FLUOCOL-1 : Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,010
- 试验地点
- 28
- 主要终点
- The primary endpoint is the occurrence of an anastomotic leakage 90-days post-operation. Anastomotic leakage is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer
研究概览
简要总结
To demonstrate that the assessment of anastomotic perfusion using intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) will reduce AL in left-sided or high anterior resection with intraperitoneal anastomosis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
- •Signed informed consent
- •Affiliated to the French social security system (CMU included).
- •Adult patients (age >18 years)
排除标准
- •Emergent surgery
- •Inflammatory bowel disease
- •History of known allergy to indocyanine
- •Pregnant patients
- •Refusal to participate or inability to provide informed consent
- •Protected adults (individuals under guardianship by court order).
- •Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion
- •Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more)
- •Colon cancer requiring transverse colectomy
- •Recurrent colorectal cancer
- •Locally advanced colorectal cancer requiring multi-visceral excision
- •History of colectomy
- •Associated concomitant resection of other organ (liver, etc.)
- •Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer
结局指标
主要结局
The primary endpoint is the occurrence of an anastomotic leakage 90-days post-operation. Anastomotic leakage is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer
The primary endpoint is the occurrence of an anastomotic leakage 90-days post-operation. Anastomotic leakage is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer
次要结局
- Change in planned anastomosis during surgery defined as any decision change upon perfusion assessment such as modifying the initially planned transection level of the descending colon or refashioning anastomosis including the decision to undertake a permanent stoma rather than an anastomosis
- Rate of defunctioning stoma
- Postoperative reintervention within 90 days
- Overall 90-day postoperative morbidity, including all complications according to the Clavien-Dindo classification, and occurring within 90 days after surgery
- Postoperative mortality, including all deaths occurring within 90 days after surgery
- Duration of hospital stay, calculated from the day of surgery to the day of hospital discharge
- HRQoL using the QLQ-C30 and QLQ-CR29 at baseline and 90 days post-operation
- Medico-economic interest of IOFA with ICG use
研究者
Zaher LAKKIS
Scientific
Centre Hospitalier Regional Universitaire