Actively Recruiting

Age: 18Years +
All Genders
ID02811900

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

Led by IHU Strasbourg · Updated on 2017-11-09

10000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the outcomes of bariatric surgery, focusing on patients with morbid obesity who have undergone procedures like Roux en Y gastric bypass. This study compares the quality of life and postoperative course of patients treated for internal hernia with those who had an uncomplicated recovery after surgery. Data were collected prospectively starting in 1996 at the University Hospital of Strasbourg, France, with patient information anonymized for research purposes. The study includes various bariatric procedures such as laparoscopic Roux en Y gastric bypass, sleeve gastrectomy, gastric banding, and intragastric balloon placement. Each procedure is described in detail, including surgical techniques and device use. Patients were evaluated preoperatively by a multidisciplinary team, and follow-up data on weight loss, nutritional status, and complications were collected over many years. Participants undergo regular assessments including nutritional counseling, psychological evaluation, imaging, blood tests, and quality of life questionnaires. The study tracks outcomes like excess weight loss, body mass index, vitamin levels, glucose metabolism, lipid profile, and postoperative morbidity at intervals up to 30 years. Quality of life is measured using specific questionnaires, and data on abdominal pain and weight loss are collected by phone. This long-term monitoring helps understand the impact of internal hernia on patient recovery and well-being after bariatric surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years old
  • Body Mass Index (BMI) greater than 35 kg/m²
Not Eligible

You will not qualify if you...

  • Incapacity of giving an informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo bariatric surgery such as Roux en Y gastric bypass, sleeve gastrectomy, gastric banding, or intragastric balloon placement.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 30 years

Participants have clinical and biological follow-up including nutritional counseling, psychological evaluation, and various laboratory tests to monitor outcomes and complications after surgery.

Multiple visits over years with assessments at 1, 3, 5, 10, 15, and 30 years

Trial Site Locations

Total: 1 location

1

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, France, 67000

Actively Recruiting

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Research Team

D

Didier Mutter, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Endoscopic intragastric balloon: a bridge toward definitive bariatric surgical management of a morbidly obese patient with situs ambiguous and midgut malrotation (with videos).

Gianfranco Donatelli, Federico Costantino, Parag Dhumane...

https://pubmed.ncbi.nlm.nih.gov/21444079

Evolution of glycolipid profile after sleeve gastrectomy vs. Roux-en-Y gastric bypass: results of a prospective randomized clinical trial.

Michel Vix, Michele Diana, Keng-Hao Liu...

https://pubmed.ncbi.nlm.nih.gov/23207829

Impact of Roux-en-Y gastric bypass versus sleeve gastrectomy on vitamin D metabolism: short-term results from a prospective randomized clinical trial.

Michel Vix, Keng-Hao Liu, Michele Diana...

https://pubmed.ncbi.nlm.nih.gov/24196556