Clinical trial NCT05957237: Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life
Official title: Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life in Patients Hospitalised in UZ Leuven
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 796
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised with non-surgical complications of bariatric surgery Patients with bariatric surgery who were never hospitalised with non-surgical complications Patients with 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.

Eligibility 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
* 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

Primary outcomes:
measure: RETROSPECTIVE STUDY: Type of non-surgical complication
timeFrame: 01/01/2014 to 31/12/2018
measure: CROSS-SECTIONAL STUDY: Quality of life
timeFrame: Moment of inclusion
Secondary outcomes:
measure: CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight
timeFrame: Questionnaires are to be completed at the moment of inclusion
measure: CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity
timeFrame: Questionnaires are to be completed at the moment of inclusion
measure: CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders
timeFrame: Questionnaires are to be completed at the moment of inclusion
measure: CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity
timeFrame: Questionnaires are to be completed at the moment of inclusion
measure: CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use
timeFrame: Questionnaires are to be completed at the moment of inclusion
measure: CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour
timeFrame: Questionnaires are to be completed at the moment of inclusion
measure: CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour
timeFrame: Questionnaires are to be completed at the moment of inclusion
Other outcomes:
Locations:
Study officials:
affiliation: UZ Leuven
name: Ann Mertens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: