Clinical Trial: Efficiency of TISSEEL for Sleeve Gastrectomy Complications
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized Prospective Clinical Study Evaluating the Usefulness of Fibrin Glue (TISSEEL® KIT) to Prevent Gastric Fistula, Intra Abdominal Haemorrhage and Intra Abdomi
Brief Summary: Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. However, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently reliable technique to prevent these complications.
Detailed Summary:
The hypothesis is the following : the use of fibrin glue (Tissucol ®) during Laparoscopic Sleeve Gastrectomy would reduce the incidence of complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection).
The aim is to investigate whether the use of fibrin glue (Tissucol®) during Laparoscopic Sleeve Gastrectomy reduces the incidence of postoperative complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection)
Sponsor: Centre Hospitalier Universitaire, Amiens
Current Primary Outcome: presence of post-operative complications [ Time Frame: post operative day 30 ]
The primary endpoint corresponds to the presence of complications after laparoscopic sleeve gastrectomy during the follow up period. A complication is considered as "present" if at least one of the following three items is present:
- Gastric fistula
- Postoperative hemorrhage
- intra-abdominal locoregional collection
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The gastric fistula's rate [ Time Frame: post operative day 30 ]
- The postoperative hemorrhage's rate [ Time Frame: post-operative day 30 ]
- The intra-abdominal locoregional collection's rate [ Time Frame: post-operative day 30 ]
- the length of stay [ Time Frame: post-operative day 30 ]
- the rate of readmission [ Time Frame: post-operative day 30 ]
- the rate of reintervention [ Time Frame: post-operative day 30 ]
- the overall mortality at one month [ Time Frame: post-operative day 30 ]
- the specific mortality at one month [ Time Frame: post-operative day 30 ]
- the rate of postoperative morbidity [ Time Frame: postoperative day 30 ]the morbidity will be evaluated according to the clavien dindo classification
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire, Amiens
Dates:
Date Received: June 5, 2012
Date Started: February 2014
Date Completion: February 2017
Last Updated: January 30, 2017
Last Verified: January 2017