1. ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer.
- Author
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Leitao MM Jr, Iasonos A, Tomberlin M, Moukarzel LA, Price H, Bennetti G, Ramesh B, Chi DS, Long Roche K, Sonoda Y, Al-Niami A, Mueller JJ, Gardner GJ, Broach V, Jewell EL, Kim S, Feinberg J, Abu-Rustum NR, and Zivanovic O
- Subjects
- Female, Humans, Angiography methods, Colon, Sigmoid surgery, Colon, Sigmoid diagnostic imaging, Cytoreduction Surgical Procedures methods, Indocyanine Green administration & dosage, Postoperative Complications, Randomized Controlled Trials as Topic, Rectum surgery, Rectum diagnostic imaging, Spectroscopy, Near-Infrared methods, Anastomosis, Surgical methods, Anastomosis, Surgical adverse effects, Ovarian Neoplasms surgery, Ovarian Neoplasms diagnostic imaging, Ovarian Neoplasms pathology
- Abstract
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., Competing Interests: Competing interests: Dr Leitao reports personal fees from Medtronic, Intuitive Surgical, J&J/Ethicon, and Immunogen. Dr Abu-Rustum reports research funding paid to the institution from GRAIL. Memorial Sloan Kettering Cancer Center also has equity in GRAIL. Dr Chi reports personal fees from AstraZeneca, UptoDate, Biom’Up, Apyx Medical Corp, and Verthemia, as well as stock ownership in Doximity., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
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