Efficacy and Safety of Colorectal Anastomotic Leak Testing

Recruiting now · Not applicable

Conditions studied: Colorectal Cancer, Leakage Testing, Colorectal Surgery, Complications, Anastomotic Leakage

In brief

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

Key facts

Study ID

NCT06865638

Run by

Nanchong Central Hospital

People needed

264

Starts

2024-12-22

Expected to finish

2029-04-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nanchong Central Hospital — Nanchong, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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