Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA
Department of OB/GYN, Weill Cornell Medical College of Cornell University, New York, New York, USA.
Int J Gynecol Cancer. 2024 Jul 1;34(7):1098-1101. doi: 10.1136/ijgc-2024-005395.
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.
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.
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.
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.
Rate of 30-day post-operative pelvic complications.
310 (155 per arm) ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Q2 2027 and Q4 2027, respectively.
NCT04878094.
广泛转移累及盆腔结构的卵巢癌常需行直肠乙状结肠切除术以达到完全肉眼切除，但这会增加手术并发症的风险。目前直肠乙状结肠切除吻合术中应用近红外技术评估灌注的相关数据有限，且尚无卵巢癌方面的数据。
比较卵巢癌患者行细胞减灭术时，在直肠乙状结肠切除和再吻合时是否应用近红外技术评估灌注（术中给予静脉注射吲哚菁绿和内镜近红外荧光成像），与标准术中评估相比，对术后 30 天内发生盆腔脓肿、吻合口漏和感染等并发症的影响。
我们假设与标准术中评估相比，在直肠乙状结肠切除和再吻合时使用近红外技术（静脉注射吲哚菁绿和内镜近红外荧光成像）评估吻合口灌注，可降低术后盆腔并发症的发生率。
这是一项计划中的多中心随机对照试验。接受直肠乙状结肠切除术作为卵巢细胞减灭术一部分的患者将以 1:1 的比例随机分为标准吻合术评估组（对照组）或近红外血管造影术评估组（实验组），后者使用吲哚菁绿和内镜荧光成像。在直肠乙状结肠切除完成后，当外科医生宣布计划行预防性造口术时，将进行随机分组。随机分组将根据行预防性造口术的计划进行分层。
主要纳入/排除标准：主要纳入标准包括原发性或复发性卵巢癌、输卵管癌或原发性腹膜癌患者，计划行细胞减灭术，且疑似需行低位前侧直肠乙状结肠切除术。
术后 30 天内盆腔并发症发生率。
310 例（每组 155 例）
分别为 2027 年第 2 季度和第 4 季度。
NCT04878094。
