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Clinical Trials in China / NCT06865638
Recruiting Not applicable

Efficacy and Safety of Colorectal Anastomotic Leak Testing

NCT06865638 · tracked via the Priya Life Science China tracker
Sponsor
Nanchong Central Hospital
Phase
Not applicable
Started
2024-12-22
Last updated
2026-03-31

Condition(s) studied

Colorectal CancerLeakage TestingColorectal SurgeryComplicationsAnastomotic Leakage

Investigational drug(s) / intervention(s)

Intraoperative leak testing

Intraoperative leak testing: ◦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.

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment 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 informed consent form and is willing to cooperate throughout the study process. Exclusion Criteria: 1. Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections. 2. 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. 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 are receiving anticoagulant therapy that cannot be adjusted. 5. Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures. 6. Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy. 7. Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nanchong Central Hospital Nanchong Sichuan Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06865638 on ClinicalTrials.gov ↗ ← All trials in China