RESUMO
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.
Assuntos
Anastomose Cirúrgica , Neoplasias Ovarianas , Humanos , Feminino , Neoplasias Ovarianas/cirurgia , Neoplasias Ovarianas/diagnóstico por imagem , Neoplasias Ovarianas/patologia , Anastomose Cirúrgica/métodos , Anastomose Cirúrgica/efeitos adversos , Reto/cirurgia , Reto/diagnóstico por imagem , Colo Sigmoide/cirurgia , Colo Sigmoide/diagnóstico por imagem , Procedimentos Cirúrgicos de Citorredução/métodos , Verde de Indocianina/administração & dosagem , Complicações Pós-Operatórias , Angiografia/métodos , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Intercollegiate Horse Show Association (IHSA) competitions evaluate riders on equitation and skills when riding randomly drawn horses. This study considered demographic and competition-related variables of horses involved in IHSA competitions, and their correlation to performance through points accumulated. Demographics were recorded for fifty-nine horses in two-day Hunter Seat and Western IHSA shows along with use of artificial riding aids, day of competition, number of rides, and points, to evaluate performance. Data were analyzed using a mixed effect model and correlation coefficients with significance set at P < 0.05 (SAS 9.4). Hunter Seat horses averaged more rides per day than Western (P < 0.0001), but points per ride were not different between disciplines (P = 0.57) or days of shows (P = 0.47). Use of artificial aids did not impact points per ride a horse accumulated (P = 0.63 Hunter Seat, P = 0.41 Western). Age, (r = -0.10, P = 0.60; r = 0.02, P = 0.90), BCS (r = 0.15, P = 0.42; r = 0.17, P = 0.34), height (r = 0.20, P = 0.28; r = 0.15, P = 0.39), and weight (r = 0.23, P = 0.23; r = 0.20, P = 0.25) were weakly correlated with points earned for Hunter Seat and Western horses, respectively. Random draw in IHSA is suggested to be effective for equitation competitions, allowing a fair opportunity for riders, regardless of the horse-related factors evaluated in this study.