COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Efficiency of TISSEEL for Sleeve Gastrectomy Complications (TISSEEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613664
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : July 14, 2020
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: tisseel Other: no tisseel Phase 3

Detailed Description:

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 597 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Prospective Clinical Study Evaluating the Usefulness of Fibrin Glue (TISSEEL® KIT) to Prevent Gastric Fistula, Intra Abdominal Haemorrhage and Intra Abdominal Loco Regional Collections After Laparoscopic Sleeve Gastrectomy
Study Start Date : February 2014
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: tisseel
tisseel will be applied during the surgery
Drug: tisseel
The product will be given as a 2 mL bottle per patient, which will be spread along the staple line. If necessary, a second bottle of 2 mL is used. The precautions for use are described in the user manual.

Placebo Comparator: no tisseel
no tisseel will be applied during the surgery
Other: no tisseel
the surgeon does not applied tissucol during the surgery

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. The gastric fistula's rate [ Time Frame: post operative day 30 ]
  2. The postoperative hemorrhage's rate [ Time Frame: post-operative day 30 ]
  3. The intra-abdominal locoregional collection's rate [ Time Frame: post-operative day 30 ]
  4. the length of stay [ Time Frame: post-operative day 30 ]
  5. the rate of readmission [ Time Frame: post-operative day 30 ]
  6. the rate of reintervention [ Time Frame: post-operative day 30 ]
  7. the overall mortality at one month [ Time Frame: post-operative day 30 ]
  8. the specific mortality at one month [ Time Frame: post-operative day 30 ]
  9. the rate of postoperative morbidity [ Time Frame: postoperative day 30 ]
    the morbidity will be evaluated according to the clavien dindo classification

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Obesity requiring bariatric surgery (Laparoscopic Sleeve Gastrectomy) according to the Haute Autorité de Santé
  • Patients younger than 60 years old
  • BMI ≤ 60 kg/m2
  • Surgery accepted by an Obesity-related specific committee
  • Patient with social protection

Exclusion Criteria:

  • Previous bariatric or gastric surgery
  • BMI > 60 kg/m2
  • Under 18 years old
  • Allergy to Tissucol®
  • peroperative fistula
  • Consent not signed
  • Incapable of giving his opinion
  • Pregnancy or breast-feeding
  • Contraindication to surgery
  • ASA classification IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613664

Layout table for location information
North Universitary Hospital
Amiens, France, 80054
Charles Nicolle Universitary Hospital
Rouen, France, 76031
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Layout table for investigator information
Principal Investigator: Jean-Marc REGIMBEAU, MD,phD chu amiens
Principal Investigator: michel scotte, MD PhD chu Rouen
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT01613664    
Other Study ID Numbers: PI11-PR-REGIMBEAU-2
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Keywords provided by Centre Hospitalier Universitaire, Amiens:
surgical management
sleeve gastrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Nutrition Disorders
Body Weight
Fibrin Tissue Adhesive