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Performance of the Gynaecological Examination in the Lateral Decubitus Position (EXADELA)

Primary Purpose

Medical Care

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gynaecological examination in lateral decubitus
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Medical Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Woman of legal age, 18 years or older. Who already had a gynaecological examination in the conventional position. Requiring a gynaecological consultation in primary care with speculum for screening, diagnosis or prevention. Woman of childbearing age with a negative urine pregnancy test or postmenopausal woman (no period in the last 12 months). Patient who has read and understood the information letter and signed the consent form. Affiliated to the social security. Exclusion Criteria: Pregnant woman Who already participated to this protocol Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship. Major cognitive impairment that prevents the subject from fully understanding the requirements for participation in the study or from giving informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

    Arm Description

    Outcomes

    Primary Outcome Measures

    Gynaecological speculum examination in the lateral decubitus position will be perform during the visit to assess if the performance is sufficient to be offered as an alternative to the examination in the conventional position.
    Examination realize during the visit of the patient.

    Secondary Outcome Measures

    Clinicians' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
    The questionnaire will be completed by the investigator during each visit.
    patients' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
    The questionnaire will be completed by the patient during each visit.
    The performance (success rate) of early examination (6 first examinations) will be evaluated for each practicioner.
    Success rate in the first 6 patients of each practicioner. This result will allow us to know if the technique is accessible.
    The occurrence of complications at 3 months during IUD insertion in the lateral position will be quantified
    We will call each patient for follow-up at 3 months for patients with IUD insertion in the lateral position.
    The predictive factors for failure of the lateral decubitus examination will be determined
    Age (years), weight (kg) and reason for speculum exam (IUD placement, pelvic pain, vaginal discomfort) will be collected and correlated. This information will make it possible to define a population at risk of failure of the examination in lateral decubitus.

    Full Information

    First Posted
    March 21, 2023
    Last Updated
    May 19, 2023
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05880290
    Brief Title
    Performance of the Gynaecological Examination in the Lateral Decubitus Position
    Acronym
    EXADELA
    Official Title
    Performance of the Gynaecological Examination in the Lateral Decubitus Position
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The gynaecological examination consists of a breast examination, abdominal examination, inspection of the vulva, vaginal touch and pelvic examination with a speculum. The latter is essential for the insertion and removal of intrauterine devices (IUDs), for the diagnosis and screening of pathologies that may cause pelvic symptoms, for assessment of the vaginal wall and for regular screening for cervical cancer. The gynaecological examination is feared by many women because of the feeling of exposure, vulnerability and loss of control. The parallel with a sexual position is particularly disturbing for patients who do not want to see this representation mixed with a medical necessity, which can lead some women to have irregular or even discontinued follow-up. For the past ten years, medical practice theses and midwifery dissertations have evaluated the interest of another position for the pelvic examination with the speculum : the lateral decubitus position in which the patient lies on her side. The lateral decubitus pelvic examination seems to be an alternative for comfort and respect for modesty, which is favoured by the patients. This examination position would have advantages in situations of anterior anatomical position of the position of the cervix, prolapse, severe obesity, hip pathology or significant reluctance to the examination. The effectiveness of this technique in terms of examination performance needs to be evaluated to promote its dissemination. The impact of an examination that is better experienced by patients is that of better adherence and therefore better follow-up, which is the particular challenge of primary care. Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Medical Care

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    564 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    gynaecological examination in lateral decubitus
    Intervention Description
    Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
    Primary Outcome Measure Information:
    Title
    Gynaecological speculum examination in the lateral decubitus position will be perform during the visit to assess if the performance is sufficient to be offered as an alternative to the examination in the conventional position.
    Description
    Examination realize during the visit of the patient.
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Clinicians' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
    Description
    The questionnaire will be completed by the investigator during each visit.
    Time Frame
    1 day
    Title
    patients' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
    Description
    The questionnaire will be completed by the patient during each visit.
    Time Frame
    1 day
    Title
    The performance (success rate) of early examination (6 first examinations) will be evaluated for each practicioner.
    Description
    Success rate in the first 6 patients of each practicioner. This result will allow us to know if the technique is accessible.
    Time Frame
    1 day
    Title
    The occurrence of complications at 3 months during IUD insertion in the lateral position will be quantified
    Description
    We will call each patient for follow-up at 3 months for patients with IUD insertion in the lateral position.
    Time Frame
    3 months
    Title
    The predictive factors for failure of the lateral decubitus examination will be determined
    Description
    Age (years), weight (kg) and reason for speculum exam (IUD placement, pelvic pain, vaginal discomfort) will be collected and correlated. This information will make it possible to define a population at risk of failure of the examination in lateral decubitus.
    Time Frame
    1 day

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Woman of legal age, 18 years or older. Who already had a gynaecological examination in the conventional position. Requiring a gynaecological consultation in primary care with speculum for screening, diagnosis or prevention. Woman of childbearing age with a negative urine pregnancy test or postmenopausal woman (no period in the last 12 months). Patient who has read and understood the information letter and signed the consent form. Affiliated to the social security. Exclusion Criteria: Pregnant woman Who already participated to this protocol Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship. Major cognitive impairment that prevents the subject from fully understanding the requirements for participation in the study or from giving informed consent

    12. IPD Sharing Statement

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    Performance of the Gynaecological Examination in the Lateral Decubitus Position

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