An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study

Morbid Obesity Clinical Trial

— ChirBar  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02811900
• Other study ID #: 16-002-OBS
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2016
• Last updated: November 8, 2017
• Start date: January 1996
• Est. completion date: December 2026

Study information

• Verified date: November 2017
• Source: IHU Strasbourg
• Contact: Didier Mutter, MD, PhD
• Phone: +33 (0)3 90 11 90 41
• Email: didier.mutter[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient >18 years old

• BMI > 35 kg/m²

Exclusion Criteria:

• Incapacity of giving an informed consent

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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.
• 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.
• 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.
• Intragastric balloon
Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (4)

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 malrot — View 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. — View 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/s1169 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss		1 - 3 - 5 - 10 - 15 and 30 years
Secondary	BMI		1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Albumin	Albumin	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Pre-albumin	Pre-albumin	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Vitamin A	Vitamin A	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Vitamin D	Vitamin D	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Vitamin B6	Vitamin B6	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Vitamin B9	Vitamin B9	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Vitamin B12	Vitamin B12	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Plasma ferritin	Plasma ferritin	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Fasting plasma glucose	Fasting plasma glucose	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Serum insulin	Serum insulin	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	HbA1c	HbA1c	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Triglycerides	Triglycerides	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Cholesterol	Cholesterol (total, HDL, LDL)	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire	Moorehead-Ardelt Quality of life II questionnaire	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Quality of life assessed by Gastro-intestinal Quality of Life Index	Gastro-intestinal Quality of Life Index	1 - 3 - 5 - 10 - 15 and 30 years
Secondary	Postoperative morbidity	Postoperative morbidity	1 - 3 - 5 - 10 - 15 and 30 years