Bleeding Control Methods in Open Myomectomy

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.

Study Overview

• Status: Completed
• Conditions: Uterine Leiomyomas
• Intervention / Treatment: Procedure: Tourniquet application; Procedure: Uterine artery bulldog clamp

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Tuşba
    • Van, Tuşba, Turkey (Türkiye), 65080
      • Van Yüzüncü Yıl University Faculty of Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tourniquet group; 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.	Procedure: Tourniquet 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.
Experimental: Bulldog clamp group; Participants undergoing open myomectomy in whom bilateral uterine arteries were dissected and temporarily occluded using bulldog clamps during surgery to control intraoperative bleeding.	Procedure: Uterine 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.
No Intervention: No-compression group; Participants undergoing open myomectomy without the use of any mechanical or surgical compression technique for uterine arteries; standard surgical procedures were applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Yuzuncu Yil University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Myomectomy; Tourniquet; Uterine artery; Intraoperative Blood Salvage
• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Skin and Connective Tissue Diseases; Myofibroma
• Other Study ID Numbers: VYYU-KHD-OK-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No