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Clinical Trials/NCT02811900
NCT02811900
Recruiting
Not Applicable

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

IHU Strasbourg1 site in 1 country10,000 target enrollmentJanuary 1996
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
IHU Strasbourg
Enrollment
10000
Locations
1
Primary Endpoint
Excess weight loss
Status
Recruiting
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1996
End Date
December 2026
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IHU Strasbourg
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Incapacity of giving an informed consent

Outcomes

Primary Outcomes

Excess weight loss

Time Frame: 1 - 3 - 5 - 10 - 15 and 30 years

Secondary Outcomes

  • Vitamin A(1 - 3 - 5 - 10 - 15 and 30 years)
  • Postoperative morbidity(1 - 3 - 5 - 10 - 15 and 30 years)
  • BMI(1 - 3 - 5 - 10 - 15 and 30 years)
  • Albumin(1 - 3 - 5 - 10 - 15 and 30 years)
  • Pre-albumin(1 - 3 - 5 - 10 - 15 and 30 years)
  • Vitamin B12(1 - 3 - 5 - 10 - 15 and 30 years)
  • Fasting plasma glucose(1 - 3 - 5 - 10 - 15 and 30 years)
  • HbA1c(1 - 3 - 5 - 10 - 15 and 30 years)
  • Triglycerides(1 - 3 - 5 - 10 - 15 and 30 years)
  • Cholesterol(1 - 3 - 5 - 10 - 15 and 30 years)
  • Vitamin B6(1 - 3 - 5 - 10 - 15 and 30 years)
  • Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire(1 - 3 - 5 - 10 - 15 and 30 years)
  • Vitamin B9(1 - 3 - 5 - 10 - 15 and 30 years)
  • Plasma ferritin(1 - 3 - 5 - 10 - 15 and 30 years)
  • Quality of life assessed by Gastro-intestinal Quality of Life Index(1 - 3 - 5 - 10 - 15 and 30 years)
  • Vitamin D(1 - 3 - 5 - 10 - 15 and 30 years)
  • Serum insulin(1 - 3 - 5 - 10 - 15 and 30 years)

Study Sites (1)

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