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Efficiency of TISSEEL for Sleeve Gastrectomy Complications (TISSEEL)

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
tisseel
no tisseel
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring obesity, surgical management, sleeve gastrectomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Universitary Hospital
  • Charles Nicolle Universitary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tisseel

no tisseel

Arm Description

tisseel will be applied during the surgery

no tisseel will be applied during the surgery

Outcomes

Primary Outcome Measures

presence of post-operative complications
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
The postoperative hemorrhage's rate
The intra-abdominal locoregional collection's rate
the length of stay
the rate of readmission
the rate of reintervention
the overall mortality at one month
the specific mortality at one month
the rate of postoperative morbidity
the morbidity will be evaluated according to the clavien dindo classification

Full Information

First Posted
June 5, 2012
Last Updated
July 13, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01613664
Brief Title
Efficiency of TISSEEL for Sleeve Gastrectomy Complications
Acronym
TISSEEL
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
obesity, surgical management, sleeve gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tisseel
Arm Type
Experimental
Arm Description
tisseel will be applied during the surgery
Arm Title
no tisseel
Arm Type
Placebo Comparator
Arm Description
no tisseel will be applied during the surgery
Intervention Type
Drug
Intervention Name(s)
tisseel
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
no tisseel
Intervention Description
the surgeon does not applied tissucol during the surgery
Primary Outcome Measure Information:
Title
presence of post-operative complications
Description
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
Time Frame
post operative day 30
Secondary Outcome Measure Information:
Title
The gastric fistula's rate
Time Frame
post operative day 30
Title
The postoperative hemorrhage's rate
Time Frame
post-operative day 30
Title
The intra-abdominal locoregional collection's rate
Time Frame
post-operative day 30
Title
the length of stay
Time Frame
post-operative day 30
Title
the rate of readmission
Time Frame
post-operative day 30
Title
the rate of reintervention
Time Frame
post-operative day 30
Title
the overall mortality at one month
Time Frame
post-operative day 30
Title
the specific mortality at one month
Time Frame
post-operative day 30
Title
the rate of postoperative morbidity
Description
the morbidity will be evaluated according to the clavien dindo classification
Time Frame
postoperative day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc REGIMBEAU, MD,phD
Organizational Affiliation
chu amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
michel scotte, MD PhD
Organizational Affiliation
chu Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Universitary Hospital
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Charles Nicolle Universitary Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22328096
Citation
Pequignot A, Fuks D, Verhaeghe P, Dhahri A, Brehant O, Bartoli E, Delcenserie R, Yzet T, Regimbeau JM. Is there a place for pigtail drains in the management of gastric leaks after laparoscopic sleeve gastrectomy? Obes Surg. 2012 May;22(5):712-20. doi: 10.1007/s11695-012-0597-0.
Results Reference
background
PubMed Identifier
21769286
Citation
Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.
Results Reference
background
PubMed Identifier
20971049
Citation
Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.
Results Reference
background
PubMed Identifier
19902316
Citation
Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.
Results Reference
background
PubMed Identifier
19081482
Citation
Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.
Results Reference
background
PubMed Identifier
30080735
Citation
Rebibo L, Dhahri A, Chati R, Cosse C, Huet E, Regimbeau JM. Effectiveness of Fibrin Sealant Application on the Development of Staple Line Complications After Sleeve Gastrectomy: A Prospective Randomized Trial. Ann Surg. 2018 Nov;268(5):762-768. doi: 10.1097/SLA.0000000000002892.
Results Reference
derived

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Efficiency of TISSEEL for Sleeve Gastrectomy Complications

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