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

Anastomotic Leak Clinical Trial

Official title:

Multicenter, Randomized, Controlled, Single Blinded, Phase IV Study Comparing 2 Parallel Groups in the Evaluation of the Prevention of Anastomotic Leaks in GI High Risk Anastomosis, With or Without the Application of Fibrin Glue in the Anastomotic Line

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01306851
• Other study ID #: PROTTISUCOL-001
• Status: Recruiting
• Phase: Phase 4
• First received: March 1, 2011
• Last updated: March 1, 2011
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: May 2007
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Lago Jesus, MD
• Phone: +34618302092
• Email: jesus.lago[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

Drug:
• Fibrin glue
In the intervention group, 5 or 10 ml of fibrin glue are applied in the anastomotic line.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of anastomotic leak	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.	6 months	Yes
Secondary	Evidence of infectious collections in the anastomotic area		3 months	No