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Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy

NCT01440543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2013-01-28

Study results available
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Summary

Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.

This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).

Conditions

  • Colonoscopy

Interventions

PROCEDURE

Water immersion insertion AND CO2 insufflation

* room temperature water infused by water pump into the colon just to facilitate scope insertion * CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection

PROCEDURE

Water immersion insertion

* room temperature water infused by water pump into the colon just to facilitate scope insertion * standard room air insufflation during colonoscope withdrawal and mucosal inspection

PROCEDURE

CO2 insufflation

\- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal

Sponsors & Collaborators

  • Vitkovice Hospital

    lead OTHER

Principal Investigators

  • Premysl Falt, MD · Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-07-31
Completion
2011-09-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01440543 on ClinicalTrials.gov