Testing for leaks in colorectal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a specific leak testing method using gastroscopy, air, and methylene blue (GAM) to reduce postoperative complications, particularly anastomotic leakage, in patients undergoing surgery for colorectal cancer. The primary focus is on measuring the incidence of anastomotic complications within 30 days post-surgery. By implementing intraoperative leak testing, the study aims to improve surgical outcomes and patient safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanchong Central Hospital
  Nanchong, Sichuan, China Recruiting

Study contacts

• Study coordinator: Yunhong Tian, doctor
• Email: drtianyunhong@126.com
• Phone: 13508087719

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.