NCT02310178

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

14 years

First QC Date

October 28, 2014

Last Update Submit

May 2, 2024

Conditions

Obesity, MorbidBariatric Surgery Candidate

Keywords

weight losssleeve gastrectomygastric bypassgastric bandingbariatric procedurescohortmorbid obesitymedical and economical impactsevere obesity

Outcome Measures

Primary Outcomes (1)

  • Assessment of the long-term efficiency of bariatric surgery on weight loss

    Assessment of weight loss

    Change from intervention to 5 years

Secondary Outcomes (9)

  • Assessment of the long-term efficiency of bariatric surgery on diabetes

    Change from intervention to 5 years

  • Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure

    Change from intervention to 5 years

  • Assessment of the long-term efficiency of bariatric surgery on dyslipidemia

    Change from intervention to 5 years

  • Assessment of the long-term efficiency of bariatric surgery on rheumatism

    Change from intervention to 5 years

  • Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies

    Change from intervention to 5 years

  • +4 more secondary outcomes

Study Arms (1)

Group/Cohort

OTHER

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

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

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

Group/Cohort

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to follow the patient in the long term (foreign patients, surgical use ...)
  • Inability to follow in the long run

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU - Hôpital Saint Eloi

Montpellier, 34295, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37652841DERIVED

  • 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.

    PMID: 35524904DERIVED

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Central Study Contacts

David NOCCA, PUPH

CONTACT

0467337731d-nocca@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

December 8, 2014

Study Start

May 21, 2012

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

FR(1)