Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Anastomotic leakage (ISREC), within 90 days
研究概览
简要总结
The goal of this observational multicenter study is to evaluate the safety and feasibility of a single-stapled technique (SST) for colorectal anastomosis and to explore whether this technique is associated with a reduced rate of anastomotic leakage compared with the conventional double-stapled technique (DST).
The study includes adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis, including sigmoid resection, left hemicolectomy, or partial mesorectal excision (PME), for benign or malignant disease.
The main questions it aims to answer are:
What is the rate of anastomotic leakage within 90 days after surgery in patients operated with the single-stapled technique?
Is the single-stapled technique feasible and safe across different surgical approaches (open, laparoscopic, and robot-assisted surgery) in a multicenter setting?
Furthermore, outcomes after single-stapled anastomosis will be compared with a retrospective cohort of patients operated with the conventional double-stapled technique to explore potential differences in anastomotic leakage rates and postoperative complications.
Participants will receive standard surgical care as determined by the treating surgical team. Patients included in the prospective part of the study will undergo colorectal anastomosis using the single-stapled technique as part of routine clinical practice. Data on perioperative variables, postoperative complications (including anastomotic leakage graded according to international consensus definitions), and follow-up outcomes will be collected prospectively using an electronic case report form (eCRF). A retrospective cohort from the same participating centers will be identified through medical record review using identical inclusion criteria.
The results of this study are intended to provide robust multicenter data on the safety and clinical outcomes of the single-stapled technique and to serve as the basis for planning a future randomized controlled multicenter trial.
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.
- •Planned (elective) left-sided colorectal resection with creation of a colorectal anastomosis, including: Left hemicolectomy, and/or Sigmoid resection, and/or Partial mesorectal excision (PME).
- •Benign or malignant indication.
- •Prospective cohort: Ability to provide written informed consent.
- •Retrospective cohort: Eligible patients operated during 2023-2025 at participating centers, identified through medical record review, meeting the same surgical inclusion criteria.
排除标准
- •Total mesorectal excision (TME) (e.g., low rectal cancer surgery requiring TME).
- •Non-left-sided colorectal resections (e.g., right-sided colectomy) or procedures outside the study-defined operations.
- •Surgery not involving a colorectal anastomosis (e.g., end colostomy/Hartmann's procedure without anastomosis).
- •Emergency/urgent colorectal resection (non-elective surgery).
- •Prospective cohort: Inability to provide informed consent.
研究组 & 干预措施
Prospective single-stapled technique cohort
Adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis (including sigmoid resection, left hemicolectomy, or partial mesorectal excision) in whom the anastomosis is constructed using the single-stapled technique (SST) as part of routine clinical practice. Patients are included prospectively and followed for postoperative complications, including anastomotic leakage within 90 days, as well as longer-term outcomes.
干预措施: Single-stapled colorectal anastomosis (Procedure)
Retrospective double-stapled technique cohort
A retrospective cohort of adult patients who previously underwent planned left-sided colorectal resection with colorectal anastomosis using the conventional double-stapled technique (DST) during the years 2023-2025. Patients are identified through medical record review at participating centers using the same inclusion criteria as the prospective cohort, and outcome data are collected retrospectively for comparison.
干预措施: Double-stapled colorectal anastomosis (Procedure)
结局指标
主要结局
Anastomotic leakage (ISREC), within 90 days
时间窗: Within 90 days after surgery
Anastomotic leakage following colorectal anastomosis, defined according to the International Study Group of Rectal Cancer (ISREC). Anastomotic leakage is recorded as a binary outcome (yes/no). Severity grading (ISREC Grade A, B, or C) will be reported descriptively as part of the same outcome.
次要结局
- Feasibility of the single-stapled technique (SST)(During surgery)
- Completeness of stapled anastomotic rings(During surgery)
- Intraoperative air leak test result(During surgery)
- Duration of surgery(During surgery)
- Length of postoperative hospital stay(Within 90 days of primary surgery)
- Hospital readmission rate(Within 90 days after surgery)
- Postoperative complications (Clavien-Dindo classification)(Within 90 days after surgery)
- All-cause mortality(Within 90 days after surgery)
- Recurrence-free survival(Upto three years after primary surgery)
- Stoma-free survival(At one and three years after surgery)