Obesity &Amp; OverweightOBEPERNCT07118540
Evaluation of the Care Provided to Patients Who Underwent Bariatric Surgery and Were Lost to Follow-up 5 Years After Surgery
An observational study of Obesity &Amp; Overweight, run by Central Hospital, Nancy, France at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity &Amp; Overweight
- How many people
- 176 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2025to 10 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- > 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.
Who cannot join
- >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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Enrolling by invitation
Centre Hospitalier Universitaire de Nancy
Nancy, Lorraine, 54000
- Recruiting
Centre Hospitalier Universitaire de Nancy
Nancy, Lorraine, 54000
About this study
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.
Read the detailed description
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
- Obesity &Amp; Overweight
- Keywords
- obesity, bariatric surgery, overweight, lost to follow-up
- Medical subject headings
- Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %.
Measured: from bariatric surgery to 5 years after
Secondary outcomes (5)
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 (%)
Measured: 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
Describe who follow the patients lost to follow-up by the referral center :
- another center (%)
- their attending physician (%)
- no follow-up for bariatric surgery
Measured: 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.
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
Measured: 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 %)
Compare comorbidities of obesity frequency between patients lost to follow-up and patients still being monitored :
- hypertension (%),
- diabetes (%),
- dyslipidaemia (%)
- obstructive sleep apnoea ( %)
Measured: from surgery to 5 years after
Compare the proportion of post-bariatric surgery complications requiring surgery (%)
Compare the proportion of post-bariatric surgery complications requiring surgical intervention among the groups 2 groups (patients lost to follow up compared to patients who are still being monitored) (%)
Measured: from bariatric surgery to 5 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jun 2025
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NOMINE-CRIQUI Claire, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118540
- Sponsor's protocol ID
- 16062025
- Acronym
- OBEPER
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
(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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Care Provided to Patients Who Underwent Bariatric Surgery and Were Lost to Follow-up 5 Years After Surgery
- ClinicalTrials.gov ID
- NCT07118540
- Acronym / sponsor ID
- OBEPER / 16062025
- Conditions
- Obesity &Amp; Overweight
- Keywords
- obesity, bariatric surgery, overweight, lost to follow-up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- > Patients included in the OBESEPI cohort;
Key exclusion criteria (4 listed)
- >Patient who objects to participating in this research;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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 %.
5 secondary outcomes
Describe the reasons for discontinuing post-bariatric surgery follow-up at Nancy University Hospital.
Time frame: 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
Time frame: 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.
Time frame: 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 %)
Time frame: from surgery to 5 years after
Compare the proportion of post-bariatric surgery complications requiring surgery (%)
Time frame: from bariatric surgery to 5 years after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background(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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity &Amp; Overweight, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire NOMINE-CRIQUI, MD (+33632149814, c.nomine-criqui@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07118540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.