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NCT Number: NCT05957237

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

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.

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. RETROSPECTIVE STUDY: Type of non-surgical complication

    Time frame: 01/01/2014 to 31/12/2018

    Collect the type of non-surgical complication following bariatric surgery for which the patient is hospitalised

  2. CROSS-SECTIONAL STUDY: Quality of life

    Time frame: Moment of inclusion

    Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.

Secondary outcomes

  1. CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight

    Time frame: Questionnaires are to be completed at the moment of inclusion

    IWQOL-Lite

  2. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity

    Time frame: Questionnaires are to be completed at the moment of inclusion

    IPAQ

  3. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders

    Time frame: Questionnaires are to be completed at the moment of inclusion

    CIDI

  4. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity

    Time frame: Questionnaires are to be completed at the moment of inclusion

    BIS-11

  5. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use

    Time frame: Questionnaires are to be completed at the moment of inclusion

    AUDIT

  6. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour

    Time frame: Questionnaires are to be completed at the moment of inclusion

    EDE-Q

  7. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour

    Time frame: Questionnaires are to be completed at the moment of inclusion

    eating behaviour after bariatric surgery (questionnaire developed at UZ Leuven)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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