NCT06865638Recruiting
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.
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- First submitted
- 6 Mar 2025
- Start date
- 22 Dec 2024
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Nanchong Central Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06865638
What you commit to
- Study type: Interventional
- Planned participants: 264
- From 22 Dec 2024 to the primary completion date, 31 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
Other illness
- 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 a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
- Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanchong Central Hospital Coordinator of this site? Confirm its status | Nanchong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.