跳至主要内容
临床试验/NCT06426290
NCT06426290招募中不适用

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 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
360
试验地点
1
主要终点
Determine the predictive value of depressive symptomatology dimension on the evolution of BMI.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Centre Hospitalier de Moulins Yzeure
申办方类型
Other
责任方
Sponsor

研究点 (1)

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