The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After … (NCT07588386) | Clinical Trial Compass
RecruitingNot Applicable
The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After Surgery for Low Colorectal Cancer
China140 participantsStarted 2026-06-21
Plain-language summary
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:
1. Will the median diagnosis time of AL in the intervention group (early colonoscopy group) be significantly shorter than that in the control group?
2. 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):
1. 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).
2. 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):
1. Receive standard postoperative management, including monitoring vital signs, abdominal signs, drainage fluid properties, etc.
2. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Distant metastasis was confirmed by emergency operation, palliative operation or intraoperative metastasis (M1).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnosis time lag: the number of days from the end of the operation (the last stitch of skin suturing) to the final diagnosis of AL (confirmed by imaging, endoscopic or surgical exploration).
. 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.