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

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: Completed
• Conditions: Obesity; Bariatric Surgery

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: Observational
• Enrollment (Actual): 796

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	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 Outcome Measures

Outcome Measure	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	IPAQ	Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders	CIDI	Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity	BIS-11	Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use	AUDIT	Questionnaires are to be completed at the moment of inclusion
CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour	EDE-Q	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)	Questionnaires are to be completed at the moment of inclusion

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Ann Mertens, MD PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2016
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID 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