Patient Reported Outcome After Bariatric Surgery

NCT ID: NCT03490630

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-02

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia Analgesia Bariatric Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Patients undergoing elective surgery with anesthesia

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrike M Stamer, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

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

Frank Stüber

Role: STUDY_DIRECTOR

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

Locations

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

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Ulrike M Stamer, Prof. MD

Role: CONTACT

+41-316329995

Frank Stüber, MD

Role: CONTACT

+41-316322483

Facility Contacts

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Ulrike M Stamer, MD

Role: primary

041-316329995

Lan Zhang, PhD

Role: backup

0041-316328872

Other Identifiers

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041/09d (bariatric ss)

Identifier Type: -

Identifier Source: org_study_id

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