NCT01790139

Brief Summary

To determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

February 7, 2013

Last Update Submit

March 24, 2014

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Colonic bubble-related image quality

    Colonic bubble-specific image quality is evaluated semi-quantitatively in terms of colonic mucosal surface obscured/covered by colonic bubbles.

    within 1 month after assessment of the other primary endpoint

Secondary Outcomes (2)

  • Overall image quality

    within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients

  • diagnostic performance

    within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients

Study Arms (2)

Control

NO INTERVENTION

Control group undergoes CT colonography after usual cathartic bowel cleansing using Colonlyte and fecal/fluid tagging. The tagging is done by administering orally 50 mL of iohexol (Omnipaque 350, GE Healthcare) 10 minutes after the completion of Colonlyte.

Intervention-Oral Simethicone

EXPERIMENTAL

Intervention group undergoes CT colonography after usual cathartic bowel cleansing using Colonlyte, fecal/fluid tagging, and oral administration of simethicone. The tagging is done by administering orally 50 mL of iohexol (Omnipaque 350, GE Healthcare) 10 minutes after the completion of Colonlyte. As the interventional procedure in this intervention group, 10 mL of simethicone is administered orally immediately following the administration of iohexol.

Drug: Oral simethicone

Interventions

Oral simethiconeDRUG

10 mL of simethicone is administered as an agent to prevent colonic bubbles

Also known as: Simethicone manufactured by Taejoon Pharm Co., Ltd.
Intervention-Oral Simethicone

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients who are schedule to undergo colonoscopy for a suspicion of colonic neoplasia at the investigators' institution
  • Those who agree to participate in the study

You may not qualify if:

  • Colonoscopy for reasons other than detecting colonic neoplasia, e.g. evaluation of inflammatory bowel disease
  • Contraindications to iodinated contrast including renal insufficiency, hypersensitivity, and hyperthyroidism
  • Acute severe colonic obstruction which is likely preclude safe and successful performance of CTC
  • Patient who is suspicious for colonic perforation
  • Pregnancy
  • Phenylketonuria (contraindication to simethicone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

SimethiconeLong-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Seong Ho Park, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 13, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

KR(1)