ObesityNCT05957237
Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life
An observational study of Obesity and Bariatric Surgery, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery
- How many people
- 796 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2016to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
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:
- 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.
- Conditions
- Obesity, Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects hospitalised with non-surgical complications after bariatric surgery (case) | Not described | |
| Subjects with bariatric surgery without nonsurgical complications (control) | Not described | |
| Subjects with obesity (control) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
RETROSPECTIVE STUDY: Type of non-surgical complication
Collect the type of non-surgical complication following bariatric surgery for which the patient is hospitalised
Measured: 01/01/2014 to 31/12/2018
CROSS-SECTIONAL STUDY: Quality of life
Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.
Measured: Moment of inclusion
Secondary outcomes (7)
CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight
IWQOL-Lite
Measured: Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity
IPAQ
Measured: Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders
CIDI
Measured: Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity
BIS-11
Measured: Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use
AUDIT
Measured: Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour
EDE-Q
Measured: Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour
eating behaviour after bariatric surgery (questionnaire developed at UZ Leuven)
Measured: Questionnaires are to be completed at the moment of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start15 Nov 2016
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Mertens, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957237
- Sponsor's protocol ID
- s59712
- Status last verified
- Sep 2022
- First submitted
- 10 Jun 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life in Patients Hospitalised in UZ Leuven
- ClinicalTrials.gov ID
- NCT05957237
- Acronym / sponsor ID
- s59712
- Conditions
- Obesity, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects hospitalised with non-surgical complications after bariatric surgery (case) | – | – |
| Subjects with bariatric surgery without nonsurgical complications (control) | – | – |
| Subjects with obesity (control) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
Key exclusion criteria (8 listed)
- Patients with bariatric surgery who were never hospitalised with non-surgical complications
- Patients with obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
7 secondary outcomes
CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight
Time frame: 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
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders
Time frame: 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
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use
Time frame: 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
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour
Time frame: Questionnaires are to be completed at the moment of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Mertens, MD PhD principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RETROSPECTIVE STUDY: Type of non-surgical complication (time frame: 01/01/2014 to 31/12/2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.