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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Excess weight loss
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patient >18 years old
- •BMI > 35 kg/m²
Exclusion Criteria
- •Incapacity of giving an informed consent
Outcomes
Primary Outcomes
Excess weight loss
Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years
Secondary Outcomes
- Vitamin A(1 - 3 - 5 - 10 - 15 and 30 years)
- Postoperative morbidity(1 - 3 - 5 - 10 - 15 and 30 years)
- 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 B12(1 - 3 - 5 - 10 - 15 and 30 years)
- Fasting plasma glucose(1 - 3 - 5 - 10 - 15 and 30 years)
- HbA1c(1 - 3 - 5 - 10 - 15 and 30 years)
- Triglycerides(1 - 3 - 5 - 10 - 15 and 30 years)
- Cholesterol(1 - 3 - 5 - 10 - 15 and 30 years)
- Vitamin B6(1 - 3 - 5 - 10 - 15 and 30 years)
- Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire(1 - 3 - 5 - 10 - 15 and 30 years)
- Vitamin B9(1 - 3 - 5 - 10 - 15 and 30 years)
- Plasma ferritin(1 - 3 - 5 - 10 - 15 and 30 years)
- Quality of life assessed by Gastro-intestinal Quality of Life Index(1 - 3 - 5 - 10 - 15 and 30 years)
- Vitamin D(1 - 3 - 5 - 10 - 15 and 30 years)
- Serum insulin(1 - 3 - 5 - 10 - 15 and 30 years)