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NCT Number: NCT06865638

Efficacy and Safety of Colorectal Anastomotic Leak Testing

To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.
  • Aged between 18 and 85 years.
  • American Society of Anesthesiologists (ASA) physical status classification is I - III.
  • The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.

Exclusion criteria

  • Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.
  • Patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests.
  • Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate < 30 ml/min).
  • Patients with coagulation disorders (such as platelet count < 50×10⁹/L, international normalized ratio (INR) > 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted.
  • Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
  • Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
  • Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.

Treatment and study plan

Intraoperative leak testing

Procedure

◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.

Primary outcomes

  1. Number of Participants with Anastomotic Leak within 30 days

    Time frame: 30 days

    Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.

Secondary outcomes

  1. Number of Participants with Postoperative Complications within 30 days

    Time frame: 30 days

    Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery.

Study contacts

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

Yunhong Tian, doctor

CONTACT

[email protected]

13508087719

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2025
Registry last updated
Mar 31, 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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