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OpenTrials
Completed

NCT Number: NCT07553091

Bleeding Control Methods in Open Myomectomy

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Van Yüzüncü Yıl University Faculty of Medicine Hospital

Van, Tuşba, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Intraoperative blood loss

    Time frame: 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 outcomes

  1. Postoperative hemoglobin level

    Time frame: 24 and 48 hours after surgery

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

  2. Postoperative hematocrit level

    Time frame: 24 and 48 hours after surgery

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

  3. Operative time

    Time frame: During surgery

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

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Effects of Different Intraoperative Bleeding Control Methods on Haematological Outcomes and the Amount of Bleeding in Open Myomectomy: A Prospective Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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