NCT07588386招募中不适用
The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After Surgery for Low Colorectal Cancer:A Randomized Controlled Trial
Nanchong Central Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年6月21日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn whether early postoperative colonoscopy is valuable in the early diagnosis of anastomotic leakage after surgery for low colorectal cancer.The main questions it aims to answer are:
- Will the median diagnosis time of AL in the intervention group (early colonoscopy group) be significantly shorter than that in the control group?
- Can targeted treatment (such as endoscopic vacuum therapy (EVT)) be initiated earlier in the early colonoscopy group, thereby reducing the incidence of AL and the rate of unplanned re-laparotomy?
Researchers will compare the median diagnosis time of AL in the intervention group (early colonoscopy group) with the control group to observe whether early postoperative colonoscopy can detect anastomotic leakage earlier.
Participants will:
Experimental group (early colonoscopy group):
- Colonoscopy will be performed on the 5th to 8th day after surgery (the surgeon will decide the specific date within this time window based on the patient's recovery).
- Carry out adequate intestinal preparation before the examination (the specific plan is formulated according to the hospital's routine, which may involve antegrade or retrograde enema, etc., and needs to be recorded and standardized).
Control group (routine observation group):
- Receive standard postoperative management, including monitoring vital signs, abdominal signs, drainage fluid properties, etc.
- Only when clinical symptoms suspected of anastomotic leakage occur (such as persistent fever, worsening abdominal pain, turbid drainage fluid or stool samples), CT scan, gastrointestinal angiography or diagnostic colonoscopy should be performed according to clinical indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old.
- •Pathologically diagnosed as colorectal adenocarcinoma.
- •The distance between the lower edge of the tumor and the anal verge is ≤15cm.
- •Accept laparoscopic or open radical resection and complete primary colorectal or colosal anastomosis.
- •Voluntarily participate and sign the written informed consent.
排除标准
- •Distant metastasis was confirmed by emergency operation, palliative operation or intraoperative metastasis (M1).
- •Unsatisfactory anastomosis or poor blood circulation were found during the operation, and reinforcement suture or preventive colostomy were performed during the operation.
- •There are serious contraindications for enteroscopy (such as acute myocardial infarction, severe cardiopulmonary insufficiency, blood coagulation dysfunction, etc.).
- •Pregnant or lactating women.
- •Previous history of colorectal surgery (except endoscopic polypectomy).
- •Unable to understand or cooperate with the research process.
研究组 & 干预措施
Control group (routine observation group)
No Intervention
Experimental group (early colonoscopy group)
Experimental
干预措施: electronic colonoscopy (Behavioral)
研究者
研究点 (1)
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