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 16, 2019
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|
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.
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?
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 Type :||Observational|
|Estimated Enrollment :||2000 participants|
|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|
Patients undergoing elective surgery with anesthesia
- 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.
- 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.
- 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
- 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
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
|Contact: Ulrike M Stamer, Prof. MDemail@example.com|
|Contact: Frank Stüber, MDfirstname.lastname@example.org|
|Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Ulrike M Stamer, MD 041-316329995 email@example.com|
|Contact: Christoph Lippuner, PhD 0041-316320826 firstname.lastname@example.org|
|Principal Investigator: Ulrike M Stamer, MD|
|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|