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

• Sponsor: Universitaire Ziekenhuizen KU Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT05957237
• Collaborator: (none)
• Enrollment: 796
• Actual Duration (Months): 40.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 796 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Evaluation of Characteristics of Patients With Nonsurgical Complications After Bariatric Surgery and Quality of Life in Patients Hospitalised in UZ Leuven
• Actual Study Start Date: Nov 15, 2016
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Subjects hospitalised with non-surgical complications after bariatric surgery (case)
Subjects with bariatric surgery without nonsurgical complications (control)
Subjects with obesity (control)

Outcome Measures

Primary Outcome Measures

1. RETROSPECTIVE STUDY: Type of non-surgical complication [01/01/2014 to 31/12/2018]

   Collect the type of non-surgical complication following bariatric surgery for which the patient is hospitalised

2. CROSS-SECTIONAL STUDY: Quality of life [Moment of inclusion]

   Using the WHODAS 2.0 questionnaire, health-related quality of life will be assessed.

Secondary Outcome Measures

1. CROSS-SECTIONAL STUDY: Scores on questionnaire concerning impact of weight [Questionnaires are to be completed at the moment of inclusion]

   IWQOL-Lite

2. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning physical activity [Questionnaires are to be completed at the moment of inclusion]

   IPAQ

3. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning anxiety, depression and personality disorders [Questionnaires are to be completed at the moment of inclusion]

   CIDI

4. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning impulsivity [Questionnaires are to be completed at the moment of inclusion]

   BIS-11

5. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning alcohol use [Questionnaires are to be completed at the moment of inclusion]

   AUDIT

6. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour [Questionnaires are to be completed at the moment of inclusion]

   EDE-Q

7. CROSS-SECTIONAL STUDY: Scores on questionnaires concerning eating behaviour [Questionnaires are to be completed at the moment of inclusion]

   eating behaviour after bariatric surgery (questionnaire developed at UZ Leuven)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universitaire Ziekenhuizen KU Leuven

Investigators

• Principal Investigator: Ann Mertens, MD PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen KU Leuven
• ClinicalTrials.gov Identifier: NCT05957237
• Other Study ID Numbers: s59712
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 24, 2023