Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life

Study Overview
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Brief Summary
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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
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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: 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. 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.

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

Conditions
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Obesity, Bariatric Surgery

Participation Criteria
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Eligibility Criteria
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CROSS-SECTIONAL STUDY Patients hospitalised with non-surgical complications of bariatric surgery Inclusion Criteria: Signed informed consent Patients underwent bariatric surgery Patients are hospitalised for nonsurgical complications of bariatric surgery at the Endocrinology unit of UZ Leuven Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects hospitalised with non-surgical complications after bariatric surgery (case)<br> | |
| Subjects with bariatric surgery without nonsurgical complications (control)<br> | |
| Subjects with obesity (control)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RETROSPECTIVE STUDY: Type of non-surgical complication | Collect the type of non-surgical complication following bariatric surgery for which the patient is hospitalised | 01/01/2014 to 31/12/2018 | 
| CROSS-SECTIONAL STUDY: Quality of life | Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed. | Moment of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight | IWQOL-Lite | Questionnaires are to be completed at the moment of inclusion | 
| CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity | IPAQ | Questionnaires are to be completed at the moment of inclusion | 
| CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders | CIDI | Questionnaires are to be completed at the moment of inclusion | 
| CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity | BIS-11 | Questionnaires are to be completed at the moment of inclusion | 
| CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use | AUDIT | Questionnaires are to be completed at the moment of inclusion | 
| CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour | EDE-Q | Questionnaires are to be completed at the moment of inclusion | 
| CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour | eating behaviour after bariatric surgery (questionnaire developed at UZ Leuven) | Questionnaires are to be completed at the moment of inclusion |