Uterine LeiomyomasNCT07553091
Bleeding Control Methods in Open Myomectomy
A study testing Tourniquet application and Uterine artery bulldog clamp in people with Uterine Leiomyomas, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Excessive intraoperative bleeding remains a major challenge during open myomectomy and may lead to postoperative anemia and increased morbidity. Numerous methods have been proposed to minimize hemorrhage; however, evidence regarding their effectiveness in open surgery remains limited. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Leiomyomas
- What is being tested?
- Tourniquet application and Uterine artery bulldog clamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 18 and 50 years
- Diagnosis of symptomatic uterine leiomyoma
- Planned abdominal (open) myomectomy
- No additional surgical procedure performed during the operation
- Availability of complete preoperative and postoperative laboratory data
Who cannot join
- Pregnancy or suspected pregnancy
- Presence of more than 7 myomas
- Suspicion or diagnosis of uterine malignancy
- History of coagulopathy or use of anticoagulant/antiplatelet therapy
- Preoperative blood transfusion
- Concomitant major surgical procedures (e.g., hysterectomy or adnexal surgery)
- History of previous myomectomy
- Incomplete laboratory or clinical data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University Faculty of Medicine Hospital
Van, Tuşba, 65080
About this study
Official title: Effects of Different Intraoperative Bleeding Control Methods on Haematological Outcomes and the Amount of Bleeding in Open Myomectomy: A Prospective Randomized Controlled Study
Excessive intraoperative bleeding remains a major challenge during open myomectomy and may lead to postoperative anemia and increased morbidity. Numerous methods have been proposed to minimize hemorrhage; however, evidence regarding their effectiveness in open surgery remains limited.
This prospective randomized controlled trial aims to evaluate the effects of tourniquet application, uterine artery bulldog clamping, and no-compression techniques on intraoperative blood loss and postoperative hematological parameters in patients undergoing open myomectomy.
A total of 120 patients undergoing open myomectomy will be randomly assigned to three groups: tourniquet group (n = 40), uterine artery bulldog clamp group (n = 40), and no-compression group (n = 40). The primary outcome is intraoperative blood loss. Secondary outcomes include hemoglobin (Hb) and hematocrit (Hct) levels at 24 and 48 hours postoperatively. Myoma volume will be calculated using the spherical formula based on the maximum myoma diameter. Statistical analyses will be performed using one-way analysis of variance (ANOVA) or the Kruskal-Wallis test, as appropriate.
Read the detailed description
This prospective randomized controlled trial aims to evaluate the effectiveness of different intraoperative bleeding control techniques during open myomectomy. Uterine leiomyomas are highly vascular tumors, and excessive intraoperative bleeding remains a major challenge, potentially leading to postoperative anemia and increased morbidity.
Various strategies have been developed to reduce intraoperative blood loss, including mechanical and surgical methods aimed at temporarily reducing uterine arterial blood flow. However, most available evidence focuses on minimally invasive approaches, and data regarding open myomectomy remain limited.
In this study, patients undergoing open myomectomy will be randomized into three groups according to the intraoperative bleeding control method: tourniquet application, bilateral uterine artery occlusion using bulldog clamps, and no compression. All procedures will be performed using a standardized surgical technique.
The study aims to compare these techniques in terms of intraoperative blood loss and postoperative hematological parameters.
- Conditions
- Uterine Leiomyomas
- Being tested
- Tourniquet application, Uterine artery bulldog clamp
- Keywords
- Myomectomy, Uterine artery, Tourniquet, Intraoperative Blood Salvage
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet applicationProcedure or surgery
Application of an elastic surgical tourniquet at the level of the lower uterine segment/cervix during open myomectomy to temporarily reduce uterine arterial blood flow. The tourniquet was maintained throughout myoma enucleation and released after completion of uterine repair.
Uterine artery bulldog clampProcedure or surgery
Bilateral uterine arteries were surgically identified and temporarily occluded using bulldog vascular clamps during open myomectomy. The clamps were applied prior to myoma enucleation and removed after uterine repair to restore uterine perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet group | Experimental | Participants undergoing open myomectomy in whom an elastic surgical tourniquet was applied at the level of the lower uterine segment/cervix to temporarily reduce uterine blood flow during surgery. Receives: Procedure: Tourniquet application |
| Bulldog clamp group | Experimental | Participants undergoing open myomectomy in whom bilateral uterine arteries were dissected and temporarily occluded using bulldog clamps during surgery to control intraoperative bleeding. Receives: Procedure: Uterine artery bulldog clamp |
| No-compression group | No intervention | Participants undergoing open myomectomy without the use of any mechanical or surgical compression technique for uterine arteries; standard surgical procedures were applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Intraoperative blood loss measured in milliliters by calculating the difference between the weight of dry and blood-soaked surgical materials and the volume of blood collected in the suction canister.
Measured: During Surgery
Secondary outcomes (3)
Postoperative hemoglobin level
Hemoglobin levels measured postoperatively to assess the impact of surgical technique on hematological status.
Measured: 24 and 48 hours after surgery
Postoperative hematocrit level
Hematocrit levels measured postoperatively at 24 and 48 hours to assess changes in hematological status.
Measured: 24 and 48 hours after surgery
Operative time
Total duration of surgery measured in minutes from skin incision to closure.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 Dec 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine LeiomyomasStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a prospective, randomized, parallel-group controlled trial. Participants were randomly assigned in a 1:1:1 ratio to one of three groups according to the intraoperative bleeding control method: tourniquet application, bilateral uterine artery occlusion using bulldog clamps, or no compression. Each participant received only one intervention, and no crossover between groups occurred.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Karaaslan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553091
- Sponsor's protocol ID
- VYYU-KHD-OK-12
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality concerns and the relatively small sample size, which may increase the risk of participant identification. Data may be available from the corresponding author upon reasonable request and with appropriate ethical approval.
Publications
Kara U, Karaaslan O. Uterine artery bulldog clamping versus tourniquet for reducing blood loss in open myomectomy: a randomized controlled trial. Sci Rep. 2026 Aug 4;16(1):27388. doi: 10.1038/s41598-026-64820-1.
PubMed 42680787
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Intraoperative Bleeding Control Methods on Haematological Outcomes and the Amount of Bleeding in Open Myomectomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07553091
- Acronym / sponsor ID
- VYYU-KHD-OK-12
- Conditions
- Uterine Leiomyomas
- Keywords
- Myomectomy, Uterine artery, Tourniquet, Intraoperative Blood Salvage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 27 Apr 2026 (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.
Excessive intraoperative bleeding remains a major challenge during open myomectomy and may lead to postoperative anemia and increased morbidity. Numerous methods have been proposed to minimize hemorrhage; however, evidence regarding their effectiveness in open surgery remains limited.
This prospective randomized controlled trial aims to evaluate the effects of tourniquet application, uterine artery bulldog clamping, and no-compression techniques on intraoperative blood loss and postoperative hematological parameters in patients undergoing open myomectomy.
A total of 120 patients undergoing open myomectomy will be randomly assigned to three groups: tourniquet group (n = 40), uterine artery bulldog clamp group (n = 40), and no-compression group (n = 40). The primary outcome is intraoperative blood loss. Secondary outcomes include hemoglobin (Hb) and hematocrit (Hct) levels at 24 and 48 hours postoperatively. Myoma volume will be calculated using the spherical formula based on the maximum myoma diameter. Statistical analyses will be performed using one-way analysis of variance (ANOVA) or the Kruskal-Wallis test, as appropriate.
Detailed description
This prospective randomized controlled trial aims to evaluate the effectiveness of different intraoperative bleeding control techniques during open myomectomy. Uterine leiomyomas are highly vascular tumors, and excessive intraoperative bleeding remains a major challenge, potentially leading to postoperative anemia and increased morbidity.
Various strategies have been developed to reduce intraoperative blood loss, including mechanical and surgical methods aimed at temporarily reducing uterine arterial blood flow. However, most available evidence focuses on minimally invasive approaches, and data regarding open myomectomy remain limited.
In this study, patients undergoing open myomectomy will be randomized into three groups according to the intraoperative bleeding control method: tourniquet application, bilateral uterine artery occlusion using bulldog clamps, and no compression. All procedures will be performed using a standardized surgical technique.
The study aims to compare these techniques in terms of intraoperative blood loss and postoperative hematological parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study was designed as a prospective, randomized, parallel-group controlled trial. Participants were randomly assigned in a 1:1:1 ratio to one of three groups according to the intraoperative bleeding control method: tourniquet application, bilateral uterine artery occlusion using bulldog clamps, or no compression. Each participant received only one intervention, and no crossover between groups occurred.
| Arm | Type | Receives |
|---|---|---|
| Tourniquet group | Experimental | Procedure: Tourniquet applicationParticipants undergoing open myomectomy in whom an elastic surgical tourniquet was applied at the level of the lower uterine segment/cervix to temporarily reduce uterine blood flow during surgery. |
| Bulldog clamp group | Experimental | Procedure: Uterine artery bulldog clampParticipants undergoing open myomectomy in whom bilateral uterine arteries were dissected and temporarily occluded using bulldog clamps during surgery to control intraoperative bleeding. |
| No-compression group | No intervention | –Participants undergoing open myomectomy without the use of any mechanical or surgical compression technique for uterine arteries; standard surgical procedures were applied. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged between 18 and 50 years
- Diagnosis of symptomatic uterine leiomyoma
- Planned abdominal (open) myomectomy
- No additional surgical procedure performed during the operation
- Availability of complete preoperative and postoperative laboratory data
Key exclusion criteria (8 listed)
- Pregnancy or suspected pregnancy
- Presence of more than 7 myomas
- Suspicion or diagnosis of uterine malignancy
- History of coagulopathy or use of anticoagulant/antiplatelet therapy
- Preoperative blood transfusion
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 |
|---|---|---|
| Tourniquet applicationApplication of an elastic surgical tourniquet at the level of the lower uterine segment/cervix during open myomectomy to temporarily reduce uterine arterial blood flow. The tourniquet was maintained throughout myoma enucleation and released after completion of uterine repair. | Procedure or surgery | Tourniquet group |
| Uterine artery bulldog clampBilateral uterine arteries were surgically identified and temporarily occluded using bulldog vascular clamps during open myomectomy. The clamps were applied prior to myoma enucleation and removed after uterine repair to restore uterine perfusion. | Procedure or surgery | Bulldog clamp group |
Primary outcome
Intraoperative blood loss
Time frame: During Surgery
Intraoperative blood loss measured in milliliters by calculating the difference between the weight of dry and blood-soaked surgical materials and the volume of blood collected in the suction canister.
3 secondary outcomes
Postoperative hemoglobin level
Time frame: 24 and 48 hours after surgery
Postoperative hematocrit level
Time frame: 24 and 48 hours after surgery
Operative time
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42680787Kara U, Karaaslan O. Uterine artery bulldog clamping versus tourniquet for reducing blood loss in open myomectomy: a randomized controlled trial. Sci Rep. 2026 Aug 4;16(1):27388. doi: 10.1038/s41598-026-64820-1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality concerns and the relatively small sample size, which may increase the risk of participant identification. Data may be available from the corresponding author upon reasonable request and with appropriate ethical approval.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet application and Uterine artery bulldog clamp in people with Uterine Leiomyomas, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: During Surgery). 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 NCT07553091, which also lists 1 linked publication.
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 27 Apr 2026.