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Patient Reported Outcome After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03490630
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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.


Condition or disease
Anesthesia Analgesia Bariatric Surgery

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Outcome After Bariatric Surgery
Study Start Date : January 2011
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
All patients
Patients undergoing elective surgery with anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in pain related outcome after bariatric surgery [ Time Frame: 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.

  2. Change in interference with daily activities after bariatric surgery [ Time Frame: 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

  3. Change in quality of life after bariatric surgery [ Time Frame: Up to 5 years after surgery ]
    Measured by the 12 item short-form health survey (SF-12).


Biospecimen Retention:   Samples With DNA
whole blood (plasma and cells) or mucosal swab

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective bariatric surgery
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490630


Contacts
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Contact: Ulrike M Stamer, Prof. MD +41-316329995 ulrike.stamer@dbmr.unibe.ch
Contact: Frank Stüber, MD +41-316322483 frank.stueber@insel.ch

Locations
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Switzerland
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern Recruiting
Bern, Switzerland, 3010
Contact: Ulrike M Stamer, MD    041-316329995    ulrike.stamer@dbmr.unibe.ch   
Contact: Christoph Lippuner, PhD    0041-316320826    christoph.lippuner@dbmr.unibe.ch   
Principal Investigator: Ulrike M Stamer, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Ulrike M Stamer, Prof. MD Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
Study Director: Frank Stüber Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03490630    
Other Study ID Numbers: 041/09d (bariatric ss)
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Keywords provided by University Hospital Inselspital, Berne:
patient reported outcome
postoperative pain
pain related impairment
quality of life
prospective association study