Anastomotic Leakage, Colorectal Cancer, Colorectal Surgery, Complications, Leakage Testing
Conditions
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
Interventions
PROCEDUREIntraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
Sponsors
Nanchong Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Anastomotic Leak within 30 days | 30 days | Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Postoperative Complications within 30 days | 30 days | Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery. |
Countries
China
Contacts
CONTACTYunhong Tian, doctor
Outcome results
None listed