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

Obesity Clinical Trial

Official title:

Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life in Patients Hospitalised in UZ Leuven

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957237
• Other study ID #: s59712
• Status: Completed
• Start date: November 15, 2016
• Est. completion date: March 30, 2020

Study information

• Verified date: September 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 bariatric patients without hospitalisation for complications and obese patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	CROSS-SECTIONAL STUDY: Quality of life	Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.	Moment of inclusion
Secondary	CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight	IWQOL-Lite	Questionnaires are to be completed at the moment of inclusion
Secondary	CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity	IPAQ	Questionnaires are to be completed at the moment of inclusion
Secondary	CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders	CIDI	Questionnaires are to be completed at the moment of inclusion
Secondary	CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity	BIS-11	Questionnaires are to be completed at the moment of inclusion
Secondary	CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use	AUDIT	Questionnaires are to be completed at the moment of inclusion
Secondary	CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour	EDE-Q	Questionnaires are to be completed at the moment of inclusion
Secondary	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