Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery

NCT ID: NCT02310178

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-21

Study Completion Date

2026-05-31

Brief Summary

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The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.

Detailed Description

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The main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. Moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. From a methodological point of view, the Obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. The number of inclusions is to 1500 patients. After surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. The recommendations of the french health ministry (HAS), the frequency of visits may be increased according to the patient's progress. Follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . It will be insured for life, obesity is a chronic disease and because of the risk of late complications.

Conditions

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Obesity, Morbid Bariatric Surgery Candidate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group/Cohort

all of the current bariatric surgeries are allowed in this prospective cohort study

Group Type OTHER

Bariatric surgery

Intervention Type PROCEDURE

all of the current bariatric surgeries are allowed in this prospective cohort study

Interventions

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Bariatric surgery

all of the current bariatric surgeries are allowed in this prospective cohort study

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery
* Patients treated by bariatric surgery on CHU Montpellier
* Agreed to participate to the study by signing an informed consent
* Eligible to health insurance

Exclusion Criteria

* Unable to follow the patient in the long term (foreign patients, surgical use ...)
* Inability to follow in the long run
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU - Hôpital Saint Eloi

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David NOCCA, PUPH

Role: CONTACT

0467337731 ext. +33

Facility Contacts

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David NOCCA, PUPH

Role: primary

0467337731 ext. +33

References

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Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study. Lancet Digit Health. 2023 Oct;5(10):e692-e702. doi: 10.1016/S2589-7500(23)00135-8. Epub 2023 Aug 29.

Reference Type DERIVED
PMID: 37652841 (View on PubMed)

Nocca D, Galtier F, Taleb S, Picot MC, Jaussent A, Silvestri M, Lefebvre P, de Jong A, Gautier T, Loureiro M, Nedelcu M. Peri-operative Morbidity of Nissen Sleeve Gastrectomy: Prospective Evaluation of a Cohort of 365 Patients, Beyond the Learning Curve. Obes Surg. 2022 Jul;32(7):1-7. doi: 10.1007/s11695-022-06066-0. Epub 2022 May 7.

Reference Type DERIVED
PMID: 35524904 (View on PubMed)

Other Identifiers

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UF 8855

Identifier Type: -

Identifier Source: org_study_id

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