Efficiency of TISSEEL for Sleeve Gastrectomy Complications

Morbid Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613664
• Other study ID #: PI11-PR-REGIMBEAU-2
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: May 15, 2018

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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.

Other:
• no tisseel
the surgeon does not applied tissucol during the surgery

Locations

Country	Name	City	State
France	North Universitary Hospital	Amiens
France	Charles Nicolle Universitary Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View Citation

Péquignot 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The gastric fistula's rate		post operative day 30
Secondary	The postoperative hemorrhage's rate		post-operative day 30
Secondary	The intra-abdominal locoregional collection's rate		post-operative day 30
Secondary	the length of stay		post-operative day 30
Secondary	the rate of readmission		post-operative day 30
Secondary	the rate of reintervention		post-operative day 30
Secondary	the overall mortality at one month		post-operative day 30
Secondary	the specific mortality at one month		post-operative day 30
Secondary	the rate of postoperative morbidity	the morbidity will be evaluated according to the clavien dindo classification	postoperative day 30