Patient Reported Outcome After Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anesthesia, Analgesia, Bariatric Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- What influences pain related impairment after bariatric surgery [Time frame: First day after surgery]
Secondary outcome measures (3)
- Change in pain related outcome after bariatric surgery [Time frame: Up to 12 months after surgery]
- Change in interference with daily activities after bariatric surgery [Time frame: Up to to 5 years after surgery]
- Change in quality of life after bariatric surgery [Time frame: Up to 5 years after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern — Bern
Identifiers
NCT: NCT03490630 · 041/09d (bariatric ss)