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Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Unknown status
CT.gov ID
NCT04033250
Collaborator
(none)
600
Enrollment
1
Location
3
Arms
15
Anticipated Duration (Months)
40
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.

The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial
Anticipated Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional arm (group A)

Patients with risk factors for IBP who will receive "intensified" bowel preparation

Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
Bowel preparation
Other Names:
  • Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses

    		•
    Active Comparator: Control arm (group B)

    Patients with risk factors for IBP who will receive standard bowel preparation

    Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
    Bowel preparation
    Other Names:
  • Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses

    		•
    Active Comparator: Control arm (group c)

    Patients without risk factors for IPB who will receive standard bowel preparation

    Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
    Bowel preparation
    Other Names:
  • Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improved bowel preparation [Index colonoscopy]

      Boston Bowel Preparation Scale at index colonoscopy will be measured. The grading is between 1 and 3 for each segment of colon (ascending, transverse, descending) where 1 is poor and 3 is excellent (subscale). The final score is between 3 and 9 summing up the scores for each segment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • previous IBP

    • concurrent medical conditions (e.g. diabetes, constipation)

    • medications (e.g. opioids and tricyclic antidepressants)

    Exclusion Criteria:

    • previous colonic resection

    • patients with IBD

    • active CRC

    • chronic kidney disease at any stage

    • congestive heart failure at any stage

    • liver cirrhosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam MC Haifa Israel

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amir Klein MD, Principal Investigator, Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT04033250
    Other Study ID Numbers:
    • 0117-19-RMB CTIL
    First Posted:
    Jul 26, 2019
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bisacodyl
    Picosulfate sodium
    Magnesium Oxide
    Sodium Citrate
    Citric Acid

    Study Results

    No Results Posted as of Sep 25, 2019