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

NCT ID: NCT05957237

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

796 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-15

Study Completion Date

2020-03-30

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:

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.

Conditions

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Obesity Bariatric Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Subjects hospitalised with non-surgical complications after bariatric surgery (case)

No interventions assigned to this group

Subjects with bariatric surgery without nonsurgical complications (control)

No interventions assigned to this group

Subjects with obesity (control)

No interventions assigned to this group

Eligibility Criteria

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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

* Signed informed consent
* Patients underwent bariatric surgery
* Patients without history of hospitalisation for nonsurgical complications of bariatric surgery

* 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

Patients with bariatric surgery who were never hospitalised with non-surgical complications


* Patients are not able to complete the questionnaires themselves
* Patients who do not understand Dutch

Patients with obesity


* Patients are not able to complete the questionnaires themselves
* Patients who do not understand Dutch
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Mertens, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Other Identifiers

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s59712

Identifier Type: -

Identifier Source: org_study_id

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