Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life
- Conditions
- Bariatric SurgeryObesity
- Registration Number
- NCT05957237
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 796
- Signed informed consent
- Patients underwent bariatric surgery
- Patients are hospitalised for nonsurgical complications of bariatric surgery at the Endocrinology unit of UZ Leuven
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CROSS-SECTIONAL STUDY: Quality of life Moment of inclusion Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.
RETROSPECTIVE STUDY: Type of non-surgical complication 01/01/2014 to 31/12/2018 Collect the type of non-surgical complication following bariatric surgery for which the patient is hospitalised
- Secondary Outcome Measures
Name Time Method CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight Questionnaires are to be completed at the moment of inclusion IWQOL-Lite
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity Questionnaires are to be completed at the moment of inclusion BIS-11
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders Questionnaires are to be completed at the moment of inclusion CIDI
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour Questionnaires are to be completed at the moment of inclusion eating behaviour after bariatric surgery (questionnaire developed at UZ Leuven)
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity Questionnaires are to be completed at the moment of inclusion IPAQ
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use Questionnaires are to be completed at the moment of inclusion AUDIT