An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study
- Conditions
- Morbid Obesity
- Registration Number
- NCT02811900
- Lead Sponsor
- IHU Strasbourg
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- patient >18 years old
- BMI > 35 kg/m²
- Incapacity of giving an informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Excess weight loss 1 - 3 - 5 - 10 - 15 and 30 years
- Secondary Outcome Measures
Name Time Method Serum insulin 1 - 3 - 5 - 10 - 15 and 30 years Serum insulin
BMI 1 - 3 - 5 - 10 - 15 and 30 years Albumin 1 - 3 - 5 - 10 - 15 and 30 years Albumin
Vitamin A 1 - 3 - 5 - 10 - 15 and 30 years Vitamin A
Postoperative morbidity 1 - 3 - 5 - 10 - 15 and 30 years Postoperative morbidity
Pre-albumin 1 - 3 - 5 - 10 - 15 and 30 years Pre-albumin
Vitamin B12 1 - 3 - 5 - 10 - 15 and 30 years Vitamin B12
Fasting plasma glucose 1 - 3 - 5 - 10 - 15 and 30 years Fasting plasma glucose
HbA1c 1 - 3 - 5 - 10 - 15 and 30 years HbA1c
Triglycerides 1 - 3 - 5 - 10 - 15 and 30 years Triglycerides
Cholesterol 1 - 3 - 5 - 10 - 15 and 30 years Cholesterol (total, HDL, LDL)
Vitamin B6 1 - 3 - 5 - 10 - 15 and 30 years Vitamin B6
Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire 1 - 3 - 5 - 10 - 15 and 30 years Moorehead-Ardelt Quality of life II questionnaire
Vitamin B9 1 - 3 - 5 - 10 - 15 and 30 years Vitamin B9
Plasma ferritin 1 - 3 - 5 - 10 - 15 and 30 years Plasma ferritin
Quality of life assessed by Gastro-intestinal Quality of Life Index 1 - 3 - 5 - 10 - 15 and 30 years Gastro-intestinal Quality of Life Index
Vitamin D 1 - 3 - 5 - 10 - 15 and 30 years Vitamin D
Trial Locations
- Locations (1)
Service de Chirurgie Digestive et Endocrinienne
🇫🇷Strasbourg, France