Health TrialsbyHealthPanel

Efficacy and Safety of Colorectal Anastomotic Leak Testing

ConditionsColorectal CancerLeakage TestingColorectal SurgeryComplicationsAnastomotic Leakage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNanchong Central Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraoperative leak testing

    Procedure/Surgery

    ◦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.

Treatment groups

264 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: ≤5cm Rectal, Pre-chemo, Leak TestExperimental treatment 1 intervention
Group B: ≤5cm Rectal, Pre-chemo, No Leak TestNo intervention 0 interventions
Group C: ≤5cm Rectal, No pre-chemo, Leak TestExperimental treatment 1 intervention
Group D: ≤5cm Rectal, No pre-chemo, No Leak TestNo intervention 0 interventions
Group E: >5cm Colorectal, Pre-chemo, Leak TestExperimental treatment 1 intervention
Group F: >5cm Colorectal, Pre-chemo, No Leak TestNo intervention 0 interventions
Group G: >5cm Colorectal, No pre-chemo, Leak TestExperimental treatment 1 intervention
Group H: >5cm Colorectal, No pre-chemo, No Leak TestNo intervention 0 interventions

Trial outcomes

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.

Time frame
30 days

Secondary outcomes

1

Number of Participants with Postoperative Complications within 30 days

Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanchong Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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