Recruiting

PEG & Low-Residue Diet

Sponsor:

University of Calgary

Code:

NCT01610895

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

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

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

Study Details

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

Conditions

Colorectal Cancer

Study ID

NCT01610895

Start date

Dec, 2011

Status verified date

May, 2012

Completion date

Oct, 2012

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

345 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: 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.

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.

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.

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. ]

Central Contacts and Locations

Locations

Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Anitha Jambula, M.Sc, CCRP

403-592-5019ajambula@ucalgary.ca

Robert Hilsden, MD

403-592-5042rhilsden@ucalgary.ca

Principal Investigator:

Alaa Rostom, MD

More Information

Sponsor

University of Calgary

Last update posted

Jun 4, 2012

Last verified

May, 2012

Keywords

  • Colonoscopy
  • low fibre diet
  • clear fluids
  • Bowel Preparation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2012-06-04.