Pain Clinical Trial
Official title:
Water Method With Water Exchange Versus Air Insufflation in Patients With Incomplete Colonoscopy: a Prospective Randomized, Controlled Trial
Verified date | March 2016 |
Source | Fourth Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
China | Endoscopic center, Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Fourth Military Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cecal intubation success rate | Insertion of a colonoscope to the cecum | up to two years | No |
Secondary | Adenoma detection rate | The proportion of participants with at least one adenoma in each group | up to two years | No |
Secondary | Pain Scores on the Visual Analog Scale | 0 = no pain, to 10 = most severe pain | up to two years | No |
Secondary | Cecum intubation time | Total time of colonoscope intubation from anus to cecum | up to two years | No |
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