ClinicalTrials.gg
Status unknownNCT03455998Updated Mar 13, 2018

Chronic Abdominal Pain After Gastric Bypass

An observational study in Abdominal Pain, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Oslo University Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The study aims to explore patients perception of chronic abdominal pain after Roux en Y gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass will be explored.

Read the detailed description

This is a single-center, prospective, longitudinal, cohort study performed at the Department of Morbid Obesity and Bariatric Surgery, Oslo University Hospital. Patients undergoing gastric bypass are eligible for inclusion. The study is approved by the Regional Committee for Medical and Health Research Ethics (no.2013/1263), South-East health region. All participants provide written consent for study paennrollment.

The participants are asked to fill inn a set of questionnaires before and during follow-up after gastric bypass surgery. Symptom characteristics are explored and evaluated. Quality of life is included in the analyses. The main outcome is findings at 2 years post surgery, but the patients will be followed for 5 years.

The investigators also aim to evaluate by objective measures the patients perception of pain by temperature and skin pressure stimulants before and after surgery (2 years).

02

Conditions studied

  • Abdominal Pain

Keywords

  • morbid obesity
  • gastric bypass
  • pain
  • symptoms
03

In context

Abdominal Pain

387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.

This study's planned enrollment of 250 is above the median of 127 across 80 observational studies indexed under Abdominal Pain.

Browse Abdominal Pain studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients planned for bariatric surgery (gastric bypass) at a single center

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

  • Indication for gastric bypass surgery i.e. > 40 kg/m2 or BMI > 35 kg/m2 and obesity related comorbidity following failed attempts of sustained weight loss

Exclusion criteria

Exclusion Criteria:

  • Other indications for gastric bypass surgery than obesity
  • Previous bariatric surgery
  • Other concomitant surgical procedures for abdominal pain such as cholecystectomy
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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • post surgery

    Patienst consultation Questionnaires

    Other: questionnaires

  • pre and post surgery

    Patient consultation Questionnaires

    Other: questionnaires

Interventions

  • Otherquestionnaires
06

What researchers measure

Primary outcomes

  1. Chronic abdominal pain 2 years post gastric bypass surgery

    questionnaire

    Time frame: Patient follow up complete 2020

Secondary outcomes

  1. Quality of life

    questionnaire

    Time frame: patient follow up complete 2020

  2. Objective evaluation of pain perception

    skin sensors

    Time frame: baseline and 2 years

07

Study locations

1 site
  • Oslo university Hopsital
    Oslo, 0424, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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

Ran from Feb 2014 to primary completion in Jun 2015, 16 months.

Of 28 non-industry observational studies under Abdominal Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 38. This study's 16 months is below that.

Counting every sponsor, half of 37 studies reached it within 16 months; a quarter within 7 and three quarters within 38.

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

Registered
Feb 28, 2018
First posted
Mar 7, 2018
StartActual
Feb 1, 2014
Primary completionActual
Jun 30, 2015
CompletionEst.
Oct 31, 2020
Last update
Mar 13, 2018
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 Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03455998
Responsible party
Tom Mala (consultant, phd, Oslo University Hospital) — Principal investigator
First posted
Mar 7, 2018
Start date
Feb 1, 2014
Primary completion
Jun 30, 2015
Completion
Oct 31, 2020 (estimated)
Last update
Mar 13, 2018

Study contacts

Tom Mala, MD.phd
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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