NCT02563132

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

September 28, 2015

Last Update Submit

May 28, 2016

Conditions

ColonoscopyCarbon DioxideInflammatory Bowel Disease

Keywords

colonoscopycarbon dioxideinflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • Bloating score 1 hour after the colonoscopy

    Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy

    1 hour

Study Arms (2)

Carbon dioxide insufflation colonoscopy (CO2)

EXPERIMENTAL

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

Procedure: Carbon dioxide insufflation

Air insufflation colonoscopy (AI)

NO INTERVENTION

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

Interventions

Carbon dioxide insufflationPROCEDURE

Carbon dioxide insufflation during diagnostic colonoscopy

Carbon dioxide insufflation colonoscopy (CO2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Diseases Center - Vitkovice Hospital

Ostrava, 703 84, Czechia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Premysl Falt, M.D., Ph.D.

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 29, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

CZ(1)