NCT05957237

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
796

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
Last Updated

July 24, 2023

Status Verified

September 1, 2022

Enrollment Period

3.4 years

First QC Date

June 10, 2022

Last Update Submit

July 13, 2023

Conditions

ObesityBariatric Surgery

Outcome Measures

Primary Outcomes (2)

  • 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 (7)

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

    Questionnaires are to be completed at the moment of inclusion

  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity

    Questionnaires are to be completed at the moment of inclusion

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

    Questionnaires are to be completed at the moment of inclusion

  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity

    Questionnaires are to be completed at the moment of inclusion

  • CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use

    Questionnaires are to be completed at the moment of inclusion

  • +2 more secondary outcomes

Study Arms (3)

Subjects hospitalised with non-surgical complications after bariatric surgery (case)

Subjects with bariatric surgery without nonsurgical complications (control)

Subjects with obesity (control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Signed informed consent
  • Patients underwent bariatric surgery
  • Patients are hospitalised for nonsurgical complications of bariatric surgery at the Endocrinology unit of UZ Leuven

You may not qualify if:

  • 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
  • Signed informed consent
  • Patients underwent bariatric surgery
  • Patients without history of hospitalisation for nonsurgical complications of bariatric surgery
  • Patients are not able to complete the questionnaires themselves
  • Patients who do not understand Dutch
  • Patients with obesity
  • Signed informed consent
  • Patients visit the Obesity Clinic of UZ Leuven
  • Patients are not able to complete the questionnaires themselves
  • Patients who do not understand Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ann Mertens, MD PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

July 24, 2023

Study Start

November 15, 2016

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

July 24, 2023

Record last verified: 2022-09