A Trial of Four Different Bowel Cleansing Regimens Prior to Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00831064
First received: January 27, 2009
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

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 Intervention
Bowel Preparation
Procedure: colonoscopy bowel prep (PEG, bisacodyl, NaP, PSMC and Mg-citrate)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • bowel preparation quality as measured by the Ottawa scale [ Time Frame: at the time of endoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • patient tolerability of bowel preparation [ Time Frame: at the time of colonoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: September 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. 4L PEG Procedure: colonoscopy bowel prep (PEG, bisacodyl, NaP, PSMC and Mg-citrate)
colonoscopy bowel prep
Active Comparator: 2. 2L PEG plus 4 tablets of bisacodyl Procedure: colonoscopy bowel prep (PEG, bisacodyl, NaP, PSMC and Mg-citrate)
colonoscopy bowel prep
No Intervention: 3. 90 cc NaP Procedure: colonoscopy bowel prep (PEG, bisacodyl, NaP, PSMC and Mg-citrate)
colonoscopy bowel prep
No Intervention: 4. PSMC plus 1 bottle of Mg-citrate
PSMC plus 1 bottle of Mg-citrate (300 cc)
Procedure: colonoscopy bowel prep (PEG, bisacodyl, NaP, PSMC and Mg-citrate)
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).
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831064

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

Publications:

Responsible Party: Sander van Zanten and Dina Kao9840, University of Alberta
ClinicalTrials.gov Identifier: NCT00831064     History of Changes
Other Study ID Numbers: 1-Kao
Study First Received: January 27, 2009
Last Updated: October 1, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
bowel preparation quality
colonoscopy

Additional relevant MeSH terms:
Bisacodyl
Magnesium citrate
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014