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NCT Number: NCT07588386

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University

Nanchong, Sichuan, 637000, China

Location status: Recruiting

Location contact

Yunhong Tian, Doctor

CONTACT

[email protected]

86+13508087719

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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.

Treatment and study plan

electronic colonoscopy

Behavioral

Colonoscopy on days 5 to 8 after colorectal cancer surgery

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).

    Time frame: day 30

Secondary outcomes

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

    Time frame: day 8

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

    Time frame: day 30

  3. Total postoperative days of hospitalization.

    Time frame: 2 months

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

    Time frame: 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Yunhong Tian, Doctor

CONTACT

[email protected]

86+13508087719

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

The Value of Early Postoperative Colonoscopy in The Early Diagnosis of Anastomotic Leakage After Surgery for Low Colorectal Cancer:A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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