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Идёт набор NCT06426290

Prediction of Response to Bariatric Surgery in Patients With Severe Obesity

— Наблюдательное Body Weight Changes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: post-surgery psychological evaluation.
Кому может быть актуально
Состояния в реестре: Body Weight Changes. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое post-surgery psychological evaluation
    Following questionnaires will be done : Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder (GAD-7) Three Factor Eating Questionnaire (TFEQ-R21) Quality of life for obesity and dietetic questionnaire (EQVOD) Body Esteem Scale (BES) Figure Rating Scale (auto-questionnaire)

Первичные конечные точки

  • Determine the predictive value of depressive symptomatology dimension on the evolution of BMI. [Срок оценки: At inclusion psychological consultation]
Вторичные конечные точки (6)
  • Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI [Срок оценки: At inclusion psychological consultation]
  • Determine the predictive value of eating behavior dimension on the evolution of BMI [Срок оценки: At inclusion psychological consultation]
  • Determine the predictive value of quality of life dimension on the evolution of BMI [Срок оценки: At inclusion psychological consultation]
  • Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI [Срок оценки: At inclusion psychological consultation]
  • Determine typical profiles of patients who have finally denied surgery apart from medical contraindications [Срок оценки: At inclusion psychological consultation]
  • Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery [Срок оценки: At inclusion psychological consultation]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Centre hospitalier Moulins-Yzeure — Moulins

Идентификаторы

NCT: NCT06426290 · CHMY-2021-06

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗