Testing for leaks in colorectal surgery

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.

This study is testing a new method to check for leaks during colorectal cancer surgery to see if it helps reduce complications after the operation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Nanchong Central Hospital (other gov)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanchong, Sichuan)
• Trial ID: NCT06865638 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with colorectal cancer and scheduled for surgical treatment.

Not a fit: Patients with pre-existing anastomotic leaks or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of postoperative complications for colorectal cancer patients.

How similar studies have performed: While similar approaches have been explored, the specific use of GAM leak testing in this context is relatively novel.

Eligibility criteria

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 this trial is running

Nanchong, Sichuan

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

Study contacts

• Study coordinator: Yunhong Tian, doctor

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