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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tisseel | Experimental | tisseel will be applied during the surgery |
|
| no tisseel | Placebo Comparator | no tisseel will be applied during the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tisseel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| post operative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc REGIMBEAU, MD,phD | chu amiens | Principal Investigator |
| michel scotte, MD PhD | chu Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Universitary Hospital | Amiens | 80054 | France | |||
| Charles Nicolle Universitary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22328096 | Background | 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. | |
| 21769286 | Background | 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. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| no tisseel | Other | the surgeon does not applied tissucol during the surgery |
|
| post-operative day 30 |
| the length of stay | post-operative day 30 |
| the rate of readmission | post-operative day 30 |
| the rate of reintervention | post-operative day 30 |
| the overall mortality at one month | post-operative day 30 |
| the specific mortality at one month | post-operative day 30 |
| the rate of postoperative morbidity | the morbidity will be evaluated according to the clavien dindo classification | postoperative day 30 |
| Rouen |
| 76031 |
| France |
| 20971049 | Background | 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. |
| 19902316 | Background | 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. |
| 19081482 | Background | 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. |
| 30080735 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |