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

Overview

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

• Procedure Roux 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.
• Procedure Sleeve 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.
• Procedure Gastric banding
  Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.
• Procedure Intragastric balloon
  Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.

Primary outcome measures

• Excess weight loss [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]

Secondary outcome measures (12)

• BMI [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Albumin [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Pre-albumin [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Vitamin A [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Vitamin D [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Vitamin B6 [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Vitamin B9 [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Vitamin B12 [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Plasma ferritin [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Fasting plasma glucose [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• Serum insulin [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]
• HbA1c [Time frame: 1 - 3 - 5 - 10 - 15 and 30 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Incapacity of giving an informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Service de Chirurgie Digestive et Endocrinienne — Strasbourg

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. PMID 15946441
• 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. PMID 21444079
• 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. PMID 23207829
• 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. PMID 24196556

Identifiers

NCT: NCT02811900 · 16-002-OBS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗