RecruitingNot ApplicableNCT06865638

Efficacy and Safety of Colorectal Anastomotic Leak Testing

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.

Sponsor

Nanchong Central Hospital

Enrollment

264 participants

Start Date

Dec 22, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Colorectal Surgery Complications Anastomotic Leakage Leakage Testing

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

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.

Exclusion Criteria7

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.

Interventions

PROCEDUREIntraoperative 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.