Evaluation of Characteristics of Patients With Nonsurgica... | NCT05957237

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

NCT05957237

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jul 24, 2023Actual

Enrollment

796Actual

Phase

Not provided

Conditions

Obesity
Bariatric Surgery

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2016Actual

Primary Completion Date

Mar 30, 2020Actual

Completion Date

Mar 30, 2020Actual

First Submitted Date

Jun 10, 2022

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2023

Last Update Posted Date

Jul 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

796Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RETROSPECTIVE STUDY: Type of non-surgical complication	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	Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.	Moment of inclusion

Secondary Outcomes

Measure	Description	Time Frame
CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight	IWQOL-Lite	Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Probability Sample

Label	Type	Description	Intervention Names
Subjects hospitalised with non-surgical complications after bariatric surgery (case)
Subjects with bariatric surgery without nonsurgical complications (control)
Subjects with obesity (control)

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases