Efficacy and Safety of Colorectal Anastomotic Leak Testing

NCT06865638 | Recruiting

• 1 other identifier: 2025008
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Anastomotic Leak within 30 days

  Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.

  30 days

Secondary Outcomes (1)

• Number of Participants with Postoperative Complications within 30 days

  30 days

Study Arms (8)

≤5cm Rectal, Pre-chemo, Leak Test

EXPERIMENTAL

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

Procedure: Intraoperative leak testing

≤5cm Rectal, Pre-chemo, No Leak Test

NO INTERVENTION

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

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

Procedure: Intraoperative leak testing

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

NO INTERVENTION

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

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

Procedure: Intraoperative leak testing

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

NO INTERVENTION

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

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

Procedure: Intraoperative leak testing

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

NO INTERVENTION

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

Interventions

Intraoperative leak testing PROCEDURE

◦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.

>5cm Colorectal, No pre-chemo, Leak Test; >5cm Colorectal, Pre-chemo, Leak Test; ≤5cm Rectal, No pre-chemo, Leak Test; ≤5cm Rectal, Pre-chemo, Leak Test

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.
• 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 other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
• Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yunhong Tian, doctor

CONTACT

13508087719; drtianyunhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 10, 2025
• Study Start: December 22, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)