Analgesia, Anesthesia, Bariatric Surgery
Conditions
Keywords
patient reported outcome, postoperative pain, pain related impairment, quality of life, prospective association study
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.
Interventions
None listed
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| What influences pain related impairment after bariatric surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain related outcome after bariatric surgery | Up to 12 months after 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. |
| Change in interference with daily activities after bariatric surgery | Up to to 5 years after 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 |
| Change in quality of life after bariatric surgery | Up to 5 years after surgery | Measured by the 12 item short-form health survey (SF-12). |
Countries
Switzerland
Contacts
Primary ContactUlrike M Stamer, Prof. MD
Backup ContactFrank Stüber, MD
Outcome results
None listed