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CompletedNCT05957237Updated Jul 24, 2023

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

An observational study in Obesity and Bariatric Surgery, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
796
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Obesity
  • Bariatric Surgery

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03

In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 796 is above the median of 132 across 1,338 observational studies indexed under Obesity.

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Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
796 participants (actual)
Patient registry
No

Groups and cohorts

  • Subjects hospitalised with non-surgical complications after bariatric surgery (case)
  • Subjects with bariatric surgery without nonsurgical complications (control)
  • Subjects with obesity (control)
06

What researchers measure

Primary outcomes

  1. RETROSPECTIVE STUDY: Type of non-surgical complication

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

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

  2. CROSS-SECTIONAL STUDY: Quality of life

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

    Time frame: Moment of inclusion

Secondary outcomes

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

    IWQOL-Lite

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

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

    IPAQ

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

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

    CIDI

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

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

    BIS-11

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

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

    AUDIT

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

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

    EDE-Q

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

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

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2016 to primary completion in Mar 2020, 40 months.

Of 537 non-industry observational studies under Obesity, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 121. This study's 40 months is close to that.

Counting every sponsor, half of 569 studies reached it within 40 months; a quarter within 19 and three quarters within 111.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2022
First posted
Jul 24, 2023
StartActual
Nov 15, 2016
Primary completionActual
Mar 30, 2020
CompletionActual
Mar 30, 2020
Last update
Jul 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05957237
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Jul 24, 2023
Start date
Nov 15, 2016
Primary completion
Mar 30, 2020
Completion
Mar 30, 2020
Last update
Jul 24, 2023

Study contacts

Ann Mertens, MD PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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