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NCT03455998 Clinical Trial

Chronic Abdominal Pain After Gastric Bypass

Abdominal Pain Clinical Trial

Official title:
Chronic Abdominal Pain After Gastric Bypass for Morbid Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03455998
Other study ID # Gastric bypass/pain
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 28, 2018
Last updated March 10, 2018
Start date February 1, 2014
Est. completion date October 31, 2020

Study information
Verified date March 2018
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 250
Est. completion date October 31, 2020
Est. primary completion date June 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

• 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

Exclusion Criteria:

- Other indications for gastric bypass surgery than obesity

- Previous bariatric surgery

- Other concomitant surgical procedures for abdominal pain such as cholecystectomy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaires

Locations
Country Name City State
Norway Oslo university Hopsital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chronic abdominal pain 2 years post gastric bypass surgery questionnaire Patient follow up complete 2020
Secondary Quality of life questionnaire patient follow up complete 2020
Secondary Objective evaluation of pain perception skin sensors baseline and 2 years
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