An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study (ChirBar)

An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study Internal Hernia After Laparoscopic Roux-en-Y Gastric Bypass: an Evaluation of the Impact on the Postoperative Course and a Quality of Life Case-control Study

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).

Study Overview

• Status: Recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Roux en Y gastric bypass; Procedure: Sleeve gastrectomy; Procedure: Gastric banding; Procedure: Intragastric balloon

Detailed Description

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. Patients were evaluated by a multidisciplinary team. The standard preoperative assessment included nutritional counseling, psychological evaluation, abdominal ultrasound, upper gastrointestinal endoscopy, and blood tests. Type and date of surgery, biological and clinical follow-up data and morbidity data were recorded prospectively in the database.

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Didier Mutter, MD, PhD; Phone Number: +33 (0)3 90 11 90 41; Email: didier.mutter@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Service de Chirurgie Digestive et Endocrinienne
    • Contact: Michel Vix, MD; Phone Number: +33 (0)3 69 55 10 52; Email: michel.vix@chru-strasbourg.fr
    • Contact: Didier Mutter, MD, PhD; Phone Number: +33 (0)3 90 11 90 41; Email: didier.mutter@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient >18 years old BMI >35 kg/m²

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Incapacity of giving an informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Excess weight loss	1 - 3 - 5 - 10 - 15 and 30 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI		1 - 3 - 5 - 10 - 15 and 30 years
Albumin	Albumin	1 - 3 - 5 - 10 - 15 and 30 years
Pre-albumin	Pre-albumin	1 - 3 - 5 - 10 - 15 and 30 years
Vitamin A	Vitamin A	1 - 3 - 5 - 10 - 15 and 30 years
Vitamin D	Vitamin D	1 - 3 - 5 - 10 - 15 and 30 years
Vitamin B6	Vitamin B6	1 - 3 - 5 - 10 - 15 and 30 years
Vitamin B9	Vitamin B9	1 - 3 - 5 - 10 - 15 and 30 years
Vitamin B12	Vitamin B12	1 - 3 - 5 - 10 - 15 and 30 years
Plasma ferritin	Plasma ferritin	1 - 3 - 5 - 10 - 15 and 30 years
Fasting plasma glucose	Fasting plasma glucose	1 - 3 - 5 - 10 - 15 and 30 years
Serum insulin	Serum insulin	1 - 3 - 5 - 10 - 15 and 30 years
HbA1c	HbA1c	1 - 3 - 5 - 10 - 15 and 30 years
Triglycerides	Triglycerides	1 - 3 - 5 - 10 - 15 and 30 years
Cholesterol	Cholesterol (total, HDL, LDL)	1 - 3 - 5 - 10 - 15 and 30 years
Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire	Moorehead-Ardelt Quality of life II questionnaire	1 - 3 - 5 - 10 - 15 and 30 years
Quality of life assessed by Gastro-intestinal Quality of Life Index	Gastro-intestinal Quality of Life Index	1 - 3 - 5 - 10 - 15 and 30 years
Postoperative morbidity	Postoperative morbidity	1 - 3 - 5 - 10 - 15 and 30 years

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Investigators: Study Chair: Didier Mutter, MD, PhD, Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 1996
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; sleeve gastrectomy; obesity surgery; Roux en Y gastric bypass; excess weight loss
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 16-002-OBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO