Efficiency of TISSEEL for Sleeve Gastrectomy Complications

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01613664
First received: June 5, 2012
Last updated: May 19, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • presence of post-operative complications [ Time Frame: post operative day 30 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
  • The postoperative hemorrhage's rate [ Time Frame: post-operative day 30 ] [ Designated as safety issue: Yes ]
  • The intra-abdominal locoregional collection's rate [ Time Frame: post-operative day 30 ] [ Designated as safety issue: Yes ]
  • the length of stay [ Time Frame: post-operative day 30 ] [ Designated as safety issue: No ]
  • the rate of readmission [ Time Frame: post-operative day 30 ] [ Designated as safety issue: No ]
  • the rate of reintervention [ Time Frame: post-operative day 30 ] [ Designated as safety issue: Yes ]
  • the overall mortality at one month [ Time Frame: post-operative day 30 ] [ Designated as safety issue: Yes ]
  • the specific mortality at one month [ Time Frame: post-operative day 30 ] [ Designated as safety issue: Yes ]
  • the rate of postoperative morbidity [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]
    the morbidity will be evaluated according to the clavien dindo classification


Estimated Enrollment: 600
Study Start Date: February 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 5, 2012
Last Updated: May 19, 2014
Health Authority: France : ANSM French health product Safety Agency

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

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014