Carbon Dioxide Insufflation Colonoscopy in IBD Patients

NCT ID: NCT02563132

Last Updated: 2016-06-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-05-31

Brief Summary

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Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Detailed Description

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Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Conditions

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Colonoscopy Carbon Dioxide Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Carbon dioxide insufflation colonoscopy (CO2)

Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.

Group Type EXPERIMENTAL

Carbon dioxide insufflation

Intervention Type PROCEDURE

Carbon dioxide insufflation during diagnostic colonoscopy

Air insufflation colonoscopy (AI)

Air insufflation during both insertion and withdrawal phase of the colonoscopy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Carbon dioxide insufflation

Carbon dioxide insufflation during diagnostic colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* known diagnosis of Crohn´s disease and ulcerative colitis
* indication for diagnostic colonoscopy
* informed consent
* unsedated or minimally sedated procedure (\< 3 mg of midazolam)

Exclusion Criteria

* planned incomplete or therapeutic procedure
* deep sedation or general anesthesia
* intestinal resection longer than ileocecal resection
* isolated gastroduodenal or jejunal location of Crohn´s disease (L4)
* ulcerative proctitis (E1)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitkovice Hospital

OTHER

Sponsor Role lead

Responsible Party

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Premysl Falt, M.D., Ph.D.

Premysl Falt, M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Digestive Diseases Center - Vitkovice Hospital

Ostrava, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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DDC VN 08

Identifier Type: -

Identifier Source: org_study_id

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