Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy

Sponsor
Alexandra Hospital, Athens, Greece (Other)
Overall Status
Recruiting
CT.gov ID
NCT05107505
Collaborator
(none)
1,000
1
24
41.8

Study Details

Study Description

Brief Summary

A prospective observational study in order to:
  1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.

  2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Unsuccessful preparation for lower gastrointestinal endoscopy is to date the main obstacle to a comprehensive examination and the main reason for its recurrence. It is also directly related to its diagnostic value.

    The literature shows that the diet prior to colonoscopy, the time of assumption of the preparation and certain epidemiological and clinical characteristics of the patient can affect the outcome of the intestinal preparation for colonoscopy.

    This seems that adequasy of colonoscopy affects a number of qualitative indicators of lower gastrointestinal endoscopy, such as the duration, the catheterization of the fundus of the cecum and the number of polyps found.

    This is a prospective observational study in order to:
    1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.

    2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.

    With starting date:01/07/2021 and expiration date:30/06/2022 (duration: 12 months). All patients who come to the Gastroenterology Department of Alexandra Hospital for endoscopy of the lower digestive tract are eligible for the research protocol. Patients younger than 18 years old or patients who refuse to participate are excluded.

    The study has 3 phases. Phase 0 entails the completion of a questionnaire that will include epidemiological, clinical and preparation-related data in all patients who undergoing colonoscopy at the Endoscopy Department. Phase I incorporates Completion of data related to the time of the examination, the result of the preparation (Boston Bowel Preparation Scale) as well as the findings of the endoscopic examination and phase II includes the statistical analysis of the data.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy
    Actual Study Start Date :
    Jul 15, 2021
    Anticipated Primary Completion Date :
    Jul 14, 2022
    Anticipated Study Completion Date :
    Jul 14, 2023

    Outcome Measures

    Primary Outcome Measures

    1. improper bowel preparation [01/07/2021-30/06/2022]

      Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.

    Secondary Outcome Measures

    1. quality of preparation for colonoscopy [01/07/2021-30/06/2022]

      Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Patients undergoing colonoscopy:
    • Age > 18 years

    • Have been prepared for lower gastrointestinal endoscopy

    • Have agreed to participate in the study

    Exclusion Criteria:
    • Age <18 years

    • Non-acceptance of participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandra General Hospital Athens Greece 11528

    Sponsors and Collaborators

    • Alexandra Hospital, Athens, Greece

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    SPYRIDON MICHOPOULOS, Head Of The Gastroenterology Departement, Alexandra Hospital, Athens, Greece
    ClinicalTrials.gov Identifier:
    NCT05107505
    Other Study ID Numbers:
    • Alexandra Bowel Preparation
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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 Mar 3, 2022