Evaluation of the Care Provided to Patients Who Underwent Bariatric Surgery and Were Lost to Follow-up 5 Years After Surgery

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery

NCT02440087

Obesity Bariatric Surgery

COMPLETED

Trajectories of Resilience and Bariatric Surgery Outcomes

NCT05341414

Severe Obesity Psychological Distress Bariatric Surgery Candidate

COMPLETED

Outcome of Bariatric Surgery in Patients With BMI Greater Than 60 .

NCT04663425

Bariatric Surgery Candidate

COMPLETED

Study of Bariatric Surgery

NCT02857179

Bariatric Surgery

RECRUITING

Nutritional Health and Satisfaction After Bariatric Surgery: a Five-Year Retrospective Study

NCT06664580

Obesity and Overweight Nutritional Deficiency Bariatric Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Duration of the inclusion period: 3 months Duration of subject participation (from inclusion to the last visit for the same subject): 30 minutes (time required to complete the questionnaire) Total duration of the research: 9 months

Patients with obesity who met the HAS (French high health authority) criteria for surgical treatment were recruited.

This corresponds to patients with a BMI \> 35 kg/m2 with obesity-related complications (hypertension and/or diabetes and/or dyslipidemia and/or obstructive apnea syndrom ) and patients with a BMI \> 40 with or without obesity-related complications.

These patients, who were candidates for scheduled bariatric surgery, were recruited by a surgeon involved in the protocol during preoperative consultations in the Metabolic, Visceral and oncologic department of surgery ; Department at Nancy University Hospital; between 2013 and 2018 (the OBESEPI-ALDEPI cohort - clinical trial NCT02663388) ). All patients met the HAS's eligibility criteria previously cited for bariatric surgery.

Two groups could be studied:

Patients who underwent surgery and were lost to follow-up five years after after bariatric surgery

The second group comprised patients who underwent surgery and were still being monitored at Nancy University Hospital five years after their inclusion.

Patients were considered lost to follow-up if there was no record of them visiting the Metabolic, Visceral and oncologic department of surgery five years after their inclusion, as determined using the DXCare software (which contain medical file).

A questionnaire is used to collect all data. This is completed by telephone or sent by email to patients who have been lost to follow-up.

This questionnaire contains questions designed to help us achieve the main and secondary objectives described in the dedicated section.

Statistical analysis :

All data will be presented as numbers and percentages for qualitative variables, and as means, standard deviations, medians, quartiles, and extreme values for quantitative variables.

The characteristics of patients lost to follow-up from the OBESPI cohort will be compared with those still being followed up using Fisher's exact test, Chi-squared test or Wilcoxon's rank sum test.

To meet the objectives, these tests will also be used to compare patients lost to follow-up with those still being followed.

Assessment of research benefits:

Methods for monitoring patients lost to follow-up should be assessed in order to develop training for general practitioners in the Lorraine region, enabling them to provide appropriate follow-up care to patients who have undergone bariatric surgery.

Train general practitioners to prevent nutritional complications of bariatric surgery.

Train general practitioners to recognise the warning signs that require referral to a specialist centre.

There is major interest in improving healthcare practices, given that 60,000 bariatric surgeries are performed annually in France, with 800,000 patients having undergone surgery in 2019.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity &Amp; Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No