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CompletedNCT03989661EMBOFIBUpdated Apr 27, 2023

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

An observational study in Uterine Fibroid, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
119
Ages
18 Years and older
Sex
Female
01

Study 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).

02

Conditions studied

  • Uterine Fibroid
03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's enrollment of 119 is below the median of 150 across 119 observational studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

    • Patients under guardianship or curatorship
  • Patient deprived of liberty
  • Patient opposing the use of his data for this research
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
119 participants (actual)
Patient registry
No

Groups and cohorts

  • Test group

    This group corresponds to patients who had undergone preoperative embolization (with resorbable material) before myomectomy.

  • Control group

    This group corresponds to patients with myomectomy without embolization.

06

What researchers measure

Primary outcomes

  1. Risk of intraoperative hemorrhage

    This outcome measure pre- and postoperative hemoglobin levels for the 2 groups.

    Time frame: Day 1

Secondary outcomes

  1. Intraoperative transfusion rate

    This outcome measure the number of patients who had Intraoperative transfusion.

    Time frame: Day 1

  2. Post-operative transfusion rate

    This outcome measure the number of patients who had post-operative transfusion.

    Time frame: Day 1

07

Study locations

1 site
  • Groupe Hospitalier Paris Saint-Joseph
    Paris, 75014, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03989661
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Jun 18, 2019
Start date
Jul 12, 2019
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Apr 27, 2023

Study contacts

Eric SAUVANET, MD
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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