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NCT Number: NCT07526311

Reducing Blood Loss During Myomectomy:Uterine Artery Ligation Vs Pericervical Tourniquet

The goal of this clinical trial is to compare two surgical techniques for reducing blood loss during transabdominal myomectomy in women with symptomatic uterine fibroids. The main question it aims to answer is whether bilateral uterine artery ligation reduces intraoperative blood loss more effectively than pericervical mechanical tourniquet application, without increasing operative complications. Researchers will compare bilateral uterine artery ligation with pericervical mechanical tourniquet application during open myomectomy to evaluate blood loss and surgical safety. Participants will undergo elective transabdominal myomectomy and will be randomly assigned to one of the two vascular control techniques before myoma enucleation.

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Key information

Age range

25 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Al-Manial, 11956, Egypt

Location status: Recruiting

Location contact

Abd el megeed Mahfouz Qasem, MD

CONTACT

[email protected]

+2 3649281

About this study

Uterine fibroids are among the most common benign gynecologic tumors and may cause heavy menstrual bleeding, pelvic pain, pressure symptoms, infertility, and other reproductive problems. For women who desire uterine preservation, myomectomy remains an important treatment option. In patients with large, multiple, or deeply located fibroids, transabdominal myomectomy is still widely performed. However, one of its major challenges is significant intraoperative bleeding, which may increase operative difficulty, prolong surgery, increase postoperative morbidity, and raise the need for blood transfusion.

Several methods have been used to reduce bleeding during myomectomy. Among the commonly used surgical approaches are bilateral uterine artery ligation and pericervical mechanical tourniquet application. Bilateral uterine artery ligation reduces uterine arterial inflow before myoma enucleation and may provide sustained hemostasis during surgery. Pericervical tourniquet application is a simple mechanical method that temporarily compresses the uterine vessels at the cervico-isthmic level during the procedure. Although both techniques are used in practice, comparative evidence remains limited, and further evaluation is needed to determine the more effective and safe method for blood loss reduction during fertility-sparing surgery.

This study is a prospective, randomized, comparative clinical trial conducted at the Department of Obstetrics and Gynecology, Kasr Al-Ainy Hospital, Cairo University, Egypt. Women scheduled for elective transabdominal myomectomy for symptomatic uterine fibroids will be recruited and randomized into two parallel groups. One group will undergo bilateral uterine artery ligation before myoma enucleation, while the other group will undergo pericervical mechanical tourniquet application using a Foley catheter at the level of the internal os before myoma enucleation. All procedures will be performed by the same experienced surgical team under standardized perioperative conditions to reduce inter-operator variability.

During surgery, after the assigned vascular control technique is applied, myoma enucleation and uterine repair will proceed according to a standardized operative technique. Blood loss assessment will include intraoperative blood loss measured from surgical swabs and suctioned blood, as well as postoperative blood loss measured from the intraperitoneal drain. The trial is designed to determine whether bilateral uterine artery ligation provides superior hemostatic control compared with pericervical mechanical tourniquet application, while also evaluating perioperative safety and recovery outcomes.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • Female participants aged 25 to 48 years
  • Body mass index less than 35 kg/m²
  • Symptomatic uterine myomas requiring surgical treatment
  • Intramural myomas classified as FIGO types 3 to 6
  • Diagnosis confirmed by transvaginal ultrasound and/or magnetic resonance imaging
  • Maximum diameter of the largest myoma 20 cm or less
  • Scheduled for elective transabdominal myomectomy
  • Able and willing to provide written informed consent
  • Exclusion Criteria:
  • Submucosal, intracavitary, pedunculated subserosal, cervical, or adnexal myomas
  • FIGO types 0, 1, 2, 7, or 8 myomas
  • History of pelvic inflammatory disease or peritonitis
  • Previous abdominal or pelvic surgery for non-obstetric causes
  • Previous uterine surgery
  • Use of hormonal therapy within the previous 3 months
  • Known bleeding disorder
  • Use of anticoagulant or antiplatelet therapy
  • Preoperative hemoglobin less than 10 g/dL
  • Body mass index 35 kg/m² or greater
  • Intraoperative conversion from myomectomy to hysterectomy

Treatment and study plan

Bilateral uterine artery ligation

Procedure

A surgical hemostatic procedure performed before myoma enucleation during transabdominal myomectomy to reduce uterine arterial blood flow and intraoperative bleeding. Bilateral ligation is carried out at the level of the internal cervical os using absorbable sutures as part of the assigned vascular control technique.

Other names: Uterine artery ligation

Pericervical Mechanical Tourniquet Application

Procedure

A temporary mechanical vascular control technique performed before myoma enucleation during transabdominal myomectomy to reduce uterine blood flow and intraoperative bleeding. A sterile Foley catheter is placed around the cervico-isthmic region at the level of the internal os and removed after uterine repair and hemostasis are completed

Other names: Pericervical tourniquet, Foley catheter tourniquet

Primary outcomes

  1. Estimated blood loss

    Time frame: During surgery and until drain removal on the second postoperative day

    Total blood loss measured as the sum of intraoperative blood loss and postoperative blood loss. Intraoperative blood loss will be assessed by weighing surgical swabs and measuring suctioned blood volume, while postoperative blood loss will be measured from the intraperitoneal drain.

Secondary outcomes

  1. Need for blood transfusion

    Time frame: From surgery until hospital discharge, assessed up to 3 days.

    Number of participants requiring blood transfusion as an indicator of significant perioperative hemorrhage.

Study contacts

Contact information is provided by the study sponsor or research team.

Maged Elmohamady Rashedy, MD

CONTACT

[email protected]

01090013685

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kafrelsheikh University

Registry information

Official study title

Bilateral Uterine Artery Ligation Versus Pericervical Mechanical Tourniquet Application in Reducing Intraoperative Blood Loss During Transabdominal Myomectomy.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 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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