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Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation for Colonoscopy Under Anesthesia

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06000241
Collaborator
(none)
220
Enrollment
2
Locations
29.9
Actual Duration (Months)
110
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

220 patients are allocated randomly to the morning group (am group) or the afternoon group (pm group) and assessed by quality of bowel preparation and residual volume gastric residue.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    220 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation Under Anesthesia
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Jun 15, 2023
    Actual Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. ottawa score [a day]

      Two nurses observe cleaning of three parts of colon and give a score for each.

    2. gastric residual volume [30 minutes]

      Gastric contents are suctioned and measured.

    3. colonic residual volume [30 minutes]

      Colonic fluids are suctioned and measured.

    Secondary Outcome Measures

    1. reflux [60mins]

      incidence of reflux during both the EGD and colonoscopy

    2. adenoma detection rate [a day]

      percentages of patients screened with colonic adenoma in total patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients are able to follow the instructions of bowel preparation and have good ability of walking at least an hour.

    Exclusion Criteria:

    Clinical diagnosis of obstruction of bowel and sever renal and heart disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical Hospital Beijing Beijing China 100730
    2 Peking Union Medical College Hospital Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT06000241
    Other Study ID Numbers:
    • JS-3388
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 21, 2023