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Recruiting NCT03517072

Determinants of the Long-Term Success of Bariatric Surgery

Observational Morbid Obesity Bariatric Surgery Candidate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Morbid Obesity, Bariatric Surgery Candidate. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Determinants of the Long-Term Success of Bariatric Surgery "- Multicenter Regional Observational Study: Regional Multicentre Prospective Study

Overview

The management of obesity is based on a multidisciplinary approach and justifies the use of surgery in patients with the most severe forms. Surgery for obesity or bariatric surgery generally allows rapid and significant weight loss however it is associated with significant risks, and its long-term results remain heterogeneous and unpredictable. Long-term data will clarify the role of different types of bariatric surgery in surgical strategy, improve patient information and identify predictors of failure in order to provide personalised and tailored surgery for each candidate .

Detailed description

Currently, there is insufficient data to determine the persistence over time of the positive results of bariatric surgery on weight loss. Moreover, there is no consensus or criteria for choosing one surgical weight loss procedure over another. The best choice for one patient may not be the most appropriate for another.

The results of this project will allow to better select obese patients likely to benefit from bariatric surgery, and to further personalise the management of severe obesity.

Primary outcome measures

  • Success rate in terms of weight loss [Time frame: at 5 years after bariatric surgery]
Secondary outcome measures (4)
  • Success rate in terms of weight loss according to type of bariatric surgery [Time frame: at 1 year after bariatric surgery]
  • Success rate in terms of weight loss according to type of bariatric surgery [Time frame: at 5 years after bariatric surgery]
  • Rate of re- interventions related to bariatric surgery [Time frame: 5 years]
  • Lost rate seen [Time frame: at 5 years after bariatric surgery]

Eligibility criteria

Inclusion criteria

  • Patients who received bariatric surgery 5 years ago.

Exclusion criteria

  • Refusal to participate in the study,
  • Unable to receive informed information,
  • Unable to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • CH ARRAS — Arras
  • Ch Boulogne-Sur-Mer — Boulogne-sur-Mer
  • Hôpital Claude Huriez, CHU — Lille
  • Ch de Valenciennes — Valenciennes

Identifiers

NCT: NCT03517072 · 2016_24 · 2016-A02058-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗