Bleeding Control Methods in Open Myomectomy

NCT07553091 | Completed

• 1 other identifier: VYYU-KHD-OK-12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Leiomyomas

Keywords

Myomectomy; Uterine artery; Tourniquet; Intraoperative Blood Salvage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative hemoglobin level

  24 and 48 hours after surgery

• Postoperative hematocrit level

  24 and 48 hours after surgery

• Operative time

  During surgery

Study Arms (3)

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.

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.

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.

Interventions

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.

Tourniquet group

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.

Bulldog clamp group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University Faculty of Medicine Hospital

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 27, 2026
• Study Start: December 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)