Evaluation of the Care Provided to Patients Who Underwent Bariatric Surgery and Were Lost to Follow-up 5 Years After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- 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 %.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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.
排除标准
- •>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.
结局指标
主要结局
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 %.
时间窗: from bariatric surgery to 5 years after
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 %.
次要结局
- Describe the reasons for discontinuing post-bariatric surgery follow-up at Nancy University Hospital.(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(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.(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 %)(from surgery to 5 years after)
- Compare the proportion of post-bariatric surgery complications requiring surgery (%)(from bariatric surgery to 5 years after)
研究者
NOMINE-CRIQUI Claire
Staff surgeon in Visceral Metabolic and oncologic surgery department, head of the endocrine surgery Unit
Central Hospital, Nancy, France