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

University of Calgary

Status: Unknown

Conditions: Colorectal Cancer

Treatments: Other: Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions; Other: Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions

Study type: Interventional

Funder types: Other

Identifiers

NCT01610895

24206

Details and patient eligibility

About

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

Full 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.

Enrollment: 345 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

345 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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