Efficacy and Safety of Colorectal Anastomotic Leak Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNanchong Central Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intraoperative leak testing
Treatment groups
264 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov