Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

NCT ID: NCT00671177

Last Updated: 2017-05-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-06-30

Brief Summary

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Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.

Detailed Description

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Conditions

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Colonoscopy Digestive System Endoscopy Gastrointestinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Water Immersion Colonoscopy

Water Immersion Colonoscopy

Group Type EXPERIMENTAL

water immersion colonoscopy

Intervention Type PROCEDURE

instillation of 300cc of water in the rectum

Standard Air Colonoscopy

Standard Air Colonoscopy

Group Type ACTIVE_COMPARATOR

standard air colonoscopy

Intervention Type PROCEDURE

air instillation in colon for visualization

Interventions

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water immersion colonoscopy

instillation of 300cc of water in the rectum

Intervention Type PROCEDURE

standard air colonoscopy

air instillation in colon for visualization

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* presentation for colonoscopy
* male
* age 18 or older

Exclusion Criteria

* women
* known inflammatory bowel disease
* presentation for emergency colonoscopy
* history of partial colectomy
* chronic narcotic or benzodiazepine use
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

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Roy Soetikno

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Soetikno, MD, MS

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto/Stanford University Medical Center

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.

Reference Type DERIVED
PMID: 20593332 (View on PubMed)

Other Identifiers

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Protocol10642

Identifier Type: -

Identifier Source: org_study_id

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