Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery
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: Bariatric surgery.
- Кому может быть актуально
- Состояния в реестре: Obesity, Morbid, Bariatric Surgery Candidate. Базовые параметры: от 15 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 →
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Обзор
The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.
Подробное описание
The main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. Moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. From a methodological point of view, the Obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. The number of inclusions is to 1500 patients. After surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. The recommendations of the french health ministry (HAS), the frequency of visits may be increased according to the patient's progress. Follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . It will be insured for life, obesity is a chronic disease and because of the risk of late complications.
Вмешательства
- Процедура Bariatric surgery
all of the current bariatric surgeries are allowed in this prospective cohort study
Первичные конечные точки
- Assessment of the long-term efficiency of bariatric surgery on weight loss [Срок оценки: Change from intervention to 5 years]
Вторичные конечные точки (9)
- Assessment of the long-term efficiency of bariatric surgery on diabetes [Срок оценки: Change from intervention to 5 years]
- Assessment of the long-term efficiency of bariatric surgery on High Blood Pressure [Срок оценки: Change from intervention to 5 years]
- Assessment of the long-term efficiency of bariatric surgery on dyslipidemia [Срок оценки: Change from intervention to 5 years]
- Assessment of the long-term efficiency of bariatric surgery on rheumatism [Срок оценки: Change from intervention to 5 years]
- Assessment of the long-term efficiency of bariatric surgery on respiratory pathologies [Срок оценки: Change from intervention to 5 years]
- Assessment of the long-term efficiency of bariatric surgery on sleep apnea syndrome [Срок оценки: Change from intervention to 3 months]
- Assessment of the long-term efficiency of bariatric surgery on quality of life [Срок оценки: Change from intervention to 5 years]
- Assessment of medico-economic impact of bariatric surgery [Срок оценки: Change from intervention to 5 years]
- Assessment of mortality of bariatric surgery [Срок оценки: Change from intervention to 5 years]
Критерии участия
Критерии включения
- Only be considered in patients operated and followed at CHU Montpellier with bariatric surgery
- Patients treated by bariatric surgery on CHU Montpellier
- Agreed to participate to the study by signing an informed consent
- Eligible to health insurance
Критерии исключения
- Unable to follow the patient in the long term (foreign patients, surgical use ...)
- Inability to follow in the long run
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
Франция · 1 центр
- CHRU - Hôpital Saint Eloi — Montpellier
Публикации
- Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development PMID 37652841
- Nocca D, Galtier F, Taleb S, Picot MC, Jaussent A, Silvestri M, Lefebvre P, de Jong A, Gautier T, Loureiro M, Nedelcu M. Peri-operative Morbidity of Nissen Sleeve Gastrectomy: Prospective Evaluation of a Cohort of 365 Patients, Beyond the Learning Curve. Obes Surg. 2022 Jul;32(7):1-7. doi: 10.1007/s11695-022-06066-0. Epub 2022 May 7. PMID 35524904
Идентификаторы
NCT: NCT02310178 · UF 8855