Trial record 3 of 3 for: "Hemoperitoneum"

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Efficiency of TISSEEL for Sleeve Gastrectomy Complications (TISSEEL)

This study is currently recruiting participants.

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Contacts and Locations

Verified January 2017 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: January 30, 2017

Last verified: January 2017

History of Changes

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 Intervention Model: Parallel Assignment Masking: 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

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

Primary Outcome Measures:

presence of post-operative complications [ Time Frame: post operative day 30 ]
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 ]
The postoperative hemorrhage's rate [ Time Frame: post-operative day 30 ]
The intra-abdominal locoregional collection's rate [ Time Frame: post-operative day 30 ]
the length of stay [ Time Frame: post-operative day 30 ]
the rate of readmission [ Time Frame: post-operative day 30 ]
the rate of reintervention [ Time Frame: post-operative day 30 ]
the overall mortality at one month [ Time Frame: post-operative day 30 ]
the specific mortality at one month [ Time Frame: post-operative day 30 ]
the rate of postoperative morbidity [ Time Frame: postoperative day 30 ]
the morbidity will be evaluated according to the clavien dindo classification


Estimated Enrollment:	600
Study Start Date:	February 2014
Estimated Study Completion Date:	February 2017
Estimated Primary Completion Date:	February 2017 (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 (Adult)
Sexes Eligible for Study:	All
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:

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.

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.

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.

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.

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.


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:	January 30, 2017

Keywords provided by Centre Hospitalier Universitaire, Amiens:


obesity surgical management sleeve gastrectomy

Additional relevant MeSH terms:


Obesity, Morbid Obesity Overnutrition Nutrition Disorders Overweight	Body Weight Signs and Symptoms Fibrin Tissue Adhesive Hemostatics Coagulants

ClinicalTrials.gov processed this record on July 14, 2017

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