An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study
NCT ID: NCT02811900
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
1996-01-31
2026-12-31
Brief Summary
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A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group).
Detailed Description
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A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group). Patients who had IH were paired with patients of the same age and sex and at the same postoperative interval. Paired patients were contacted by phone to obtain the QoL questionnaires, abdominal pain evaluation, and weight loss data.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Roux en Y gastric bypass
Laparoscopic RYGB is performed as following: a gastric pouch of approximately 30mL was obtained using successive firings of the Endo GIATM linear stapler, followed by the creation of an antecolic alimentary limb of 150cm and of a biliopancreatic limb of 75cm. A gastrojejunal anastomosis was fashioned with the PCEEA™ 28 circular stapler until 2012, and using the Endo GIA™ linear stapler afterwards. The mesenteric defect and Petersen's defect were closed using a non-absorbable running suture.
Sleeve gastrectomy
Laparoscopic SG is performed as following: after greater curvature mobilization, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using successive firings of 3.5- or 4.8-mm-high staples, depending on gastric thickness.
Gastric banding
Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.
Intragastric balloon
Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.
Eligibility Criteria
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Inclusion Criteria
* BMI \> 35 kg/m²
Exclusion Criteria
18 Years
ALL
No
Sponsors
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IHU Strasbourg
OTHER
Responsible Party
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Principal Investigators
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Didier Mutter, MD, PhD
Role: STUDY_CHAIR
Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg
Locations
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Service de Chirurgie Digestive et Endocrinienne
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Didier Mutter, MD, PhD
Role: primary
Michel Vix, MD
Role: backup
References
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Lunca S, Vix M, Rikkers A, Rubino F, Marescaux J. Late gastric prolapse with pouch necrosis after laparoscopic adjustable gastric banding. Obes Surg. 2005 Apr;15(4):571-5. doi: 10.1381/0960892053723420.
Donatelli G, Costantino F, Dhumane P, Vix M, Perretta S, D' Agostino J, Dallemagne B, Marescaux J. Endoscopic intragastric balloon: a bridge toward definitive bariatric surgical management of a morbidly obese patient with situs ambiguous and midgut malrotation (with videos). Gastrointest Endosc. 2012 Jan;75(1):217-8. doi: 10.1016/j.gie.2011.01.022. Epub 2011 Mar 27. No abstract available.
Vix M, Diana M, Liu KH, D'Urso A, Mutter D, Wu HS, Marescaux J. Evolution of glycolipid profile after sleeve gastrectomy vs. Roux-en-Y gastric bypass: results of a prospective randomized clinical trial. Obes Surg. 2013 May;23(5):613-21. doi: 10.1007/s11695-012-0827-5.
Vix M, Liu KH, Diana M, D'Urso A, Mutter D, Marescaux J. Impact of Roux-en-Y gastric bypass versus sleeve gastrectomy on vitamin D metabolism: short-term results from a prospective randomized clinical trial. Surg Endosc. 2014 Mar;28(3):821-6. doi: 10.1007/s00464-013-3276-x. Epub 2013 Nov 7.
Other Identifiers
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16-002-OBS
Identifier Type: -
Identifier Source: org_study_id