Patient Reported Outcome After Bariatric Surgery

Anesthesia Clinical Trial

Official title:

Patient Reported Outcome After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03490630
• Other study ID #: 041/09d (bariatric ss)
• Status: Recruiting
• Start date: January 2011
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Ulrike M Stamer, Prof. MD
• Phone: +41-316329995
• Email: ulrike.stamer[@]dbmr.unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective association study to analyse patients' outcome after bariatric surgery.

Outcome comprises postoperative pain, analgesia, postoperative side-effects, long-lasting pain, patients' impairment in daily living.

Description:

Background

Bariatric surgery is a common procedure. Data on patient related outcome beyond loss of body weight are scarce. The question arises which patient is at specific risk for an unfavorable outcome after bariatric surgery.

Objective

The aim of this study is to investigate variables possibly associated with impaired outcome and increased patients' interference after bariatric surgery. Which patients are at risk for clinically meaningful impaired daily living?

Methods

Patients will be enrolled in a prospective observational study. Data will be collected in a registry with documentation of patient, surgery, anesthesia and analgesia related variables including preoperative status and postoperative patient reported outcome with a follow-up period up to 5 years after bariatric surgery.

Patients fill in standardized validated outcome questionnaires at predefined time points. The registry provides the basis for large scale analyses and benchmarks for several parameters.

Variables to be considered are pain scores after surgery, patient reported outcome, pain related interference after surgery (Brief Pain Inventory), quality of life (SF-12), long-term outcome, chronic (neuropathic) postsurgical pain, BMI, psychological questionnaires, surgery and patient related variables, including genetic variants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• Written informed consent

• Elective bariatric surgery

• Patients' ability to understand the purpose of the study

Exclusion Criteria

• No informed consent

• Cognitive impairment

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Bariatric Surgery

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What influences pain related impairment after bariatric surgery	Measured by the validated International Pain Outcomes Questionnaire: Patient reported outcome using the numeric rating scale 0-10 (0=no impairment, 10=worst experience possible). Patients with severe pan (pain scores of NRS 6 and higher) are compared to those with no and mild pain.	First day after surgery
Secondary	Change in pain related outcome after bariatric surgery	Measurement of patient reported outcome by the BPI (Brief Pain Inventory). The BPI gives information on the physical and affective interference as well as pain scores using the numeric rating scale (NRS: 0-10). Cut-offs discussed for the three groups no/mild interference, moderate interference and severe interference are mean NRS-scores of 3 and 5.	Up to 12 months after surgery
Secondary	Change in interference with daily activities after bariatric surgery	Physical and affective interference as well as pain scores measured by the Brief Pain Inventory (BPI). Independent variables e.g. Hospital Anxiety and Depression Scale (HADS) and further validated psychological questionnaires	Up to to 5 years after surgery
Secondary	Change in quality of life after bariatric surgery	Measured by the 12 item short-form health survey (SF-12).	Up to 5 years after surgery