Clinical trial NCT01613664: Efficiency of TISSEEL for Sleeve Gastrectomy Complications
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Morbid Obesity
Keywords: obesity
surgical management
sleeve gastrectomy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: presence of post-operative complications
timeFrame: post operative day 30
Secondary outcomes:
measure: The gastric fistula's rate
timeFrame: post operative day 30
measure: The postoperative hemorrhage's rate
timeFrame: post-operative day 30
measure: The intra-abdominal locoregional collection's rate
timeFrame: post-operative day 30
measure: the length of stay
timeFrame: post-operative day 30
measure: the rate of readmission
timeFrame: post-operative day 30
measure: the rate of reintervention
timeFrame: post-operative day 30
measure: the overall mortality at one month
timeFrame: post-operative day 30
measure: the specific mortality at one month
timeFrame: post-operative day 30
measure: the rate of postoperative morbidity
timeFrame: postoperative day 30
Other outcomes:
Locations:
city: Amiens
country: France
facility: North Universitary Hospital
city: Rouen
country: France
facility: Charles Nicolle Universitary Hospital
Study officials:
affiliation: chu amiens
name: Jean-Marc REGIMBEAU, MD,phD
role: PRINCIPAL_INVESTIGATOR
affiliation: chu Rouen
name: michel scotte, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.