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

Primary Purpose

Anastomotic Leak

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Fibrin glue
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anastomotic Leak focused on measuring fibrin glue, anastomotic leak, gastrointestinal high risk anastomosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General Universitario Gregorio MarañonRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Fibrin glue

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evidence of infectious collections in the anastomotic area

Full Information

First Posted
March 1, 2011
Last Updated
March 1, 2011
Sponsor
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT01306851
Brief Title
Prevention of Anastomotic Leak in Gastrointestinal (GI) Anastomosis With the Application of Tisseal in the Anastomotic Line
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital General Universitario Gregorio Marañon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak
Keywords
fibrin glue, anastomotic leak, gastrointestinal high risk anastomosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibrin glue
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fibrin glue
Intervention Description
In the intervention group, 5 or 10 ml of fibrin glue are applied in the anastomotic line.
Primary Outcome Measure Information:
Title
Occurence of anastomotic leak
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evidence of infectious collections in the anastomotic area
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lago Jesus, MD
Phone
+34618302092
Email
jesus.lago@salud.madrid.org
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lago Jesus, MD
Phone
+34618302092
Email
jesus.lago@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Lago Jesus, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22748849
Citation
Lago Oliver J, Arjona Medina I, Martin Garcia-Almenta E, Martin Gil J, Sanz Sanchez M, Perez Diaz MD, Alonso Poza A, Turegano Fuentes F, Torres Garcia A. [Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001]. Cir Esp. 2012 Dec;90(10):647-55. doi: 10.1016/j.ciresp.2012.05.007. Epub 2012 Jun 27. Spanish.
Results Reference
derived

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

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