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

March 1, 2011 updated by: Hospital General Universitario Gregorio Marañon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
        • Principal Investigator:
          • Lago Jesus, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fibrin glue
Drug: Fibrin glue
In the intervention group, 5 or 10 ml of fibrin glue are applied in the anastomotic line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of anastomotic leak
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of infectious collections in the anastomotic area
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTTISUCOL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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