Uterine Leiomyomas
Conditions
Keywords
Myomectomy, Uterine artery, Tourniquet, Intraoperative Blood Salvage
Brief 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. 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.
Interventions
PROCEDURETourniquet application
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.
PROCEDUREUterine artery bulldog clamp
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.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hemoglobin level | 24 and 48 hours after surgery | Hemoglobin levels measured postoperatively to assess the impact of surgical technique on hematological status. |
| Postoperative hematocrit level | 24 and 48 hours after surgery | Hematocrit levels measured postoperatively at 24 and 48 hours to assess changes in hematological status. |
| Operative time | During surgery | Total duration of surgery measured in minutes from skin incision to closure. |
Countries
Turkey (Türkiye)
Outcome results
None listed