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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 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.

Disqualifiers

>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.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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 %.

Time frame
from bariatric surgery to 5 years after

Secondary outcomes

1

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

1.Describe the reasons for discontinuing post-bariatric surgery follow-up at Nancy University Hospital using a questionnaire : * I am doing well (%) * I do not see the point (%) * I live far away (%) * I do not have time (%) * other reason (%)

Time frame
from surgery to 5 years after
2

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

Describe who follow the patients lost to follow-up by the referral center : * another center (%) * their attending physician (%) * no follow-up for bariatric surgery

Time frame
from surgery to 5 years after
3

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

Compare the proportion of patients receiving vitamin supplementation between those lost to follow-up in the OBESEPI cohort and those still being monitored. * % of patient who received Vitamin D in the 2 groups * % of patients who received vitamin B12 in the 2 groups * % of patients who received zinc in the 2 groups

Time frame
from time of surgery to 5 years after
4

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

Compare comorbidities of obesity frequency between patients lost to follow-up and patients still being monitored : * hypertension (%), * diabetes (%), * dyslipidaemia (%) * obstructive sleep apnoea ( %)

Time frame
from surgery to 5 years after

Other outcomes

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