A Trial of Four Different Bowel Cleansing Regimens Prior to Colonoscopy

NCT00831064 | Completed

• 1 other identifier: 1-Kao
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To compare 4 commonly used bowel preparations in terms of efficacy, patient tolerability and safety. All these 4 bowel preparations are likely to be efficacious and safe. However, those with lower volume are likely to be better tolerated and completed by patients.

Conditions

Bowel Preparation

Keywords

bowel preparation quality; colonoscopy

Outcome Measures

Primary Outcomes (1)

• bowel preparation quality as measured by the Ottawa scale

  at the time of endoscopy

Secondary Outcomes (2)

• electrolyte and renal function abnormalities

  2 sets of measurements will be obtained: prior to the start of bowel preparation and at the time of colonoscopy

• patient tolerability of bowel preparation

  at the time of colonoscopy

Study Arms (4)

1. 4L PEG only

ACTIVE COMPARATOR

4L PEG PO

Procedure: colonoscopy bowel prep

2. 2L PEG plus bisacodyl

ACTIVE COMPARATOR

2L PEG PO + 4 tablets bisacodyl PO

Procedure: colonoscopy bowel prep

3. NaP

ACTIVE COMPARATOR

90 cc NaP PO

Procedure: colonoscopy bowel prep

4. PSMC plus Mg-citrate

ACTIVE COMPARATOR

PSMC plus 300 cc Mg-citrate PO

Procedure: colonoscopy bowel prep

Interventions

colonoscopy bowel prep PROCEDURE

PEG, bisacodyl, NaP, PSMC and Mg-citrate

1. 4L PEG only; 2. 2L PEG plus bisacodyl; 3. NaP; 4. PSMC plus Mg-citrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 18 and 75.
• Planned elective outpatient colonoscopy.

You may not qualify if:

• History of renal insufficiency or abnormal creatinine clearance with GFR \<59.
• History of congestive heart failure.
• History of acute coronary syndrome or unstable angina.
• History of liver cirrhosis or ascites.
• Chronic lasix therapy.
• History of colorectal resection.
• Known or suspected bowel obstruction, megacolon or ileus

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Related Publications (9)

• Sharma VK, Chockalingham SK, Ugheoke EA, Kapur A, Ling PH, Vasudeva R, Howden CW. Prospective, randomized, controlled comparison of the use of polyethylene glycol electrolyte lavage solution in four-liter versus two-liter volumes and pretreatment with either magnesium citrate or bisacodyl for colonoscopy preparation. Gastrointest Endosc. 1998 Feb;47(2):167-71. doi: 10.1016/s0016-5107(98)70351-7.

  PMID: 9512283 BACKGROUND

• Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.

  PMID: 15044882 BACKGROUND

• American Society of Colon and Rectal Surgeons (ASCRS); American Society for Gastrointestinal Endoscopy (ASGE); Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE. A consensus document on bowel preparation before colonoscopy: prepared by a Task Force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc. 2006 Jul;20(7):1161. doi: 10.1007/s00464-006-3037-1. No abstract available.

  PMID: 16799744 BACKGROUND

• Rostom A, Jolicoeur E, Dube C, Gregoire S, Patel D, Saloojee N, Lowe C. A randomized prospective trial comparing different regimens of oral sodium phosphate and polyethylene glycol-based lavage solution in the preparation of patients for colonoscopy. Gastrointest Endosc. 2006 Oct;64(4):544-52. doi: 10.1016/j.gie.2005.09.030.

  PMID: 16996347 BACKGROUND

• Schmidt LM, Williams P, King D, Perera D. Picoprep-3 is a superior colonoscopy preparation to Fleet: a randomized, controlled trial comparing the two bowel preparations. Dis Colon Rectum. 2004 Feb;47(2):238-42. doi: 10.1007/s10350-003-0027-4.

  PMID: 15043296 BACKGROUND

• Barkun A, Chiba N, Enns R, Marcon M, Natsheh S, Pham C, Sadowski D, Vanner S. Commonly used preparations for colonoscopy: efficacy, tolerability, and safety--a Canadian Association of Gastroenterology position paper. Can J Gastroenterol. 2006 Nov;20(11):699-710. doi: 10.1155/2006/915368.

  PMID: 17111052 BACKGROUND

• Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.

  PMID: 17299615 BACKGROUND

• Poon CM, Lee DW, Mak SK, Ko CW, Chan KC, Chan KW, Sin KS, Chan AC. Two liters of polyethylene glycol-electrolyte lavage solution versus sodium phosphate as bowel cleansing regimen for colonoscopy: a prospective randomized controlled trial. Endoscopy. 2002 Jul;34(7):560-3. doi: 10.1055/s-2002-33207.

  PMID: 12170410 BACKGROUND

• Frommer D. Cleansing ability and tolerance of three bowel preparations for colonoscopy. Dis Colon Rectum. 1997 Jan;40(1):100-4. doi: 10.1007/BF02055690.

  PMID: 9102248 BACKGROUND

Study Officials

• Sander van Zanten, MD

  University of Alberta

  STUDY DIRECTOR

• Din a Kao, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: September 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

CA (1)