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出境医 / 临床实验 / Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids (EMBOFIB)

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

Study Description
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).


Condition or disease
Uterine Fibroid

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 119 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids
Actual Study Start Date : July 12, 2019
Actual Primary Completion Date : March 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Group/Cohort
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.
Outcome Measures
Primary Outcome Measures :
  1. Risk of intraoperative hemorrhage [ Time Frame: Day 1 ]
    This outcome measure pre- and postoperative hemoglobin levels for the 2 groups.


Secondary Outcome Measures :
  1. Intraoperative transfusion rate [ Time Frame: Day 1 ]
    This outcome measure the number of patients who had Intraoperative transfusion.

  2. Post-operative transfusion rate [ Time Frame: Day 1 ]
    This outcome measure the number of patients who had post-operative transfusion.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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
Contacts and Locations

Locations
Layout table for location information
France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Layout table for investigator information
Principal Investigator: Eric SAUVANET, MD Groupe Hospitalier Paris Saint Joseph
Tracking Information
First Submitted Date June 14, 2019
First Posted Date June 18, 2019
Last Update Posted Date April 27, 2021
Actual Study Start Date July 12, 2019
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2019)
Risk of intraoperative hemorrhage [ Time Frame: Day 1 ]
This outcome measure pre- and postoperative hemoglobin levels for the 2 groups.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 17, 2019)
  • Intraoperative transfusion rate [ Time Frame: Day 1 ]
    This outcome measure the number of patients who had Intraoperative transfusion.
  • Post-operative transfusion rate [ Time Frame: Day 1 ]
    This outcome measure the number of patients who had post-operative transfusion.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids
Official Title Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Uterine Fibroid
Intervention Not Provided
Study Groups/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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 5, 2019)
119
Original Estimated Enrollment
 (submitted: June 17, 2019)
123
Estimated Study Completion Date December 31, 2021
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03989661
Other Study ID Numbers EMBOFIB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators
Principal Investigator: Eric SAUVANET, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date April 2021

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