Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events.

Participants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study.

Preoperatively, women will undergo the following two examinations:

1. A pelvic MRI, the characteristics of which will be analyzed by the expert women\'s imaging team. 2. A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy.

250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM).

Able to give written consent

Beneficiary or beneficiary of a social security scheme

Disqualifiers

Person in a period of exclusion from another research protocol at the time consent is signed.

Pregnant women, parturients and nursing mothers

Persons deprived of their liberty by judicial or administrative decision

Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8.

Trial design

Design model

Single group

Treatments tested in this trial

  • Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy

    Procedure/Surgery

    Echoguided transuterine vaginal biopsy performed before myomectomy or hysterectomy

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Echoguided transuterine vaginal biopsyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Validate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy

Estimate the anatomopathological sensitivity of BVTE, with its 95% confidence interval, by comparing it with the reference technique, i.e. anatomopathological diagnosis on surgical specimens, to ensure a low number of false negatives (fibroid diagnosis on BVTE with final diagnosis of TMM)

Time frame
From enrollment before surgery to the follow-up visit 3 months after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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