Split Dose Polyethylene Glycol (PEG) + Clear Fluids Versus Split Dose PEG + Low-Residue Diet

NCT ID: NCT01610895

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-10-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Split-dose PEG Based Lavage (2L + 2L) + Low-fiber Diet

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.

Group Type: ACTIVE_COMPARATOR

Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions

Intervention Type: OTHER

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) + Clear fluid diet

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.

Group Type: PLACEBO_COMPARATOR

Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions

Intervention Type: OTHER

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.

Interventions

Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions

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.

Intervention Type: OTHER

Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Alaa Rostom

Associate Professor - Medical Director, Colon Cancer Screening Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa Rostom, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Anitha Jambula, M.Sc, CCRP

Role: primary

ajambula@ucalgary.ca

403-592-5019

Robert Hilsden, MD

Role: backup

rhilsden@ucalgary.ca

403-592-5042

Other Identifiers

24206

Identifier Type: -

Identifier Source: org_study_id