Incidence of postoperative venous thromboembolism in patients with vulvar carcinoma undergoing vulvectomy with or without lymphadenectomy.

OBJECTIVES: The incidence of venous thromboembolism (VTE) following radical surgery for vulvar carcinoma remains poorly characterized, and recommendations for postoperative chemoprophylaxis are varied. Our objective was to assess the incidence of postoperative VTE in patients undergoing surgery for vulvar carcinoma and to determine if VTE incidence differs by radical vulvectomy with or without lymph node assessment. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried for patients with a diagnosis of vulvar cancer undergoing radical vulvectomy with or without lymph node assessment from 2012 to 2020. Clinical characteristics and 30-day incidence of VTE as well as other postoperative outcomes were abstracted. Variables were compared using Chi-square test and Fischer's exact test, as well as Kruskal-Wallis and Wilcoxon rank sum tests where appropriate. RESULTS: A total of 1672 patients underwent radical vulvectomy for vulvar carcinoma. 11 patients (0.7%) experienced postoperative VTE within 30 days of surgery. The incidence of VTE was similar when radical vulvectomy was performed alone or with lymph node dissection by any method (p = 0.116). Longer operative times (p = 0.033) and greater postoperative length of stay (p = 0.001) were associated with increased risk of postoperative VTE. CONCLUSIONS: The incidence of postoperative VTE is low in patients undergoing radical vulvar surgery in this national cohort. Inguinofemoral lymph node dissection by any method does not appear to be a risk factor for VTE when compared to radical vulvectomy alone. Further research is needed to determine if extended VTE prophylaxis is beneficial in this population.

Postpartum Opportunistic Salpingectomy Compared With Bilateral Tubal Ligation After Vaginal Delivery for Ovarian Cancer Risk Reduction: A Cost-Effectiveness Analysis.

OBJECTIVE: To compare the cost effectiveness of opportunistic salpingectomy and bilateral tubal ligation for sterilization immediately after vaginal delivery. METHODS: A cost-effectiveness analytic decision model was used to compare opportunistic salpingectomy with bilateral tubal ligation during vaginal delivery admission. Probability and cost inputs were derived from local data and available literature. Salpingectomy was assumed to be performed with a handheld bipolar energy device. The primary outcome was the incremental cost-effectiveness ratio (ICER) in 2019 U.S. dollars per quality-adjusted life-year (QALY) at a cost-effectiveness threshold of $100,000/QALY. Sensitivity analyses were performed to determine the proportion of simulations in which salpingectomy would be cost effective. RESULTS: Opportunistic salpingectomy was more cost effective than bilateral tubal ligation with an ICER of $26,150/QALY. In 10,000 patients desiring sterilization after vaginal delivery, opportunistic salpingectomy would result in 25 fewer ovarian cancer cases, 19 fewer ovarian cancer deaths, and 116 fewer unintended pregnancies than bilateral tubal ligation. In sensitivity analysis, salpingectomy was cost effective in 89.8% of simulations and cost saving in 13% of simulations. CONCLUSION: In patients undergoing sterilization immediately after vaginal deliveries, opportunistic salpingectomy is more cost effective and may be more cost saving than bilateral tubal ligation for reducing ovarian cancer risk.

Fluorescein Mapping in Vulvar Paget Disease.

BACKGROUND: Vulvar Paget disease often requires extensive and, in some cases, multiple resections to treat. A fluorescein-mapping procedure followed by a staged vulvectomy may be an effective technique to tailor resection and identify clinically occult lesions. TECHNIQUE: We describe a two-step procedure; first, intravenous fluorescein sodium is injected, and the vulva is illuminated with a Wood's lamp. Representative biopsies are obtained and correlated on final pathology with the extent of disease to develop a final plan for excision. Second, using fluorescein to identify the confirmed areas of disease, the appropriate excisional procedure is performed once mapping biopsy pathology is known. EXPERIENCE: We describe our experience with eight patients with vulvar Paget disease undergoing fluorescein mapping biopsies and staged vulvectomy. Using intravenous fluorescein sodium, all patients were found to have Paget disease beyond the visible margins of their gross lesions. No patients experienced a recurrence of Paget disease within a median follow-up time of 32 months, comparable with other directed methods of surgical resection. CONCLUSION: We report a technique for the injection of fluorescein sodium for the visualization of vulvar Paget disease capable of providing accurate surgical margins and identification of occult satellite lesions with a high degree of safety and a favorable cost profile. This staged approach to vulvectomy could offer improved accuracy of resection for vulvar Paget disease with few drawbacks.

When we open and close: Postoperative outcomes after aborted primary cytoreduction for ovarian cancer.

Objective: Little data exists to adequately counsel patients on the postsurgical morbidity and outcomes of an aborted primary debulking (AD) for advance stage epithelial ovarian cancer. Our objectives were to examine the 30-day morbidity of AD, percentage of patients who subsequently undergo neoadjuvant chemotherapy (NACT) and interval cytoreductive surgery (ICS), residual disease at ICS, and predictors for complications after AD. Methods: This was a single-institution retrospective analysis of patients who underwent AD for ovarian cancer from 01/2008 to 12/2020 using ICD-10 diagnoses and procedure codes. Patient demographics, perioperative metrics, and residual disease at ICS were collected. Thirty-day postoperative complications were graded by the Common Terminology Criteria for Adverse Events. Fisher's exact tests compared categorical and Wilcoxon rank-sum tests compared continuous variables. Logistic regression provided unadjusted odds ratios to identify predictors for post-AD complications. Results: Forty-eight patients underwent AD, and 43 were included for analysis. All had at least stage IIIC high grade serous ovarian cancer. All patients subsequently underwent ICS, with 21 (48.8%) achieving no residual macroscopic disease and 21 (48.8%) to ≤ 1 cm of macroscopic disease. After AD, 16 (37.2%) experienced at least one G ≥ 3 event within the first 30 days. The most common complication was gastrointestinal complications. Preoperative albumin was the only significant predictor for G ≥ 3 complication after AD. Conclusions: Approximately one-third of patients will experience at least one G ≥ 3 complications after AD. Complications may be anticipated by low preoperative albumin. Patients can be counseled that, after AD, proceeding to subsequent NACT and ICS and achieving optimal debulking is common.

Racial and ethnic enrollment disparities in clinical trials of poly(ADP-ribose) polymerase inhibitors for gynecologic cancers.

OBJECTIVES: Disparities persist in the enrollment of racial/ethnic groups in clinical trials for ovarian cancers. We sought to analyze the enrollment rates of patients by race/ethnicity in phase II/III clinical trials involving poly(ADP-ribose) polymerase (PARP) inhibitors for ovarian cancers and compare these to the racial/ethnic prevalence of ovarian cancers in the United States. METHODS: This study was a retrospective review of clinical trials registered with ClinicalTrials.gov. Studies included evaluated PARP inhibitors for the treatment of ovarian, fallopian tube, and primary peritoneal cancers. Enrollment rates for clinical trials were stratified by race/ethnicity and type of cancer. Enrollment fractions (EFs) were calculated using prevalence data from the Surveillance, Epidemiology, and End Results Program. Odds ratios (OR) and 95% confidence intervals (CI) were calculated to compare racial/ethnic group enrollment rates to Non-Hispanic (NH) White enrollment rates. RESULTS: Forty-eight trials were identified, 15 of which met inclusion criteria. The EFs for included trials, were 1.5% for NH-White, 0.47% for NH-Black, 0.33% for Hispanic, and 2.38% for Asian/Pacific Islander. Patients who identified as NH-Black and Hispanic were significantly underrepresented compared to those who identified as NH-White (OR 0.23, 95% CI [0.18-0.29] and OR 0.3, 95% CI [0.25-0.38] respectively, p < 0.001). CONCLUSIONS: NH-Black and Hispanic patients are significantly underrepresented in clinical trials evaluating PARP inhibitors for ovarian cancers compared to NH-White cohorts. Phase II/III trials assessing PARP inhibitors for ovarian cancers do not accurately represent the populations diagnosed with these malignancies. Enrollment strategies are needed to increase diversity in PARP inhibitor clinical trials for women's cancers.

Postoperative venous thromboembolism in gynecologic oncology patients undergoing minimally invasive surgery: Does modality matter?

OBJECTIVES: Minimally invasive surgery (MIS) is increasingly utilized for gynecologic cancers. While incidence of venous thromboembolism (VTE) after MIS is low, some guidelines recommend extended chemoprophylaxis for these patients undergoing MIS. Our objectives were to determine incidence of postoperative VTE in patients undergoing MIS, evaluate differences in the incidence by MIS modality and assess the need for extended chemoprophylaxis. METHODS: We conducted a retrospective cohort study including all patients undergoing MIS (robot-assisted, multi-port laparoscopy, single-port laparoscopy) for gynecologic cancers between January 2014 and December 2018 at our institution. Demographic and perioperative variables were collected. Patients <18 years, with benign pathology, or on preoperative anticoagulation were excluded. Chi-square, Fisher's exact test, and one-way ANOVA were performed to determine risk factors related to VTE occurrence. RESULTS: We identified 806 patients who underwent MIS with median age 61. Most had Stage I disease (81.5%) and uterine cancer (81.5%). Five VTE events occurred within 90 days following surgery (0.6%). Incidence of 90-day VTE did not differ between MIS modalities (p = 0.6). Patients with longer OR times (p = 0.004) were more likely to experience VTE. Age, smoking status, BMI, type of cancer and stage were not significant risk factors for VTE. CONCLUSIONS: The incidence of postoperative VTE in patients with gynecologic cancers undergoing MIS is low and does not appear to differ by MIS modality. Given the very low incidence of postoperative VTE, extended chemoprophylaxis is unlikely to benefit patients with gynecologic malignancies undergoing MIS procedures.

Postpartum Salpingectomy Compared With Standard Tubal Ligation After Vaginal Delivery.

OBJECTIVE: To compare operative outcomes of postpartum salpingectomy and tubal ligation after vaginal delivery. METHODS: This retrospective cohort study identified patients who underwent tubal sterilization between January 1, 2009, and December 31, 2019, at a large academic hospital, using the electronic medical record. All patients who delivered vaginally and underwent tubal sterilization during their delivery admissions were included. The primary outcome was total operative time. Secondary outcomes included estimated blood loss, perioperative complications, and readmission within 6 weeks postpartum. Patients who underwent bilateral tubal ligation were compared with those who underwent bilateral salpingectomy using Pearson's χ2 test, Fisher exact, and Student's t test. RESULTS: A total of 317 eligible patients were identified. One hundred and six (94%) salpingectomies were completed using a bipolar electrocautery device. Operative time was 3 minutes shorter in the salpingectomy group, 30 minutes (interquartile range 24-38) compared with 33.5 (26-42) minutes, P=.032. Patients who underwent salpingectomy were more likely to have estimated blood loss of 5 mL or less (our institutional shorthand for minimal blood loss) than women who underwent bilateral tubal ligation (78 [69%] vs 112 [55%], P=.015). There were no significant differences in perioperative complications between the groups. CONCLUSION: When using electrocautery, bilateral salpingectomy can be completed in the immediate postpartum period after vaginal delivery with equivalent operative times to bilateral tubal ligation.

The impact of using an intraoperative goal directed fluid therapy protocol on clinical outcomes in patients undergoing total pancreatectomy and islet cell autotransplantation.

BACKGROUND: Patients undergoing total pancreatectomy and islet cell autotransplant (TPIAT) for treatment of pancreatitis are at risk for complications of over and under resuscitation. We hypothesized that using a goal directed fluid therapy (GDFT) protocol might impact clinical outcomes. MATERIALS AND METHODS: A consecutive series of adult patients undergoing TPIAT were managed intraoperatively using either standard fluid therapy (SFT, n = 44) or GDFT (n = 23) as part of a pilot study between January 2013 and May 2015. Patient characteristics, intraoperative, and postoperative data were recorded prospectively, then retrospectively analyzed for differences between the groups. RESULTS: The GDFT group had lower total fluid resuscitation (3,240 cc vs 5,173 cc, p < 0.0001) and transfusion requirements (1.0 cc/kg vs 3.3 cc/kg, p = 0.050) compared to the SFT group. The pre to postop nadir hemoglobin change was significantly less for GDFT (4.2 vs 5.1 gm/dl, p = 0.021) despite less transfusion. CONCLUSIONS: Compared to SFT, using an intraoperative GDFT protocol in TPIAT patients was associated with significantly decreased intraoperative fluid resuscitation, blood transfusion and less postoperative dilutional anemia, without any difference in complications of underresuscitation. This pilot study suggests that GDFT is likely safe and further investigation is warranted.