Trial Title:
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
NCT ID:
NCT06269809
Condition:
Fibroid Uterus
Conditions: Official terms:
Leiomyoma
Myofibroma
Conditions: Keywords:
myomectomy
fibroid
myoma
blood loss
temporary artery clipping
hemostatic measures
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicentric non-blinded randomized controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Temporary clipping of the uterine arteries and the utero-ovarian ligmants.
Description:
Temporary clipping of the uterine arteries and the utero-ovarian ligaments using
laparoscopic clips/bulldog clamps, during robotically assisted myomectomy.
Arm group label:
Temporary artery clipping
Intervention type:
Procedure
Intervention name:
No temporary clipping of the uterine arteries and the utero-ovarian ligmants.
Description:
Robotically assisted myomectomy, for which no temporary clipping of the uterine arteries
and the utero-ovarian ligaments
Arm group label:
Control
Summary:
This study aims to investigate the efficacy of temporary clipping of the uterine artery
and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine
fibroids. While RAM is increasingly used for myomectomy, bleeding control remains
challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy
but has not been studied in RAM. This randomized controlled trial will assess primary
endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop,
alongside secondary outcomes like complication rates and operation time.
Detailed description:
Uterine fibroids, also known as myomas or leiomyomas, are benign smooth muscle neoplasms
of the uterus. Uterine fibroids are the most common neoplasms affecting women of
reproductive age (up to 70-80% at the age of 50)(1). As fibroids grow, they may induce
clinical problems such as menorrhagia, abdominal pain, or infertility.(2,3) Removal of
uterine fibroids (myomectomy) is a gynaecological surgical procedure performed most
frequently through laparotomy or minimally invasive surgery such as conventional
laparoscopic or robotically assisted surgery. Because of the straight-stick instruments
with limited degree of freedom, the excision and suturing of the myoma can be rather
cumbersome, not in the least because myomectomies may be associated with relatively
profuse peri-operative bloodloss. Owing to its enhanced 3D vision and wristed
instruments, robotically assisted surgery may be a more suitable surgical technique,
especially in the case of multiple myomas, large myomas or posterior localization.
Consequently, in recent years a gradual shift has been seen to the use of robotically
assisted myomectomies.
However, control of the bleeding during a myomectomy can be a challenge, even in the
hands of an experienced robotic surgeon. Various strategies have been developed to combat
this scenario; including rectal or IV misoprostol, intramyometrial injection of
bupivacaine with epinephrine or vasopressin, , tranexaminic acid IV or various ligation
strategies. There is moderate quality evidence for some of these interventions. Recently,
the use of clips to temporary occlude the uterine artery for myomectomy with conventional
laparoscopy for prevention of blood loss was validated in several studies, including 2
randomized controlled trials. To enhance hemostasis, recent articles described a
technique to temporary clip both the uterine artery and infundibulopelvic artery with
conventional laparoscopy, also resulting in fewer intra-operative bleeding compared to no
artery clipping. The possible benefit of these ligation technique has never been studied
in the setting of robotically-assisted myomectomies. On the one hand, RAM may involve
more complex cases due to myoma size, localization or multiple myomas, and on the other
hand, bleeding control may also be better with robotic surgery. This makes a prediction
of the usefulness of this technique difficult, in terms of reducing blood loss.
Estimated blood loss remains a difficult outcome to reliably quantify, especially when
using only visual parameters. During RAM, often only suction is used, making the
estimation easier in comparison to open surgery, for which a variety of compresses and
suction is used. This study will work with multiple primary endpoints, combining
estimated blood loss over 500 mL, the need for a peri-operative blood transfusion or a
hemoglobin drop exceeding 2 g/dL.
Other secondary outcomes will include complication rate, the operation time,
postoperative pain and the need for additional hemostatic measures. In the literature,
the risk of changes in ovarian reserve is also investigated, however it proved not
significant and this was only a theoretical risk in the context of temporary clipping the
infundibulopelvic artery, which is the main blood supply of the ovary. In this study,
which will involve temporary clipping the utero-ovarian ligmant, there is no risk for a
decrease in ovarian reserve.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participants eligible for inclusion in this Trial must meet all of the following
criteria:
1. Voluntary written informed consent of the participant or their legally authorized
representative has been obtained prior to any screening procedures
2. Use of highly effective methods of birth control; defined as those that, alone or in
combination, result in low failure rate (i.e., less than 1% per year) when used
consistently and correctly; such as implants, injectables, combined oral
contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual
intercourse during the entire period of risk associated with the Trial treatment(s))
or commitment to a vasectomised partner.
3. Female
4. Age: 18-50 years
5. Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas.
Exclusion Criteria:
Participants eligible for this Trial must not meet any of the following criteria:
1. Any disorder, which in the Investigator's opinion might jeopardise the participant's
safety or compliance with the protocol
2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety
or that would compromise the integrity of the Trial
3. Participation in an interventional Trial with an investigational medicinal product
(IMP) or device
4. Patient refusal to participate in the Trial
5. (Possible) malignancy
6. any contra indication for a laparoscopic or robotic surgery
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Wouter Froyman, MD, PhD
Phone:
+3216342612
Email:
wouter.froyman@uzleuven.be
Facility:
Name:
Department of Gynecology and Obstetrics, Hopital Bichat
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Martin Koskas, MD, PhD
Email:
martin.koskas@aphp.fr
Facility:
Name:
Service de gynécologie, Centre Hospitalier Universitaire de Rennes
Address:
City:
Rennes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Vincent Lavoué, MD, PhD
Facility:
Name:
Amsterdam UMC, locatie VUmc
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Robert De Leeuw, MD, PhD
Email:
r.a.deleeuw@amsterdamumc.nl
Start date:
May 4, 2023
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Collaborator:
Agency:
Bichat Hospital
Agency class:
Other
Collaborator:
Agency:
Rennes University Hospital
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06269809
