Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-26 @ 3:37 PM
Study NCT ID:
NCT01610895
Status:
UNKNOWN
Last Update Posted:
2012-06-04
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Split Dose Polyethylene Glycol (PEG) + Clear Fluids Versus Split Dose PEG + Low-Residue Diet
Sponsor:
University of Calgary
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BP
Brief 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.
The primary outcomes will be 1) quality of preparation in cleansing the colon and 2) patient satisfaction
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: