NCT06865638 Efficacy and Safety of Colorectal Anastomotic Leak Testing
| NCT ID | NCT06865638 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanchong Central Hospital |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2024-12-22 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 264 participants in total. It began in 2024-12-22 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06865638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06865638 currently recruiting?
Yes, NCT06865638 is actively recruiting participants. Contact the research team at drtianyunhong@126.com for enrollment information.
Where is the NCT06865638 trial being conducted?
This trial is being conducted at Nanchong, China.
Who is sponsoring the NCT06865638 clinical trial?
NCT06865638 is sponsored by Nanchong Central Hospital. The trial plans to enroll 264 participants.
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