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Clinical Trials/NCT06426290
NCT06426290
Recruiting
Not Applicable

Prediction of Response to Bariatric Surgery Treatment in Patients Suffering From Severe Obesity, Based on the Scales of the MMPI-2-RF Questionnaire Carried Out Preoperatively

Centre Hospitalier de Moulins Yzeure1 site in 1 country360 target enrollmentMay 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Weight Changes
Sponsor
Centre Hospitalier de Moulins Yzeure
Enrollment
360
Locations
1
Primary Endpoint
Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2024
End Date
December 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier de Moulins Yzeure
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.

Time Frame: 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 Outcomes

  • Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI(At inclusion psychological consultation)
  • Determine the predictive value of eating behavior dimension on the evolution of BMI(At inclusion psychological consultation)
  • Determine the predictive value of quality of life dimension on the evolution of BMI(At inclusion psychological consultation)
  • Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI(At inclusion psychological consultation)
  • Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery(At inclusion psychological consultation)
  • Determine typical profiles of patients who have finally denied surgery apart from medical contraindications(At inclusion psychological consultation)

Study Sites (1)

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