跳至主要内容
临床试验/NCT06043206
NCT06043206已完成不适用

Bariatric Surgery in Patients With Schizophrenia

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Weight loss

研究概览

简要总结

It is known that schizophrenia is associated with obesity in a significant number of patients and it implies a poor prognostic factor, with weight loss being important in this population. However, data about the prognosis of weight loss surgery in subjects with schizophrenia is scant.

Hypothesis: Bariatric surgery in subjects with schizophrenia leads to an improvement in weight and cardiometabolic comorbidities similar to that of subjects without schizophrenia Main goal: To study the evolution after bariatric surgery in patients with obesity and schizophrenia Design: Multicenter retrospective case control study. Disease under study: Schizophrenia and Obesity Methodology: Retrospective observational study Study population and total number of subjects Cases: Patients with schizophrenia and obesity undergoing bariatric surgery. (number: all cases collected within the GOSEEN group).

Controls: Patients without psychiatric pathology matched by age, sex, body mass index and type of surgery and in a 4:1 ratio to cases.

Calendar. Expected duration of the study. 12 months ethical considerations Informed consent will be obtained from patients who are currently being followed up at the reference centers.

详细描述

THEORETICAL FRAMEWORK. PROBLEM STATEMENT:

Background Obesity affects approximately 45-55% of patients with schizophrenia (1). Weight gain in these patients may be due to different factors such as the use of antipsychotic drugs with an unfavorable metabolic profile, the coexistence of sleep disorders or negative cognitive symptoms that often translate into a more sedentary lifestyle and alterations in eating behavior, among others (2). The coexistence of obesity and its comorbidities in this group of patients significantly worsens both their physical and mental health (3). In fact, cardiovascular disease is one of the main causes of mortality in patients with schizophrenia (4).

Lifestyle interventions, while they may be effective in people with schizophrenia (5), often fall short of achieving weight goals. At present, obesity surgery represents the most effective treatment in terms of weight loss and resolution of comorbidities, being indicated in cases of patients with a body mass index (BMI) > 35 kg/m2 with comorbidities or BMI > 40 Kg/m2 with/without comorbidities. However, the access of patients with schizophrenia to bariatric surgery techniques is usually limited by different factors such as fear of a possible worsening of the underlying disease, or a lower weight loss in this population, among others. In addition, clinical practice guidelines recommend that all patients with psychiatric pathologies be evaluated in a regulated manner prior to surgery (6), although the content of this evaluation and the criteria for declining or accepting surgery are not clear. Although the course of schizophrenia is variable and its symptoms may be stable without being a clear contraindication for bariatric surgery, in actual practice, a considerable number of professionals contraindicate bariatric surgery in the presence of a psychotic disorder (7).

For these reasons, data on the efficacy of bariatric surgery in patients with schizophrenia are scarce and limited to very small case series with short-term follow-up (2,8,9). Our objective is therefore to carry out a multicenter retrospective study that allows us to study the long-term evolution after bariatric surgery in a large series of patients, focusing not only on weight evolution but also on the long-term evolution of psychiatric pathology.

Justification It is necessary to have information about the prognosis of subjects with severe obesity and schizophrenia who undergo bariatric surgery. This knowledge will make it possible to establish clear guidelines for action in these cases.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Weight loss

时间窗: 12 months and 5 years after the surgery

short (first year after bariatric surgery) and long-term (up to 5 years of follow-up after bariatric surgery) evolution in terms of weight loss of patients with obesity and schizophrenia who underwent bariatric surgery

次要结局

  • post-surgical complications(up to 30 days post-surgery) or late post-surgical complications (through study completion, up to five years post-surgery))
  • Comorbidity progression(12 months and 5 years after the surgery)
  • Clincial Caracteristics description(inclusion, day 1)
  • Psychiatric pathology progression(30 days post surgery and 5 years after the surgery)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Bariatric Surgery in Patients With Schizophrenia | 临床试验