Morbid Obesity
Conditions
Keywords
obesity surgery, Roux en Y gastric bypass, sleeve gastrectomy, excess weight loss, quality of life
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.
Interventions
PROCEDURERoux en Y gastric bypass
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.
PROCEDURESleeve gastrectomy
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.
PROCEDUREGastric banding
Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.
PROCEDUREIntragastric balloon
Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.
Sponsors
IHU Strasbourg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient \>18 years old * BMI \> 35 kg/m²
Exclusion criteria
* Incapacity of giving an informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excess weight loss | 1 - 3 - 5 - 10 - 15 and 30 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Albumin | 1 - 3 - 5 - 10 - 15 and 30 years | Albumin |
| Pre-albumin | 1 - 3 - 5 - 10 - 15 and 30 years | Pre-albumin |
| Vitamin A | 1 - 3 - 5 - 10 - 15 and 30 years | Vitamin A |
| Vitamin D | 1 - 3 - 5 - 10 - 15 and 30 years | Vitamin D |
| Vitamin B6 | 1 - 3 - 5 - 10 - 15 and 30 years | Vitamin B6 |
| Vitamin B9 | 1 - 3 - 5 - 10 - 15 and 30 years | Vitamin B9 |
| Vitamin B12 | 1 - 3 - 5 - 10 - 15 and 30 years | Vitamin B12 |
| Plasma ferritin | 1 - 3 - 5 - 10 - 15 and 30 years | Plasma ferritin |
| BMI | 1 - 3 - 5 - 10 - 15 and 30 years | — |
| Serum insulin | 1 - 3 - 5 - 10 - 15 and 30 years | Serum insulin |
| 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) |
| 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 |
| 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 |
| Postoperative morbidity | 1 - 3 - 5 - 10 - 15 and 30 years | Postoperative morbidity |
| Fasting plasma glucose | 1 - 3 - 5 - 10 - 15 and 30 years | Fasting plasma glucose |
Countries
France
Contacts
Primary ContactDidier Mutter, MD, PhD
Outcome results
None listed