Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

Recruiting

• Conditions: Body Weight Changes

• Registration Number: NCT06426290
• Lead Sponsor: Centre Hospitalier de Moulins Yzeure

Brief Summary

This is an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an MMPI-2-RF (Minnesota Multiphasic Personality Inventory-2-Restructured form) questionnaire in the preoperative phase of a bariatric surgery project.

The evolution of their BMI will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery.

The presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve BMI evolution and bariatric surgery success.

Detailed Description

A first phase of data collection will concern data from the MMPI-2-RF questionnaire as well as clinical data, collected during preoperative consultations.

For the second phase, post-operative data will be collected, during a routine follow-up consultation in the nutrition Department, where specific psychological questionnaires are taken by patients.

Study Timeline

• Study Start: 2024-05-10
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Having been treated in the Nutrition department for severe obesity and considered for bariatric surgery because having met the criteria validating bariatric surgery:
• Having passed the MMPI-2-RF questionnaire between January 1, 2014 and December 31, 2023 in the preoperative phase, as part of psychological follow-up
• Having benefited from bariatric surgery or patients who have abandoned the surgery plan for a reason other than a medical contraindication.
• Informed of the study, having agreed to participate and not having opposed the use of their data

Exclusion Criteria

• Subjects who generated an invalid MMPI-2-RF questionnaire, according to the test validity criteria (verified by the principal investigator)
• Subjects who expressly objected to the use of their data for this study
• Subjects who have not undergone bariatric surgery due to a medical contraindication.
• Patient unable to understand the study or complete the post-operative phase visit
• Persons under guardianship or curators or under legal protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.	At inclusion psychological consultation	Depressive dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.

Secondary Outcome Measures

Name	Time	Method
Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI	At inclusion psychological consultation	Anxiety dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.
Determine the predictive value of eating behavior dimension on the evolution of BMI	At inclusion psychological consultation	Eating behaviour dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.
Determine the predictive value of quality of life dimension on the evolution of BMI	At inclusion psychological consultation	Quality of life dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.
Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI	At inclusion psychological consultation	satisfaction and body perception dimensions assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires.
Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery	At inclusion psychological consultation	Using the MMPI-2-RF preoperative questionnaire
Determine typical profiles of patients who have finally denied surgery apart from medical contraindications	At inclusion psychological consultation	Using the MMPI-2-RF preoperative questionnaire

Trial Locations

Locations (1)

Centre hospitalier Moulins-Yzeure; 🇫🇷 Moulins, France