Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery: A Prospective Single-Center Observational Study With a Historical Control Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Anastomotic Leakage Rate
研究概览
简要总结
Anastomotic leakage remains a major complication after colorectal cancer surgery. Indocyanine green fluorescence angiography (ICG-FA) allows real-time intraoperative assessment of bowel perfusion; however, its clinical impact remains controversial.
This prospective single-center observational study evaluated the association between intraoperative use of ICG-FA and postoperative outcomes in patients undergoing laparoscopic sigmoid or rectal cancer surgery. Outcomes of patients assessed with ICG-FA were compared with those of a historical control cohort treated without fluorescence imaging.
详细描述
This was a prospective, single-center observational cohort study conducted at a tertiary academic surgical center. Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma were included. In the prospective cohort, indocyanine green fluorescence angiography was used intraoperatively to assess bowel perfusion prior to anastomosis creation. The decision to modify the transection line was left to the operating surgeon based on fluorescence imaging.
Study outcomes in the ICG-FA cohort were compared with a historical control group of patients who underwent similar laparoscopic procedures without fluorescence imaging during an earlier period at the same institution. The primary outcome was the incidence of anastomotic leakage within 30 days after surgery, defined according to the International Study Group of Rectal Cancer criteria. Secondary outcomes included anastomotic stricture diagnosed during follow-up, postoperative complications, reoperation rate, length of hospital stay, and 30-day mortality.
All patients were treated according to standard institutional perioperative protocols. Data were collected prospectively for the ICG-FA cohort and retrospectively for the control cohort. The study was approved by the local Research Ethics Board, and all procedures were performed in accordance with the Declaration of Helsinki.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically confirmed or clinically suspected sigmoid or rectal adenocarcinoma
- •Elective laparoscopic resection with curative intent and planned colorectal/coloanal anastomosis
- •Ability to provide informed consent
排除标准
- •Pregnancy or breastfeeding
- •Known hypersensitivity to indocyanine green or iodine
- •Emergency surgery
- •Planned end colostomy without anastomosis
- •Conversion to open surgery
研究组 & 干预措施
ICG-FA group
Prospective cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery with intraoperative indocyanine green fluorescence angiography for bowel perfusion assessment.
Control group
Historical control cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery without fluorescence imaging.
结局指标
主要结局
Anastomotic Leakage Rate
时间窗: Within 30 days after surgery
Incidence of anastomotic leakage defined according to the International Study Group of Rectal Cancer criteria.
次要结局
- Overall Postoperative Complications(Within 30 days after surgery)
- Postoperative Anastomotic Stricture(Up to 6 months after surgery)
- Non-elective Reoperation(Within 30 days after surgery)
- Length of Hospital Stay(Up to 60 days)
- Hospital Readmission(Within 30 days after discharge)
- 30-day All-cause Mortality(Within 30 days after surgery)
研究者
Mateusz Rubinkiewicz
Associate Professor
Jagiellonian University