Follow-up care for people five years after bariatric surgery who were lost to follow-up
Evaluation of the Care Provided to Patients Who Underwent Bariatric Surgery and Were Lost to Follow-up 5 Years After Surgery
This project will try to compare health outcomes and care needs for people who had bariatric surgery and either were lost to follow-up or remained under follow-up five years after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 2 sites (Nancy, Lorraine and 1 other locations) |
| Trial ID | NCT07118540 on ClinicalTrials.gov |
What this trial studies
Using the OBESEPI cohort from Nancy University Hospital, researchers will identify patients who underwent bariatric surgery between 2013 and 2018 and compare those lost to follow-up at five years with those still being monitored. Participation involves a single 30-minute questionnaire and review of medical records; the inclusion period is 3 months and the total project duration is 9 months. Eligible patients met French HAS criteria for surgery (BMI > 40 or BMI > 35 with obesity-related complications). Patients are classified as lost to follow-up if there is no record of a visit to the surgical department five years after inclusion.
Who should consider this trial
Good fit: Ideal candidates are patients included in the OBESEPI cohort who had bariatric surgery at Nancy University Hospital between 2013 and 2018, meet HAS surgical criteria (BMI > 40 or BMI > 35 with complications), and have not objected to use of their data.
Not a fit: Patients not in the OBESEPI cohort, those who object to participation or data use, pregnant or breastfeeding women, people under legal guardianship or curatorship, and those deprived of liberty are excluded and will not benefit from this project.
Why it matters
Potential benefit: If successful, the project could reveal where long-term care breaks down and guide steps to improve lifelong monitoring to prevent nutritional deficiencies and other complications after bariatric surgery.
How similar studies have performed: Previous cohort studies have consistently shown high rates of loss to follow-up after bariatric surgery and linked this to nutritional complications, but interventions to reliably prevent loss to follow-up have had limited and mixed success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 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. Exclusion Criteria: * \>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.
Where this trial is running
Nancy, Lorraine and 1 other locations
- Centre Hospitalier Universitaire de Nancy — Nancy, Lorraine, France (Enrolling_by_invitation)
- Centre Hospitalier Universitaire de Nancy — Nancy, Lorraine, France (Recruiting)
Study contacts
- Study coordinator: Claire NOMINE-CRIQUI, MD
- Email: c.nomine-criqui@chru-nancy.fr
- Phone: +33632149814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.