Efficacy and Safety of Colorectal Anastomotic Leak Testing

Last updated: March 11, 2025
Sponsor: Nanchong Central Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Colon Cancer; Rectal Cancer

Treatment

Intraoperative leak testing

Clinical Study ID

NCT06865638
2025008
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients diagnosed with colorectal cancer by pathology and scheduled for surgicaltreatment who meet the surgical indications.

  2. Aged between 18 and 85 years.

  3. American Society of Anesthesiologists (ASA) physical status classification is I -III.

  4. The patient or his/her legal representative can understand and sign the informedconsent form and is willing to cooperate throughout the study process.

Exclusion

Exclusion Criteria:

  1. Patients with preoperatively diagnosed anastomotic leak or other severe abdominalinfections.

  2. Patients with severe cardiovascular and cerebrovascular diseases (such as recentmyocardial infarction, unstable angina pectoris, severe heart failure, acutecerebral infarction, etc.) who cannot tolerate surgery and related tests.

  3. Patients with severely impaired liver and kidney function (liver function Child -Pugh classification C or above, creatinine clearance rate < 30 ml/min).

  4. Patients with coagulation disorders (such as platelet count < 50×10⁹/L,international normalized ratio (INR) > 1.5, etc.) that cannot be corrected or arereceiving anticoagulant therapy that cannot be adjusted.

  5. Patients with a history of abdominal radiotherapy or multiple abdominal surgeriesand severe abdominal adhesions that may affect the operation and detectionprocedures.

  6. Patients with other malignant tumors who are receiving active anti-tumor treatmentsuch as radiotherapy and chemotherapy.

  7. Patients with mental illness or cognitive impairment who cannot cooperate with thestudy process and follow-up.

Study Design

Total Participants: 264
Treatment Group(s): 1
Primary Treatment: Intraoperative leak testing
Phase:
Study Start date:
December 22, 2024
Estimated Completion Date:
April 01, 2026

Connect with a study center

  • Nanchong Central Hospital

    Nanchong, Sichuan
    China

    Active - Recruiting

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