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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

Tracking Information
First Submitted Date June 13, 2016
First Posted Date June 23, 2016
Last Update Posted Date November 9, 2017
Study Start Date January 1996
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2016)
Excess weight loss [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2016)
  • BMI [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
  • Albumin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Albumin
  • Pre-albumin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Pre-albumin
  • Vitamin A [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin A
  • Vitamin D [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin D
  • Vitamin B6 [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin B6
  • Vitamin B9 [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin B9
  • Vitamin B12 [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Vitamin B12
  • Plasma ferritin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Plasma ferritin
  • Fasting plasma glucose [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Fasting plasma glucose
  • Serum insulin [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Serum insulin
  • HbA1c [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    HbA1c
  • Triglycerides [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Triglycerides
  • Cholesterol [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Cholesterol (total, HDL, LDL)
  • 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
  • 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
  • Postoperative morbidity [ Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years ]
    Postoperative morbidity
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 30 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient >18 years old BMI >35 kg/m²
Condition Morbid Obesity
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.
  • 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 21, 2016)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Incapacity of giving an informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Didier Mutter, MD, PhD +33 (0)3 90 11 90 41 didier.mutter@chru-strasbourg.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02811900
Other Study ID Numbers 16-002-OBS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party IHU Strasbourg
Study Sponsor IHU Strasbourg
Collaborators Not Provided
Investigators
Study Chair: Didier Mutter, MD, PhD Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg
PRS Account IHU Strasbourg
Verification Date November 2017