Chronic Abdominal Pain After Gastric Bypass

NCT ID: NCT03455998

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-01

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Abdominal Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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post surgery

Patienst consultation Questionnaires

questionnaires

Intervention Type OTHER

pre and post surgery

Patient consultation Questionnaires

questionnaires

Intervention Type OTHER

Interventions

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questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tom Mala

consultant, phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Mala, MD.phd

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo university Hopsital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Gastric bypass/pain

Identifier Type: -

Identifier Source: org_study_id

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