NCT07118540

Brief Summary

In 2025, bariatric surgery combined with nutritional and psychological support is one of the most effective treatments for patients with morbid obesity. (2)(3) However, it causes various deficiencies, such as vitamin and iron deficiencies, which justify lifelong personalised vitamin supplementation and, consequently, lifelong medical supervision. The latest recommendations from the French National Authority for Health (Haute Autorité de Santé) clearly state that patients must commit to lifelong medical follow-up after bariatric surgery. (HAS, February 2024, R94). R94. Regular biological monitoring after bariatric surgery is recommended: three times in the first year and then once or twice a year thereafter. Within the OBESEPI cohort (clinical trial number NCT02663388), which comprises patients who underwent surgery at Nancy University Hospital between 2013 and 2018, we observed that over 50% of patients were lost to follow-up five years after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

June 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 8, 2025

Last Update Submit

August 7, 2025

Conditions

Keywords

obesitybariatric surgeryoverweightlost to follow-up

Outcome Measures

Primary Outcomes (1)

  • Assess the proportion of patients lost to follow-up from the OBESEPI cohort who are still receiving medical care (at another centre or from their general practitioner)in %.

    Assess the proportion of patients lost to follow-up from the OBESEPI cohort who are still receiving medical care (at another centre or from their general practitioner) in %.

    from bariatric surgery to 5 years after

Secondary Outcomes (5)

  • Describe the reasons for discontinuing post-bariatric surgery follow-up at Nancy University Hospital.

    from surgery to 5 years after

  • Describe how often patients lost to follow-up by Nancy University Hospital are followed up by another centre or their attending physician

    from surgery to 5 years after

  • Compare the proportion of patients receiving vitamin supplementation between those lost to follow-up in the OBESEPI cohort and those still being monitored.

    from time of surgery to 5 years after

  • Compare comorbidities in patients lost to follow-up in the OBESEPI cohort with those in patients still being monitored (in %)

    from surgery to 5 years after

  • Compare the proportion of post-bariatric surgery complications requiring surgery (%)

    from bariatric surgery to 5 years after

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

These patients were obese with BMI\> 35kg/m2. These patients, who were candidates for scheduled bariatric surgery, were recruited during preoperative consultations by surgeons involved in the protocol at the Digestive, Hepatobiliary, Endocrine and Oncology Surgery Department at Nancy University Hospital between 2013 and 2018 (the OBESEPI cohort).

You may qualify if:

  • \> Patients included in the OBESEPI cohort;
  • Individuals who have received complete information about the organisation of the research and have not objected to their participation and the use of their data;
  • Affiliation with a social security scheme.

You may not qualify if:

  • \>Patient who objects to participating in this research;
  • Pregnant and breastfeeding women;
  • Patients under legal guardianship or curatorship;
  • Patients deprived of their liberty by a judicial or administrative decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Nancy

Nancy, Lorraine, 54000, France

ENROLLING BY INVITATION

Centre Hospitalier Universitaire de Nancy

Nancy, Lorraine, 54000, France

RECRUITING

Related Publications (1)

  • (1)Global, regional, and national prevalence of adult overweight and obesity, 1990-2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021 Lancet. 2025 Mar 8; (2)Peirson L, Douketis J, Ciliska D, Fitzpatrick-Lewis D, Ali MU, Raina P. Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis. CMAJ Open. Oct 2014;2(4):E306-317. (3)Jackson VM, Breen DM, Fortin JP, et al. Latest approaches for the treatment of obesity. Expert opinion on drug discovery. 2015;10(8):825-839. (4)Recommandation HAS février 2024 : Prise en charge de l'obésité de niveau 2 et 3 https://www.has-sante.fr/upload/docs/application/pdf/2024-02/reco369_recommandations_obesite_2e_3e_niveaux_ii_cd_2024_02_08_preparation_mel.pdf (5)Chirurgie bariatrique : état des lieux en France en 2019 Halimi et al Médecine des maladies Métaboliques

    BACKGROUND

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Claire NOMINE-CRIQUI, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff surgeon in Visceral Metabolic and oncologic surgery department, head of the endocrine surgery Unit

Study Record Dates

First Submitted

July 8, 2025

First Posted

August 12, 2025

Study Start

June 1, 2025

Primary Completion

October 10, 2025

Study Completion

October 10, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations