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

I

IHU Strasbourg

Status

Enrolling

Conditions

Morbid Obesity

Treatments

Procedure: Sleeve gastrectomy
Procedure: Intragastric balloon
Procedure: Gastric banding
Procedure: Roux en Y gastric bypass

Study type

Observational

Funder types

Other

Identifiers

NCT02811900
16-002-OBS

Details and patient eligibility

About

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).

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Incapacity of giving an informed consent

Trial contacts and locations

1

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Central trial contact

Didier Mutter, MD, PhD

Data sourced from clinicaltrials.gov

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