The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After Surgery for Low Colorectal Cancer

NCT07588386 | Recruiting

• 1 other identifier: 2026 Review No. (050)
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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?
3. 3.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).
4. 4.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).
5. 5.Receive standard postoperative management, including monitoring vital signs, abdominal signs, drainage fluid properties, etc.
6. 6.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.

Conditions

Anastomotic Leakage

Outcome Measures

Primary Outcomes (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).

  day 30

Secondary Outcomes (4)

• Diagnostic efficacy: The sensitivity and specificity of early colonoscopy in diagnosing AL, etc.

  day 8

• Clinical outcomes: AL incidence rate within 30 days (divided into grades A, B, and C).

  day 30

• Total postoperative days of hospitalization.

  2 months

• Safety indicators: the incidence of complications (such as bleeding, perforation, cardiovascular events) directly related to early enteroscopy.

  1 month

Study Arms (2)

Experimental group (early colonoscopy group)

EXPERIMENTAL

Behavioral: electronic colonoscopy

Control group (routine observation group)

NO INTERVENTION

Interventions

electronic colonoscopy BEHAVIORAL

Colonoscopy on days 5 to 8 after colorectal cancer surgery

Experimental group (early colonoscopy group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University

Nanchong, Sichuan, 637000, China

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yunhong Tian, Doctor

CONTACT

86+13508087719; drtianyunhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 14, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-04

Locations

CN (1)