Role of Intraoperative Fluorescence Angiography to Prevent Anastomotic Leaks in patients undergoing Anterior resection - a Prospective Randomized study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anastomotic leak at 30 days from the day of surgery.
研究概览
简要总结
**Aim:**The purpose of the study is to evaluate the role of intraoperative fluorescence angiography using Indocyanine green (ICG) assessment for microperfusion assessment in preventing anastomotic leaks during rectal cancer surgery. The fluorescence assessment is done using a near IR camera system which detects ICG fluorescence using fluorescence detection systems.
Procedure:
Following an informed consent, patients with rectal cancer planned for an anterior resection (high or low) will be prospectively randomised in a 1:1 fashion at the time of consenting into a conventional surgery arm (No IFA used) and an IFA arm.
Conventional surgery arm (no IFA)
Laparoscopic or robot-assisted AR (high or low) will be performed as per the surgeon preference. Perfusion assessment will be performed with white light (WL) only.
IFA arm
For participants randomized to surgery with IFA, AR will be performed according to the surgeon’s usual technique, using either a laparoscopic or a robotic approach.
Two IFA assessments will be performed, each involving an intravenous bolus of 0.1 mg/kg of ICG. The first assessment will be performed after rectal mobilization but before bowel transection. Under white light laparoscopy, the point of planned bowel transection will be first marked. Using either an intra- or extracorporeal IFA technique, the time to first fluorescence and any change in the planned bowel transection point following IFA will be recorded. The second assessment will be performed after construction of the anastomosis. One additional IFA assessment is permitted at the operating surgeon’s discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Medically fit to undergo surgery
- •Who have given informed consent.
排除标准
- •Patients not undergoing a colo-rectal/anal anastomosis
- •Patients undergoing synchronous colonic resections
- •Locally advanced rectal cancer requiring extended or multi-visceral resections
- •Coexistent colorectal pathology
- •Previous pelvic RT, recurrent rectal cancers
- •Hepatic dysfunction, renal dysfunction, known allergy to ICG or iodine dyes
- •Pregnancy
- •Did not consent.
结局指标
主要结局
Anastomotic leak at 30 days from the day of surgery.
时间窗: Anastomotic leak at 30 days from the day of surgery. | Revision of bowel segment, stoma placement, vascular anomalies - will be recorded intraoperatively
Revision of bowel segment, stoma placement, vascular anomalies - will be recorded intraoperatively
时间窗: Anastomotic leak at 30 days from the day of surgery. | Revision of bowel segment, stoma placement, vascular anomalies - will be recorded intraoperatively
次要结局
- Changes in planned anastomosis(Intraoperatively)
- Rates of stoma formation(Intraoperatively)
- Intraoperative and perioperative complications(30 days from day of surgery)