Patient Reported Outcome After Bariatric Surgery
Overview
- Phase
- Not Applicable
- Intervention
- All patients
- Conditions
- Anesthesia
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- What influences pain related impairment after bariatric surgery
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
All patients
Patients undergoing elective surgery with anesthesia
Outcomes
Primary Outcomes
What influences pain related impairment after bariatric surgery
Time Frame: First day after 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.
Secondary Outcomes
- Change in pain related outcome after bariatric surgery(Up to 12 months after surgery)
- Change in interference with daily activities after bariatric surgery(Up to to 5 years after surgery)
- Change in quality of life after bariatric surgery(Up to 5 years after surgery)