Water Method in Elder Patients With Unsedated Colonoscopy

Study Description

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Brief Summary:

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Older age is independently associated with incomplete colonoscopy, the investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in elder patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in elder patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.

Condition or disease	Intervention/treatment	Phase
Adenoma; Pain	Other: Water colonoscopy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Screening
Official Title:	Water Method With Water Exchange Versus Air Insufflation in Elder Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial
Study Start Date :	November 2011
Estimated Primary Completion Date :	November 2014
Estimated Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
No Intervention: Air colonoscopy; Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Water colonoscopy; Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.	Other: Water colonoscopy; Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.; Other Names: Water; colonoscopy

Outcome Measures

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Primary Outcome Measures :

1. Cecal intubation success rate [ Time Frame: up to two years ]
   Insertion of a colonoscope to the cecum

Secondary Outcome Measures :

1. Adenoma detection rate [ Time Frame: up to two years ]
   The proportion of participants with at least one adenoma in each group
2. Pain Scores on the Visual Analog Scale [ Time Frame: up to two years ]
   0 = no pain, to 10 = most severe pain
3. Cecum intubation time [ Time Frame: up to two years ]
   Total time of colonoscope intubation from anus to cecum

Eligibility Criteria

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Ages Eligible for Study:	70 Years to 80 Years (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients over the age of 70

Exclusion Criteria:

• History of colorectal surgery
• Severe colonic stricture or obstructing tumor
• Patients who cannot give informed consent and those who are hemodynamically unstable

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Fourth Military Medical University

Investigators

Principal Investigator:	Yanglin Pan, MD	Fourth Military Medical University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier:	NCT01546220 History of Changes
Other Study ID Numbers:	20120216-5
First Posted:	March 7, 2012
Last Update Posted:	March 25, 2016
Last Verified:	March 2016

Keywords provided by Yanglin Pan, Fourth Military Medical University:

colonoscopy; elder patient; water; unsedated

Additional relevant MeSH terms:

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms