Clinical trial NCT06269809: Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Official title: Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibroid Uterus
Keywords: myomectomy
fibroid
myoma
blood loss
temporary artery clipping
hemostatic measures
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Bichat Hospital
name: Rennes University Hospital
First posted: 2024-02-21
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric non-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Peri-operative blood loss: Estimated blood loss
timeFrame: 1 week
measure: Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL
timeFrame: 1 day
measure: Peri-operative blood loss: Need for peri-operative blood transfusion
timeFrame: 1 week
Secondary outcomes:
measure: Hospitalisation time
timeFrame: 6 weeks
measure: Operation time in minutes
timeFrame: 1 day
measure: Number of patients with complications postoperatively, graded by Clavien Dindo classification
timeFrame: 6 weeks
measure: Number of patients requiring secondary hemostatic measures
timeFrame: 1 day
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Paris
country: France
facility: Department of Gynecology and Obstetrics, Hopital Bichat
city: Rennes
country: France
facility: Service de gynécologie, Centre Hospitalier Universitaire de Rennes
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Wouter Froyman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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