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Morbid ObesityChirBarNCT02811900

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

An observational study of Morbid Obesity, run by IHU Strasbourg at 1 site in France.

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Sites and contacts
Official record

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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Morbid Obesity
What is being tested?
Roux en Y gastric bypass, Sleeve gastrectomy and Gastric banding
Type of treatment
Surgery or procedure
How many people
10,000 participants
Where
1 siteFrance
Study dates
Jan 1996to Dec 2026
How long will I take part?
30 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient >18 years old BMI >35 kg/m²

Who may be able to join

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

Who cannot join

  • Incapacity of giving an informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Didier Mutter, MD, PhD contact

+33 (0)3 90 11 90 41

didier.mutter@chru-strasbourg.fr

France1 site, 1 recruiting

  • Service de Chirurgie Digestive et Endocrinienne

    Strasbourg, 67000

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

    Michel Vix, MD, +33 (0)3 69 55 10 52, michel.vix@chru-strasbourg.fr

    Recruiting

Other trials in France

About this 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

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).

Read the 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.

Conditions
Morbid Obesity
Being tested
Roux en Y gastric bypass, Sleeve gastrectomy, Gastric banding, Intragastric balloon
Keywords
obesity surgery, Roux en Y gastric bypass, sleeve gastrectomy, excess weight loss, quality of life
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roux en Y gastric bypassProcedure or surgery

    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 gastrectomyProcedure or surgery

    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 bandingProcedure or surgery

    Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.

  • Intragastric balloonProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excess weight loss

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

Secondary outcomes (17)

  1. BMI

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  2. Albumin

    Albumin

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  3. Pre-albumin

    Pre-albumin

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  4. Vitamin A

    Vitamin A

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  5. Vitamin D

    Vitamin D

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  6. Vitamin B6

    Vitamin B6

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  7. Vitamin B9

    Vitamin B9

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  8. Vitamin B12

    Vitamin B12

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  9. Plasma ferritin

    Plasma ferritin

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  10. Fasting plasma glucose

    Fasting plasma glucose

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  11. Serum insulin

    Serum insulin

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  12. HbA1c

    HbA1c

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  13. Triglycerides

    Triglycerides

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  14. Cholesterol

    Cholesterol (total, HDL, LDL)

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  15. Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire

    Moorehead-Ardelt Quality of life II questionnaire

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  16. Quality of life assessed by Gastro-intestinal Quality of Life Index

    Gastro-intestinal Quality of Life Index

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

  17. Postoperative morbidity

    Postoperative morbidity

    Measured: 1 - 3 - 5 - 10 - 15 and 30 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2016 (estimated)
  2. Study startJan 1996
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
Target duration
30 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02811900
Sponsor's protocol ID
16-002-OBS
Acronym
ChirBar
Status last verified
Nov 2017
First submitted
13 Jun 2016
Last updated
9 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 24196556

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