Clinical trial NCT02811900: An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Morbid Obesity
Keywords: obesity surgery
Roux en Y gastric bypass
sleeve gastrectomy
excess weight loss
quality of life
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient \>18 years old BMI \>35 kg/m²

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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Incapacity of giving an informed consent

Primary outcomes:
measure: Excess weight loss
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
Secondary outcomes:
measure: BMI
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Albumin
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Pre-albumin
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Vitamin A
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Vitamin D
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Vitamin B6
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Vitamin B9
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Vitamin B12
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Plasma ferritin
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Fasting plasma glucose
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Serum insulin
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: HbA1c
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Triglycerides
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Cholesterol
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Quality of life assessed by Gastro-intestinal Quality of Life Index
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
measure: Postoperative morbidity
timeFrame: 1 - 3 - 5 - 10 - 15 and 30 years
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne
Study officials:
affiliation: Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg
name: Didier Mutter, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.