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.

A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer.

OBJECTIVES: This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix. METHODS: Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m(2), 30 mg/m(2) and 40 mg/m(2) given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD. RESULTS: Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m(2) dose level consisting of colonic and ureteral obstruction. At the 30 mg/m(2) dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m(2) dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67%) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67%) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months). CONCLUSIONS: The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m(2).

Ovarian cancer in elderly women.

The incidence of ovarian carcinoma increases with advancing age, peaking during the 7th decade of life and remaining elevated until age 80 years. Despite the high prevalence of ovarian cancer in the elderly, the management of these patients is often less aggressive than that of their younger counterparts. As a result, many elderly cancer patients receive inadequate treatment. However, data do not support the concept that age, per se, is a negative prognostic factor. In fact, the majority of elderly patients are able to tolerate the standard of care for ovarian cancer including initial surgical cytoreduction followed by platinum and taxane chemotherapy. Because functional status has not demonstrated a reliable correlation with either tumor stage or comorbidity, each patient's comorbidities should be assessed independently. For elderly patients with significant medical comorbidity, the extent of surgery and aggressiveness of chemotherapy should be tailored to the extent of disease, symptoms, overall health, and life goals. In addition, enhanced cooperation between geriatricians and oncologists may assist the pretreatment assessment of elderly patients and improve treatment guidelines in this population.

Sigmoid impaction secondary to urinary stones: case report and review of literature.

BACKGROUND: This is the first case report of a Miami pouch sigmoid fistula developing passage of urinary stones resulting in the presentation of constipation secondary to impaction. CASE REPORT: A 49-year-old woman who developed a recurrence of invasive squamous cell cervical carcinoma 1 year after pelvis radiation. She then underwent anterior pelvic exenteration and creation of a Miami pouch. Approximately 14 years after the primary radiation therapy and 13 years after the creation of the exenterative procedure, the patient developed a Miami pouch sigmoid fistula. The decision was made at this time to repair the fistula and remove the urinary stones from the sigmoid colon. Postoperatively, the patient remained continent using intermittent catheterization of the pouch and there was no evidence of recurrence of the cancer. CONCLUSION: Conservative management of urinary reservoir complications should always be considered before surgical intervention is attempted. When indicated, surgical management should not be delayed.

Malignant peripheral nerve sheath tumor of the vulva: a multimodal treatment approach.

BACKGROUND: Malignant peripheral nerve sheath tumors (MPNSTs) are rare in the gynecological population and have a high risk for local and distant failures. Multimodal management of a patient with MPNST of the vulva and review of the literature are outlined. CASE: A 34-year-old woman presented with a complaint of a rapidly increasing pelvic mass, pain, and difficulty ambulating. A disfiguring 20 x 20-cm vulvar mass was identified and a recurrent MPNST diagnosed. Therapy included external-beam radiation, anterior pelvic exenteration with pelvic reconstruction, and adjuvant chemotherapy without complication. CONCLUSION: It is recommended that for malignant peripheral nerve sheath tumors of the vulva, complete surgical resection be performed with adjuvant radiation and chemotherapy in selected cases.

Conversion of an incontinent urinary conduit to a continent urinary reservoir (Miami Pouch).

OBJECTIVE: External urinary or gastrointestinal appliances can impair a patient's quality of life. We report on the feasibility of converting an incontinent colonic urinary diversion to a continent urinary reservoir (Miami Pouch). CASE: We describe the case of a 66-year-old white female with a history of stage Ib(2) cervical cancer treated by radical abdominal hysterectomy and adjuvant radiation therapy. The patient developed severe radiation cystitis with a neurogenic bladder and bilateral ureteral obstruction. After failing conservative management, a urinary diversion with a transverse colon conduit was performed. The patient remained without evidence of disease for 2 years and led an active lifestyle with regular tennis games. After 7 months of an external appliance for the urinary conduit, the patient presented to the University of Miami for conversion to a continent urinary mechanism which would not require an appliance. We performed an exploratory laparotomy, conversion of a transverse colon conduit to a continent ileo-colonic urinary reservoir (Miami Pouch). There were no postoperative complications. The patient remains disease-free and performs self-catheterization with no need for an external appliance. The patient has been able to resume an active life including sports. CONCLUSIONS: Successful conversion of an incontinent urinary conduit to a continent urinary reservoir is possible in a select case resulting in a perceived improvement of quality of life.

Optimal surgical cytoreduction in patients with Stage III and Stage IV endometrial carcinoma: a study of morbidity and survival.

OBJECTIVE: To evaluate the survival impact of residual disease at the time of primary surgery for patients with Stage III and IV endometrial carcinoma; to assess morbidity associated with surgical cytoreduction. METHOD: All patients with endometrial carcinoma who underwent primary surgical therapy at the University of Miami between January 1, 1990 and June 1, 2002 were identified. Patients meeting FIGO criteria for Stage III or IV disease were selected. Papillary serous and clear cell histology was excluded. RESULTS: Eighty-five patients were identified: 66 Stage III and 19 Stage IV. Only Stage IIIC and Stage IV were included in survival analysis: 72% (33 Stage IIIC, 9 Stage IV) had optimal cytoreduction and 28% (6 Stage IIIC, 10 Stage IV) had suboptimal cytoreduction. The median survival for Stage IIIC and IV disease was 6.7 months for patients with suboptimal cytoreduction and 17.8 months for patients with optimal cytoreduction (P = 0.001). The proportion of patients with major postoperative complications (37.50% vs. 7.25%, P = 0.005), unplanned postoperative SICU admissions (31.25% vs. 7.25%, P = 0.018), and length of hospital stay exceeding 15 days (31.25% vs. 4.35%, P = 0.005) was greater in patients with suboptimal cytoreductive surgery. CONCLUSIONS: Overall survival is lower and morbidity is higher in patients with advanced endometrial carcinoma having suboptimal cytoreduction at the time of primary surgery. Patients with suspected advanced stage endometrial carcinoma should be counseled on the potential benefits of optimal cytoreductive surgery. Alternative treatment options should be considered in those patients with surgically unresectable disease.