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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05957237
Enrollment
796
Registered
2023-07-24
Start date
2016-11-15
Completion date
2020-03-30
Last updated
2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obesity

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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 *

Design outcomes

Primary

MeasureTime frameDescription
RETROSPECTIVE STUDY: Type of non-surgical complication01/01/2014 to 31/12/2018Collect the type of non-surgical complication following bariatric surgery for which the patient is hospitalised
CROSS-SECTIONAL STUDY: Quality of lifeMoment of inclusionUsing the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.

Secondary

MeasureTime frameDescription
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disordersQuestionnaires are to be completed at the moment of inclusionCIDI
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivityQuestionnaires are to be completed at the moment of inclusionBIS-11
CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weightQuestionnaires are to be completed at the moment of inclusionIWQOL-Lite
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviourQuestionnaires are to be completed at the moment of inclusionEDE-Q
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol useQuestionnaires are to be completed at the moment of inclusionAUDIT
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activityQuestionnaires are to be completed at the moment of inclusionIPAQ

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026