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

July 13, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Subjects hospitalised with non-surgical complications after bariatric surgery (case)
Subjects with bariatric surgery without nonsurgical complications (control)
Subjects with obesity (control)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
01/01/2014 to 31/12/2018
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.
Moment of inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight
Time Frame: Questionnaires are to be completed at the moment of inclusion
IWQOL-Lite
Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity
Time Frame: Questionnaires are to be completed at the moment of inclusion
IPAQ
Questionnaires are to be completed at the moment of inclusion
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
Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity
Time Frame: Questionnaires are to be completed at the moment of inclusion
BIS-11
Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use
Time Frame: Questionnaires are to be completed at the moment of inclusion
AUDIT
Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour
Time Frame: Questionnaires are to be completed at the moment of inclusion
EDE-Q
Questionnaires are to be completed at the moment of inclusion
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)
Questionnaires are to be completed at the moment of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann Mertens, MD PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • s59712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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