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A Trial of Four Different Bowel Cleansing Regimens Prior to Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00831064
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 13, 2016
Information provided by (Responsible Party):
Dina Kao, University of Alberta

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.

Condition or disease Intervention/treatment
Bowel Preparation Procedure: colonoscopy bowel prep

Detailed Description:

Adequate bowel preparation is imperative for diagnostic accuracy and therapeutic safety. Several bowel cleansing preparations have been approved by Health Canada and are commonly used prior to colonoscopy. Polyethylene glycol (PEG) has been considered to be the "gold standard" for bowel preparation. It is a nonabsorbable solution which passes through the bowel without net absorption or secretion. Significant fluid and electrolyte shifts are therefore avoided. However, the large volume (4 liters), the salty taste and the sulphur smell frequently lead to poor tolerability and compliance, sometimes resulting in inadequate bowel preparation. Several other bowel cleansing preparations have been developed and include sodium phosphate (NaP), magnesium citrate, and sodium picosulphate plus magnesium oxide (PSMC)-containing preparations. NaP is a low volume hyperosmotic solution which draws plasma water into the bowel lumen to promote colonic cleansing. As a result, significant fluid and electrolyte shifts can occur. The advantage of the low volume is better patient tolerance compared to PEG. However, even in healthy individuals severe electrolyte disturbances have been reported when the 2 required doses are taken 12 hours apart. Therefore Health Canada has recommended that 2 doses of NaP be taken 24 hours apart. Patients with renal failure, congestive heart failure and liver failure should avoid this preparation (Grade I A). PSMC is a hyperosmotic saline laxative which increases intraluminal volume resulting in increased intestinal motility. Magnesium, a constituent of PSMC, stimulates the release of cholecystokinin which also stimulates intestinal motility. Since magnesium is eliminated by the kidney, patients with renal insufficiency or failure should also avoid this preparation.

Many randomized controlled trials have compared the efficacy and tolerability of various bowel cleansing regimens. Studies comparing full-volume (4 liters) PEG with low-volume (2 liters) PEG combined with magnesium citrate or bisacodyl have demonstrated equal efficacy of colonic cleansing but with improved patient tolerance. However, there is little data on how low volume PEG compares with NaP. The only meta-analysis of twenty nine trials on optimal bowel preparation concluded that NaP was more effective in bowel cleansing than 4-liter PEG or PSMC. However, there were only three trials comparing NaP to PSMC that met inclusion and exclusion criteria in this meta-analysis and the results have been conflicting. Also there were only three trials comparing PEG to PSMC in this meta-analysis with inconclusive data. Moreover, the mean number of patients per trial was small at 223, with the highest number of patients in a trial at 500.

A consensus document prepared by three leading American gastrointestinal societies (American Society of Gastrointestinal Endoscopy, American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons) as well as a position paper by the Canadian Association of Gastroenterology identified the lack of an ideal bowel preparation which meets all these criteria. Furthermore, the need for further studies was identified in the following areas:

  1. Two-liter PEG vs NaP
  2. PSMC vs NaP

Outpatients who need to undergo routine colonoscopy will be recruited. Each patient will be randomly assigned to one of the four bowel preparations after they have given consent to participate in the study:

  1. Group 1. 4L PEG.
  2. Group 2. 2L PEG plus 4 tablets of bisacodyl.
  3. Group 3. 90 cc NaP.
  4. Group 4. PSMC plus 1 bottle of Mg-citrate (300 cc).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial of Four Different Bowel Cleansing Regimens Prior to Colonoscopy: Efficacy, Patient Tolerability and Safety
Study Start Date : September 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1. 4L PEG only
Procedure: colonoscopy bowel prep
PEG, bisacodyl, NaP, PSMC and Mg-citrate
Active Comparator: 2. 2L PEG plus bisacodyl
2L PEG PO + 4 tablets bisacodyl PO
Procedure: colonoscopy bowel prep
PEG, bisacodyl, NaP, PSMC and Mg-citrate
Active Comparator: 3. NaP
90 cc NaP PO
Procedure: colonoscopy bowel prep
PEG, bisacodyl, NaP, PSMC and Mg-citrate
Active Comparator: 4. PSMC plus Mg-citrate
PSMC plus 300 cc Mg-citrate PO
Procedure: colonoscopy bowel prep
PEG, bisacodyl, NaP, PSMC and Mg-citrate

Primary Outcome Measures :
  1. bowel preparation quality as measured by the Ottawa scale [ Time Frame: at the time of endoscopy ]

Secondary Outcome Measures :
  1. electrolyte and renal function abnormalities [ Time Frame: 2 sets of measurements will be obtained: prior to the start of bowel preparation and at the time of colonoscopy ]
  2. patient tolerability of bowel preparation [ Time Frame: at the time of colonoscopy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00831064

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Study Director: Sander van Zanten, MD University of Alberta
Principal Investigator: Din a Kao, MD University of Alberta


Responsible Party: Dina Kao, Associate Professor, University of Alberta Identifier: NCT00831064     History of Changes
Other Study ID Numbers: 1-Kao
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Dina Kao, University of Alberta:
bowel preparation quality

Additional relevant MeSH terms:
Magnesium citrate
Gastrointestinal Agents