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Water Method in Elder Patients With Unsedated Colonoscopy
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Purpose
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 | Intervention |
|---|---|
| Adenoma Pain | Other: Water colonoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Cecal intubation success rate [ Time Frame: up to two years ]Insertion of a colonoscope to the cecum
- Adenoma detection rate [ Time Frame: up to two years ]The proportion of participants with at least one adenoma in each group
- Pain Scores on the Visual Analog Scale [ Time Frame: up to two years ]0 = no pain, to 10 = most severe pain
- Cecum intubation time [ Time Frame: up to two years ]Total time of colonoscope intubation from anus to cecum
| Enrollment: | 0 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Air colonoscopy
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
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Water colonoscopy
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.
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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:
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Eligibility| Ages Eligible for Study: | 70 Years to 80 Years (Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01546220
| China, Shaanxi | |
| Endoscopic center, Xijing Hospital of Digestive Diseases | |
| Xi'an, Shaanxi, China, 710032 | |
| Principal Investigator: | Yanglin Pan, MD | Fourth Military Medical University |
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 |
| Study First Received: | February 24, 2012 |
| Last Updated: | March 24, 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 |
ClinicalTrials.gov processed this record on July 19, 2017