Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids

Completed

• Conditions: Uterine Fibroid

• Registration Number: NCT03989661
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

Uterine fibroids are the most common benign tumors of the female genital tract, with an estimated incidence of 25-80% during the reproductive period in the general population.

If the affected patients do not usually have any symptoms, uterine fibroids may also, depending on their location, be responsible for acute and chronic pelvic pain, bleeding and infertility.

Symptomatic uterine fibroids are now treated in the first line by surgery (hysterectomy, laparotomy myomectomy, laparoscopy or hysteroscopy). When conservative treatment is indicated and the fibroid is not hysteroscopically accessible, myomectomy can be performed by laparotomy or laparoscopy.

Excision of myomas often richly vascularized exposes the surgeon and the patient to a risk of bleeding per- and / or post-operative sometimes severe, resulting in an increase in operating times, an increased risk of postoperative complications and need transfusion.

The literature is rather poor on this subject but some factors favoring bleeding have been identified: the history of myomectomy, a uterine volume equivalent to more than 20 weeks of amenorrhea, the excision of more than 10 fibroids, or an incisional approach.

In order to reduce these intraoperative bleeds, numerous therapeutic strategies have been developed, using drug alternatives (GnRH agonists, Ullipristal) or interventional radiology (embolisation of the uterine arteries).

The improvement of interdisciplinary collaboration is now seeing the emergence of numerous therapeutic strategies combined.

The effectiveness of uterine artery embolization has been demonstrated for several years in the treatment of fibroids, alone or in combination with surgical myomectomy.

Some studies on preoperative embolization (maximum 24 hours before the intervention) have shown encouraging results with regard to the volume of bleeding, the need for per or post-operative transfusion or the need for surgical revision, or even decision to hystérectomie.

In 2011, Butori et al. propose the use of absorbable spongy particles (Curaspon type) for preoperative embolization. The use of these resorbable particles would reduce the risk of postoperative synechia. Some studies indicate that embolization of the uterine arteries using non-absorbable material would be responsible for ovarian failure by hypo-infusion. The use of absorbable material would avoid this adverse effect while preserving its effectiveness for the surgical procedure, but to date no study clearly demonstrates this.

This retrospective case-control study aims to compare the occurrence of per-and post-operative adverse effects between a test group consisting of patients who had undergone preoperative embolization (with resorbable material) before myomectomy (intervention group) and a control group with myomectomy without embolization (control group).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Study Start: 2019-07-12
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 119

Inclusion Criteria

• Patients whose age is ≥ 18 years
• Patients who underwent a single myomectomy or laparotomy polymyomectomy in the gynecological surgery department of the Paris Saint-Joseph Hospital Group between January 2016 and June 2018, with or without preoperative embolization
• Francophone patients

Exclusion Criteria

• • Patients under guardianship or curatorship
• Patient deprived of liberty
• Patient opposing the use of his data for this research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of intraoperative hemorrhage	Day 1	This outcome measure pre- and postoperative hemoglobin levels for the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Intraoperative transfusion rate	Day 1	This outcome measure the number of patients who had Intraoperative transfusion.
Post-operative transfusion rate	Day 1	This outcome measure the number of patients who had post-operative transfusion.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France