Prevention of Anastomotic Leak in Gastrointestinal (GI) Anastomosis With the Application of Tisseal in the Anastomotic Line

Phase 4

• Conditions: Anastomotic Leak
• Interventions: Drug: Fibrin glue

• Registration Number: NCT01306851
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief Summary

The anastomotic leak is one of the most feared complications in abdominal surgery. Certain control methods have been described but the incidence of that complication remains high and is the first cause of mortality in operations where gut anastomosis are performed.

With the aim to prove that the use of fibrin glue in the gut anastomosis can improve gut cicatrization, the investigators started the recruitment of patients to that clinical trial in 2007 with the study hypothesis that patients with a gut anastomosis where fibrin glue was used, had less anastomotic leaks than that where the fibrin glue was not used.

The investigators have calculated the number of patients necessaries to have statistical significant differences in 200 patients with a rate anastomotic leak expected to be higher than 10%.

The study include all the patients that usually arrive to our surgery department and that are expected to have a high risk gut anastomosis: rectal anastomosis, GI anastomosis in the obese patient, small bowel anastomosis in the obstructed one and esophageal anastomosis.

The study is randomized, simple blind where the patient does not know if they are in the fibrin glue group or not, and prospectively analyzed. All the clinical and laboratory or radiographic finds relative to the occurrence of an anastomotic leak are recorded.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-05
• Study Start: 2007-06
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Study First Posted: 2011-03-02
• Last Update Posted: 2011-03-02
• Primary Completion: 2013-03
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients undergoing GI surgery where a high risk anastomosis is preview to be done

Exclusion Criteria

• Haemodynamic instability
• Advanced oncologic disease
• Proteins below 4 gr/ml

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin glue	Fibrin glue	-

Primary Outcome Measures

Name	Time	Method
Occurence of anastomotic leak	6 months	The occurence of anastomotic leak in the 6 months after the surgery is the most important factor to determine if fibrin glue is helpful in the prevention of that complicacion.

Secondary Outcome Measures

Name	Time	Method
Evidence of infectious collections in the anastomotic area	3 months

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain