Cathartic ColonPhase 4NCT01554111
Comparing Bowel Preparation Regimens for Flexible Sigmoidoscopy
A Phase 4 study testing Picosulfate sodium,, phosphosoda rectal enema and Pico-Salax and Sodium phosphate enema in people with Cathartic Colon, run by Queen's University at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cathartic Colon
- What is being tested?
- Picosulfate sodium,, phosphosoda rectal enema and Pico-Salax and Sodium phosphate enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive male and non-pregnant female patients >18 years old who require outpatient sigmoidoscopy will be considered for inclusion.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
About this study
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.
Read the 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
- Being tested
- Picosulfate sodium,, phosphosoda rectal enema, Pico-Salax and Sodium phosphate enema
- Keywords
- Bowel Evacuants, Purgatives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picosulfate sodium,Drug
Also called PicoSalax
One sachet of picosalax will be given with at least 4 cups of clear fluids.
phosphosoda rectal enemaDrug
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 enemaDrug
Also called Sodium picosulfate
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
| Study group | Role | What they receive |
|---|---|---|
| Picosalax with rectal enema | Active comparator | This arm will receive one satchet of Picosalx and a rectal enema before the sigmoidoscopy for their bowel preparation regimen. Receives: Drug: Pico-Salax and Sodium phosphate enema |
| rectal enema | Active comparator | This group of patients will receive only a rectal enema for bowel preparation before their flexible sigmoidoscopy. Receives: Drug: phosphosoda rectal enema |
| Pico-Salax | Active comparator | patient will take one sachet of pico-salax Receives: Drug: Picosulfate sodium, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
Secondary outcomes (4)
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.
Measured: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
Requirement for an additional rectal enema.
We also will record whether an additional enema was required to complete an adequate examination.
Measured: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
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.
Measured: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
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.
Measured: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cathartic ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, MD, Principal investigator, Queen's UniversitySamson K. Haimanot, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554111
- Sponsor's protocol ID
- DMED-1429-11
- Status last verified
- Sep 2015
- First submitted
- 1 Mar 2012
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing PicoSalax, Versus PicoSalax and Fleet Enema Versus Fleet Enema Alone for Sigmoidoscopy
- ClinicalTrials.gov ID
- NCT01554111
- Acronym / sponsor ID
- DMED-1429-11
- Conditions
- Cathartic Colon
- Keywords
- Bowel Evacuants, Purgatives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Picosalax with rectal enema | Active comparator | Drug: Pico-Salax and Sodium phosphate enemaThis arm will receive one satchet of Picosalx and a rectal enema before the sigmoidoscopy for their bowel preparation regimen. |
| rectal enema | Active comparator | Drug: phosphosoda rectal enemaThis group of patients will receive only a rectal enema for bowel preparation before their flexible sigmoidoscopy. |
| Pico-Salax | Active comparator | Drug: Picosulfate sodium,patient will take one sachet of pico-salax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive male and non-pregnant female patients >18 years old who require outpatient sigmoidoscopy will be considered for inclusion.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picosulfate sodium,Also: PicoSalaxOne sachet of picosalax will be given with at least 4 cups of clear fluids. | Drug | Pico-Salax |
| phosphosoda rectal enemaThe 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. | Drug | rectal enema |
| Pico-Salax and Sodium phosphate enemaAlso: Sodium picosulfatePt 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 | Drug | Picosalax with rectal enema |
Primary outcome
Quality of colon cleansing
Time frame: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
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
4 secondary outcomes
Patient tolerance questionnaire
Time frame: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
Requirement for an additional rectal enema.
Time frame: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
Maximum length of scope inserted
Time frame: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
Reason for discontinuing further advancement of the scope
Time frame: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Hookey, MD principal investigator
Queen's University
Samson K. Haimanot, MD principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Picosulfate sodium,, phosphosoda rectal enema and Pico-Salax and Sodium phosphate enema in people with Cathartic Colon, run by Queen's University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of colon cleansing (time frame: At the time of the flexible sigmoidoscopy, therefore, within 24 hours of flexible sigmoidoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.