Water Method in Elder Patients With Unsedated Colonoscopy

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01546220
First received: February 24, 2012
Last updated: January 19, 2014
Last verified: May 2013

February 24, 2012
January 19, 2014
November 2011
November 2014   (final data collection date for primary outcome measure)
Cecal intubation success rate [ Time Frame: up to two years ] [ Designated as safety issue: No ]
Insertion of a colonoscope to the cecum
Same as current
Complete list of historical versions of study NCT01546220 on ClinicalTrials.gov Archive Site
  • Adenoma detection rate [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    0 = no pain, to 10 = most severe pain
  • Cecum intubation time [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    Total time of colonoscope intubation from anus to cecum
Same as current
Not Provided
Not Provided
 
Water Method in Elder Patients With Unsedated Colonoscopy
Water Method With Water Exchange Versus Air Insufflation in Elder Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
  • Adenoma
  • Pain
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
  • 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.
    Intervention: Other: Water colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
140
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
70 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01546220
20120216-5
Yes
Yanglin Pan, Fourth Military Medical University
Fourth Military Medical University
Not Provided
Principal Investigator: Yanglin Pan, MD Fourth Military Medical University
Fourth Military Medical University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP