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Prone-position CT for Diagnosing Inguinal Hernia

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
supine- and prone-position Computed Tomography
Sponsored by
Nagareyama Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hernia, Inguinal

Eligibility Criteria

20 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • inguinal hernia

Exclusion Criteria:

  • emergency surgery for incarcerated hernia
  • femoral hernia
  • recurrent inguinal hernia after laparoscopic inguinal hernia repair

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    cross-sectional study

    Arm Description

    Outcomes

    Primary Outcome Measures

    The detection rate of inguinal hernia

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2016
    Last Updated
    October 18, 2016
    Sponsor
    Nagareyama Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02939443
    Brief Title
    Prone-position CT for Diagnosing Inguinal Hernia
    Official Title
    Diagnosis of Inguinal Hernia by Prone- vs. Supine-position Computed Tomography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nagareyama Central Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Background: The aim of this study was to investigate the efficacy of prone-position computed tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT before laparoscopic inguinal hernia repair. Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine and prone positions for preoperative assessment. The anatomy of the right and left inguinal regions was confirmed during the surgery and compared with the preoperative CT findings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hernia, Inguinal

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cross-sectional study
    Arm Type
    Other
    Intervention Type
    Radiation
    Intervention Name(s)
    supine- and prone-position Computed Tomography
    Primary Outcome Measure Information:
    Title
    The detection rate of inguinal hernia
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: inguinal hernia Exclusion Criteria: emergency surgery for incarcerated hernia femoral hernia recurrent inguinal hernia after laparoscopic inguinal hernia repair

    12. IPD Sharing Statement

    Learn more about this trial

    Prone-position CT for Diagnosing Inguinal Hernia

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