Association of bowel preparation with surgical-site infection in gynecologic oncology surgery: Post-hoc analysis of a randomized controlled trial.

OBJECTIVE: To determine the relationship between bowel preparation and surgical-site infection (SSI) incidence following colorectal resection during gynecologic oncology surgery. METHODS: This post-hoc analysis used data from a randomized controlled trial of patients enrolled from 03/01/2016-08/20/2019 with presumed gynecologic malignancy investigating negative-pressure wound therapy among those requiring laparotomy. Patients were treated preoperatively without bowel preparation, oral antibiotic bowel preparation (OABP), or OABP plus mechanical bowel preparation (MBP) per surgeon preference. Univariate and multivariable analyses with stepwise model selection for SSI were performed for confirmed gynecologic malignancies requiring colorectal resection. RESULTS: Of 161 cases, 15 (9%) had no preparation, 39 (24%) OABP only, and 107 (66%) OABP+MBP. The overall SSI rate was 19% (n = 31)-53% (n = 8/15) in the no preparation, 21% (n = 8/39) in the OABP alone, and 14% (n = 15/107) in the OABP+MBP groups (P = 0.003). The difference between OABP and OABP+MBP was non-significant (P = 0.44). The median length of stay was 9 (range, 6-12), 6 (range, 5-8), and 7 days (range, 6-10), respectively (P = 0.045). The overall complication rate (34%; n = 54) did not significantly vary by preparation type (P = 0.23). On univariate logistic regression analysis, OABP (OR, 0.23; 95% CI: 0.06-0.80) and OABP+MBP (OR, 0.14; 95% CI: 0.04-0.45) were associated with decreased SSI risk compared to no preparation (P = 0.004). On multivariate analysis, both methods of preparation retained a significant impact on SSI rates (P = 0.004). CONCLUSION: Bowel preparation is associated with reduced SSI incidence and is beneficial for patients undergoing gynecologic oncology surgery with anticipated colorectal resection. Further investigation is needed to determine whether OABP alone is sufficient.

Prophylactic Negative Pressure Wound Therapy After Laparotomy for Gynecologic Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate the effectiveness of prophylactic negative pressure wound therapy in patients undergoing laparotomy for gynecologic surgery. METHODS: We conducted a randomized controlled trial. Eligible, consenting patients, regardless of body mass index (BMI), who were undergoing laparotomy for presumed gynecologic malignancy were randomly allocated to standard gauze or negative pressure wound therapy. Patients with BMIs of 40 or greater and benign disease also were eligible. Randomization, stratified by BMI, occurred after skin closure. The primary outcome was wound complication within 30 (±5) days of surgery. A sample size of 343 per group (N=686) was planned. RESULTS: From March 1, 2016, to August 20, 2019, we identified 663 potential patients; 289 were randomized to negative pressure wound therapy (254 evaluable participants) and 294 to standard gauze (251 evaluable participants), for a total of 505 evaluable patients. The median age of the entire cohort was 61 years (range 20-87). Four hundred ninety-five patients (98%) underwent laparotomy for malignancy. The trial was eventually stopped for futility after an interim analysis of 444 patients. The rate of wound complications was 17.3% in the negative pressure wound therapy (NPWT) group and 16.3% in the gauze group, absolute risk difference 1% (90% CI -4.5 to 6.5%; P=.77). Adjusted odds ratio controlling for estimated blood loss and diabetes was 0.99 (90% CI 0.62-1.60). Skin blistering occurred in 33 patients (13%) in the NPWT group and in three patients (1.2%) in the gauze group (P<.001). CONCLUSION: Negative pressure wound therapy after laparotomy for gynecologic surgery did not lower the wound complication rate but did increase skin blistering. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02682316. FUNDING SOURCE: The protocol was supported in part by KCI/Acelity.

Trocar site hernia development in patients undergoing robotically assisted or standard laparoscopic staging surgery for endometrial cancer.

OBJECTIVES: To compare the incidence and potential risk factors of trocar site hernia formation in women undergoing robotically assisted versus standard laparoscopic staging (RBT vs. LSC, respectively) for endometrial cancer. METHODS: We retrospectively identified all patients who underwent MIS staging for endometrial cancer at our institution from 01/09-12/12. Data collection involved the review of all operative notes, postoperative follow-up visit notes, and postoperative imaging reports. Appropriate statistical tests were used. RESULTS: We identified 760 eligible patients (LSC, 193; RBT, 567). The overall median age was 61years (range, 33-90). The median BMI was 28.5kg/m2 for LSC (range, 16.6-67.6) and 29.5kg/m2 for RBT (range, 17.9-66) patients (p=0.8). A trocar site hernia developed in 16 patients (2.1%)-5 (2.6%) of 193 LSC and 11 (1.9%) of 567 RBT patients (p=0.6). Median time to hernia diagnosis was 13months (range, 5-20.5) and 18months (range, 3-49), respectively (p=0.5). All hernias in the LSC cohort developed at the camera trocar site. In the RBT cohort, 10 developed at the camera trocar site and 1 at a lateral trocar site. Only BMI was associated with the development of hernias. A hernia was diagnosed in 7 (6.9%) of 101 patients with a BMI ≥40kg/m2 compared with 9 (1.4%) of 659 with a BMI <40kg/m2 (p=0.001). CONCLUSION: MIS for endometrial cancer is associated with a low rate of trocar site hernia formation, with similar rates associated with RBT and standard LSC. Higher BMI is associated with the development of postoperative trocar site hernias.

Surgical site infection reduction bundle in patients with gynecologic cancer undergoing colon surgery.

OBJECTIVE: Surgical site infections (SSIs) can lead to substantial morbidity, prolonged hospitalization, increased costs, and death in patients undergoing colorectal procedures. We sought to investigate the effect of using an SSI reduction bundle on the rate of SSIs in gynecologic cancer patients undergoing colon surgery. METHODS: We identified all gynecologic cancer patients who underwent colon resection at our institution from 2014 to 2016, during which time a service-wide SSI reduction bundle was introduced. The intervention included preoperative oral antibiotics with optional mechanical bowel preparation, skin preparation with antibacterial solution, and the use of a separate surgical closing tray. SSI rates were assessed within 30days post-surgery. RESULTS: Of 233 identified patients, 115 had undergone colon surgery prior to (PRE) and 118 after (POST) the implementation of the intervention. A low anterior resection was the most common colon surgery in both cohorts. The incidence of SSI within 30days of surgery was 43/115 (37%) in the PRE and 14/118 (12%) in the POST cohorts (p≤0.001). Wound dehiscence was noted in 30/115 (26%) and 2/118 (2%) patients, respectively (p≤0.001). In patients whose operation took longer than 360min, 30-day SSI rates were 37% (28/76) and 12% (8/67), respectively (p≤0.001). In patients with an estimated blood loss >500cm3, SSI rates were 44% (27/62) and 15% (10/67), respectively (p≤0.001). CONCLUSIONS: The implementation of an SSI reduction bundle was associated with a significant reduction in 30-day SSIs in these patients. The intervention remained effective in patients undergoing longer operations and in those with increased blood loss.

Survival of Patients with Serous Uterine Carcinoma Undergoing Sentinel Lymph Node Mapping.

OBJECTIVE: The aim of this study was to determine progression-free survival (PFS) in patients with serous uterine carcinoma undergoing sentinel lymph node (SLN) mapping compared with patients undergoing standard lymphadenectomy. METHODS: We retrospectively reviewed all uterine cancer patients treated at our institution from 2005 to 2015. Patients were separated into two cohorts: those who underwent SLN mapping at the time of staging (SLN) and those who underwent routine lymphadenectomy (the non-SLN group). SLN mapping was performed according to institutional protocol, incorporating a surgical algorithm and pathologic ultrastaging. RESULTS: Overall, 248 patients were identified-153 SLN mappings and 95 routine lymphadenectomies (pelvic and/or paraaortic lymph node dissection). No significant difference in age or body mass index was observed between the groups (p = 0.08 and p = 0.9, respectively). Minimally invasive surgery was utilized in 117/153 (77%) SLN patients and 30/95 (32%) non-SLN patients (p = <0.001). Stage distribution for the SLN and non-SLN cohorts demonstrated 106/153 (69%) and 59/95 (62%) patients with stage I/II disease, respectively, and 47/153 (31%) and 36/95 (38%) patients with stage III/IV disease, respectively (p = 0.3). The median number of nodes removed was 12 (range, 1-50) in the SLN cohort versus 21 (range, 1-75) in the non-SLN cohort (p = <0.001). Adjuvant chemotherapy alone or with radiation therapy was administered in 122/153 (80%) SLN patients and 79/95 (83%) non-SLN patients; radiotherapy alone was administered in 12/153 (8%) SLN patients and 7/95 (7%) non-SLN patients (p = 0.8). At a median follow-up of 40 months, the 2-year PFS rates were 77% (95% confidence interval [CI], 68-83%) in the SLN group and 71% (95% CI, 61-79%) in the non-SLN group (p = 0.3). CONCLUSIONS: Incorporation of the SLN mapping algorithm into the staging of uterine serous cancer is feasible and does not appear to compromise prognosis. PFS in patients with uterine serous carcinoma undergoing SLN mapping, followed by adjuvant therapy, was similar to PFS in patients undergoing standard lymphadenectomy and adjuvant therapy.

Optimal primary management of bulky stage IIIC ovarian, fallopian tube and peritoneal carcinoma: Are the only options complete gross resection at primary debulking surgery or neoadjuvant chemotherapy?

OBJECTIVE: To explore the impact of primary debulking surgery (PDS) to minimal but gross residual disease (RD) in women with bulky stage IIIC ovarian, fallopian tube, or primary peritoneal cancer. METHODS: We retrospectively reviewed all patients with the aforementioned diagnosis who underwent PDS at our institution from 01/2001-12/2010. Those with disease of non-epithelial histology or borderline tumors were excluded. Clinicopathologic data were abstracted, and appropriate statistical tests were used. RESULTS: We identified 496 eligible patients. Median age was 62years; 91% had disease of serous histology. Patients were grouped by RD status: no gross RD, 184 (37%); RD of 1-5mm, 127 (26%); RD of 6-10mm, 54 (11%); and RD >10mm, 131 (26%). With a median follow-up of 53months, the median progression-free survivals (PFS) were: 26.7, 20.7, 16.2, and 13.6months, respectively (p<0.001). The median overall survivals (OS) were 83.4, 54.5, 43.8, and 38.9months, respectively (p<0.001). Among patients with RD following PDS, those with RD of 1-10mm had improved PFS (p<0.001) and OS (p=0.001) compared with those with RD >10mm. Patients with RD 1-10mm who received intravenous/intraperitoneal (IV/IP) chemotherapy were younger and had prolonged OS compared with those solely exposed to IV chemotherapy (p<0.001 and p=0.002, respectively). CONCLUSIONS: PDS to no gross RD was associated with the longest PFS and OS. However, cytoreduction to 1-10mm of RD was also associated with better survival outcomes compared with cytoreduction to >10mm of RD. We conclude that PDS remains an appropriate option for patients with a high likelihood of achieving RD 1-10mm, especially for younger patients who can receive IV/IP chemotherapy after PDS.

Robotically Assisted Laparoscopic Ovarian Transposition in Women with Lower Gastrointestinal Cancer Undergoing Pelvic Radiotherapy.

BACKGROUND: Pelvic radiotherapy (RT) is a standard component of the management for patients with locally advanced rectal cancer or squamous cell carcinoma of the anus. Pelvic RT leads to permanent and irreversible ovarian failure in young women. This study aimed to determine the effectiveness of robotically assisted laparoscopic ovarian transposition (OT) before RT in women with rectal or anal cancer who wanted to preserve normal ovarian function. METHODS: The study reviewed the medical records of all patients treated at our institution from August 2009 to October 2014 who received robotically assisted laparoscopic OT for rectal or anal cancer before RT. Clinical and hormonal data were abstracted to determine ovarian function. RESULTS: The study identified 22 women with rectal (n = 20) or anal (n = 2) cancer. The median age of the women was 39 years (range 26-45 years). For one patient, OT was technically not feasible. The postoperative course was uneventful in all but one case. Follow-up data on ovarian function were unavailable for 3 patients. The median times from RT initiation to the last gynecologic or hormonal evaluation were 9 months (range 5-47 months) and 10.5 months (range 5-47 months), respectively. At the last gynecologic or hormonal follow-up visit, ovarian function was preserved in 12 (67%) of 18 evaluable patients, including 9 (90%) of 10 patients 40 years of age or younger and 3 (38%) of 8 patients older than 40 years (P = 0.07). CONCLUSIONS: Robotically assisted laparoscopic bilateral OT is safe and can lead to preservation of ovarian function in two-thirds of patients with low gastrointestinal cancer undergoing pelvic RT. It should be considered in this setting, especially for women age 40 years or younger, to avoid premature menopause and its associated sequelae.

Combined immunotherapy and radiation for treatment of mucosal melanomas of the lower genital tract.

OBJECTIVE: To report our experience using ipilimumab, a monoclonal antibody targeting CTLA-4, combined with radiation therapy in women diagnosed with mucosal melanoma of the lower genital tract. METHODS: We retrospectively identified all patients who received ipilimumab with concurrent radiation treatment of mucosal melanoma of the lower genital tract at Memorial Sloan Kettering Cancer Center from 2012 to 2015. Various clinicopathologic data and treatment response were abstracted and analyzed. RESULTS: Four patients were identified. Median age was 61.5 years (range 44-68); 3 were diagnosed with vaginal melanoma, 1 with cervical melanoma. All would have required extensive surgical procedures to remove entirety of disease. Median size of lesions was 4.7 cm (range, 3.3-5.3); all were Ballantyne stage I. Median number of doses of upfront ipilimumab was 4 (range, 3-4). Two patients suffered CTCAE grade 3 adverse events (colitis, rash). All received external beam radiation: 3 to 3000 cGy, 1 to 6020 cGy. Post-radiation surgical resection was performed in 3 patients (75%); 1 (33%) of 3 patients achieved complete pathologic response. Complete local radiographic response was observed in all patients after completion of initial therapy and surgery. Two developed recurrence at 9 and 10 months post-diagnosis (mediastinum, lung); 2 remain disease-free at 20 and 38 months. CONCLUSIONS: Mucosal melanoma of the lower genital tract is rare, and data-driven treatment strategies limited. Immunotherapy has demonstrated durable efficacy in the treatment of cutaneous melanomas. Our small case series shows a favorable response to combined ipilimumab and radiation therapy. Larger studies are needed to validate these promising results.

Herniation formation in women undergoing robotically assisted laparoscopy or laparotomy for endometrial cancer.

OBJECTIVE: To compare the incidence of trocar site hernia in women who underwent robotically assisted laparoscopic surgery (RBT) for endometrial cancer staging with the incidence of ventral hernia formation in patients who underwent laparotomy (LAP) for the same indication. To analyze risk factors for hernia formation in women undergoing RBT for endometrial cancer. METHODS: We retrospectively identified all patients who underwent surgical staging for endometrial cancer via RBT or LAP from 2009-2012. Clinicopathologic data were analyzed. Appropriate statistical tests were used. RESULTS: 738 patients were staged via RBT (n=567) or LAP (n=171). Overall median age was 61 years (RBT range, 33-90; LAP range,28-86; p=0.4). Median BMI was 29.5 kg/m(2) (range, 17.9-66) and 30.3 kg/m(2) (range, 16.8-67.2), respectively (p=1.0). Eleven (1.9%) of 567 patients in the RBT cohort developed a trocar site hernia compared with 11 (6.4%) of 171 LAP patients who developed a ventral hernia (p=0.002). Median time to diagnosis was 18 months (range, 3-49) and 17 months (range, 7-30), respectively (p=0.7). Of the 11 RBT patients who developed a trocar site hernia, 10 (91%) were midline defects and 1 (9%) was a lateral defect of a prior inferior epigastric port site. No hernias required emergent operative intervention. Four (0.7%) of 567 RBT patients compared with 2 (1.2%) of 171 LAP patients required surgical hernia repair (p=0.4). CONCLUSIONS: Trocar site herniation after RBT staging for endometrial cancer is uncommon and less likely to occur than ventral hernia formation with LAP staging. Furthermore, surgical revision rates are low.

Survival of Patients with Uterine Carcinosarcoma Undergoing Sentinel Lymph Node Mapping.

PURPOSE: This study was designed to evaluate the outcome of patients with uterine carcinosarcoma undergoing sentinel lymph node (SLN) mapping. METHODS: A prospectively maintained database was reviewed for all women with uterine cancer treated at our institution from January 1, 1998 to August 31, 2014. Patients were grouped based on whether they had undergone SLN mapping or routine lymphadenectomy at the time of staging. SLN evaluation was performed according to a standard institutional protocol that incorporates a surgical algorithm and pathologic ultrastaging. RESULTS: We identified 136 patients with uterine carcinosarcoma who had undergone lymph node evaluation; 48 had surgical staging with SLN mapping and 88 had routine lymphadenectomy consisting of pelvic and/or para-aortic lymph node dissection. Stage distribution for the SLN group included: stage I, 31 (65 %); stage II, 1 (2 %); stage III, 11 (23 %); stage IV, 5 (10 %). Stage distribution for the non-SLN group included: stage I, 48 (55 %); stage II, 4 (4 %); stage III, 19 (22 %); stage IV, 17 (19 %) (p = 0.4). Median number of lymph nodes removed was 8 and 20, respectively (p ≤ 0.001). Median number of positive nodes was similar between the groups (p = 0.2). Of the 67 patients who had a documented recurrence, 14 of 20 (70 %) in the SLN and 34 of 47 (74 %) in the non-SLN group demonstrated a distant/multifocal pattern of recurrence. There was no difference in median progression-free survival between the groups (23 vs. 23.2 months, respectively; p = 0.7). CONCLUSIONS: Progression-free survival in women with uterine carcinosarcoma undergoing SLN mapping with adjuvant therapy appears similar to that of patients treated before the incorporation of the SLN protocol. Additional prospective studies with longer follow-up are necessary to validate these early results.

Prognostic significance of mucinous differentiation of endometrioid adenocarcinoma of the endometrium.

Using Surveillance, Epidemiology, and End Results database we identified 43,882 (97.0%) women with endometrioid adenocarcinomas and 1,374 (3.0%) with mucinous adenocarcinomas. Women with mucinous tumors were older (P < .0001), more often white (P = .04), and more often to present at advanced stage (P = .001). Survival was similar for both histologies; the hazard ratio for cancer-specific survival for mucinous compared to endometrioid tumors was 0.90 (95% CI, 0.74-1.09) while the hazard ratio for overall survival was 0.95 (95% CI, 0.85-1.07). Five-year survival for stage I mucinous tumors was 89.9% (95% CI, 87.6-91.9%) compared to 89.0% (95% CI, 88.6-89.4%) for endometrioid tumors.

Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy.

OBJECTIVE: We examined the use, safety, and economic impact of same-day discharge for women undergoing laparoscopic hysterectomy. STUDY DESIGN: We identified women in the Perspective database who underwent laparoscopic hysterectomy from 2000 through 2010. Discharge was classified as same-day, 1 day, and ≥2 days. Multivariable models were used to examine predictors of same-day discharge, reevaluation, and cost. RESULTS: Among 128,634 women, 34,070 (26.5%) were discharged on the day of surgery. Same-day discharge increased from 11.3% in 2000 to 46.0% by 2010 (P < .0001). The rate of reevaluation within 60 days was 4.0% for those discharged same day, 3.6% after a 1-day stay, and 5.1% for patients whose stay was ≥2 days (P < .0001). In a multivariable model, patients discharged on postoperative day 1 were less likely to require reevaluation (risk ratio, 0.89; 95% confidence interval, 0.82-0.96), but costs were $207 (95% confidence interval, $179-234) greater. CONCLUSION: Same-day discharge after laparoscopic hysterectomy is safe and associated with decreased cost.

The commercialization of robotic surgery: unsubstantiated marketing of gynecologic surgery by hospitals.

OBJECTIVE: We analyzed the content, quality, and accuracy of information provided on hospital web sites about robotic gynecologic surgery. STUDY DESIGN: An analysis of hospitals with more than 200 beds from a selection of states was performed. Hospital web sites were analyzed for the content and quality of data regarding robotic-assisted surgery. RESULTS: Among 432 hospitals, the web sites of 192 (44.4%) contained marketing for robotic gynecologic surgery. Stock images (64.1%) and text (24.0%) derived from the robot manufacturer were frequent. Although most sites reported improved perioperative outcomes, limitations of robotics including cost, complications, and operative time were discussed only 3.7%, 1.6%, and 3.7% of the time, respectively. Only 47.9% of the web sites described a comparison group. CONCLUSION: Marketing of robotic gynecologic surgery is widespread. Much of the content is not based on high-quality data, fails to present alternative procedures, and relies on stock text and images.

Biologic therapies and personalized medicine in gynecologic malignancies.

Through advances in human genomic sequencing, the unique molecular biology that predisposes certain individuals to either health or disease has now been illuminated. Although many malignancies behave similarly on a phenotypic level, biologically there exist multiple layers of interconnected molecular and cellular pathways that may make each patient's disease significantly more unique than previously appreciated. In gynecologic oncology, the most progress in developing targeted biologics has been in the treatment of ovarian cancers. Future investigations will see further development in endometrial and cervical cancers. Technology such as whole genome sequencing can theoretically identify the individual tumor's genetic profile; however, identifying the priority pathways for therapeutic interventions and subsequent complex interactions remains a significant challenge. New therapeutic technologies such as siRNA and immune modulators will also play a promising role in the movement toward individualized therapies. It is hoped that the identification and use of targeted agents will lead to individualized care that in turn will lead to significantly improved outcomes manifested by more cures and better quality of life through amelioration of toxicities.

Cervical neoplasia.

Cervical intraepithelial neoplasia is common in young women, and invasive cervical cancer is one of the most common malignancies seen in pregnancy. Women with cervical cancer diagnosed at <20 to 24 weeks of gestation are typically treated immediately, whereas patients diagnosed later in pregnancy often defer treatment until after delivery. Women with early stage cervical cancer can be treated with either surgery or radiation, whereas those with advanced-stage disease are usually treated with radiation, often in combination with chemotherapy.

Natural history and outcome of mucinous carcinoma of the ovary.

OBJECTIVE: We performed a population-based analysis to compare the clinical characteristics of women with mucinous tumors with women with other epithelial tumors. STUDY DESIGN: The Surveillance, Epidemiology, and End Results database was queried to identify all women with epithelial ovarian cancer diagnosed from 1988 to 2007. The natural history, clinical characteristics, and survival of women with serous tumors were compared with women with mucinous carcinomas. RESULTS: A total of 40,571 women including 4811 with mucinous carcinomas (11.9%) were identified. Among women with stage I neoplasms, the presence of mucinous histology had no effect on either cancer-specific survival (hazard ratio, 0.87; 95% confidence interval, 0.74-1.04). Survival was inferior in patients with advanced-stage mucinous compared with serous tumors. The hazard ratio for cancer-specific survival for women with stage III mucinous tumors was 1.55 (95% confidence interval, 1.43-1.96). CONCLUSION: Although survival for early-stage mucinous and serous tumors is similar, survival for advanced-stage mucinous neoplasms is inferior to that of serous carcinomas.