Colorectal CancerBPNCT01610895
Split Dose Polyethylene Glycol (PEG) + Clear Fluids Versus Split Dose PEG + Low-Residue Diet
A study testing Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions and Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions in people with Colorectal Cancer, run by University of Calgary at 1 site in Canada.
Trial summary
The objective of the study is to examine the effect of adding a strict low-residue lunch on the day before colonoscopy has on clinical efficacy and patient tolerability of bowel preparation, with patients receiving split-dose Polyethylene Glycol Based Lavage. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions and Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Oct 2012
- Phase
- Interventional
- 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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 to 74 Years referred to the Forzani \& MacPhail Colon Cancer Screening Centre in Calgary, Alberta, Canada for Colonoscopy will be considered for inclusion.
Who cannot join
- Patients with acute Coronary Syndrome,
- Congestive Heart Failure,
- Unstable Angina,
- Known or suspected Renal Failure,
- Ascites,
- Known or suspected Bowel obstruction or
- Other comorbidities that may prevent Colonoscopy will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services
Calgary, Alberta, T2N 4N1
Anitha Jambula, M.Sc, CCRP, 403-592-5019, ajambula@ucalgary.ca
Robert Hilsden, MD, 403-592-5042, rhilsden@ucalgary.ca
About this study
Official title: A Randomized Prospective Trial Comparing Split Dose Polyethylene Glycol-Based Lavage With Clear Fluids Versus Split Dose Polyethylene Glycol-Based Lavage With a Low-Residue Diet in Preparation of Patients for Colonoscopy.
The objective of the study is to examine the effect of adding a strict low-residue lunch on the day before colonoscopy has on clinical efficacy and patient tolerability of bowel preparation, with patients receiving split-dose Polyethylene Glycol Based Lavage.
The primary outcomes will be 1) quality of preparation in cleansing the colon and 2) patient satisfaction
Read the detailed description
All patients between the ages 18-74 years referred to the Forzani MacPhail Colon Cancer Screening Centre (CCSC) in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients are asked to consider a general research consent. If they agree to that, then they will be approached for consideration of participating in this study and presented with an "Invitation to Participate in a Research Study" form ; the study assistant will obtain final consent if they agree. Those not interested in participating will simply receive their physician's standard bowel preparation protocol. There will be no coercion of any sort. Enrollment of participants will be performed with block randomizations of 2, 4, 6 and 8 by using a computer-generated table, with allocation concealment maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and investigators will be blinded to allocation groups. Patients will be allocated to one of two groups: (1) Split dose Polyethylene Glycol Based Lavage (2L + 2L) with Standard dietary instructions- a low fibre diet for 4 days prior to colonoscopy and clear fluids after a low-fibre breakfast on the day before procedure; (2) Split dose Polyethylene Glycol Based Lavage (2L + 2L) with Low Fibre Lunch dietary instructions- a low fibre diet for 4 days prior to colonoscopy and clear fluids after a low-fibre breakfast and low-fibre lunch on the day before procedure
A study assistant will assign patients to their group based on the Randomization and instruct them on the proper use of their assigned bowel preparation method. Patients will be given a tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the CCSC for the colonoscopy (included in the appendix). Patient concerns or questions regarding the preparation will be directed toward the study assistant or clinic nurses as opposed to their endoscopist, so as to avoid un-blinding the Colonoscopist. The physician performing the procedure will then complete an Ottawa Bowel Preparation Scale, a validated Simplified Bowel Preparation scale and a New Bowel Prep Scale to assess colon cleanliness.
- Conditions
- Colorectal Cancer
- Being tested
- Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions, Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions
- Keywords
- Colonoscopy, low fibre diet, clear fluids, Bowel Preparation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructionsOther
Patients will be instructed to arrive for colonoscopy at or after 10 AM. Preparation Instructions: At 8pm the day before the colonoscopy drink 2L of PEG within 2 hours. Starting 5 hours before their arrival time on the day of Colonoscopy, drink the remaining 2L of PEG within 2 hours.
Dietary Instructions: Low fibre diet for 4 days prior to Colonoscopy. The day before Colonoscopy, low-fibre breakfast, a low-fibre lunch by 2 PM (Created from the table of acceptable foods) and then drink clear fluids until after the procedure is completed.
Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary InstructionsOther
Patients will be instructed to arrive for colonoscopy at or after 10 AM.
Preparation Instructions: At 8pm the day before the colonoscopy drink 2L of PEG within 2 hours. Starting 5 hours before their arrival time on the day of Colonoscopy, drink the remaining 2L of PEG within 2 hours.
Dietary Instructions: Low fibre diet for 4 days prior to Colonoscopy. The day before Colonoscopy, low-fibre breakfast and then drink clear fluids until after the procedure is completed.
| Study group | Role | What they receive |
|---|---|---|
| Split-dose PEG Based Lavage (2L + 2L) + Low-fiber Diet | Active comparator | Patients randomized to this arm will have a split-dose Polyethylene Glycol Based lavage (2L + 2L), have a low-fibre diet 4 days prior to Colonoscopy and the day before Colonoscopy, have a low-fibre breakfast, a low-fibre lunch by 2PM and then drink only clear fluids until after the procedure is completed. Receives: Other: Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions |
| Split-dose PEG Based Lavage (2L + 2L) + Clear fluid diet | Placebo comparator | Patients randomized to this arm will have a split-dose Polyethylene Glycol Based lavage (2L + 2L), have a low-fibre diet 4 days prior to Colonoscopy and the day before Colonoscopy, have a low-fibre breakfast and then drink only clear fluids until after the procedure is completed. Receives: Other: Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bowel Cleanliness
Ottawa bowel prep scale will be done by the Doctor to assess the quality of bowel cleanliness. The right, mid and rectosigmoid colon are each rated on a 5-point scale (0-4). Also a complete 3 point rating for overall colonic fluid is assessed giving an overall score range of 0-14. An excellent preperation should score 0-1, a good preparation 2-4, while scores >4 would indicate progressively worsening bowel preparations. A Simplified overall cleanliness score and a New bowel prep score will be completed and compared to the Ottawa scale.
Measured: Procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day of collection.
Secondary outcomes (1)
Patient satisfaction with preparation
Patients will be given an anonymous tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the Centre for the Colonoscopy. The tool asks questions of patient satisfaction with preparation, ease or difficulty of completing the preparation and any side effects that have been experienced during the preparation.
Measured: Questionnaire given on the day of pre-screen will be collected on the day of colonoscopy, approximately 3 weeks. Patients are not followed or contacted past the day of colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Rostom, University of Calgary
- Investigators
- Alaa Rostom, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610895
- Sponsor's protocol ID
- 24206
- Acronym
- BP
- Status last verified
- May 2012
- First submitted
- 30 May 2012
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial Comparing Split Dose Polyethylene Glycol-Based Lavage With Clear Fluids Versus Split Dose Polyethylene Glycol-Based Lavage With a Low-Residue Diet in Preparation of Patients for Colonoscopy.
- ClinicalTrials.gov ID
- NCT01610895
- Acronym / sponsor ID
- BP / 24206
- Conditions
- Colorectal Cancer
- Keywords
- Colonoscopy, low fibre diet, clear fluids, Bowel Preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 4 Jun 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.
The objective of the study is to examine the effect of adding a strict low-residue lunch on the day before colonoscopy has on clinical efficacy and patient tolerability of bowel preparation, with patients receiving split-dose Polyethylene Glycol Based Lavage.
The primary outcomes will be 1) quality of preparation in cleansing the colon and 2) patient satisfaction
Detailed description
All patients between the ages 18-74 years referred to the Forzani MacPhail Colon Cancer Screening Centre (CCSC) in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients are asked to consider a general research consent. If they agree to that, then they will be approached for consideration of participating in this study and presented with an "Invitation to Participate in a Research Study" form ; the study assistant will obtain final consent if they agree. Those not interested in participating will simply receive their physician's standard bowel preparation protocol. There will be no coercion of any sort. Enrollment of participants will be performed with block randomizations of 2, 4, 6 and 8 by using a computer-generated table, with allocation concealment maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and investigators will be blinded to allocation groups. Patients will be allocated to one of two groups: (1) Split dose Polyethylene Glycol Based Lavage (2L + 2L) with Standard dietary instructions- a low fibre diet for 4 days prior to colonoscopy and clear fluids after a low-fibre breakfast on the day before procedure; (2) Split dose Polyethylene Glycol Based Lavage (2L + 2L) with Low Fibre Lunch dietary instructions- a low fibre diet for 4 days prior to colonoscopy and clear fluids after a low-fibre breakfast and low-fibre lunch on the day before procedure
A study assistant will assign patients to their group based on the Randomization and instruct them on the proper use of their assigned bowel preparation method. Patients will be given a tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the CCSC for the colonoscopy (included in the appendix). Patient concerns or questions regarding the preparation will be directed toward the study assistant or clinic nurses as opposed to their endoscopist, so as to avoid un-blinding the Colonoscopist. The physician performing the procedure will then complete an Ottawa Bowel Preparation Scale, a validated Simplified Bowel Preparation scale and a New Bowel Prep Scale to assess colon cleanliness.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split-dose PEG Based Lavage (2L + 2L) + Low-fiber Diet | Active comparator | Other: Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructionsPatients randomized to this arm will have a split-dose Polyethylene Glycol Based lavage (2L + 2L), have a low-fibre diet 4 days prior to Colonoscopy and the day before Colonoscopy, have a low-fibre breakfast, a low-fibre lunch by 2PM and then drink only clear fluids until after the procedure is completed. |
| Split-dose PEG Based Lavage (2L + 2L) + Clear fluid diet | Placebo comparator | Other: Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary InstructionsPatients randomized to this arm will have a split-dose Polyethylene Glycol Based lavage (2L + 2L), have a low-fibre diet 4 days prior to Colonoscopy and the day before Colonoscopy, have a low-fibre breakfast and then drink only clear fluids until after the procedure is completed. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 18 to 74 Years referred to the Forzani \& MacPhail Colon Cancer Screening Centre in Calgary, Alberta, Canada for Colonoscopy will be considered for inclusion.
Key exclusion criteria (7 listed)
- Patients with acute Coronary Syndrome,
- Congestive Heart Failure,
- Unstable Angina,
- Known or suspected Renal Failure,
- Ascites,
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 |
|---|---|---|
| Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructionsPatients will be instructed to arrive for colonoscopy at or after 10 AM. Preparation Instructions: At 8pm the day before the colonoscopy drink 2L of PEG within 2 hours. Starting 5 hours before their arrival time on the day of Colonoscopy, drink the remaining 2L of PEG within 2 hours. Dietary Instructions: Low fibre diet for 4 days prior to Colonoscopy. The day before Colonoscopy, low-fibre breakfast, a low-fibre lunch by 2 PM (Created from the table of acceptable foods) and then drink clear fluids until after the procedure is completed. | Other | Split-dose PEG Based Lavage (2L + 2L) + Low-fiber Diet |
| Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary InstructionsPatients will be instructed to arrive for colonoscopy at or after 10 AM. Preparation Instructions: At 8pm the day before the colonoscopy drink 2L of PEG within 2 hours. Starting 5 hours before their arrival time on the day of Colonoscopy, drink the remaining 2L of PEG within 2 hours. Dietary Instructions: Low fibre diet for 4 days prior to Colonoscopy. The day before Colonoscopy, low-fibre breakfast and then drink clear fluids until after the procedure is completed. | Other | Split-dose PEG Based Lavage (2L + 2L) + Clear fluid diet |
Primary outcome
Quality of Bowel Cleanliness
Time frame: Procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day of collection.
Ottawa bowel prep scale will be done by the Doctor to assess the quality of bowel cleanliness. The right, mid and rectosigmoid colon are each rated on a 5-point scale (0-4). Also a complete 3 point rating for overall colonic fluid is assessed giving an overall score range of 0-14. An excellent preperation should score 0-1, a good preparation 2-4, while scores >4 would indicate progressively worsening bowel preparations. A Simplified overall cleanliness score and a New bowel prep score will be completed and compared to the Ottawa scale.
1 secondary outcome
Patient satisfaction with preparation
Time frame: Questionnaire given on the day of pre-screen will be collected on the day of colonoscopy, approximately 3 weeks. Patients are not followed or contacted past the day of colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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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.
Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services
Calgary, Canada
Alaa Rostom, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions and Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions in people with Colorectal Cancer, run by University of Calgary at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Bowel Cleanliness (time frame: Procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day of collection.). 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 4 Jun 2012.