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Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

NCT01535326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2014-08-15

Study results available
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Summary

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).

This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

Conditions

  • Colon Neoplasm
  • Pain

Interventions

PROCEDURE

air insufflation

insufflate air during the insertion of colonoscopy

PROCEDURE

water immersion

infuse water during insertion, aspirate water during withdrawal

PROCEDURE

water exchange

infuse and remove water during insertion phase of colonoscopy

Sponsors & Collaborators

  • Dalin Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Yu-Hsi Hsieh, Dr. · Dalin Tzu Chi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

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 NCT01535326 on ClinicalTrials.gov