ClinicalTrials.gg
Status unknownNCT03456024Updated Nov 24, 2020

Abdominal Pain and Symptoms Post Gastric Sleeve

An observational study in Abdominal Pain and Quality of Life, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Oslo University Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Active, not recruiting — may be out of date.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

Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

Read the detailed description

The primary aim is to evaluate abdominal pain in morbid obese patients before and after sleeve gastrectomy. The investigators will especially focus on chronic abdominal pain, and its relation to quality of life and weight loss. In a sub-analysis the investigators will compare the findings of the present cohort with patients operated with Roux-en-Y gastric bypass.

Primary endpoints/outcomes:

  • Define the prevalence of chronic abdominal pain 2 years after sleeve gastrectomy

Secondary endpoints/outcomes:

  • Evaluate and characterise chronic abdominal pain in regard to:
  • Weight development
  • Obesity-related comorbidities
  • Health-related quality of life
  • Postoperative complications
  • Metabolic effects after surgery
  • Nutritional status
  • Socioeconomic status
02

Conditions studied

  • Abdominal Pain
  • Quality of Life

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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
No
Sampling method
Probability sample

Study population

Patients scheduled for sleeve gastrectomy for morbid obesity at Oslo University Hospital and Voss sykehus

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

  • Patients undergoing sleeve gastrectomy at the Center for Morbid Obesity and Bariatric Surgery, Oslo University Hospital and a collaborating center.

    • Signed written and for study enrollment

Exclusion criteria

  • Patients who dont understand Norwegian language

    • Previous bariatric surgery
    • Indication for sleeve gastrectomy for other reasons than for morbid obesity
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
250 participants (estimated)
Patient registry
No

Interventions

  • OtherQuestinnaire
06

What researchers measure

Primary outcomes

  1. Chronic abdominal pain 2 years after gastric sleeve

    questionnaire

    Time frame: 2 years

Secondary outcomes

  1. Quality of life related to abdominal pain and symptoms

    questionnaire (SF-36v2, OP scale)

    Time frame: 2 years

Other outcomes

  1. Comparison to gastric bypass

    questionnaire (SF36v2, OP scale)

    Time frame: 2 year

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, 0424, Norway
08

References and documents

Individual participant data

Plan to share: Undecided

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 Nov 2015 to primary completion in Aug 2020, 57 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 57 months is above 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
Nov 1, 2015
Primary completionActual
Aug 30, 2020
CompletionEst.
Dec 31, 2022
Last update
Nov 24, 2020
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 Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03456024
Collaborators
Voss Sykehus
Responsible party
Tom Mala (Consultant surgeon, phd, Oslo University Hospital) — Principal investigator
First posted
Mar 7, 2018
Start date
Nov 1, 2015
Primary completion
Aug 30, 2020
Completion
Dec 31, 2022 (estimated)
Last update
Nov 24, 2020

Study contacts

Tom Mala, MD,Phd
study director · 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 Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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