Abdominal Pain and Symptoms Post Gastric Sleeve

November 22, 2020 updated by: Tom Mala, Oslo University Hospital

Chronic Abdominal Pain and Discomfort in Morbid Obese Patients Before and After Sleeve Gastrectomy

Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

  • 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 informed consent 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic abdominal pain 2 years after gastric sleeve
Time Frame: 2 years
questionnaire
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life related to abdominal pain and symptoms
Time Frame: 2 years
questionnaire (SF-36v2, OP scale)
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison to gastric bypass
Time Frame: 2 year
questionnaire (SF36v2, OP scale)
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Voss Sykehus

Investigators

  • Study Director: Tom Mala, MD,Phd, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2015

Primary Completion (ACTUAL)

August 30, 2020

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sleeve and abdominal pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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