Actively Recruiting
Comparing Leak Testing Versus No Leak Testing for Anastomosis in Colorectal Cancer Surgery: A Multicenter Randomized Trial
Led by Nanchong Central Hospital · Updated on 2026-03-31
264
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of gastroscopy, air, and methylene blue (GAM) leak testing in reducing postoperative complications, especially anastomotic leakage, after colorectal cancer surgery. The study focuses on patients with colorectal cancer undergoing surgery and aims to compare clinical outcomes between those who receive leak testing during surgery and those who do not. The primary outcome is the incidence of anastomotic leaks within 30 days after surgery. Participants are divided into groups based on tumor location (rectal cancer ≤ 5 cm from the anus or colorectal cancer > 5 cm) and whether they received preoperative chemotherapy. Some groups receive intraoperative leak testing after the anastomosis is completed, which involves checking the anastomosis integrity using gastroscopy, warm saline immersion, air filling, and methylene blue injection. Others do not receive leak testing. This randomized, double-blind trial compares these groups to assess the impact of leak testing. During the study, participants are monitored for postoperative complications, especially anastomotic leaks, for 30 days following surgery. Researchers will collect data on the number of patients experiencing leaks and other complications. The study involves follow-up assessments within the first month after surgery to evaluate safety and outcomes. Participation lasts through the surgical treatment and the 30-day postoperative observation period.
CONDITIONS
Brief Title
Efficacy and Safety of Colorectal Anastomotic Leak Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with colorectal cancer by pathology and scheduled for surgery who meet surgical indications
- Aged between 18 and 85 years
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Able to understand and sign informed consent and willing to cooperate throughout the study
You will not qualify if you...
- Preoperatively diagnosed anastomotic leak or severe abdominal infections
- Severe cardiovascular or cerebrovascular diseases preventing surgery
- Severely impaired liver function (Child-Pugh C or above) or kidney function (creatinine clearance < 30 ml/min)
- Coagulation disorders that cannot be corrected or unadjustable anticoagulant therapy
- History of abdominal radiotherapy, multiple abdominal surgeries, or severe abdominal adhesions affecting surgery
- Other active malignant tumors undergoing treatment
- Mental illness or cognitive impairment preventing cooperation and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery
Participants undergo colorectal cancer surgery during which an intraoperative leak test may be performed to check the integrity of the anastomosis. This testing involves methods such as gastroscopy observation, saline immersion, air filling, or methylene blue injection.
1 surgical visit (in-person)
Duration - 30 days
Participants are monitored for post-operative complications and anastomotic leaks within 30 days after surgery.
Approximately 2 to 3 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Nanchong Central Hospital
Nanchong, Sichuan, China
Actively Recruiting
Research Team
Y
Yunhong Tian, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
8
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