Chronic Abdominal Pain After Gastric Bypass

Chronic Abdominal Pain After Gastric Bypass for Morbid Obesity

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Pain
• Intervention / Treatment: Other: questionnaires

Detailed 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).

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post surgery; Patienst consultation Questionnaires	Other: questionnaires
pre and post surgery; Patient consultation Questionnaires	Other: questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic abdominal pain 2 years post gastric bypass surgery	questionnaire	Patient follow up complete 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	questionnaire	patient follow up complete 2020
Objective evaluation of pain perception	skin sensors	baseline and 2 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Tom Mala, MD.phd, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2014
• Primary Completion (ACTUAL): June 30, 2015
• Study Completion (ANTICIPATED): October 31, 2020

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): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 10, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: pain; symptoms; morbid obesity; gastric bypass
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: Gastric bypass/pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No