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临床试验/NCT05957237
NCT05957237已完成不适用

Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life in Patients Hospitalised in UZ Leuven

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 796 人开始时间: 2016年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
796
主要终点
CROSS-SECTIONAL STUDY: Quality of life

研究概览

简要总结

Retrospective study: Analysis of characteristics of patients that were hospitalised with nonsurgical complications after bariatric surgery.

Cross-sectional study: To present and evaluate (clinical) parameters and quality of life measures of patients with nonsurgical complications after bariatric surgery compared to bariatric patients without hospitalisation for complications and obese patients.

详细描述

Retrospective study: The general objective is to describe and evaluate the characteristics of patients with nonsurgical complications after bariatric surgery based on parameters registered in the medical record.

Cross-sectional study:

  1. Primary objective: To evaluate how quality of life is perceived in patients hospitalised for nonsurgical complications after bariatric surgery compared to control groups through Health-related Quality of Life (HRQoL) questionnaires.
  2. Secondary objectives: To evaluate and compare (clinical) parameters and scoring on questionnaires about impact of weight, physical activity, anxiety and depression, impulsivity, alcohol use and eating behaviour for different bariatric and obese populations.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Patients underwent bariatric surgery
  • Patients are hospitalised for nonsurgical complications of bariatric surgery at the Endocrinology unit of UZ Leuven

排除标准

  • Patients are not able to complete the questionnaires themselves
  • Patients who do not understand Dutch
  • Patients with bariatric surgery who were never hospitalised with non-surgical complications
  • Inclusion Criteria:
  • Signed informed consent
  • Patients underwent bariatric surgery
  • Patients without history of hospitalisation for nonsurgical complications of bariatric surgery
  • Exclusion Criteria:
  • Patients are not able to complete the questionnaires themselves
  • Patients who do not understand Dutch
  • Patients with obesity
  • Inclusion Criteria:
  • Signed informed consent
  • Patients visit the Obesity Clinic of UZ Leuven
  • Exclusion Criteria:
  • Patients are not able to complete the questionnaires themselves
  • Patients who do not understand Dutch

结局指标

主要结局

CROSS-SECTIONAL STUDY: Quality of life

时间窗: Moment of inclusion

Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.

RETROSPECTIVE STUDY: Type of non-surgical complication

时间窗: 01/01/2014 to 31/12/2018

Collect the type of non-surgical complication following bariatric surgery for which the patient is hospitalised

次要结局

  • CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight(Questionnaires are to be completed at the moment of inclusion)
  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity(Questionnaires are to be completed at the moment of inclusion)
  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders(Questionnaires are to be completed at the moment of inclusion)
  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour(Questionnaires are to be completed at the moment of inclusion)
  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity(Questionnaires are to be completed at the moment of inclusion)
  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use(Questionnaires are to be completed at the moment of inclusion)

研究者

申办方类型
Other
责任方
Sponsor

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