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