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

U

University Hospital, Rouen

Status

Not yet enrolling

Conditions

Medical Care

Treatments

Procedure: gynaecological examination in lateral decubitus

Study type

Interventional

Funder types

Other

Identifiers

NCT05880290
2021/0375/HP

Details and patient eligibility

About

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

Enrollment

564 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

564 participants in 1 patient group

gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
Experimental group
Treatment:
Procedure: gynaecological examination in lateral decubitus

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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