Water Method in Patients With Incomplete Colonoscopy

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01546246

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Colonoscopy has been considered the gold standard procedure in screening for colorectal disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult anatomy and prior abdominal or pelvic surgery. 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 patients with immediately failed colonoscopy.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with incomplete colonoscopy. 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
Failed or Difficult Intubation Adenoma Pain	Other: Water colonoscopy	N/A

Study Design

Study Type:

Interventional

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 Patients With Incomplete Colonoscopy: a Prospective Randomized, Controlled Trial

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Nov 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Air colonoscopy Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Other: 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

Arm

Intervention/Treatment

No Intervention: Air colonoscopy

Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.

Other: 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

Primary Outcome Measures

Cecal intubation success rate [up to two years]
Insertion of a colonoscope to the cecum

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with incomplete colonoscopy

Exclusion Criteria:

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