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Efficiency of TISSEEL for Sleeve Gastrectomy Complications (TISSEEL)

This study is currently recruiting participants.
Verified January 2017 by Centre Hospitalier Universitaire, Amiens
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613664
First Posted: June 7, 2012
Last Update Posted: January 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
  Purpose
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 Intervention Phase
Morbid Obesity Drug: tisseel Other: no tisseel Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 600
Study Start Date: February 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01613664


Contacts
Contact: Jean-Marc REGIMBEAU, MD, phD +33322667928 regimbeau.jean-marc@chu-amiens.fr

Locations
France
North Universitary Hospital Recruiting
Amiens, France, 80054
Principal Investigator: Jean-Marc REGIMBEAU, MD, phD         
Charles Nicolle Universitary Hospital Not yet recruiting
Rouen, France, 76031
Principal Investigator: michel scotte, MD phD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Jean-Marc REGIMBEAU, MD,phD chu amiens
Principal Investigator: michel scotte, MD PhD chu Rouen
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01613664     History of Changes
Other Study ID Numbers: PI11-PR-REGIMBEAU-2
First Submitted: June 5, 2012
First Posted: June 7, 2012
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Centre Hospitalier Universitaire, Amiens:
obesity
surgical management
sleeve gastrectomy

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Fibrin Tissue Adhesive
Hemostatics
Coagulants