Efficacy and Safety of Colorectal Anastomotic Leak Testing

Launched by NANCHONG CENTRAL HOSPITAL · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to test for complications after colorectal surgery, specifically focusing on patients with colorectal cancer. The researchers want to see if a testing method called gastroscopy, along with air and a blue dye called methylene blue, can help reduce the chances of a serious problem known as anastomotic leakage. This is when the connection made during surgery between two parts of the intestine leaks, which can lead to complications. The main goal is to find out how often these leaks occur within 30 days after surgery.

To participate in this study, individuals must be between 18 and 85 years old and diagnosed with colorectal cancer. They should be scheduled for surgery and be in good enough health to tolerate the surgery and testing. However, those with certain serious health conditions or prior complications related to their surgery are not eligible. Participants can expect to undergo the testing method being studied and will be monitored for any complications after their surgery. This trial is currently recruiting participants, and anyone interested should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

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.