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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Loss; Myoma;Uterus
• Intervention / Treatment: Procedure: Bilateral Uterine Artery Ligation; Procedure: Pericervical Mechanical Tourniquet Application

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maged Elmohamady Rashedy, MD; Phone Number: 01090013685; Email: Magedalmohamady50@gmail.com

Study Locations

• Egypt
  • Al-Manial
    • Cairo, Al-Manial, Egypt, 11956
      • Recruiting
      • Cairo University
      • Contact: Abd el megeed Mahfouz Qasem, MD; Phone Number: +2 3649281; Email: scholar@cu.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral Uterine Artery Ligation; Participants assigned to this arm will undergo transabdominal myomectomy with bilateral uterine artery ligation performed before myoma enucleation. The uterine arteries will be identified bilaterally near the level of the internal cervical os and ligated using absorbable sutures to reduce uterine blood flow during surgery. Myoma enucleation and uterine repair will then be completed according to the study protocol.	Procedure: Bilateral Uterine Artery Ligation; 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
Experimental: Pericervical Mechanical Tourniquet; Participants assigned to this arm will undergo transabdominal myomectomy with application of a pericervical mechanical tourniquet before myoma enucleation. A sterile Foley catheter will be passed around the cervico-isthmic region at the level of the internal os and tied firmly to compress the uterine vessels during surgery. The tourniquet will remain in place throughout myoma enucleation and uterine repair and will be removed after completion of hemostasis.	Procedure: Pericervical Mechanical Tourniquet Application; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss	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.	During surgery and until drain removal on the second postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for blood transfusion	Number of participants requiring blood transfusion as an indicator of significant perioperative hemorrhage.	From surgery until hospital discharge, assessed up to 3 days.

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): April 10, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: blood loss; myomectomy; uterine artery ligation; peri cervical mechanical tourniquet
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemorrhage; Myofibroma
• Other Study ID Numbers: Cairo-MD-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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