NCT01547247

Brief Summary

Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 28, 2013

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

February 26, 2012

Results QC Date

December 20, 2012

Last Update Submit

October 4, 2015

Conditions

Colonoscopy

Keywords

colonoscopycap-assisted colonoscopywater immersion colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Cecal Intubation Time

    The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.

    3 months

Secondary Outcomes (2)

  • Patient Comfort During Insertion Phase of the Colonoscopy

    3 months

  • Success Rate of Minimal Sedation Colonoscopy

    3 months

Study Arms (2)

cap-assisted water immersion colonoscopy

EXPERIMENTAL

Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope

water immersion colonoscopy

ACTIVE COMPARATOR

Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Procedure: water immersion colonoscopy

Interventions

soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscopeDEVICE

Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

cap-assisted water immersion colonoscopy
water immersion colonoscopyPROCEDURE

Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.

water immersion colonoscopy

Eligibility Criteria

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

You may qualify if:

  • outpatient diagnostic colonoscopy
  • bowel prep with macrogolum
  • initial 2 mg of midazolam i.v.
  • signed informed consent form

You may not qualify if:

  • planned therapeutic intervention
  • colorectal surgery in history
  • known inflammatory bowel disease or colorectal cancer
  • refusal of sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Diseases Center, Vitkovice Hospital

Ostrava, 703 84, Czechia

Location

Related Publications (1)

  • Falt P, Smajstrla V, Fojtik P, Liberda M, Kliment M, Tvrdik J, Urban O. Cap-assisted water immersion for minimal sedation colonoscopy: prospective, randomized, single-center trial. Dig Endosc. 2013 Jul;25(4):434-9. doi: 10.1111/j.1443-1661.2012.01402.x. Epub 2012 Dec 5.

    PMID: 23808948RESULT

Limitations and Caveats

There were no complications recorded in the study.

Results Point of Contact

Title
Přemysl Falt MD
Organization
Digestive Diseases Center, Vítkovice Hospital, Ostrava, Czech Republic
faltprem@centrum.cz
+420602689561

Study Officials

  • Premysl Falt, MD

    Digestive Diseases Center, Vitkovice Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2012

First Posted

March 7, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

October 23, 2015

Results First Posted

January 28, 2013

Record last verified: 2015-10

Locations

CZ(1)