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An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study (ChirBar)

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ClinicalTrials.gov Identifier: NCT02811900
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Morbid Obesity Procedure: Roux en Y gastric bypass Procedure: Sleeve gastrectomy Procedure: Gastric banding Procedure: Intragastric balloon

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
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
Study Start Date : January 1996
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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 :
  1. Excess weight loss [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]

Secondary Outcome Measures :
  1. BMI [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
  2. Albumin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Albumin

  3. Pre-albumin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Pre-albumin

  4. Vitamin A [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin A

  5. Vitamin D [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin D

  6. Vitamin B6 [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin B6

  7. Vitamin B9 [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin B9

  8. Vitamin B12 [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin B12

  9. Plasma ferritin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Plasma ferritin

  10. Fasting plasma glucose [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Fasting plasma glucose

  11. Serum insulin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Serum insulin

  12. HbA1c [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    HbA1c

  13. Triglycerides [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Triglycerides

  14. Cholesterol [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Cholesterol (total, HDL, LDL)

  15. Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Moorehead-Ardelt Quality of life II questionnaire

  16. Quality of life assessed by Gastro-intestinal Quality of Life Index [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Gastro-intestinal Quality of Life Index

  17. Postoperative morbidity [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Postoperative morbidity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient >18 years old BMI >35 kg/m²
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Incapacity of giving an informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811900


Contacts
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Contact: Didier Mutter, MD, PhD +33 (0)3 90 11 90 41 didier.mutter@chru-strasbourg.fr

Locations
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France
Service de Chirurgie Digestive et Endocrinienne Recruiting
Strasbourg, France, 67000
Contact: Didier Mutter, MD, PhD    +33 (0)3 90 11 90 41    didier.mutter@chru-strasbourg.fr   
Contact: Michel Vix, MD    +33 (0)3 69 55 10 52    michel.vix@chru-strasbourg.fr   
Sponsors and Collaborators
IHU Strasbourg
Investigators
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Study Chair: Didier Mutter, MD, PhD Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg
Additional Information:

Publications of Results:
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Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT02811900    
Other Study ID Numbers: 16-002-OBS
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by IHU Strasbourg:
obesity surgery
Roux en Y gastric bypass
sleeve gastrectomy
excess weight loss
quality of life
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight