Comparing Bowel Preparation Regimens for Flexible Sigmoidoscopy

NCT ID: NCT01554111

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed Description

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.

Conditions

Cathartic Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Picosalax with rectal enema

This arm will receive one satchet of Picosalx and a rectal enema before the sigmoidoscopy for their bowel preparation regimen.

Group Type: ACTIVE_COMPARATOR

Pico-Salax and Sodium phosphate enema

Intervention Type: DRUG

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

rectal enema

This group of patients will receive only a rectal enema for bowel preparation before their flexible sigmoidoscopy.

Group Type: ACTIVE_COMPARATOR

phosphosoda rectal enema

Intervention Type: DRUG

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

patient will take one sachet of pico-salax

Group Type: ACTIVE_COMPARATOR

Picosulfate sodium,

Intervention Type: DRUG

One sachet of picosalax will be given with at least 4 cups of clear fluids.

Interventions

Picosulfate sodium,

One sachet of picosalax will be given with at least 4 cups of clear fluids.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

PicoSalax; Sodium picosulfate

Eligibility Criteria

Inclusion Criteria

• Consecutive male and non-pregnant female patients >18 years old who require outpatient sigmoidoscopy will be considered for inclusion.

Exclusion Criteria

• previous colorectal surgery and patients with reduced renal function or other medical conditions that would increase the risk of receiving oral PicoSalx would be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lawrence Hookey

Associate Professor, Queen's University, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Hookey, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Samson K. Haimanot, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Kingston General Hospital

Kingston, Ontario, Canada

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DMED-1429-11

Identifier Type: -

Identifier Source: org_study_id