib (150 mg orally daily for 14 days), followed by paclitaxel, carboplatin and dasatinib (daily) for six cycles (21-day cycles). Seventeen patients were evaluable for toxicity and 11 patients for response. A reverse phase protein array and proximity ligation assay revealed that CRAF/BRAF dimerization, caveolin-1 level, and Notch pathway signaling were predictive of response and resistance to dasatinib. Overall, the objective response rate was 45% (95% CI: 17%-77%), with median progression-free survival duration of 10.5 months and median overall survival duration of 30.4 months. The most common grade 3 or 4 adverse events were neutropenia (76%), thrombocytopenia (53%), anemia (53%), and fatigue (12%).

Conclusions: Caveolin-1 expression, in combination with CRAF/BRAF heterodimerization, is associated with resistance to EphA2 targeting by dasatinib. The triplet combination showed interesting clinical activity in endometrial cancer with acceptable toxicity. Pretreatment with dasatinib may accentuate combination therapy toxicity.
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http://dx.doi.org/10.1016/j.ygyno.2021.01.022DOI Listing
April 2021

Impact of anesthesia technique on post-operative opioid use in open gynecologic surgery in an enhanced recovery after surgery pathway.

Int J Gynecol Cancer 2021 Apr 22;31(4):569-574. Epub 2021 Jan 22.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Objective: To examine the effect of anesthesia technique in an enhanced recovery after surgery (ERAS) pathway on post-operative opioid use.

Methods: Patients undergoing open gynecologic surgery under an ERAS pathway from November 2014 through December 2018 were included retrospectively. All patients received pre-operative analgesia consisting of oral acetaminophen, pregabalin, celecoxib, and tramadol extended release, unless contraindicated. Patients received local wound infiltration with bupivacaine; the post-operative analgesic regimen was standardized. Patients were categorized by anesthesia technique: (1) inhalational, (2) total intravenous anesthesia (TIVA), and (3) combined technique. The primary outcome was post-operative opioid consumption measured as morphine equivalent dose, recorded as the total opioid dose received post-operatively, including doses received through post-operative day 3.

Results: A total of 1184 patients underwent general anesthesia using either inhalational (386, 33%), TIVA (349, 29%), or combined (449, 38%) techniques. Patients who received combined anesthesia had longer surgery times (p=0.005) and surgical complexity was higher among patients who underwent TIVA (moderate/higher in 76 patients, 38%) compared with those who received inhaled anesthesia (intermediate/higher in 41 patients, 23%) or combined anesthesia (intermediate/higher in 72 patients, 30%). Patients who underwent TIVA anesthesia consumed less post-operative opioids than those managed with inhalational technique (0 (0-46.3) vs 10 (0-72.5), p=0.009) or combined anesthesia (0 (0-46.3) vs 10 (0-87.5), p=0.029). Similarly, patients who underwent the combined technique had similar opioid consumption post-operatively compared with those who received inhalational anesthesia (10 (0-87.5) vs 10 (0-72.5), p=0.34).

Conclusions: TIVA technique is associated with a decrease in post-operative consumption of opioids after open gynecologic surgery in patients on an ERAS pathway.
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http://dx.doi.org/10.1136/ijgc-2020-002004DOI Listing
April 2021

Effect of preoperative intravenous vs oral acetaminophen on postoperative opioid consumption in an enhanced recovery after surgery (ERAS) program in patients undergoing open gynecologic oncology surgery.

Gynecol Oncol 2021 02 6;160(2):464-468. Epub 2020 Dec 6.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Objective: Both intravenous (IV) and oral acetaminophen provide effective opioid-sparing analgesia after surgery when used as part of a multimodal preemptive pain management strategy. The purpose of this study was to compare postoperative opioid consumption in patients undergoing open gynecologic oncology surgery who received preoperative IV vs oral acetaminophen within an enhanced recovery after surgery (ERAS) program.

Methods: Retrospective data were collected on consecutive patients undergoing open gynecologic oncology surgery from May 1, 2016 to February 28, 2018 in patients receiving either 1 g IV or oral acetaminophen preoperatively. Patients were given a preoperative multimodal analgesia regimen including acetaminophen, celecoxib, pregabalin and tramadol. The primary outcomes were morphine equivalent daily doses (MEDD) on postoperative days (POD) 0 and 1. Secondary outcomes included highest patient-reported pain score in the post-anesthesia care unit (PACU) and intraoperative MEDD. Regression models adjusted by matched pairs were fit to estimate the average treatment effect of IV vs oral acetaminophen on MEDD.

Results: Of 353 patients, 178 (50.4%) received IV acetaminophen and 175 (49.6%) received oral acetaminophen. When balancing across the matched samples, there was no difference in postoperative MEDD for POD 0 between the IV and oral acetaminophen groups (Beta = -1.11; 95% CI: -4.83 to 2.60; p = 0.56). On POD 1, there was no difference between the IV and oral groups (Beta = 2.24; 95% CI: -2.76 to 7.25; p = 0.38).

Conclusions: There was no difference in postoperative opioid consumption between patients receiving preoperative IV or oral acetaminophen within an ERAS program for patients undergoing open gynecologic oncology surgery.
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http://dx.doi.org/10.1016/j.ygyno.2020.11.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7861133PMC
February 2021

In memory of Professor Dr Costantino Mangioni.

Int J Gynecol Cancer 2021 Jan 23;31(1):159-160. Epub 2020 Nov 23.

Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.

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http://dx.doi.org/10.1136/ijgc-2020-002204DOI Listing
January 2021

Fertility considerations prior to conservative management of gynecologic cancers.

Int J Gynecol Cancer 2021 Mar 11;31(3):339-344. Epub 2020 Nov 11.

Gynecologic Oncology & Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Fertility-sparing management of early-stage gynecologic cancers is becoming more prevalent as increasing evidence demonstrates acceptable oncologic and reproductive outcomes in appropriately selected patients. However, in the absence of randomized controlled trials, most of the commonly used treatment algorithms are based only on observational studies. As women are increasingly postponing childbearing, the need for evidence-based guidance on the optimal selection of appropriate candidates for fertility-sparing therapies is paramount. It is imperative to seriously consider the fertility potential of a given individual prior to making major oncologic treatment decisions that may deviate from the accepted standard of care. It is a disservice to patients to undergo a fertility-sparing procedure in hopes of ultimately achieving a live birth, only to determine later they have poor baseline fertility potential or other substantial barriers to conception including excess financial toxicity. Many women with oncologic diagnoses are of advanced maternal age and their obstetric and neonatal risks must be considered. In the era of advanced assisted reproductive technologies, patients should be provided realistic expectations regarding success rates while understanding the potential oncologic perils. A multidisciplinary approach to the conservative treatment of early-stage gynecologic cancers with early referral to reproductive specialists as well as maternal-fetal medicine specialists is warranted. In this review, we discuss the recommended fertility evaluation for patients with newly diagnosed, early-stage gynecologic cancers who are considering fertility-sparing management.
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http://dx.doi.org/10.1136/ijgc-2020-001783DOI Listing
March 2021

Longitudinal patient-reported outcomes and restrictive opioid prescribing after minimally invasive gynecologic surgery.

Int J Gynecol Cancer 2021 Jan 6;31(1):114-121. Epub 2020 Nov 6.

Department of Gynecologic Oncology & Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Objective: To determine post-discharge patient-reported symptoms before and after implementation of restrictive opioid prescribing among women undergoing minimally invasive gynecologic surgery.

Methods: We compared clinical outcomes and symptom burden among a cohort of 389 women undergoing minimally invasive gynecologic surgery at a single institution before and after implementation of a restrictive opioid prescribing quality improvement initiative in July 2018. Post-discharge symptom burdens were collected up to 42 days after discharge using the MD Anderson Symptom Inventory and analyzed using linear mixed effects models.

Results: The majority of women included in this study were white non-smokers and the median age was 55 (range 23-83). Most women underwent hysterectomy (64%), had surgery for malignancy (71%), and were discharged from the hospital on the day of surgery (65%). Women in the restrictive opioid prescribing group had a median reduction in morphine equivalent dose prescribed at discharge of 83%, corresponding to a median reduction in 25 tablets of 5 mg oxycodone per person. There was no difference between opioid prescribing groups in either the rate of refill requests (P=1) or hospital re-admission (P=1) up to 30 days after discharge. After adjustment for co-variates, there was no statistically significant difference in post-discharge symptom burden including patient-reported pain (P=0.08), sleep (P=0.30), walking interference (P=0.64), activity interference (P=0.12), or affective interference (P=0.67). There was a trend toward less reported constiptation in the restrictive opioid prescribing group that did not reach statistical significance (P=0.05).

Conclusion: We found that restrictive post-operative opioid prescribing was not associated with differences in longitudinal symptom burden among women undergoing minimally invasive gynecologic surgery. These results provide the most comprehensive picture to date of post-operative symptom recovery under different opioid prescribing approaches, lending additional support for existing recommendations to reduce opioid prescribing following gynecologic surgery.
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http://dx.doi.org/10.1136/ijgc-2020-002103DOI Listing
January 2021

Bronchocutaneous fistula from metastatic cervical cancer with COVID-19.

Int J Gynecol Cancer 2021 02 9;31(2):306. Epub 2020 Oct 9.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

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http://dx.doi.org/10.1136/ijgc-2020-001976DOI Listing
February 2021

Tumor size in cervical cancer: an ongoing dilemma.

Int J Gynecol Cancer 2020 11 21;30(11):1851. Epub 2020 Sep 21.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

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http://dx.doi.org/10.1136/ijgc-2020-002022DOI Listing
November 2020

Enhanced recovery for obese patients undergoing gynecologic cancer surgery.

Int J Gynecol Cancer 2020 10 26;30(10):1595-1602. Epub 2020 Aug 26.

Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Objective: To compare post-operative length of stay and complication rates of matched obese and non-obese patients in an enhanced recovery (ERAS) program after open gynecologic cancer surgery.

Methods: We performed an observational cohort study of patients (n=1225) undergoing open surgery from November 2014 to November 2018 at a tertiary cancer center. Patients undergoing multidisciplinary procedures, non-oncologic surgery, or procedures in addition to abdominal surgery were excluded (n=190). Obese and non-obese patients were matched by date, age, disease status, and surgical complexity. The primary outcome was post-operative length of stay. Secondary outcomes included 30-day peri-operative complications, re-operation, re-admission, opioid use, and program compliance.

Results: After matching, 696 patients (348 obese, 348 non-obese) with median age of 57 years (IQR 48-66) were analyzed. Obese patients had a longer median procedure time (218 min vs 192.5 min, p<0.001) and greater median estimated blood loss (300 mL vs 200 mL, p<0.001). Median (IQR) post-operative length of stay was the same for obese and non-obese patients: 3 days (IQR 2-4). Obese and non-obese patients had similar rates of grade III-IV complications (10.9% and 6.6%, respectively, p=0.06), re-operation (2.3% and 1.4%, respectively, p=0.58), and re-admission (11.8% and 8.0%, respectively, p=0.13). Grade I-II complications were more common among obese patients (62.4% vs 48.3%, p<0.001) because they had more wound complications (17.8% vs 4.9%, p<0.001). Obese patients received more opioids both during surgery (morphine equivalent dose 57.25 mg (IQR 35-72.5) vs 50 mg (IQR 25-622.5), p=0.003) and after surgery (morphine equivalent daily dose 45 mg/day (IQR 10-96.2) vs 29.37 mg/day (IQR 7.5-70), p=0.01). Obese and non-obese patients had similar ERAS program compliance (70.1% and 69.8%, respectively, p=0.32).

Conclusions: Neither post-operative length of stay nor the rate of serious complications differed significantly despite longer surgeries, greater blood loss, and more opioid use among obese patients. An ERAS program was safe, effective, and feasible for obese patients with suspected gynecologic cancer.
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http://dx.doi.org/10.1136/ijgc-2020-001663DOI Listing
October 2020

Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE).

Int J Gynecol Cancer 2020 09 20;30(9):1450-1454. Epub 2020 Jul 20.

Department of Women's and Children's Health, Policlinico A Gemelli, Rome, Italy.

Background: Observational studies have supported the practice of offering minimally invasive interval debulking surgery after neoadjuvant chemotherapy for well-selected patients with advanced epithelial ovarian cancer. However, there are no prospective randomized data comparing the oncologic efficacy of minimally invasive and open interval debulking surgery in epithelial ovarian cancer.

Primary Objective: The primary objective of this study is to examine whether minimally invasive surgery is non-inferior to laparotomy in terms of disease-free survival in women with advanced stage epithelial ovarian cancer that responded to three or four cycles of neoadjuvant chemotherapy.

Study Hypothesis: We hypothesize that in patients who had a complete or partial response to neoadjuvant chemotherapy, minimally invasive interval debulking surgery is not inferior to laparotomy.

Trial Design: The Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE) trial is an international, prospective, randomized, multicenter, non-inferiority phase III trial to compare minimally invasive surgery vs laparotomy in women with advanced stage high-grade epithelial ovarian cancer that had a complete or partial response to three or four cycles of neoadjuvant chemotherapy and normalization of CA-125. The first 100 participants will be enrolled into a pilot lead-in to determine feasibility. The study will be considered feasible and will continue to Phase III under the following conditions: the accrual rate reaches at least 80% of the target rate after all pilot sites are open; the crossover rate in the minimally invasive group is less than 25%; and the difference of complete gross resection between the minimally invasive and open group is less than 20%. If the study is determined to be feasible, all remaining participants will be enrolled into the Phase III stage.

Major Inclusion/exclusion Criteria: Patients with stage IIIC or IV high-grade epithelial ovarian, primary peritoneal or fallopian tube carcinoma who had a complete or partial response to three or four cycles of neoadjuvant chemotherapy based on imaging and normalization of CA-125 will be enrolled. Patients with evidence of tumor not amenable to minimally invasive resection on pre-operative imaging will be excluded.

Primary Endpoint: The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.

Sample Size: To demonstrate non-inferiority with a margin of 33% in the hazard ratio (HR=1.33), 549 patients will be randomized.
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http://dx.doi.org/10.1136/ijgc-2020-001584DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493891PMC
September 2020

A prospective randomized trial comparing liposomal bupivacaine vs standard bupivacaine wound infiltration in open gynecologic surgery on an enhanced recovery pathway.

Am J Obstet Gynecol 2021 01 16;224(1):70.e1-70.e11. Epub 2020 Jul 16.

Departments of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.

Background: Value in healthcare is reflected by patient-centered outcomes of care per health dollar expended. Although liposomal bupivacaine is more expensive, it has been shown to provide prolonged analgesia (up to 72 hours).

Objective: This study aimed to evaluate whether the addition of liposomal bupivacaine to standard bupivacaine could decrease opioid intake and improve pain control after laparotomy for gynecologic surgery compared with standard bupivacaine alone in an enhanced recovery after surgery pathway.

Study Design: A prospective randomized controlled single-blinded trial of wound infiltration with liposomal bupivacaine plus 0.25% bupivacaine (study arm) vs 0.25% bupivacaine (control arm) was performed at a National Cancer Institute-designated tertiary referral cancer center. Participants were patients aged ≥18 years undergoing exploratory laparotomy for a gynecologic indication. All patients were treated on an enhanced recovery pathway including local wound infiltration before closure. In this study, 266 mg of liposomal bupivacaine (free base; equal to 300 mg bupivacaine HCL)+150 mg of bupivacaine mixed in the same syringe was used in the study arm, and 150 mg of bupivacaine was used in the control arm. The primary outcome was the proportion of patients who were opioid-free within 48 hours after surgery. Secondary outcomes included number of opioid-free days from postoperative day 0 to postoperative day 3, days to first opioid administration, morphine equivalent daily dose, and patient-reported outcomes collected with the MD Anderson Symptom Inventory. The MD Anderson Symptom Inventory was administered as a preoperative baseline, daily while hospitalized, and at least weekly for 8 weeks after discharge. All outcomes were prespecified before data collection.

Results: In this study, 102 patients were evaluated. Among them, 16.7% of patients in the study arm received no opioids up to 48 hours compared with 14.8% in the control arm (P=.99). There were no significant differences in the amount of intraoperative opioids administered or days to first opioid use. There was no significant difference between the 2 arms in median cumulative morphine equivalent daily dose (21.3 [study arm] vs 33.8 [control arm]; P=.36) or between the groups in morphine equivalent daily dose per individual day. There were no significant differences in patient-reported pain or interference with walking between the 2 arms or other patient-reported outcomes.

Conclusion: Within an enhanced recovery after surgery pathway, adding liposomal bupivacaine to 0.25% bupivacaine wound infiltration did not decrease the proportion of patients who were opioid-free within 48 hours after surgery, did not decrease opioid intake, or did not improve patient's self-reported pain and functional recovery compared with standard bupivacaine.
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http://dx.doi.org/10.1016/j.ajog.2020.07.017DOI Listing
January 2021

Intracardiac intravenous leiomyomatosis: diagnosis and management.

Int J Gynecol Cancer 2020 08 7;30(8):1243-1247. Epub 2020 Jul 7.

Gynecologic Oncology, MD Anderson Cancer Center, Houston, Texas, USA.

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http://dx.doi.org/10.1136/ijgc-2020-001614DOI Listing
August 2020

Measurement of tumor size in early cervical cancer: an ever-evolving paradigm.

Int J Gynecol Cancer 2020 08 6;30(8):1215-1223. Epub 2020 Jul 6.

Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

The major tenets in accurately assessing tumor size in patients with early stage cervical cancer currently include physical examination, imaging studies, and pathologic evaluation. It is estimated that when comparing clinical stage based on physical examination and final pathology, the concordance diminishes as stage increases: 85.4%, 77.4%, 35.3%, and 20.5% for stage IB1, IB2, IIA, and IIB, respectively. Vaginal involvement and larger tumor diameter are considered the main causes of stage inaccuracy. When considering imaging studies, magnetic resonance imaging (MRI) provides the highest level of accuracy in the assessment of cervical tumor size. Its accuracy in determining tumor location within the cervix is approximately 91% and in predicting tumor size 93%. MRI imaging is also significantly more accurate in measuring tumor size, delineating cervical tumor boundaries, and local tumor extension when compared with computed tomography (CT) scan. When comparing with pelvic ultrasound, the accuracy of both imaging techniques (MRI and pelvic ultrasound) in the assessment of tumor size in small versus large tumors is comparable. Pertaining to pathology, the depth of invasion should be measured by convention from the nearest surface epithelium, which equates to tumor thickness. In the setting where tumor is found both in the conization and hysterectomy specimen, the horizontal extent should be measured by summing the maximum horizontal measurement in the different specimens and the depth of invasion measured as the maximum depth in either specimen. A new pattern-based classification for endocervical adenocarcinomas recommends the description of patterns of invasion for human papillomavirus (HPV)-related adenocarcinomas as this is associated with differing risks of lymph node involvement.
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http://dx.doi.org/10.1136/ijgc-2020-001436DOI Listing
August 2020

Survival After Minimally Invasive vs Open Radical Hysterectomy for Early-Stage Cervical Cancer: A Systematic Review and Meta-analysis.

JAMA Oncol 2020 07;6(7):1019-1027

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.

Importance: Minimally invasive techniques are increasingly common in cancer surgery. A recent randomized clinical trial has brought into question the safety of minimally invasive radical hysterectomy for cervical cancer.

Objective: To quantify the risk of recurrence and death associated with minimally invasive vs open radical hysterectomy for early-stage cervical cancer reported in observational studies optimized to control for confounding.

Data Sources: Ovid MEDLINE, Ovid Embase, PubMed, Scopus, and Web of Science (inception to March 26, 2020) performed in an academic medical setting.

Study Selection: In this systematic review and meta-analysis, observational studies were abstracted that used survival analyses to compare outcomes after minimally invasive (laparoscopic or robot-assisted) and open radical hysterectomy in patients with early-stage (International Federation of Gynecology and Obstetrics 2009 stage IA1-IIA) cervical cancer. Study quality was assessed with the Newcastle-Ottawa Scale and included studies with scores of at least 7 points that controlled for confounding by tumor size or stage.

Data Extraction And Synthesis: The Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist was used to abstract data independently by multiple observers. Random-effects models were used to pool associations and to analyze the association between surgical approach and oncologic outcomes.

Main Outcomes And Measures: Risk of recurrence or death and risk of all-cause mortality.

Results: Forty-nine studies were identified, of which 15 were included in the meta-analysis. Of 9499 patients who underwent radical hysterectomy, 49% (n = 4684) received minimally invasive surgery; of these, 57% (n = 2675) received robot-assisted laparoscopy. There were 530 recurrences and 451 deaths reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent minimally invasive radical hysterectomy compared with those who underwent open surgery (hazard ratio [HR], 1.71; 95% CI, 1.36-2.15; P < .001), and the hazard of death was 56% higher (HR, 1.56; 95% CI, 1.16-2.11; P = .004). Heterogeneity of associations was low to moderate. No association was found between the prevalence of robot-assisted surgery and the magnitude of association between minimally invasive radical hysterectomy and hazard of recurrence or death (2.0% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -3.4% to 7.7%]) or all-cause mortality (3.7% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -4.5% to 12.6%]).

Conclusions And Relevance: This systematic review and meta-analysis of observational studies found that among patients undergoing radical hysterectomy for early-stage cervical cancer, minimally invasive radical hysterectomy was associated with an elevated risk of recurrence and death compared with open surgery.
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http://dx.doi.org/10.1001/jamaoncol.2020.1694DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7290695PMC
July 2020

Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial.

Lancet Oncol 2020 06;21(6):851-860

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Background: In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial.

Methods: The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211.

Findings: Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7-4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]).

Interpretation: Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer.

Funding: MD Anderson Cancer Center and Medtronic.
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http://dx.doi.org/10.1016/S1470-2045(20)30081-4DOI Listing
June 2020

European Society of Gynaecological Oncology 2019 meeting summaries.

Int J Gynecol Cancer 2020 04;30(4):448-455

Gynecologic Oncology, MD Anderson Cancer Center, Houston, Texas, USA

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http://dx.doi.org/10.1136/ijgc-2020-001305DOI Listing
April 2020

Revised 2018 International Federation of Gynecology and Obstetrics (FIGO) cervical cancer staging: A review of gaps and questions that remain.

Int J Gynecol Cancer 2020 06 1;30(6):873-878. Epub 2020 Apr 1.

Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Recently the revised 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system for cervical cancer was published. In this most recent classification, imaging modalities and pathologic information have been added as tools to determine the final stage of the disease. Although there are many merits to this new staging for cervical cancer, including more detailed categorization of early-stage disease as well as information on nodal distribution, the classification falls short in clarifying areas of controversy in the staging system. Many unanswered questions remain and, as such, a number of gaps lead to further debate in the interpretation of relevant clinical data. Factors such as measurement of tumor size, definition of parametrial involvement, ovarian metastases, lower uterine segment extension, lymph node metastasis, and imaging modalities are explored in this review. The goal is to focus on items that deserve further discussion and clarification in the most recent FIGO staging for cervical cancer.
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http://dx.doi.org/10.1136/ijgc-2020-001257DOI Listing
June 2020

COVID-19 Global Pandemic: Options for Management of Gynecologic Cancers.

Int J Gynecol Cancer 2020 05 27;30(5):561-563. Epub 2020 Mar 27.

Gynecologic Oncology, Clinica ASTORGA, Medellin, Colombia.

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http://dx.doi.org/10.1136/ijgc-2020-001419DOI Listing
May 2020

World Health Organization call for action to eliminate cervical cancer globally.

Int J Gynecol Cancer 2020 04 2;30(4):426-427. Epub 2020 Mar 2.

Department of Immunization, Vaccines and Biologicals, WHO, Geneve, Switzerland.

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http://dx.doi.org/10.1136/ijgc-2020-001285DOI Listing
April 2020

International Gynecologic Cancer Society 2019 meeting summary.

Int J Gynecol Cancer 2020 02;30(2):167-173

Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, Texas, USA.

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http://dx.doi.org/10.1136/ijgc-2019-001146DOI Listing
February 2020

Quality indicators in cervical cancer surgery: a valiant step in the right direction.

Authors:
Pedro T Ramirez

Int J Gynecol Cancer 2020 01;30(1):1-2

Gynecologic Oncology, MD Anderson Cancer Center, Houston, TX 77030, USA

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http://dx.doi.org/10.1136/ijgc-2019-001075DOI Listing
January 2020

Changing treatment landscape for early cervical cancer: outcomes reported with minimally invasive surgery compared with an open approach.

Curr Opin Obstet Gynecol 2020 02;32(1):22-27

Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.

Purpose Of Review: The aim of the article is to review recent studies that compare the oncologic efficacy of minimally invasive radical hysterectomy with that of open radical hysterectomy.

Recent Findings: The Laparoscopic Approach to Cervical Cancer (LACC) trial, a randomized study design to test the hypothesis that minimally invasive radical hysterectomy is not inferior to open radical hysterectomy, was stopped early by the data and safety monitoring committee after enrolling 631 of a planned 740 patients. The disease-free survival rate at 4.5 years was 86% among women assigned to minimally invasive surgery and 96.5% in those who underwent open surgery (hazard ratio [HR] 3.74; 95% confidence interval [CI] 1.63-8.58). Minimally invasive surgery was also associated with inferior overall survival (HR 6.00; 95% CI 1.44-12.7). Recent well designed, adequately powered observational studies mostly corroborate the findings of the LACC trial.

Summary: After a decade of widespread acceptance and increasing popularity, the preponderance of evidence now suggests that minimally invasive radical hysterectomy for cervical cancer confers an excess risk of recurrence and death compared with open abdominal radical hysterectomy.
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http://dx.doi.org/10.1097/GCO.0000000000000598DOI Listing
February 2020

Impact of compliance with an enhanced recovery after surgery pathway on patient outcomes in open gynecologic surgery.

Int J Gynecol Cancer 2019 11 9;29(9):1417-1424. Epub 2019 Oct 9.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Objective: The aim of this study was to evaluate if varying levels of compliance with an enhanced recovery after surgery (ERAS) protocol impacted post-operative outcomes (length of stay, complications, readmissions, and re-operations) in gynecologic surgery at a tertiary center.

Methods: We included 584 patients who had open gynecologic surgery between November 1, 2014 and December 31, 2016. Patients were categorized into subgroups according to their date of surgery from the time of the ERAS protocol implementation. Patients were categorized by their per cent compliance into two groups:<80% versus ≥80%. We analyzed compliance with the elements of the protocol over time and its relation with post-operative outcomes, length of stay, post-operative complications, readmission, and re-operations rates. We modeled the probability of having a post-operative complication within 30 days of surgery as a function of overall compliance.

Results: Overall compliance was 72.3%. Patients with compliance ≥80% had significantly less complications (P<0.001) and shorter length of stay (P<0.001). Readmission and re-operation rates were not impacted by compliance (P=0.182, P=0.078, respectively). Avoidance of salt water overload, early mobilization, early oral nutrition, and early removal of Foley catheter were significantly associated with less post-operative complications within 30 days.

Conclusions: Compliance with an ERAS pathway exceeding 80% was associated with lower complication rates and shorter length of stay without impacting on re-operations or readmissions.
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http://dx.doi.org/10.1136/ijgc-2019-000622DOI Listing
November 2019