BP: Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose

Sponsor
University of Calgary (Other)
Overall Status
Completed
CT.gov ID
NCT01415687
Collaborator
(none)
171
2
2
7
85.5
12.2

Study Details

Study Description

Brief Summary

The objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness.

The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyethylene Glycol-Based Lavage
  • Drug: Pico-Salax (Magnesium Citrate) plus Bisacodyl
Phase 3

Detailed Description

All patients referred to the Forzani MacPhail Colon Cancer Screening Centre (CCSC) in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients are asked to consider a general research consent. If they agree to that, then they will be approached for consideration of participating in this study and presented with an "Invitation to Participate in a Research Study" form (appendix); the study assistant will obtain final consent if they agree. Those not interested in participating will simply receive their physician's standard bowel preparation protocol. There will be no coercion of any sort. Enrollment of participants will be performed with block randomizations of 8 by 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) oral Pico-Salax (two sachets, with 1.5-2L of water following each sachet) with Dulcolax (Bisacodyl, 4 tablets); (2) split dose Polyethylene Glycol-Based Lavage (2L + 2L).

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, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the CCSC for the colonoscopy (included in the appendix). Patient concerns or questions regarding the preparation will be directed toward the study assistant or clinic nurses as opposed to their endoscopist, so as to avoid un-blinding the Colonoscopist. The physician performing the procedure will then complete an Ottawa Bowel Preparation Scale and a validated Simplified Bowel Preparation scale to assess colon cleanliness.

Study Design

Study Type:
Interventional
Actual Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Official Title:
A Randomized Prospective Trial Comparing Pico-Salax (Magnesium Citrate) Plus Bisacodyl Versus Split Dose Polyethylene Glycol-Based Lavage In Preparation Of Patients For Colonoscopy
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PEG Arm

Patients randomized to this arm of the trial will be following preparation instructions using Polyethylene Glycol-Based Lavage in a split dose format

Drug: Polyethylene Glycol-Based Lavage
Split dose Polyethylene Glycol-Based Lavage (2L + 2L) If arrival for colonoscopy is prior to 10AM: at 12 noon on the day before your colonoscopy drink 2L of PEG within two hours. At 8PM that day, drink the remaining 2L of PEG within two hours. If arrival for colonoscopy is at or after 10AM: at 8PM on the day before your colonoscopy, drink 2L of PEG within two hours. Starting five hours before your arrival time at the Centre on the day of your colonoscopy, drink the remaining 2L of PEG within two hours.
Other Names:
  • Colyte
  • Active Comparator: Pico-Salax + Bisacodyl Arm

    Patients randomized to this arm will follow preparation instructions using Pico-Salax preparation plus Biscacodyl in a split dose format

    Drug: Pico-Salax (Magnesium Citrate) plus Bisacodyl
    If arrival for colonoscopy is prior to 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 12 noon, drink the first packet of Pico-Salax in 8oz water, and the second packet of Pico-Salax in 8oz of water at 8PM. Day of colonoscopy, drink clear fluids. If arrival for colonoscopy is at or after 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 8PM, drink the first packet of Pico-Salax in 8oz water. Day of colonoscopy, drink the second packet of Pico-Salax in 8oz water five hours before you are to arrive at the Centre.
    Other Names:
  • Pico-Salax or Magnesium Citrate
  • Bisacodyl is also known as Dulcolax.
  • Outcome Measures

    Primary Outcome Measures

    1. Quality of Bowel Cleanliness [Scales provided to physician at time of colonoscopy, and filled out and collected after procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day as collection.]

      Ottawa bowel Prep scale will be done by the Dr. 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 preparation would score 0-1; a good preparation, 2-4; while scores >4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of fluid. A simplified overall cleanliness score will be completed and compared to the Ottawa scale.

    Secondary Outcome Measures

    1. Patient Satisfaction with preparation [Questionnaire given on day of pre-screen and collected on day of colonoscopy, approximately 3 weeks.Patients are not followed or contacted past the day of colonoscopy.]

      Patients will be given an anonymous tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the Centre for the colonoscopy. The tool asks questions of patient satisfaction with preparation, ease or difficulty of completing satisfaction, and side effects of the preparation method used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 to 74 years referred to the in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion
    Exclusion Criteria:
    • Any history of kidney problems

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Foranzi & MacPhail Colon Cancer Screening Centre, Alberta Health Services Calgary Alberta Canada T2N 4Z6
    2 Foranzi & MacPhail Colon Cancer Screening Centre Calgary Alberta Canada T2N 4Z6

    Sponsors and Collaborators

    • University of Calgary

    Investigators

    • Principal Investigator: Alaa Rostom, MD, University of Calgary Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alaa Rostom, MD MSc FRCPC, University of Calgary
    ClinicalTrials.gov Identifier:
    NCT01415687
    Other Study ID Numbers:
    • 23798
    First Posted:
    Aug 12, 2011
    Last Update Posted:
    May 31, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Alaa Rostom, MD MSc FRCPC, University of Calgary
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 31, 2012