Patient Reported Outcome After Bariatric Surgery

NCT03490630 | Recruiting DMC

• 1 other identifier: 041/09d (bariatric ss)
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Analgesia; Bariatric Surgery

Keywords

patient reported outcome; postoperative pain; pain related impairment; quality of life; prospective association study

Outcome Measures

Primary Outcomes (1)

• What influences pain related impairment after bariatric 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.

  First day after surgery

Secondary Outcomes (3)

• Change in pain related outcome after bariatric surgery

  Up to 12 months after surgery

• Change in interference with daily activities after bariatric surgery

  Up to to 5 years after surgery

• Change in quality of life after bariatric surgery

  Up to 5 years after surgery

Study Arms (1)

All patients

Patients undergoing elective surgery with anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective bariatric surgery

You may qualify if:

• years and older
• Written informed consent
• Elective bariatric surgery
• Patients' ability to understand the purpose of the study

You may not qualify if:

• No informed consent
• Cognitive impairment

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Bern, 3010, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (plasma and cells) or mucosal swab

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Ulrike M Stamer, Prof. MD

  Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern

  PRINCIPAL INVESTIGATOR

• Frank Stüber

  Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

  STUDY DIRECTOR

Central Study Contacts

Ulrike M Stamer, Prof. MD

CONTACT

+41-316329995; ulrike.stamer@dbmr.unibe.ch

Frank Stüber, MD

CONTACT

+41-316322483; frank.stueber@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 6, 2018
• Study Start: January 2, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CH (1)