ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer.

BACKGROUND: Ovarian cancer with extensive metastatic disease involving pelvic structures often requires rectosigmoid resection for complete gross resection; however, it is associated with increased surgical morbidity. There are limited data, and none in ovarian cancer, on near-infrared assessment of perfusion in rectosigmoid resections with anastomosis. PRIMARY OBJECTIVE: To compare the rate of pelvic complications (pelvic abscesses, anastomotic leaks, and infections) within 30 days of surgery with and without near-infrared assessment of perfusion at time of rectosigmoid resection and re-anastomosis in patients undergoing cytoreductive surgery for ovarian cancer. STUDY HYPOTHESIS: We hypothesize the use of near-infrared technology (intravenous indocyanine green and endoscopic near-infrared fluorescence imaging), compared with standard intra-operative assessment, to evaluate anastomotic perfusion at time of rectosigmoid resection and re-anastomosis will result in lower rates of post-operative pelvic complications. TRIAL DESIGN: This is a planned multicenter randomized controlled trial. Patients who undergo rectosigmoid resection as part of their ovarian cytoreductive surgery will be randomized 1:1 to standard assessment of anastomosis with the surgeon's usual technique (control arm) or assessment with near-infrared angiography using indocyanine green and endoscopic fluorescence imaging (experimental arm). Randomization will occur after rectosigmoid resection has been completed and the surgeon declares their plan to create a diverting ostomy. Randomization will be stratified by plan for diverting ostomy. MAJOR INCLUSION/EXCLUSION CRITERIA: Main inclusion criteria include patients with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for cytoreductive surgery with suspected need for low-anterior rectosigmoid resection. PRIMARY ENDPOINT: Rate of 30-day post-operative pelvic complications. SAMPLE SIZE: 310 (155 per arm) ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Q2 2027 and Q4 2027, respectively. TRIAL REGISTRATION: NCT04878094.

Beyond post-operative readmissions: analysis of the impact of unplanned readmissions during primary treatment of advanced-stage epithelial ovarian cancer on long-term oncology outcome.

BACKGROUND: Multiple studies have assessed post-operative readmissions in advanced ovarian cancer. OBJECTIVE: To evaluate all unplanned readmissions during the primary treatment period of advanced epithelial ovarian cancer, and the impact of readmission on progression-free survival. METHODS: This was a single institution retrospective study from January 2008 to October 2018. Χ2/Fisher's exact and t-test, or Kruskal-Wallis test were used. Multivariable Cox proportional hazard models were used to assess the effect of covariates in progression-free survival analysis. RESULTS: A total of 484 patients (279 primary cytoreductive surgery, 205 neoadjuvant chemotherapy) were analyzed. In total, 272 of 484 (56%; 37% primary cytoreductive surgery, 32% neoadjuvant chemotherapy, p=0.29) patients were readmitted during the primary treatment period. Overall, 42.3% of the readmissions were surgery related, 47.8% were chemotherapy related, and 59.6% were cancer related but not related to surgery or chemotherapy, and each readmission could qualify for more than one reason. Readmitted patients had a higher rate of chronic kidney disease (4.1% vs 1.0%, p=0.038). Post-operative, chemotherapy, and cancer-related readmissions were similar between the two groups. However, the percentage of inpatient treatment days due to unplanned readmission was twice as high for primary cytoreductive surgery at 2.2% vs 1.3% for neoadjuvant chemotherapy (p<0.001). Despite longer readmissions in the primary cytoreductive surgery group, Cox regression analysis demonstrated that readmissions did not affect progression-free survival (HR=1.22, 95% CI 0.98 to 1.51; p=0.08). Primary cytoreductive surgery, higher modified Frailty Index, grade 3 disease, and optimal cytoreduction were associated with longer progression-free survival. CONCLUSIONS: In this study, 35% of the women with advanced ovarian cancer had at least one unplanned readmission during the entire treatment time. Patients treated by primary cytoreductive surgery spent more days during readmission than those with neoadjuvant chemotherapy. Readmissions did not affect progression-free survival and may not be valuable as a quality metric.

Use of a bioengineered skin equivalent for the management of difficult skin defects after pediatric multivisceral transplantation.

BACKGROUND: Primary wound closure is not always possible after pediatric multi-visceral transplantation because of oversized donor organs and/or intestinal or graft edema. We report our experience evaluating the safety and efficacy of Graftskin (Apligraf, Organogenesis, Canton, Mass), a bioengineered bi-layered human skin equivalent, for the management of difficult skin abdominal defects after multivisceral transplantation in a pediatric population. METHODS: A retrospective chart review was performed of pediatric multivisceral transplantation patients who were treated with Graftskin. Adverse events, course of wound reepithelialization, and time for complete closure were recorded. RESULTS: Four patients, 7 to 29 months old, were treated with Graftskin. One patient died because of unrelated reasons. Stimulation of the granulation, reepithelialization, and rapid reduction of the wound surface and depth occurred in the other 3 patients. Complete reepithelialization occurred within 5 months. No adverse events were noted. CONCLUSION: Graftskin was a successful treatment for difficult abdominal skin defects after liver and multivisceral transplantation in children.

Effect of protocol Doppler ultrasonography and urgent revascularization on early hepatic artery thrombosis after pediatric liver transplantation.

HYPOTHESIS: Protocol Doppler ultrasonography of the liver (DUSL) is useful for detecting early hepatic artery thrombosis (HAT). Urgent exploration based on DUSL findings and immediate revascularization of the liver may avoid HAT-related sequelae, namely, biliary complications and retransplantation after pediatric liver transplantation. DESIGN: Case-control study. SETTING: University hospital. PATIENTS: Group 1 included 96 liver transplantations performed in 75 pediatric patients from June 1, 1994, to August 31, 1999. Group 2 included 43 liver transplantations performed in 39 pediatric patients from September 1, 1999, to September 30, 2001. INTERVENTION: In group 1, DUSL was performed on the first posttransplantation day or on request. Angiographic confirmation of suggested HAT was treated with thrombolysis, angioplasty, or thrombectomy. In group 2, protocol DUSL was performed every 12 hours in the first week and every 24 hours in the second week. The suspicion of HAT warranted urgent surgery without the patient undergoing angiography. MAIN OUTCOME MEASURES: Incidence of HAT, biliary complications, and retransplantation. Graft and patient survival. Hospital stay, and number of admissions and operations after undergoing HAT. RESULTS: The incidence of HAT was 10.4% (10 of 96 transplantations) in group 1 and 7.0% (3 of 43 transplantations) in group 2. The incidence of biliary complications after HAT was 100% in group 1 and 0% in group 2 (P=.02). The incidence of retransplantation after HAT was 90.0% (9 of 10 patients) in group 1 and 0% in group 2 (P=.01). Of the 10 patients who experienced HAT in group 1, 5 patients underwent early retransplantation (mean length of time, 13.2 days). All 5 patients who did not undergo early retransplantation had biliary complications. Four of these 5 patients underwent retrasplantation at a later time (mean length of time, 687 days). In group 2, DUSL identified early HAT in 3 patients (7.0%). Emergent thrombectomy and arterial reconstruction were undertaken. All 3 (100%) have their original graft and are alive. None experienced biliary complications. One-year graft and patient survival is 72.0% and 84.0%, respectively, in group 1 and 80.0% and 85.0%, respectively, in group 2. Shorter hospital stay, fewer readmissions, and surgery after HAT were noted in group 2. CONCLUSIONS: Protocol DUSL detects early HAT and urgent revascularization based on DUSL can significantly reduce the incidence of biliary complication and graft loss requiring retransplantation in pediatric liver transplantation.