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

NCT01610895 | Unknown

• 1 other identifier: 24206
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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

Keywords

Colonoscopy; low fibre diet; clear fluids; Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

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.

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.

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

Interventions

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

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

Split-dose PEG Based Lavage (2L + 2L) + Clear fluid diet

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alaa Rostom, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Medical Director, Colon Cancer Screening Centre

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 4, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 4, 2012

Record last verified: 2012-05

Locations

CA (1)