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Multi-centre Failed Bowel Prep RCT (B-CLEANR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02976805
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : January 14, 2020
Sponsor:
Collaborators:
Academic Medical Organization of Southwestern Ontario
Pendopharm
University of Alberta
Université de Montréal
McGill University
University of Western Ontario, Canada
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
This is a multi-centre randomized clinical trial comparing the efficacy of two different bowel preparation regimens for patients who have already failed a bowel preparation for colonoscopy.

Condition or disease Intervention/treatment Phase
Colonoscopy Bowel Preparation Drug: 4L PegLyte + 15 mg bisacodyl Drug: 6L PegLyte + 15 mg bisacodyl Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre Endoscopist Blinded Randomized Clinical Trial to Compare Two Bowel Preparations After a Colonoscopy With Inadequate Bowel Preparation
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Bisacodyl

Arm Intervention/treatment
Experimental: Regimen A
4L PegLyte + 15 mg bisacodyl
Drug: 4L PegLyte + 15 mg bisacodyl
Randomized
Other Name: Regimen A

Experimental: Regimen B
6L PegLyte + 15 mg bisacodyl
Drug: 6L PegLyte + 15 mg bisacodyl
Randomized
Other Name: Regimen B




Primary Outcome Measures :
  1. Adequate bowel preparation [ Time Frame: Once after colonoscopy ]
    BBPS total score ≥6 and/or all segment scores ≥2.


Secondary Outcome Measures :
  1. Mean BBPS total score [ Time Frame: Once after colonoscopy ]
  2. Bowel preparation was adequate after washing to visualize lesions > 5 mm of importance to the procedure and there is no need to shorten the interval of the next colonoscopy [ Time Frame: Once after colonoscopy ]
  3. Validated patient tolerability questionnaire for bowel preparation score [ Time Frame: Once after colonoscopy ]
  4. Bowel preparation related adverse event [ Time Frame: After colonoscopy and 14 days after colonoscopy ]

    The following moderate and non-lasting symptoms related to bowel prep are expected and not considered adverse events:

    • Nausea
    • Vomiting
    • Abdominal fullness
    • Bloating
    • Abdominal cramps and pain
    • Diarrhea
    • Anal irritation

    Otherwise, all AEs will be classified as follows:

    Severity:

    • Mild
    • Moderate
    • Severe

    Causality:

    • Unrelated
    • Possible
    • Probable
    • Highly probable

    Outcome:

    • Resolved without residual effects
    • Resolved with residual effects
    • Recovering/Resolving
    • Not Recovered/Not Resolved
    • Death
    • Unknown

    A Serious Adverse Event (SAE) is defined as an event that

    • Led to a death
    • Led to a serious deterioration in the health of the subject that resulted in a life-threatening illness or injury, permanent impairment of a body structure or function, hospitalization or prolongation of hospitalization, or required medical or surgical intervention to prevent permanent impairment of a body structure or function

  5. Right sided BBPS sub-score [ Time Frame: Up to 4 weeks after colonoscopy ]

Other Outcome Measures:
  1. Detection rate by histology (polyp, adenoma, advanced adenoma (>1 cm, villous component, sessile serrated adenoma, or high grade dysplasia), and adenocarcinoma) [ Time Frame: Once after colonoscopy ]
  2. Cecal intubation rate [ Time Frame: Once after colonoscopy ]
  3. Subject product completion (% of total required intake) [ Time Frame: Once after colonoscopy ]
  4. Subject willingness to repeat the preparation [ Time Frame: Once after colonoscopy ]
  5. Subject incontinence & travel time [ Time Frame: Once after colonoscopy ]
  6. Polyp per colonoscopy [ Time Frame: Up to 4 weeks after colonoscopy ]
  7. Adenoma per colonoscopy [ Time Frame: Up to 4 weeks after colonoscopy ]
  8. Fecal incontinence rate [ Time Frame: Up to 4 weeks after colonoscopy ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Anyone undergoing a repeat colonoscopy due to failed bowel preparation at index colonoscopy. Failure is defined as preparation quality inadequate to detect lesions > 5 mm after washing and requiring a shortened colonoscopy interval as a result.
  2. Age > 18 years
  3. Outpatient colonoscopy
  4. Indication for full colonoscopy

Exclusion Criteria:

  1. Subject refusal
  2. Able to comprehend the trial
  3. Index colonoscopy performed as an inpatient
  4. Pregnancy or breastfeeding
  5. Allergies to the employed bowel preparations
  6. Any colonic surgery
  7. History of ischemic colitis
  8. Congestive heart failure
  9. Chronic renal failure
  10. Cirrhosis
  11. Severe electrolyte imbalance
  12. Non-adherence to index bowel preparation defined as failure to follow diet instructions and/or consume the entire volume of bowel preparation medication as prescribed for any reason (ex. eating a normal diet on the day of colonoscopy, PEG intolerance, etc…)
  13. Use of bowel preparation in an off-label manner for the index colonoscopy.
  14. Inability to follow verbal and written instructions in English or French.
  15. Ileus, gastric outlet obstruction, gastrointestinal obstruction, bowel preforation
  16. Toxic coitis or toxic megacolon
  17. Acute surgical abdomen including appendicitis
  18. Gastroenteritis and acute diverticulitis

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 ClinicalTrials.gov identifier (NCT number): NCT02976805


Contacts
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Contact: Michael Sey, MD 519-667-6582 msey2@uwo.ca
Contact: Cassandra McDonald, BSc 519-667-6582 ext 5 Cassandra.Mcdonald@lhsc.on.ca

Locations
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Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada
Contact: Richard Sultanian, MD         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Michael Sey, MD    519-667-6582      
Canada, Quebec
CHUM Not yet recruiting
Montreal, Quebec, Canada
Contact: Daniel Von Renteln, MD         
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada
Contact: Alan Barkun, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Academic Medical Organization of Southwestern Ontario
Pendopharm
University of Alberta
Université de Montréal
McGill University
University of Western Ontario, Canada
Investigators
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Principal Investigator: Michael Sey, MD Western University

Publications:
Nationwide Colonoscopy Program for the Uninsured [cited 2015 September 21]. Available from: http://www.colonoscopyassist.com/After_Colonoscopy.html.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02976805    
Other Study ID Numbers: HSREB108472
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives