Cathartic Colon Clinical Trial
Official title:
A Randomized Controlled Study Comparing PicoSalax, Versus PicoSalax and Fleet Enema Versus Fleet Enema Alone for Sigmoidoscopy
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.
Background:
Flexible sigmoidoscopy is an accepted screening modality for colorectal cancer, however, it
has put significant strain on endoscopy suite resources. It is important that flexible
sigmoidoscopies be done completely and efficiently.
Cleansing before sigmoidoscopy is important to optimize the diagnostic yield of the exam and
for polyp detection rates and other colonic lesions. Rectal enemas have been the mainstay of
sigmoidoscopy preparations for many endoscopy suites. Procedure prolongation due to the
requirement for additional enemas or more washing of a poorly cleansed colon can put a
strain on endoscopy time to complete the procedures.
Oral preparations have been a mainstay of colonoscopy cleansing as they allow adequate
visualization of the entire colon and are superior to rectal enemas in this regard. Large
volume preparations dominate oral colon cleansing. Polyethylene glycol is a large volume
solution with an osmotically balanced laxative. Large volume preps are poorly tolerated when
compared with small volume preparations. Small volume osmotically active agents can have
limitations also, but are being used more frequently with newer agents having a better
safety profile.
Few large controlled studies have looked at oral preparation being given in sigmoidoscopy.
Tolerability of oral prep has had a negative impact on patient compliance with these
regimens in colonoscopy. However, rectal enemas also have had a negative impact on
sigmoidoscopy experience.
Many sigmoidoscopies are incomplete or poorly done due to poor prep. Literature for oral
bowel preparation regimens has been done predominantly for colonoscopies. The few studies
comparing oral preparations to enemas are done without validated methods to record bowel
preparation adequately and objectively (1, 2). The goal of our study is to compare the
quality of the bowel preparation with oral preparations and rectal enemas to determine which
is best.
The investigators plan on determining if the concentration of combustible gases with oral
preparations during sigmoidoscopy would be reduced enough to allow for safe electrocautery
use during sigmoidoscopy. Hydrogen and methane are two major combustible gases found in a
normal colon. These gases can cause explosions in the bowel at the time on sigmoidoscopy if
electrocautery is used. The explosive range of hydrogen in air is 4-74%, and for methane
this range is 5-15% (3). Levels of combustible gases in the colon have been found to be
unsafe in a bowel prepped with two phosphosoda enemas.(4) Several bowel cleansing regimens
have been found to be safe for electrocautery by decreasing the concentrations of
combustible gases in the colon. Our hypothesis is that a partial oral bowel preparation,
will reduce the concentration of combustible gases in the colon to low enough levels to make
electrocautery safe during flexible sigmoidoscopy.
Objective and Hypothesis:
Our objective is to help determine the efficacy of oral and rectal bowel preparation
regimens for sigmoidoscopy. Our 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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