Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06151275
Collaborator
(none)
1,000
1
13.8
72.5

Study Details

Study Description

Brief Summary

In our study, we aim to evaluate the relationship between cecal intubation time during colonoscopies and factors such as the patient's age, body mass index, history of constipation, Wexner constipation score, antidepressant use, and previous abdominal surgery. The objective is to assess factors that may predict longer cecal intubation times, especially in difficult colonoscopies. Prior to the procedure, informed consent will be obtained from patients scheduled for colonoscopy in our unit, and relevant information will be recorded. During the procedure, data will be collected, including cecal intubation time, if ileal intubation is performed, and the total procedure time.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Our study is designed as a prospective single-center registry study and has been approved by the Ethics Committee of Sisli Hamidiye Etfal Training and Research Hospital on May 30, 2023. The inclusion criteria for our study involve patients scheduled for colonoscopy in our endoscopy unit who have not undergone colorectal surgery. Following informed consent obtained from patients before colonoscopy, data forms prepared by us will be completed, evaluating patients' age, height, weight, body mass index, colonoscopy indication, antidepressant use, and history of abdominal surgeries. Additionally, the Wexner constipation score will be calculated for each patient.

    The time taken to reach the cecum and, if intubated, the ileum, from the initial insertion of the endoscope in colonoscopy, as well as the total procedure time, will be recorded using a chronometer. Patients with inadequate bowel preparation preventing cecal intubation will be excluded from the study. The collected data will be analysed to assess factors prolonging cecal intubation time and, if possible, to identify predictors for difficult colonoscopy before procedure.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study
    Actual Study Start Date :
    Jun 7, 2023
    Anticipated Primary Completion Date :
    Jul 31, 2024
    Anticipated Study Completion Date :
    Jul 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Colonoscopy

    18-95 years old patients apply our endoscopy unit for colonoscopy will be included in our study. Patients that have colonic resection history will be excluded from study.

    Outcome Measures

    Primary Outcome Measures

    1. Cecal intubation rate [During the colonoscopy]

      The rate of reaching the cecum in all colonoscopies performed

    2. Ileal intubation rate [During the colonoscopy]

      The rate of reaching the terminal ileum in all colonoscopies performed

    3. Cecal intubation time [During the colonoscopy]

      Time for reaching caecum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes

    4. Ileal intubation time [During the colonoscopy]

      Time for reaching ileum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes

    Secondary Outcome Measures

    1. Adenoma detection rate [During the colonoscopy]

      The rate at which endoscopists find one or more adenoma during colonoscopies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18-95 years old, admitted for colonoscopy
    Exclusion Criteria:
    • Colonic resection history

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sisli Hamidiye Etfal Research and Training Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Sisli Hamidiye Etfal Training and Research Hospital

    Investigators

    • Principal Investigator: Burak Dincer, MD, Sisli Hamidiye Etfal Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Burak Dincer, Burak Dincer, MD, Sisli Hamidiye Etfal Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT06151275
    Other Study ID Numbers:
    • 30.05.2023-3951
    First Posted:
    Nov 30, 2023
    Last Update Posted:
    Nov 30, 2023
    Last Verified:
    Nov 1, 2023
    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
    Keywords provided by Burak Dincer, Burak Dincer, MD, Sisli Hamidiye Etfal Training and Research Hospital

    Study Results

    No Results Posted as of Nov 30, 2023