An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study

NCT02811900 | Recruiting

• 1 other identifier: 16-002-OBS
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization. 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).

Conditions

Morbid Obesity

Keywords

obesity surgery; Roux en Y gastric bypass; sleeve gastrectomy; excess weight loss; quality of life

Outcome Measures

Primary Outcomes (1)

• Excess weight loss

  1 - 3 - 5 - 10 - 15 and 30 years

Secondary Outcomes (17)

• BMI

  1 - 3 - 5 - 10 - 15 and 30 years

• Albumin

  1 - 3 - 5 - 10 - 15 and 30 years

• Pre-albumin

  1 - 3 - 5 - 10 - 15 and 30 years

• Vitamin A

  1 - 3 - 5 - 10 - 15 and 30 years

• Vitamin D

  1 - 3 - 5 - 10 - 15 and 30 years

Interventions

Roux en Y gastric bypass PROCEDURE

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 PROCEDURE

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 PROCEDURE

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 PROCEDURE

Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient \>18 years old BMI \>35 kg/m²

You may qualify if:

• patient \>18 years old
• BMI \> 35 kg/m²

You may not qualify if:

• Incapacity of giving an informed consent

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, 67000, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 15946441 RESULT

• 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.

  PMID: 21444079 RESULT

• 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.

  PMID: 23207829 RESULT

• 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.

  PMID: 24196556 RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Didier Mutter, MD, PhD

  Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg

  STUDY CHAIR

Central Study Contacts

Didier Mutter, MD, PhD

CONTACT

+33 (0)3 90 11 90 41; didier.mutter@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 23, 2016
• Study Start: January 1, 1996
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)