Efficiency of TISSEEL for Sleeve Gastrectomy Complications
TISSEEL
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
1 other identifier
interventional
597
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2014
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2018
CompletedJuly 14, 2020
July 1, 2020
4.3 years
June 5, 2012
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
post operative day 30
Secondary Outcomes (9)
The gastric fistula's rate
post operative day 30
The postoperative hemorrhage's rate
post-operative day 30
The intra-abdominal locoregional collection's rate
post-operative day 30
the length of stay
post-operative day 30
the rate of readmission
post-operative day 30
- +4 more secondary outcomes
Study Arms (2)
tisseel
EXPERIMENTALtisseel will be applied during the surgery
no tisseel
PLACEBO COMPARATORno tisseel will be applied during the surgery
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
North Universitary Hospital
Amiens, 80054, France
Charles Nicolle Universitary Hospital
Rouen, 76031, France
Related Publications (6)
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.
PMID: 22328096BACKGROUNDPequignot 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.
PMID: 21769286BACKGROUNDDhahri 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.
PMID: 20971049BACKGROUNDSabbagh 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.
PMID: 19902316BACKGROUNDFuks 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.
PMID: 19081482BACKGROUNDRebibo 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.
PMID: 30080735DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marc REGIMBEAU, MD,phD
chu amiens
- PRINCIPAL INVESTIGATOR
michel scotte, MD PhD
chu Rouen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 7, 2012
Study Start
February 1, 2014
Primary Completion
May 15, 2018
Study Completion
May 15, 2018
Last Updated
July 14, 2020
Record last verified: 2020-07