NCT03456024

Brief Summary

Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

4.8 years

First QC Date

February 28, 2018

Last Update Submit

November 22, 2020

Conditions

Abdominal PainQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Chronic abdominal pain 2 years after gastric sleeve

    questionnaire

    2 years

Secondary Outcomes (1)

  • Quality of life related to abdominal pain and symptoms

    2 years

Other Outcomes (1)

  • Comparison to gastric bypass

    2 year

Interventions

QuestinnaireOTHER

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients undergoing sleeve gastrectomy at the Center for Morbid Obesity and Bariatric Surgery, Oslo University Hospital and a collaborating center.
  • Signed written and informed consent for study enrollment

You may not qualify if:

  • Patients who dont understand Norwegian language
  • Previous bariatric surgery
  • Indication for sleeve gastrectomy for other reasons than for morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Tom Mala, MD,Phd

    Oslo University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant surgeon, phd

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

November 1, 2015

Primary Completion

August 30, 2020

Study Completion

December 31, 2022

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations

NO(1)