Bleeding Control Methods in Open Myomectomy

Yuzuncu Yil University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

Tourniquet applicationPROCEDURE

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

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: During Surgery

Secondary Outcomes

Postoperative hemoglobin level

Hemoglobin levels measured postoperatively to assess the impact of surgical technique on hematological status.

Time frame: 24 and 48 hours after surgery

Postoperative hematocrit level

Hematocrit levels measured postoperatively at 24 and 48 hours to assess changes in hematological status.

Time frame: 24 and 48 hours after surgery

Operative time

Total duration of surgery measured in minutes from skin incision to closure.

Time frame: During surgery