NCT03455998

Brief 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.

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 Feb 2014

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

February 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
2.7 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
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

February 28, 2018

Last Update Submit

March 10, 2018

Conditions

Abdominal Pain

Keywords

morbid obesitygastric bypasspainsymptoms

Outcome Measures

Primary Outcomes (1)

  • Chronic abdominal pain 2 years post gastric bypass surgery

    questionnaire

    Patient follow up complete 2020

Secondary Outcomes (2)

  • Quality of life

    patient follow up complete 2020

  • Objective evaluation of pain perception

    baseline and 2 years

Study Arms (2)

post surgery

Patienst consultation Questionnaires

Other: questionnaires

pre and post surgery

Patient consultation Questionnaires

Other: questionnaires

Interventions

questionnairesOTHER
post surgerypre and post surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university Hopsital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Abdominal PainObesity, MorbidPain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Tom Mala, MD.phd

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

February 1, 2014

Primary Completion

June 30, 2015

Study Completion

October 31, 2020

Last Updated

March 13, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)