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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01554111
Other study ID # DMED-1429-11
Secondary ID
Status Completed
Phase Phase 4
First received March 1, 2012
Last updated September 23, 2015
Start date March 2012
Est. completion date September 2015

Study information

Verified date September 2015
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Objective and Hypothesis:

The investigators objective is to help determine the efficacy of oral and rectal bowel preparation regimens for sigmoidoscopy. The investigators hypothesis is that oral preparation will reduce the amount of repeat rectal enemas required and improve the quality of a bowel exam at the sigmoidoscopy.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Picosulfate sodium,
One sachet of picosalax will be given with at least 4 cups of clear fluids.
phosphosoda rectal enema
The patient will have an enema inserted into the rectum and the liquid contents of the enema will be squeezed into the rectum. The patient will need to hold in the enema for several minutes then can release it.
Pico-Salax and Sodium phosphate enema
Pt will take one sachet of Pico-salax the evening prior to procedure and fleet enema 1 hour before leaving home on the morning of the procedure

Locations

Country Name City State
Canada Hotel Dieu Hospital Kingston Ontario
Canada Kingston General Hospital Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of colon cleansing The primary outcomes for this trial will be the quality of colon cleansing in the area of the colon examined. We will use a modified Ottawa bowel preparation scoring system measured at the time of endoscopy At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy No
Secondary Patient tolerance questionnaire The questionnaire delivered one half hour prior to the sigmoidoscopy will ask the patient about acceptability of the bowel prep, the patient's compliance with the bowel prep, if the patient would have the same bowel preparation regimen again for another sigmoidoscopy. We also will look at side effects including wind, incontinence, sleep disturbance, bottom soreness, abdominal tenderness, and nausea. At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy Yes
Secondary Requirement for an additional rectal enema. We also will record whether an additional enema was required to complete an adequate examination. At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy No
Secondary Maximum length of scope inserted The maximum scope length reached during the endoscopic procedure will be recorded. We will also record the type of endoscopic equipment used for the sigmoidoscopy, ie. gastroscope, pediatric colonoscope, sigmoidoscope, etc. At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy No
Secondary Reason for discontinuing further advancement of the scope The main reason for no further advancement of the sigmoidoscope will be recorded as: inadequate prep, patient intolerance, adequate examination length reached for procedure indication. At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy No
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