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NCT03456024 Clinical Trial

Abdominal Pain and Symptoms Post Gastric Sleeve

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03456024
Other study ID # Sleeve and abdominal pain
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2015
Est. completion date December 31, 2022

Study information
Verified date November 2020
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 250
Est. completion date December 31, 2022
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility - 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Questinnaire

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital Voss Sykehus

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Other Comparison to gastric bypass questionnaire (SF36v2, OP scale) 2 year
Primary Chronic abdominal pain 2 years after gastric sleeve questionnaire 2 years
Secondary Quality of life related to abdominal pain and symptoms questionnaire (SF-36v2, OP scale) 2 years
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