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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tourniquet application | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hemoglobin level | Hemoglobin levels measured postoperatively to assess the impact of surgical technique on hematological status. | 24 and 48 hours after surgery |
| Postoperative hematocrit level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yüzüncü Yıl University Faculty of Medicine Hospital | Van | Tuşba | 65080 | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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.
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Due to the nature of the surgical interventions, blinding of participants and care providers was not feasible. However, outcome assessors and data analysts were blinded to group allocation.
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| Uterine artery bulldog clamp | Procedure | 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. |
|
Hematocrit levels measured postoperatively at 24 and 48 hours to assess changes in hematological status.
| 24 and 48 hours after surgery |
| Operative time | Total duration of surgery measured in minutes from skin incision to closure. | During surgery |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |