Prevention of Anastomotic Leak in Gastrointestinal (GI) Anastomosis With the Application of Tisseal in the Anastomotic Line
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|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|
- Occurence of anastomotic leak [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
- Evidence of infectious collections in the anastomotic area [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Fibrin glue||
Drug: Fibrin glue
In the intervention group, 5 or 10 ml of fibrin glue are applied in the anastomotic line.
|Contact: Lago Jesus, MDfirstname.lastname@example.org|
|Hospital General Universitario Gregorio Marañon||Recruiting|
|Madrid, Spain, 28007|
|Contact: Lago Jesus, MD +34618302092 email@example.com|
|Principal Investigator: Lago Jesus, MD|