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RecruitingNCT03490630Updated Jan 7, 2026

Patient Reported Outcome After Bariatric Surgery

An observational study in Anesthesia, Analgesia and Bariatric Surgery, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

From the registry’s dates

  • Started Jan 2011; still recruiting 15 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Pain, Postoperative with a site in Switzerland — 12 open to participants now, 12 under way, none of them phase 3. Pain, Postoperative · Switzerland.

Started
2011
with 2 others
Observational
9 of 56
3 open now
Primary completion
2026-12
later than 3 of 11 live
Registered
21st of 56
by date
Lead sponsor
4 of 56
Insel Gruppe AG, University Hospital Bern

Among the 56 studies in Pain, Postoperative with a site in Switzerland, this one is one of 3 that started in 2011, is one of 9 observational ones, reaches primary completion later than 3 of the 11 other live ones, and was the 21st registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phase29 · 9 open
Phase 411 · 0 open
Observationalthis study9 · 3 open
Phase 34 · 0 open
Phase 22 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2004; this study’s year is marked. 3 started in 2011.

Size and results

Median enrollment 100 across the 47 interventional studies, 355 across the 9 observational. Of the 42 that completed or were terminated, 4 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 56 studies in Pain, Postoperative with a site in Switzerland, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Anesthesia
  • Analgesia
  • Bariatric Surgery

Browse trials for

Keywords

  • patient reported outcome
  • postoperative pain
  • pain related impairment
  • quality of life
  • prospective association study
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients scheduled for elective bariatric surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  • No
  • Cognitive impairment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • All patients

    Patients undergoing elective surgery with anesthesia

06

What researchers measure

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.

    Time frame: First day after surgery

Secondary outcomes

  1. 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.

    Time frame: Up to 12 months after surgery

  2. 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

    Time frame: Up to to 5 years after surgery

  3. Change in quality of life after bariatric surgery

    Measured by the 12 item short-form health survey (SF-12).

    Time frame: Up to 5 years after surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2011 (actual). Primary completion is estimated for Dec 2026, 191 months after the start.

Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 191 months is above that.

Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2018
First posted
Apr 6, 2018
StartActual
Jan 2, 2011
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2027
Last update
Jan 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03490630
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Jan 2, 2011
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 7, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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