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
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).
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 →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.
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
Exclusion Criteria:
This group corresponds to patients who had undergone preoperative embolization (with resorbable material) before myomectomy.
This group corresponds to patients with myomectomy without embolization.
Risk of intraoperative hemorrhage
This outcome measure pre- and postoperative hemoglobin levels for the 2 groups.
Time frame: Day 1
Intraoperative transfusion rate
This outcome measure the number of patients who had Intraoperative transfusion.
Time frame: Day 1
Post-operative transfusion rate
This outcome measure the number of patients who had post-operative transfusion.
Time frame: Day 1
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondation Hôpital Saint-Joseph