Patient Experience in Bariatric Surgery: Definition of New Indicators

NCT ID: NCT05092659

Last Updated: 2025-02-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2025-01-14

Brief Summary

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

Given the growing importance of placing the patient at the heart of care evaluation, the use of patient questionnaires such as Patient Reported Experience Measures (PREMS) or Patient-Reported Outcome Measures (PROMS) has become widespread in recent years. PROMS assess the outcomes of care, whereas PREMS assess the patient's experience of care. However, these tools only imperfectly reflect the patient's experience and only answer specific questions: satisfaction, pain management, waiting times, etc.

Patients undergoing bariatric surgery will undergo major surgery that will have an impact on their subsequent quality of life. Preparing for this surgery is a lengthy process, involving various forms of support: psychological, nutritional, physical activity, and so on. Exploring patients' experiences in depth, based on their account of their care experience, can enable carers to better understand and apprehend this type of journey from a perspective closer to that of the patient.

Detailed Description

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

Given the growing importance of placing the patient at the heart of care evaluation, the use of patient questionnaires such as Patient Reported Experience Measures (PREMS) or Patient-Reported Outcome Measures (PROMS) has become widespread in recent years. PROMS assess the outcomes of care, whereas PREMS assess the patient's experience of care. However, these tools only imperfectly reflect the patient's experience and only answer specific questions: satisfaction, pain management, waiting times, etc. Other initiatives, such as the patient tracer (https://www.has-sante.fr/jcms/c\_2807803/fr/patient-traceur), involve interviewing patients and, where appropriate, their relatives about their care by asking them specific questions about their care, such as the information they have received, the therapeutic workshops they have attended, etc. However, all these attempts to put the patient at the centre of the evaluation of the quality of care are still based on quality questions or indicators defined a priori by healthcare professionals and the health authorities.

Patients undergoing bariatric surgery will undergo major surgery that will have an impact on their subsequent quality of life. Preparing for this surgery is a lengthy process, involving various forms of support: psychological, nutritional, physical activity, and so on. Exploring patients' experiences in depth, based on their account of their care experience, can enable carers to better understand and apprehend this type of journey from a perspective closer to that of the patient.

The narrative inquiry method enables patients' unique experiences to be collected and co-constructed with the help of interviewers. In addition, this qualitative approach focuses not only on the experience of individuals, but also on the social and cultural aspects in which they are embedded, enabling a more global and less reductive approach to the patient experience.

Conditions

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

Bariatric Surgery

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient interviews

Patient enrolled in a bariatric surgical pathway scheduled for visceral surgery.

Group Type OTHER

Patient interview

Intervention Type BEHAVIORAL

Each patient included will be interviewed 3 times : before surgery, 3 and 6 months after surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patient interview

Each patient included will be interviewed 3 times : before surgery, 3 and 6 months after surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Major patient
* Patient enrolled in a bariatric surgical pathway scheduled.
* First bariatric surgery

Exclusion Criteria

* Refusal to participate
* Non proficiency in spoken French
* Previous bariatric surgery
* Protected persons (patients under guardianship, pregnant or breastfeeding women, persons deprived of liberty, persons unable to express their non-objection)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Intercommunal Créteil

Créteil, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Vignot M, Jung C, Bathaei S, Lazzati A, Gateau V, Angeli F, Delorenzo C. Patient experience in bariatric surgery: protocol of a French narrative inquiry and qualitative analysis. BMJ Open. 2024 Aug 12;14(8):e082528. doi: 10.1136/bmjopen-2023-082528.

Reference Type DERIVED
PMID: 39134437 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A02161-40

Identifier Type: OTHER

Identifier Source: secondary_id

CALEX

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Bariatric Surgery
NCT02857179 RECRUITING