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A Randomized Prospective Trial Comparing Single Dose Polyethylene Glycol-based Lavage Versus Split Dose Polyethylene Glycol-based Lavage in the Preparation of Patients Undergoing Colonoscopy


N/A
50 Years
75 Years
Not Enrolling
Both
Colonoscopy Preparation

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Trial Information

A Randomized Prospective Trial Comparing Single Dose Polyethylene Glycol-based Lavage Versus Split Dose Polyethylene Glycol-based Lavage in the Preparation of Patients Undergoing Colonoscopy


All patients between the age of 50 and 75 years referred to the Forzani & MacPhail
Colorectal Cancer Screening Centre in Calgary, Alberta, Canada for colonoscopy will be
considered for inclusion. During pre-assessments at the clinic, patients will be asked to
participate in the study by a nurse clinician. If they agree - final consent will be
obtained by a gastroenterologist along with consent for the colonoscopy. Those not
interested in participating will simply receive their physicians standard bowel preparation
protocol. There will be no coercion of any sort.

Patients with acute coronary syndrome, congestive heart failure, unstable angina, known or
suspected renal failure, ascites, megacolon, known or suspected bowel obstruction, or other
comorbidities that may prevent colonoscopy will be excluded. Patients will also be excluded
if they previously had partial or subtotal colectomy or if the colonoscopy is warranted for
the evaluation of diarrhea.

Enrollment of participants will be performed with block randomizations of 8 stratified by AM
versus PM procedure time using a computer-generated table, with allocation concealment
maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and
investigators will be blinded to allocation groups. Patients will be allocated to one of
two groups: (1) 4L PEG day prior to procedure; (2) 4L of PEG split in two 2L doses

A study assistant will assign patients to their group and instruct them on the proper use of
their assigned bowel preparation method. Patients will be given a tolerability
questionnaire, that was modified from a previously reported questionnaire, to be completed
once their bowel preparation is finished and before coming to the hospital for the
colonoscopy. Patient concerns or questions regarding the preparation will be directed
toward the assistant as opposed to their gastroenterologist, so as to avoid unblinding the
gastroenterologist.

Outcomes

The previously validated Ottawa bowel preparation scale80 will be used to assess the quality
of bowel cleanliness. Each of the right, mid and rectosigmoid colon is rated on a 5-point
scale (0-4). In addition, a complete 3-point rating for overall colonic fluid is assessed
resulting in an overall score range of 0 to 14. An excellent preparation with little fluid
would score 0 to 1; a good preparation, 2 to 4; while scores higher than 4 would indicate
progressively worsening bowel preparations. A completely unprepared colon would score 11 to
14, depending on the amount of colonic fluid.

Colonoscopy will be performed in a standard fashion and endoscopists will rate the
bowel-preparation quality during the procedure and record the result on a separate
standardized form.

Secondary outcomes will include a previously validated tolerability questionnaire and
patient and investigator reported adverse events.


Inclusion Criteria:



- All patients between the age of 50 and 75 years referred to the Forzani & MacPhail
Colorectal 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,

- megacolon,

- known or suspected bowel obstruction, or

- other comorbidities that may prevent colonoscopy will be excluded. Patients will also
be excluded if they previously had partial or subtotal colectomy or if the
colonoscopy is warranted for the evaluation of diarrhea.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)

Outcome Measure:

The Ottawa Bowel Preparation Score

Outcome Description:

A validated scale. Each of the right, mid and rectosigmoid colon is rated on a 5-point scale (0-4). In addition, a complete 3-point rating for overall colonic fluid is assessed resulting in an overall score range of 0 to 14. An excellent preparation with little fluid would score 0 to 1; a good preparation, 2 to 4; while scores higher than 4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11 to 14, depending on the amount of colonic fluid.

Outcome Time Frame:

Measured at time of Colonoscopy

Safety Issue:

Yes

Principal Investigator

Alaa Rostom, MD MSc FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Calgary

Authority:

Canada: Health Canada

Study ID:

21972

NCT ID:

NCT01610856

Start Date:

March 2010

Completion Date:

June 2010

Related Keywords:

  • Colonoscopy Preparation
  • bowel preparation
  • bowel purgative
  • bowel cleansing
  • colonoscopy

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