Determining post-operative morbidity and mortality following gynecological oncology surgery: protocol for a multicenter, international, prospective cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative-GO SOAR).

BACKGROUND: The Global Gynaecological Oncology Surgical Outcomes Collaborative (GO SOAR) aims to develop a network of gynecological oncology surgeons, surgical departments, and other interested parties that will have the long-term ability to collaborate on outcome studies. The protocol for the first collaborative study is presented here. PRIMARY OBJECTIVE: To evaluate international variation in 30-day post-operative morbidity and mortality following gynecological oncology surgery between very high/high and medium/low human development index country settings. HYPOTHESIS: There is no variation in post-operative morbidity and mortality following gynecological oncology surgery between very high/high and medium/low human development index country settings. STUDY DESIGN: International, multicenter, prospective cohort study. Patient data will be collected over a consecutive 30-day period through gynecological oncology multidisciplinary teams/tumor boards and clinics across different human development index country groups. All data are collected on a customized, secure, password protected, central REDCap database. MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion criteria include women aged ≥18 years undergoing elective/emergency, curative/palliative surgery for primary/recurrent tubo-ovarian/peritoneal, endometrial, cervical, vulval, vaginal, gestational trophoblastic malignancies. Surgical modality may be open, minimal access (laparoscopic/robotic), or vaginal. PRIMARY ENDPOINT: 30-day post-operative morbidity and mortality defined as per Clavien-Dindo classification system. SAMPLE SIZE: 1100 (550/arm). ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: It is estimated recruitment will be completed by 2022 and results published by 2023. TRIAL REGISTRATION: ClinicalTrials.gov registry: NCT04579861 (https://clinicaltrials.gov/ct2/show/NCT04579861).

Vascular repairs in gynecologic operations are uncommon but predict major morbidity and mortality.

OBJECTIVE: Gynecologic surgery has potential for adjunct vascular interventions, given the proximity of major intra-abdominal and pelvic blood vessels. Our goal was to determine contemporary incidence, associations, and outcomes of vascular repairs in gynecologic operations. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database (2005-2017) was queried for patients undergoing elective gynecologic operations. Vascular repairs were performed concurrently or during reoperation. Univariable and multivariable analyses evaluated associations with vascular repairs and 30-day morbidity. RESULTS: A total of 201,224 gynecologic operations were identified: hysterectomy (88.3%), myomectomy (5.9%), adnexal surgery (3.5%), vulvovaginectomy/other (1.1%), nonadnexal tumor or cyst excision (0.5%), ectopic pregnancy treatment (0.4%), and pelvic lymphadenectomy (0.3%). There were 187 vascular repairs in 176 (0.09%) patients. Repairs were typically concurrent (89.8%) and most commonly included open abdominal blood vessel repair (51.8%), major abdominal artery ligation (25%), vena cava reconstruction/ligation (6%), common iliac vein ligation (4.2%), and aorta/great vessel repair (4.2%). A minority were performed endovascularly (1.7%). Patients undergoing vascular repairs were older (56 vs 46 years), were more likely to have an open vs minimally invasive/vaginal operation (71.6% vs 28.4%), and were more likely to have a hysterectomy (85.2%; P < .001 for all). In multivariable analysis, vascular repairs were observed more often with hysterectomy (odds ratio [OR]; 7.63, 95% confidence interval [CI], 2.28-25.55; P = .001) and open vs minimally invasive/vaginal operations (OR, 5.24; 95% CI, 2.64-10.42; P < .001). Vascular repairs were also more common for patients with malignant disease (OR, 2.84; 95% CI, 1.78-4.53; P < .001), patients assigned to American Society of Anesthesiologists class 3 or class 4 (OR, 1.85; CI, 1.36-2.53; P = .002), and patients without obesity (OR, 1.45; 95% CI, 1.08-1.96; P = .014). Vascular repairs independently predicted major morbidity and mortality (OR, 7.26; 95% CI, 5.26-10.03; P < .001) after adjustment for open operative approach, American Society of Anesthesiologists class 3 or class 4, and hysterectomy. CONCLUSIONS: Whereas vascular repairs during gynecologic operations are rare, they are associated with morbidity and mortality. These findings provide an evidence base for risk assessment and informed consent.

Mortality Rates in Benign Laparoscopic and Robotic Gynecologic Surgery: A Systematic Review and Meta-analysis.

OBJECTIVE: To review mortality rates in benign gynecologic minimally invasive laparoscopic and robotic surgery (MIS) and the rates associated with commonly performed MIS procedures. DATA SOURCES: An electronic-based search was performed on PubMed, Embase, Scopus, Web of Science, and Cochrane Database for articles published in the last 10 years in English, French, German, Spanish, and Italian. METHODS OF STUDY SELECTION: All MIS articles in benign gynecology reporting operative mortality (within 30 days) were reviewed. TABULATION, INTEGRATION, AND RESULTS: The articles identified through the aforementioned search criteria were independently evaluated by the first 2 authors. The Newcastle-Ottawa scale for observational studies and Cochrane risk-of-bias assessment tool for randomized controlled trials were used to assess the risk of bias. Meta-analysis was applied to calculate pooled mortality rates using the inverse-variance method. Twenty-one articles (124 216 patients) were included. Operative mortality from any benign MIS (laparoscopy and robotics) procedure was 1:6456 (95% confidence interval [CI]: 1:3946-1:10 562). Studies were then grouped based on the surgical procedure. The mortality rate for hysterectomy (119 721 patients), sacrocolpopexy, and adnexal surgery and diagnostic laparoscopy was 1:6814 (95% CI: 1:4119-1:11 275), 1:1246 (95% CI: 1:36-1:44 700), and 1:2245 (95% CI: 1:45-1:113 372), respectively. Eighteen articles reported operative mortality for laparoscopic surgery and 4 for robotic surgery. CONCLUSION: Operative mortality in benign minimally invasive gynecologic surgery is low, and mortality for laparoscopic and robotic approaches appears to be similar.

Mortality Rates in Laparoscopic and Robotic Gynecologic Oncology Surgery: A Systemic Review and Meta-analysis.

OBJECTIVE: To review early operative mortality (<30 days) for minimally invasive surgery (MIS), laparoscopic and robotic, in gynecologic oncology. DATA SOURCES: An electronic-based search was performed in PubMed, Embase, Scopus, Web of Science, and Cochrane Database in the last 10 years. METHODS OF STUDY SELECTION: All MIS studies in gynecologic oncology reporting operative mortality from any cause (within 30 days) were included. Studies were excluded if mortality was not reported for MIS or included benign gynecology. TABULATION, INTEGRATION, AND RESULTS: Meta-analysis was applied to calculate pooled mortality rates using the inverse-variance method. The relative risks and their corresponding 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel method. Sixty-five studies were included (39 183 patients) for an operative mortality of 1:381 (95% CI, 1:306-1:474). Studies were subselected and analyzed by procedures, malignancy, and surgical approach. Of 39 183 patients, 38 619 underwent any type of hysterectomy for a mortality of 1:379 (95% CI, 1:304-1:472). The mortality was 1:281 (95% CI, 1:169-1:469) for a laparoscopic approach and 1:476 (95% CI, 1:365-1:620) for a robotic approach. There were 3369 patients with early cervical cancer undergoing radical hysterectomy with a mortality of 1:2049 (95% CI, 1:356-1:11 832). There were 3501 patients with endometrial cancer undergoing hysterectomy with lymph node dissection with a mortality of 1:195 (95% CI, 1:109-1:349). There were 418 patients with ovarian cancer undergoing MIS procedures with a mortality of 1 in 685 (95% CI, 1:44-1:10971). Eleven studies with 4037 patients compared mortality of gynecologic oncology surgery of any type (laparoscopic [1:626] vs robotic [1:716] for a relative risk of 1.12 [95% CI, 0.35-3.49]). CONCLUSION: The overall operative mortality for minimally invasive surgery in gynecologic oncology is 1 in 381 (95% CI, 1:306-1:474). For patients with early cervical cancer, it is 1:2049 (95% CI, 1:356-1: 11832), for endometrial cancer with node dissection it is 1:195 (95% CI, 1:109-1:349), and for ovarian cancer it is 1 in 685 (95% CI, 1:44-1:10 971). There is no difference between the type of MIS approach for patients undergoing any type of gynecologic oncology surgery.

Patient Safety in Outpatient Procedures.

The past 4 decades have seen a remarkable re-engineering of health care, particularly with respect to surgical services and the formalization of patient safety protocols. As various forces drove many surgical procedures to the ambulatory setting, many advantages, and perhaps several disadvantages, quickly became apparent. In some studies, adverse events were found to be more common in office settings for instance, and it was quickly recognized that the formal quality controls that had evolved in the hospital setting were not always transferred to the outpatient facility. This article traces the development of health care's response to this challenge.

Laparoscopic Compared With Open Surgery for Severe Pelvic Inflammatory Disease and Tubo-Ovarian Abscess.

OBJECTIVE: To compare operative outcomes of laparoscopic surgery compared with laparotomy in patients with moderate to severe pelvic inflammatory disease (PID). METHODS: Using the Diagnosis Procedure Combination database, a national inpatient database for acute-care inpatients in Japan, we performed a large, nationwide retrospective cohort study. We identified all patients aged 18 years or older who were diagnosed with PID with or without tubo-ovarian abscess and were admitted to a participating hospital from July 2010 to March 2016. We excluded patients who were pregnant, had cancer, or for whom data were missing. We compared outcomes between patients who underwent laparoscopic surgery compared with laparotomy. Propensity score-matched analyses were performed to compare operative outcomes including postoperative length of stay, surgical complications, in-hospital deaths, and revision surgery. RESULTS: Of 27,841 patients with PID, 4,419 (15.9%) underwent surgical intervention. From among 749 women undergoing laparoscopy and 3,670 women undergoing laparotomy for PID, 740 pairs were created for propensity score matching. The laparoscopic group had shorter operation duration (125 vs 166 min), fewer blood transfusions (4.7% vs 10.0%), and shorter length of hospital stay (median 5 days vs 7 days; all P<.001) compared with the laparotomy group. There were no significant differences between groups for in-hospital deaths, surgical complications, and revision surgery. CONCLUSION: Laparoscopic surgery may have clinical advantages over laparotomy in patients diagnosed with severe PID.

Perioperative morbi-mortality after pelvic organ prolapse surgery in a large French national database from gynecologist surgeons.

OBJECTIVE: To assess morbidity and mortality following pelvic organ prolapse surgery in France, irrespective of the surgical technique, using a broad national database. MATERIALS AND METHODS: This descriptive multicenter retrospective study was conducted using a database populated via an application run by a professional association. RESULTS: 286 gynecologists contributed data to the database. Of the 4322 surgeries analyzed, an abdominal approach was used in 975 of cases (22.5%), a vaginal approach in 3277 (75.9%), and a combined approach in 68 (1.6%). After one year, abdominal surgery was associated with higher rates of de novo urinary incontinence, constipation, and intestinal obstruction, whereas vaginal surgery was associated with higher rates of urinary retention, hematoma, de novo chronic pain, and vaginal mesh extrusion. There was no significant difference between the groups in the incidence of severe complications. After one year, vaginal mesh-augmented cystocele repair was associated with higher rates of de novo urinary incontinence, de novo chronic pain, and reoperation than native tissue repair. Mesh repair was also associated with higher rates of severe complications at one year. CONCLUSION: After pelvic organ prolapse surgery, the perioperative morbidity and mortality associated with transabdominal and transvaginal approaches are similar. However, transvaginal mesh repair is associated with greater perioperative morbidity than transvaginal native tissue repair.

Racial Disparities in the Receipt of Guideline Care and Cancer Deaths for Women with Ovarian Cancer.

BACKGROUND: Black women with ovarian cancer experience worse survival than white women. Receipt of guideline care improves survival, yet care may vary by race. We assessed rates of guideline care and role of guideline treatment on survival disparities. METHODS: This retrospective cohort analysis used the NCI's Patterns of Care data for women diagnosed with ovarian cancer, 2002 and 2011 (weighted n = 3,999), with follow-up through December 12, 2014. Logistic regression included patient characteristics, insurance, and gynecologic oncologist (GO) consultation to produce adjusted standardized percentages of women receiving guideline treatment by race. Cox proportional hazards analysis assessed risk of ovarian cancer death. RESULTS: Guideline care was significantly lower for black women compared with white women (adjusted 27.5% vs. 34.1%). Increased receipt of guideline care was associated with GO consultation, younger ages, stage, and insurance. Rates of GO consultation were comparable for black and white women, approximately 60%. Black women were more likely to receive no surgery or no chemotherapy if they did not consult a GO. The unadjusted death risk was significantly higher in black women (HR = 1.33). After adjusting for receipt of guideline care and other factors, black and white women had similar risk of death (HR = 1.05). CONCLUSIONS: Race was not associated with risk of death when guideline care was included in multivariate survival models. However, black patients received less guideline care. GO consultation significantly increased receipt of guideline care. IMPACT: Research is needed to understand treatment perspectives for black patients and their providers to increase the receipt of guideline care and reduce survival disparities.

Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials.

BACKGROUND: Individual patient data from two randomised trials comparing neoadjuvant chemotherapy with upfront debulking surgery in advanced tubo-ovarian cancer were analysed to examine long-term outcomes for patients and to identify any preferable therapeutic approaches for subgroup populations. METHODS: We did a per-protocol pooled analysis of individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 55971 trial (NCT00003636) and the Medical Research Council Chemotherapy Or Upfront Surgery (CHORUS) trial (ISRCTN74802813). In the EORTC trial, eligible women had biopsy-proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or IV invasive epithelial tubo-ovarian carcinoma. In the CHORUS trial, inclusion criteria were similar to those of the EORTC trial, and women with apparent FIGO stage IIIA and IIIB disease were also eligible. The main aim of the pooled analysis was to show non-inferiority in overall survival with neoadjuvant chemotherapy compared with upfront debulking surgery, using the reverse Kaplan-Meier method. Tests for heterogeneity were based on Cochran's Q heterogeneity statistic. FINDINGS: Data for 1220 women were included in the pooled analysis, 670 from the EORTC trial and 550 from the CHORUS trial. 612 women were randomly allocated to receive upfront debulking surgery and 608 to receive neoadjuvant chemotherapy. Median follow-up was 7·6 years (IQR 6·0-9·6; EORTC, 9·2 years [IQR 7·3-10·4]; CHORUS, 5·9 years [IQR 4·3-7·4]). Median age was 63 years (IQR 56-71) and median size of the largest metastatic tumour at diagnosis was 8 cm (IQR 4·8-13·0). 55 (5%) women had FIGO stage II-IIIB disease, 831 (68%) had stage IIIC disease, and 230 (19%) had stage IV disease, with staging data missing for 104 (9%) women. In the entire population, no difference in median overall survival was noted between patients who underwent neoadjuvant chemotherapy and upfront debulking surgery (27·6 months [IQR 14·1-51·3] and 26·9 months [12·7-50·1], respectively; hazard ratio [HR] 0·97, 95% CI 0·86-1·09; p=0·586). Median overall survival for EORTC and CHORUS patients was significantly different at 30·2 months (IQR 15·7-53·7) and 23·6 months (10·5-46·9), respectively (HR 1·20, 95% CI 1·06-1·36; p=0·004), but was not heterogeneous (Cochran's Q, p=0·17). Women with stage IV disease had significantly better outcomes with neoadjuvant chemotherapy compared with upfront debulking surgery (median overall survival 24·3 months [IQR 14·1-47·6] and 21·2 months [10·0-36·4], respectively; HR 0·76, 95% CI 0·58-1·00; p=0·048; median progression-free survival 10·6 months [7·9-15·0] and 9·7 months [5·2-13·2], respectively; HR 0·77, 95% CI 0·59-1·00; p=0·049). INTERPRETATION: Long-term follow-up data substantiate previous results showing that neoadjuvant chemotherapy and upfront debulking surgery result in similar overall survival in advanced tubo-ovarian cancer, with better survival in women with stage IV disease with neoadjuvant chemotherapy. This pooled analysis, with long-term follow-up, shows that neoadjuvant chemotherapy is a valuable treatment option for patients with stage IIIC-IV tubo-ovarian cancer, particularly in patients with a high tumour burden at presentation or poor performance status. FUNDING: National Cancer Institute and Vlaamse Liga tegen kanker (Flemish League against Cancer).

Morbidity and Mortality Risk Assessment in Gynecologic Oncology Surgery Using the American College of Surgeons National Surgical Quality Improvement Program Database.

INTRODUCTION: Gynecologic oncology patients represent a distinct patient population with a variety of surgical risks. The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database provides an opportunity to analyze large cohorts of patients over extended periods with high accuracy. Our goal was to develop a postoperative risk assessment calculator capable of providing a standardized, objective means of preoperatively identifying high-risk patients in the gynecologic oncology population. METHODS: We queried the ACS NSQIP database for gynecologic oncology patients from 2005 to 2013. Multivariate logistic regression was performed to generate predictive models specific for 30-day postoperative mortality and major morbidity. RESULTS: There were 12,831 patients with a primary gynecologic malignancy identified: 7847 uterine, 3366 adnexal, 1051 cervical, and 567 perineum cancers. In this cohort, 125 (0.97%) patients died, and 784 (6.11%) major morbidity events were recorded within 30 days of their surgery. For 30-day mortality, the mean calculated predictive probability was 0.128 (SD, 0.219) compared with 0.009 (SD, 0.027) in patients alive 30 days postoperatively (P < 0.0001). The mean predictive probability of major morbidity was 0.097 (SD, 0.095) compared with 0.059 (SD, 0.043) in patients who did not experience major morbidity 30 days postoperatively (P < 0.0001). CONCLUSIONS: Using NSQIP data, these predictive models will help to determine patients at risk for 30-day mortality and major morbidity. Further clinical validation of these models is required.

Laparoscopic Assessment to Determine the Likelihood of Achieving Optimal Cytoreduction in Patients Undergoing Primary Debulking Surgery for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of laparoscopic assessment to determine the likelihood of achieving optimal cytoreduction (OC) in patients undergoing primary debulking surgery (PDS) for ovarian cancer. METHODS: All patients who underwent diagnostic laparoscopy and PDS at our institution from January 2008 to December 2013 were identified. We determined the likelihood of achieving optimal cytoreduction by laparoscopic assessment based on tumor site, pattern of spread, and disease burden. Sensitivity was defined as the number of patients who achieved optimal cytoreduction after laparoscopic assessment divided by the number of patients with disease deemed resectable by laparoscopy. RESULTS: We identified 55 patients during study period. Twenty-one of the 55 patients (38%) were early stage disease. Six (10.9%) patients had disease deemed unresectable and 49 (89.1%) had disease deemed resectable at the time of laparoscopy. OC was achieved in 48 of 49 (97.9%) patients. The sensitivity of laparoscopy in predicting OC was 98% (95% confidence interval, 89.3%-99.9%). The operation was completed laparoscopically in 23 of 49 patients (47%); in 26 of 49 (53%), PDS was performed by laparotomy. There were no port site metastases reported. The rate of postoperative complications was 16%. With a median follow-up of 30 months, the median overall survival was not reached and the 75th percentile for overall survival was 37 months. CONCLUSIONS: Laparoscopy was shown to have a high sensitivity in predicting OC and is a feasible tool in triaging patients with ovarian cancer. Laparoscopy is not associated with adverse surgical outcomes.

Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial.

BACKGROUND: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer. METHODS: PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup. Eligible women had high-risk endometrial cancer with FIGO 2009 stage I, endometrioid-type grade 3 with deep myometrial invasion or lymph-vascular space invasion (or both), endometrioid-type stage II or III, or stage I to III with serous or clear cell histology. Women were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or radiotherapy and chemotherapy (consisting of two cycles of cisplatin 50 mg/m2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2) using a biased-coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The co-primary endpoints were overall survival and failure-free survival. We used the Kaplan-Meier method, log-rank test, and Cox regression analysis for final analysis by intention to treat and adjusted for stratification factors. The study was closed on Dec 20, 2013, after achieving complete accrual; follow-up is ongoing. PORTEC-3 is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138. RESULTS: 686 women were enrolled between Nov 23, 2006, and Dec 20, 2013. 660 eligible patients were included in the final analysis, of whom 330 were assigned to chemoradiotherapy and 330 were assigned to radiotherapy. Median follow-up was 60·2 months (IQR 48·1-73·1). 5-year overall survival was 81·8% (95% CI 77·5-86·2) with chemoradiotherapy versus 76·7% (72·1-81·6) with radiotherapy (adjusted hazard ratio [HR] 0·76, 95% CI 0·54-1·06; p=0·11); 5-year failure-free survival was 75·5% (95% CI 70·3-79·9) versus 68·6% (63·1-73·4; HR 0·71, 95% CI 0·53-0·95; p=0·022). Grade 3 or worse adverse events during treatment occurred in 198 (60%) of 330 who received chemoradiotherapy versus 41 (12%) of 330 patients who received radiotherapy (p<0·0001). Neuropathy (grade 2 or worse) persisted significantly more often after chemoradiotherapy than after radiotherapy (20 [8%] women vs one [1%] at 3 years; p<0·0001). Most deaths were due to endometrial cancer; in four patients (two in each group), the cause of death was uncertain. One death in the radiotherapy group was due to either disease progression or late treatment complications; three deaths (two in the chemoradiotherapy group and one in the radiotherapy group) were due to either intercurrent disease or late treatment-related toxicity. INTERPRETATION: Adjuvant chemotherapy given during and after radiotherapy for high-risk endometrial cancer did not improve 5-year overall survival, although it did increase failure-free survival. Women with high-risk endometrial cancer should be individually counselled about this combined treatment. Continued follow-up is needed to evaluate long-term survival. FUNDING: Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council Project Grant and Cancer Australia, L'Agenzia Italiana del Farmaco, and Canadian Cancer Society Research Institute.

Transjugular intrahepatic portosystemic shunt as a bridge to non-hepatic surgery in cirrhotic patients with severe portal hypertension: a systematic review.

BACKGROUND: Portal hypertension (PHTN) increases the risk of non-hepatic surgery in cirrhotic patients. This first systematic review analyzes the place of transjugular intrahepatic portosystemic shunt (TIPS) in preparation for non-hepatic surgery in such patients. METHODS: Medline, EMBASE, and Scopus databases were searched from 1990 to 2017 to identify reports on outcomes of non-hepatic surgery in cirrhotic patients with PHTN prepared by TIPS. Feasibility of TIPS and the planned surgery, and the short- and long-term outcomes of the latter were assessed. RESULTS: Nineteen studies (64 patients) were selected. TIPS was indicated for past history of variceal bleeding and/or ascites in 22 (34%) and 33 (52%) patients, respectively. The planned surgery was gastrointestinal tract cancer in 38 (59%) patients, benign digestive or pelvic surgery in 21 (33%) patients and others in 4 (6%) patients. The TIPS procedure was successful in all, with a nil mortality rate. All patients could be operated within a median delay of 30 days from TIPS (mortality rate = 8%; overall morbidity rate = 59.4%). One year overall survival was 80%. CONCLUSIONS: TIPS allows non-hepatic surgery in cirrhotic patients deemed non operable due to PHTN. Further evidence in larger cohort of patients is essential for wider applicability.

The Impact of Surgical Staging on the Prognosis of Mucinous Borderline Tumors of the Ovaries: A Multicenter Study.

BACKGROUND/AIM: The purpose of this study was to prove the effect of complete surgical staging of patients with mucinous borderline ovarian tumors (mBOTs) especially appendectomy on progression-free survival (PFS) and overall survival (OS). PATIENTS AND METHODS: The database of 14 gynecological oncology departments from Turkey and Germany were comprehensively searched for women who underwent primary surgery for an ovarian tumor between January 1, 1998, and December 31, 2015, and whose final diagnosis was mBOT. RESULTS: A total of 364 patients with mBOT with a median age of 43.1 years were included in this analysis. The median OS of all patients was 53.1 months. The majority of cases had Stage IA (78.6%). In univariate and multivariate analyses, radical surgery, omentectomy, appendectomy, lymphadenectomy, and adding adjuvant chemotherapy were not independent prognostic factors for PFS and OS. Furthermore, FIGO stage (≥IC vs.

Association Between Obesity and Perioperative Morbidity in Open Versus Laparoscopic Sacrocolpopexy.

OBJECTIVES: The aim of this study was to compare differences in 30-day perioperative morbidity and mortality for women undergoing open sacrocolpopexy (OSCP) versus laparoscopic sacrocolpopexy (LSCP) across all body mass index (BMI) groups and between patients of ideal versus elevated BMI (includes overweight, obese, and morbidly obese). MATERIALS AND METHODS: Data for this retrospective review were obtained from the American College of Surgeons-National Surgical Quality Improvement Project database using current procedural terminology. All women older than 18 years who underwent an OSCP or LSCP from 2005 to 2013 were included. Patients were divided into 4 BMI (weight [kg]/[height (m)]) subgroups: (1) less than 25, (2) 25 to 29.9, (3) 30 to 39.9, and (4) 40 or greater. The data were analyzed using Student t or χ test and Fisher exact test. RESULTS: A total of 4894 women underwent an OSCP or LSCP. Shorter operative times were observed with OSCP (P < 0.05) in all BMI groups except morbidly obese patients. Compared with patients of ideal body weight, overweight and obese patients had significantly longer operation times during LSCP (P < 0.05), a difference that was not observed during OSCP. For all BMI subgroups, the length of hospital stay was significantly shorter for LSCP (1 [1-1]) versus OSCP (2 [2-3]) (P < 0.05). Statistically significant increases in the rate of superficial surgical site infections were observed in OSCP in patients of both ideal and overweight BMIs (P < 0.05). CONCLUSIONS: Obesity increases the operative time during LSCP. For patients in all BMI groups, LSCP offers the benefit of shorter hospital stays when compared with OSCP.

Gynaecological laparoscopy deaths in Australia.

AIM: To determine the incidence and clinical features of laparoscopic gynaecological deaths in Australia. MATERIALS AND METHODS: Gynaecological laparoscopic mortality data were obtained from the National Coronial Information Systems (NCIS) and Australian State Coroners Courts, for the period July 1 2000 to December 31 2012. RESULTS: Eighteen deaths were identified, providing a mortality rate of approximately 1 per 70,000 laparoscopic procedures. The commonest cause of death was from bowel perforation, most of which were unrecognised during the operation. CONCLUSION: Gynaecologists should be trained to recognise and manage the rare event of laparoscopic perforation of a viscus or a blood vessel.

Evaluation of the National Surgical Quality Improvement Program Universal Surgical Risk Calculator for a gynecologic oncology service.

OBJECTIVES: The National Surgical Quality Improvement Program is aimed at preventing perioperative complications. An online calculator was recently published, but the primary studies used limited gynecologic surgery data. The purpose of this study was to evaluate the performance of the National Surgical Quality Improvement Program Universal Surgical Risk Calculator (URC) on the patients of a gynecologic oncology service. STUDY DESIGN: We reviewed 628 consecutive surgeries performed by our gynecologic oncology service between July 2012 and June 2013. Demographic data including diagnosis and cancer stage, if applicable, were collected. Charts were reviewed to determine complication rates. Specific complications were as follows: death, pneumonia, cardiac complications, surgical site infection (SSI) or urinary tract infection, renal failure, or venous thromboembolic event. Data were compared with modeled outcomes using Brier scores and receiver operating characteristic curves. Significance was declared based on P < 0.05. RESULTS: The model accurately predicated death and venous thromboembolic event, with Brier scores of 0.004 and 0.003, respectively. Predicted risk was 50% greater than experienced for urinary tract infection; the experienced SSI and pneumonia rates were 43% and 36% greater than predicted. For any complication, the Brier score 0.023 indicates poor performance of the model. CONCLUSIONS: In this study of gynecologic surgeries, we could not verify the predictive value of the URC for cardiac complications, SSI, and pneumonia. One disadvantage of applying a URC to multiple subspecialties is that with some categories, complications are not accurately estimated. Our data demonstrate that some predicted risks reported by the calculator need to be interpreted with reservation.

Colpocleisis: a safe, minimally invasive option for pelvic organ prolapse.

OBJECTIVE: This study aimed to describe the morbidity and mortality associated with colpocleisis and factors associated with improved outcomes. METHODS: We used University HealthSystem Consortium database, which included inpatient data from US hospitals. We included all women who underwent colpocleisis from 2002 to 2012. Centers were categorized geographically and by annual case volume. Cases were grouped by age and provider specialty. Outcome and readmission data from participating hospitals were compared between groups by analysis of variance and Tukey statistics. Average length of stay (LOS), intensive care unit (ICU) admission rate, complication rate, mortality rate, and readmission rate were calculated for each hospital and compared. RESULTS: Colpocleisis procedures (4776) were performed at 145 US medical centers. Forty-three percent of procedures were done on women older than 80 years, 52% on women 60 to 79 years, 3% on women 40 to 59 years, and 0.9% on women 20 to 39 years. Overall, rates of complications, ICU admission, and mortality were low with average rates of 6.82%, 2.80%, and 0.15%, respectively. High-volume centers had lower ICU admission and complications rates as well as a shorter LOS. Younger women had higher ICU admission and complication rates as well longer LOS. Stratification by provider specialty demonstrated higher ICU admission rates among cases performed by urologists as compared to cases performed by urogynecologists and general obstetrician-gynecologists. Complication rates were also higher among obstetrician-gynecologists and urologists as compared to urogynecologists. Length of stay was significantly longer when colpocleisis was performed by urologists rather than a urogynecologists. CONCLUSIONS: Colpocleisis is a safe minimally invasive procedure and outcomes are influenced by provider specialty and hospital volume.