Clinical trial NCT03490630: Patient Reported Outcome After Bariatric Surgery
Official title: Patient Reported Outcome After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Analgesia
Bariatric Surgery
Keywords: patient reported outcome
postoperative pain
pain related impairment
quality of life
prospective association study
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective bariatric surgery

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.

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

Primary outcomes:
measure: What influences pain related impairment after bariatric surgery
timeFrame: First day after surgery
Secondary outcomes:
measure: Change in pain related outcome after bariatric surgery
timeFrame: Up to 12 months after surgery
measure: Change in interference with daily activities after bariatric surgery
timeFrame: Up to to 5 years after surgery
measure: Change in quality of life after bariatric surgery
timeFrame: Up to 5 years after surgery
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Study officials:
affiliation: Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
name: Ulrike M Stamer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Frank Stüber
role: STUDY_DIRECTOR
References: