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Идёт набор NCT07118540

Evaluation of the Care Provided to Patients Who Underwent Bariatric Surgery and Were Lost to Follow-up 5 Years After Surgery

Наблюдательное Obesity &Amp; Overweight

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Obesity &Amp; Overweight. Базовые параметры: 18 лет — 65 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

In 2025, bariatric surgery combined with nutritional and psychological support is one of the most effective treatments for patients with morbid obesity. (2)(3) However, it causes various deficiencies, such as vitamin and iron deficiencies, which justify lifelong personalised vitamin supplementation and, consequently, lifelong medical supervision. The latest recommendations from the French National Authority for Health (Haute Autorité de Santé) clearly state that patients must commit to lifelong medical follow-up after bariatric surgery. (HAS, February 2024, R94). R94. Regular biological monitoring after bariatric surgery is recommended: three times in the first year and then once or twice a year thereafter. Within the OBESEPI cohort (clinical trial number NCT02663388), which comprises patients who underwent surgery at Nancy University Hospital between 2013 and 2018, we observed that over 50% of patients were lost to follow-up five years after surgery.

Подробное описание

Duration of the inclusion period: 3 months Duration of subject participation (from inclusion to the last visit for the same subject): 30 minutes (time required to complete the questionnaire) Total duration of the research: 9 months

Patients with obesity who met the HAS (French high health authority) criteria for surgical treatment were recruited.

This corresponds to patients with a BMI \> 35 kg/m2 with obesity-related complications (hypertension and/or diabetes and/or dyslipidemia and/or obstructive apnea syndrom ) and patients with a BMI \> 40 with or without obesity-related complications.

These patients, who were candidates for scheduled bariatric surgery, were recruited by a surgeon involved in the protocol during preoperative consultations in the Metabolic, Visceral and oncologic department of surgery ; Department at Nancy University Hospital; between 2013 and 2018 (the OBESEPI-ALDEPI cohort - clinical trial NCT02663388) ). All patients met the HAS's eligibility criteria previously cited for bariatric surgery.

Two groups could be studied:

Patients who underwent surgery and were lost to follow-up five years after after bariatric surgery

The second group comprised patients who underwent surgery and were still being monitored at Nancy University Hospital five years after their inclusion.

Patients were considered lost to follow-up if there was no record of them visiting the Metabolic, Visceral and oncologic department of surgery five years after their inclusion, as determined using the DXCare software (which contain medical file).

A questionnaire is used to collect all data. This is completed by telephone or sent by email to patients who have been lost to follow-up.

This questionnaire contains questions designed to help us achieve the main and secondary objectives described in the dedicated section.

Statistical analysis :

All data will be presented as numbers and percentages for qualitative variables, and as means, standard deviations, medians, quartiles, and extreme values for quantitative variables.

The characteristics of patients lost to follow-up from the OBESPI cohort will be compared with those still being followed up using Fisher's exact test, Chi-squared test or Wilcoxon's rank sum test.

To meet the objectives, these tests will also be used to compare patients lost to follow-up with those still being followed.

Assessment of research benefits:

Methods for monitoring patients lost to follow-up should be assessed in order to develop training for general practitioners in the Lorraine region, enabling them to provide appropriate follow-up care to patients who have undergone bariatric surgery.

Train general practitioners to prevent nutritional complications of bariatric surgery.

Train general practitioners to recognise the warning signs that require referral to a specialist centre.

There is major interest in improving healthcare practices, given that 60,000 bariatric surgeries are performed annually in France, with 800,000 patients having undergone surgery in 2019.

Первичные конечные точки

  • Assess the proportion of patients lost to follow-up from the OBESEPI cohort who are still receiving medical care (at another centre or from their general practitioner)in %. [Срок оценки: from bariatric surgery to 5 years after]
Вторичные конечные точки (5)
  • Describe the reasons for discontinuing post-bariatric surgery follow-up at Nancy University Hospital. [Срок оценки: from surgery to 5 years after]
  • Describe how often patients lost to follow-up by Nancy University Hospital are followed up by another centre or their attending physician [Срок оценки: from surgery to 5 years after]
  • Compare the proportion of patients receiving vitamin supplementation between those lost to follow-up in the OBESEPI cohort and those still being monitored. [Срок оценки: from time of surgery to 5 years after]
  • Compare comorbidities in patients lost to follow-up in the OBESEPI cohort with those in patients still being monitored (in %) [Срок оценки: from surgery to 5 years after]
  • Compare the proportion of post-bariatric surgery complications requiring surgery (%) [Срок оценки: from bariatric surgery to 5 years after]

Критерии участия

Критерии включения

  • > Patients included in the OBESEPI cohort;
  • Individuals who have received complete information about the organisation of the research and have not objected to their participation and the use of their data;
  • Affiliation with a social security scheme.

Критерии исключения

  • >Patient who objects to participating in this research;
  • Pregnant and breastfeeding women;
  • Patients under legal guardianship or curatorship;
  • Patients deprived of their liberty by a judicial or administrative decision.

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 · 2 центра
  • Centre Hospitalier Universitaire de Nancy — Nancy
  • Centre Hospitalier Universitaire de Nancy — Nancy

Публикации

  • (1)Global, regional, and national prevalence of adult overweight and obesity, 1990-2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021 Lancet. 2025 Mar 8; (2)Peirson L, Douketis J, Ciliska D, Fitzpatrick-Lewis D, Ali MU, Raina P. Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis. CMAJ Open. Oct 2014;2(4):E306-

Идентификаторы

NCT: NCT07118540 · 16062025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗