Fibroid UterusTACROMNCT06269809
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
A study testing Temporary clipping of the uterine arteries and the utero-ovarian ligmants. and No temporary clipping of the uterine arteries and the utero-ovarian ligmants. in people with Fibroid Uterus, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroid Uterus
- What is being tested?
- Temporary clipping of the uterine arteries and the utero-ovarian ligmants. and No temporary clipping of the uterine arteries and the utero-ovarian ligmants.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 4 May 2023to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion in this Trial must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 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.
- Female
- Age: 18-50 years
- Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas.
Who cannot join
- Participants eligible for this Trial must not meet any of the following criteria:
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Patient refusal to participate in the Trial
- (Possible) malignancy
- any contra indication for a laparoscopic or robotic surgery
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
France2 sites, 2 recruiting
- Not yet recruiting
Department of Gynecology and Obstetrics, Hopital Bichat
Paris
Martin Koskas, MD, PhD, martin.koskas@aphp.fr
- Not yet recruiting
Service de gynécologie, Centre Hospitalier Universitaire de Rennes
Rennes
Vincent Lavoué, MD, PhD
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Wouter Froyman, MD, PhD, +3216342612, wouter.froyman@uzleuven.be
Netherlands1 site, 1 recruiting
- Not yet recruiting
Amsterdam UMC, locatie VUmc
Amsterdam
Robert De Leeuw, MD, PhD, r.a.deleeuw@amsterdamumc.nl
About this study
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.
Read the 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.
- Conditions
- Fibroid Uterus
- Being tested
- Temporary clipping of the uterine arteries and the utero-ovarian ligmants., No temporary clipping of the uterine arteries and the utero-ovarian ligmants.
- Keywords
- myomectomy, fibroid, myoma, blood loss, temporary artery clipping, hemostatic measures
- Medical subject headings
- Leiomyoma, Myoma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary clipping of the uterine arteries and the utero-ovarian ligmants.Procedure or surgery
Temporary clipping of the uterine arteries and the utero-ovarian ligaments using laparoscopic clips/bulldog clamps, during robotically assisted myomectomy.
No temporary clipping of the uterine arteries and the utero-ovarian ligmants.Procedure or surgery
Robotically assisted myomectomy, for which no temporary clipping of the uterine arteries and the utero-ovarian ligaments
| Study group | Role | What they receive |
|---|---|---|
| Temporary artery clipping | Experimental | Patients undergoing a robotically-assisted myomectomies, with temporary clipping of the uterine arteries and the utero-ovarian ligmants. Receives: Procedure: Temporary clipping of the uterine arteries and the utero-ovarian ligmants. |
| Control | Active comparator | Patients undergoing a robotically-assisted myomectomies, without temporary clipping of the uterine arteries and the utero-ovarian ligmants. Receives: Procedure: No temporary clipping of the uterine arteries and the utero-ovarian ligmants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative blood loss: Estimated blood loss
Multiple primary endpoints will be used to asses the blood loss:
- Estimated blood loss >500 mL
Measured: 1 week
Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL
Multiple primary endpoints will be used to asses the blood loss:
- Hemoglobin drop perioperatively >2g/dL (difference between hemoglobin preoperatively and postoperatively)
Measured: 1 day
Peri-operative blood loss: Need for peri-operative blood transfusion
Multiple primary endpoints will be used to asses the blood loss:
- Need for peri-operative blood transfusion
Measured: 1 week
Secondary outcomes (4)
Hospitalisation time
Number of postoperative nights the patient had to stay in the hospital.
Measured: 6 weeks
Operation time in minutes
Total surgical time, from the completion of anesthesia induction untill the end of surgery (in minutes)
Measured: 1 day
Number of patients with complications postoperatively, graded by Clavien Dindo classification
The Clavien Dindo classification is a validated tool to quantitatively assess postoperative complications.
Grade 0: No complications Grade 1: Any deviation from normal postoperative course, without requiring intervention Grade 2: Requiring pharmacological treatment Grade 3: Requiring surgical, endoscopic or radiological intervention Grade 4: Life-treathening complication requiring intermediate or intensive care Grade 5: Death of a patient
Measured: 6 weeks
Number of patients requiring secondary hemostatic measures
Was there a need for non-routine hemostatic measures, such as:
- Tranexamic acid
- Misoprostol
- Oxytocin
- Embolisation
- Local application of sealant patch or glue (e.g TachoSil or Tisseel)
- Hysterectomy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start4 May 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric non-blinded randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Bichat Hospital, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Wouter Froyman, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269809
- Sponsor's protocol ID
- s67279
- Acronym
- TACROM
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams VS, Jones G, Mauskopf J, Spalding J, DuChane J. Uterine fibroids: a review of health-related quality of life assessment. J Womens Health (Larchmt). 2006 Sep;15(7):818-29. doi: 10.1089/jwh.2006.15.818.
PubMed 16999637Pritts, E. A., & Olive, D. L. (2012). When Should Uterine Fibroids Be Treated? Current Obstetrics and Gynecology Reports. https://doi.org/10.1007/s13669-012-0010-y
Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017 Sep;124(10):1501-1512. doi: 10.1111/1471-0528.14640. Epub 2017 May 13.
PubMed 28296146Aendekerk, S., Verguts, J., Housmans, S., & Timmerman, D. (2019). Implementing robotic assisted myomectomy in surgical practice - a retrospective cohort study. Gynecological Surgery. https://doi.org/10.1186/s10397-019-1059-7
Herrinton LJ, Raine-Bennett T, Liu L, Alexeeff SE, Ramos W, Suh-Burgmann B. Outcomes of Robotic Hysterectomy for Treatment of Benign Conditions: Influence of Patient Complexity. Perm J. 2020;24:19.035. doi: 10.7812/TPP/19.035. Epub 2019 Dec 18.
PubMed 31905335Winter ML, Leu SY, Lagrew DC Jr, Bustillo G. Cost comparison of robotic-assisted laparoscopic hysterectomy versus standard laparoscopic hysterectomy. J Robot Surg. 2015 Dec;9(4):269-75. doi: 10.1007/s11701-015-0526-z. Epub 2015 Jul 30.
PubMed 26530837Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.
PubMed 25125317Ji L, Jin L, Hu M. Laparoscopic Myomectomy with Temporary Bilateral Uterine Artery Occlusion Compared with Traditional Surgery for Uterine Myomas: Blood Loss and Recurrence. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):434-439. doi: 10.1016/j.jmig.2017.06.032. Epub 2017 Sep 21.
PubMed 28943191Vercellino G, Erdemoglu E, Joe A, Hopfenmueller W, Holthaus B, Kohler C, Schneider A, Hasenbein K, Chiantera V. Laparoscopic temporary clipping of uterine artery during laparoscopic myomectomy. Arch Gynecol Obstet. 2012 Nov;286(5):1181-6. doi: 10.1007/s00404-012-2419-y. Epub 2012 Jun 20.
PubMed 22714065Hiratsuka D, Isono W, Tsuchiya A, Okamura A, Fujimoto A, Nishii O. The effect of temporary uterine artery ligation on laparoscopic myomectomy to reduce intraoperative blood loss: A retrospective case-control study. Eur J Obstet Gynecol Reprod Biol X. 2022 Aug 8;15:100162. doi: 10.1016/j.eurox.2022.100162. eCollection 2022 Aug.
PubMed 36035234Kim HC, Song T. Temporary simultaneous two-arterial occlusion for reducing operative blood loss during laparoscopic myomectomy: a randomized controlled trial. Surg Endosc. 2019 Jul;33(7):2114-2120. doi: 10.1007/s00464-018-6482-8. Epub 2018 Oct 17.
PubMed 30334154Coll S, Feliu S, Montero C, Pellise-Tintore M, Tresserra F, Rodriguez I, Barri-Soldevila PN. Evolution of laparoscopic myomectomy and description of two hemostatic techniques in a large teaching gynecological center. Eur J Obstet Gynecol Reprod Biol. 2021 Oct;265:181-189. doi: 10.1016/j.ejogrb.2021.08.023. Epub 2021 Aug 26.
PubMed 34509877Rothermel LD, Lipman JM. Estimation of blood loss is inaccurate and unreliable. Surgery. 2016 Oct;160(4):946-953. doi: 10.1016/j.surg.2016.06.006. Epub 2016 Aug 17.
PubMed 27544540Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06269809
- Acronym / sponsor ID
- TACROM / s67279
- Conditions
- Fibroid Uterus
- Keywords
- myomectomy, fibroid, myoma, blood loss, temporary artery clipping, hemostatic measures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Bichat Hospital, Rennes University Hospital
- Study start
- 4 May 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric non-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Temporary artery clipping | Experimental | Procedure: Temporary clipping of the uterine arteries and the utero-ovarian ligmants.Patients undergoing a robotically-assisted myomectomies, with temporary clipping of the uterine arteries and the utero-ovarian ligmants. |
| Control | Active comparator | Procedure: No temporary clipping of the uterine arteries and the utero-ovarian ligmants.Patients undergoing a robotically-assisted myomectomies, without temporary clipping of the uterine arteries and the utero-ovarian ligmants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants eligible for inclusion in this Trial must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 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.
- Female
- Age: 18-50 years
Key exclusion criteria (7 listed)
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Patient refusal to participate in the Trial
- (Possible) malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary clipping of the uterine arteries and the utero-ovarian ligmants.Temporary clipping of the uterine arteries and the utero-ovarian ligaments using laparoscopic clips/bulldog clamps, during robotically assisted myomectomy. | Procedure or surgery | Temporary artery clipping |
| No temporary clipping of the uterine arteries and the utero-ovarian ligmants.Robotically assisted myomectomy, for which no temporary clipping of the uterine arteries and the utero-ovarian ligaments | Procedure or surgery | Control |
Primary outcome
Peri-operative blood loss: Estimated blood loss
Time frame: 1 week
Multiple primary endpoints will be used to asses the blood loss: - Estimated blood loss >500 mL
Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL
Time frame: 1 day
Multiple primary endpoints will be used to asses the blood loss: - Hemoglobin drop perioperatively >2g/dL (difference between hemoglobin preoperatively and postoperatively)
Peri-operative blood loss: Need for peri-operative blood transfusion
Time frame: 1 week
Multiple primary endpoints will be used to asses the blood loss: - Need for peri-operative blood transfusion
4 secondary outcomes
Hospitalisation time
Time frame: 6 weeks
Operation time in minutes
Time frame: 1 day
Number of patients with complications postoperatively, graded by Clavien Dindo classification
Time frame: 6 weeks
Number of patients requiring secondary hemostatic measures
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 16999637Williams VS, Jones G, Mauskopf J, Spalding J, DuChane J. Uterine fibroids: a review of health-related quality of life assessment. J Womens Health (Larchmt). 2006 Sep;15(7):818-29. doi: 10.1089/jwh.2006.15.818.
- BackgroundPritts, E. A., & Olive, D. L. (2012). When Should Uterine Fibroids Be Treated? Current Obstetrics and Gynecology Reports. https://doi.org/10.1007/s13669-012-0010-y
- Background: PubMed 28296146Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017 Sep;124(10):1501-1512. doi: 10.1111/1471-0528.14640. Epub 2017 May 13.
- BackgroundAendekerk, S., Verguts, J., Housmans, S., & Timmerman, D. (2019). Implementing robotic assisted myomectomy in surgical practice - a retrospective cohort study. Gynecological Surgery. https://doi.org/10.1186/s10397-019-1059-7
- Background: PubMed 31905335Herrinton LJ, Raine-Bennett T, Liu L, Alexeeff SE, Ramos W, Suh-Burgmann B. Outcomes of Robotic Hysterectomy for Treatment of Benign Conditions: Influence of Patient Complexity. Perm J. 2020;24:19.035. doi: 10.7812/TPP/19.035. Epub 2019 Dec 18.
- Background: PubMed 26530837Winter ML, Leu SY, Lagrew DC Jr, Bustillo G. Cost comparison of robotic-assisted laparoscopic hysterectomy versus standard laparoscopic hysterectomy. J Robot Surg. 2015 Dec;9(4):269-75. doi: 10.1007/s11701-015-0526-z. Epub 2015 Jul 30.
- Background: PubMed 25125317Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.
- Background: PubMed 28943191Ji L, Jin L, Hu M. Laparoscopic Myomectomy with Temporary Bilateral Uterine Artery Occlusion Compared with Traditional Surgery for Uterine Myomas: Blood Loss and Recurrence. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):434-439. doi: 10.1016/j.jmig.2017.06.032. Epub 2017 Sep 21.
- Background: PubMed 22714065Vercellino G, Erdemoglu E, Joe A, Hopfenmueller W, Holthaus B, Kohler C, Schneider A, Hasenbein K, Chiantera V. Laparoscopic temporary clipping of uterine artery during laparoscopic myomectomy. Arch Gynecol Obstet. 2012 Nov;286(5):1181-6. doi: 10.1007/s00404-012-2419-y. Epub 2012 Jun 20.
- Background: PubMed 36035234Hiratsuka D, Isono W, Tsuchiya A, Okamura A, Fujimoto A, Nishii O. The effect of temporary uterine artery ligation on laparoscopic myomectomy to reduce intraoperative blood loss: A retrospective case-control study. Eur J Obstet Gynecol Reprod Biol X. 2022 Aug 8;15:100162. doi: 10.1016/j.eurox.2022.100162. eCollection 2022 Aug.
- Background: PubMed 30334154Kim HC, Song T. Temporary simultaneous two-arterial occlusion for reducing operative blood loss during laparoscopic myomectomy: a randomized controlled trial. Surg Endosc. 2019 Jul;33(7):2114-2120. doi: 10.1007/s00464-018-6482-8. Epub 2018 Oct 17.
- Background: PubMed 34509877Coll S, Feliu S, Montero C, Pellise-Tintore M, Tresserra F, Rodriguez I, Barri-Soldevila PN. Evolution of laparoscopic myomectomy and description of two hemostatic techniques in a large teaching gynecological center. Eur J Obstet Gynecol Reprod Biol. 2021 Oct;265:181-189. doi: 10.1016/j.ejogrb.2021.08.023. Epub 2021 Aug 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wouter Froyman, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary clipping of the uterine arteries and the utero-ovarian ligmants. and No temporary clipping of the uterine arteries and the utero-ovarian ligmants. in people with Fibroid Uterus, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Timmerman, MD (+3216348826, stefan.timmerman@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-operative blood loss: Estimated blood loss (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06269809, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.