Efficacy and Safety of Colorectal Anastomotic Leak Testing

Nanchong Central Hospital

Status: Enrolling

Conditions: Leakage Testing; Complications; Colorectal Surgery; Anastomotic Leakage; Colorectal Cancer

Treatments: Procedure: Intraoperative leak testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06865638

2025008

Details and patient eligibility

About

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

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 8 patient groups

≤5cm Rectal, Pre-chemo, Leak Test

Experimental group

Description:

Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing.

Treatment:

Procedure: Intraoperative leak testing

≤5cm Rectal, Pre-chemo, No Leak Test

No Intervention group

Description:

Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.

≤5cm Rectal, No pre-chemo, Leak Test

Experimental group

Description:

Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.

Treatment:

Procedure: Intraoperative leak testing

≤5cm Rectal, No pre-chemo, No Leak Test

No Intervention group

Description:

Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.

>5cm Colorectal, Pre-chemo, Leak Test

Experimental group

Description:

Patients with colorectal cancer \> 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing.

Treatment:

Procedure: Intraoperative leak testing

>5cm Colorectal, Pre-chemo, No Leak Test

No Intervention group

Description:

Patients with colorectal cancer \> 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.

>5cm Colorectal, No pre-chemo, Leak Test

Experimental group

Description:

Patients with colorectal cancer \> 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.

Treatment:

Procedure: Intraoperative leak testing

>5cm Colorectal, No pre-chemo, No Leak Test

No Intervention group

Description:

Patients with colorectal cancer \> 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.