AnesthesiaNCT03490630
Patient Reported Outcome After Bariatric Surgery
An observational study of Anesthesia and Analgesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Analgesia, Bariatric Surgery
- How many people
- 2,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2011to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective bariatric surgery
Who may be able to join
- 18 years and older
- Written informed consent
- Elective bariatric surgery
- Patients' ability to understand the purpose of the study
Who cannot join
- No informed consent
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Bern, 3010
Ulrike M Stamer, MD, 041-316329995, ulrike.stamer@dbmr.unibe.ch
Lan Zhang, PhD, 0041-316328872, lan.zhang@unibe.ch
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Analgesia, Bariatric Surgery
- Keywords
- patient reported outcome, postoperative pain, pain related impairment, quality of life, prospective association study
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients undergoing elective surgery with anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First day after surgery
Secondary outcomes (3)
Change in pain related outcome after bariatric 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.
Measured: Up to 12 months after surgery
Change in interference with daily activities after bariatric 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
Measured: Up to to 5 years after surgery
Change in quality of life after bariatric surgery
Measured by the 12 item short-form health survey (SF-12).
Measured: Up to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start2 Jan 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrike M Stamer, Prof. MD, Principal investigator, Department of Anaestheisology and Pain Medicine, Inselspital, University of BernFrank Stüber, Study director, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490630
- Sponsor's protocol ID
- 041/09d (bariatric ss)
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcome After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03490630
- Acronym / sponsor ID
- 041/09d (bariatric ss)
- Conditions
- Anesthesia, Analgesia, Bariatric Surgery
- Keywords
- patient reported outcome, postoperative pain, pain related impairment, quality of life, prospective association study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 2 Jan 2011 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –Patients undergoing elective surgery with anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective bariatric surgery
Key inclusion criteria (4 listed)
- 18 years and older
- Written informed consent
- Elective bariatric surgery
- Patients' ability to understand the purpose of the study
Key exclusion criteria (2 listed)
- No informed consent
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Change in pain related outcome after bariatric surgery
Time frame: Up to 12 months after surgery
Change in interference with daily activities after bariatric surgery
Time frame: Up to to 5 years after surgery
Change in quality of life after bariatric surgery
Time frame: Up to 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulrike M Stamer, Prof. MD principal investigator
Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
Frank Stüber study director
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Analgesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrike M Stamer, Prof. MD (+41-316329995, ulrike.stamer@dbmr.unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What influences pain related impairment after bariatric surgery (time frame: First day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.