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NCT Number: NCT02811900

An Evaluation of the Outcomes of Bariatric Surgery - a Cohort 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).

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Incapacity of giving an informed consent

Treatment and study plan

Roux en Y gastric bypass

Procedure

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 gastrectomy

Procedure

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 Banding

Procedure

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

Intragastric balloon

Procedure

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

Primary outcomes

  1. Excess weight loss

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

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Didier Mutter, MD, PhD

CONTACT

[email protected]

+33 (0)3 90 11 90 41

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Official study 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

Acronym: ChirBar

Important dates

Study start
1996
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2016
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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