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

NCT07526311 | Recruiting DMC

• 1 other identifier: Cairo-MD-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myoma;Uterus; Blood Loss

Keywords

uterine artery ligation; peri cervical mechanical tourniquet; blood loss; myomectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need for blood transfusion

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

Study Arms (2)

Bilateral Uterine Artery Ligation

EXPERIMENTAL

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

Pericervical Mechanical Tourniquet

EXPERIMENTAL

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

Interventions

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.

Also known as: Uterine artery ligation

Bilateral 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

Also known as: Pericervical tourniquet, Foley catheter tourniquet

Pericervical Mechanical Tourniquet

Eligibility Criteria

• Age: 25 Years - 48 Years
• Gender Eligibility Details: Women scheduled for elective transabdominal myomectomy for symptomatic uterine fibroids will be recruited from the gynecology wards and outpatient clinics at Kasr Al-Ainy Hospital.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

Cairo University

Cairo, Al-Manial, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Myofibroma; Hemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maged Elmohamady Rashedy, MD

CONTACT

01090013685; Magedalmohamady50@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is designed as a double-blind randomized clinical trial. Participants will be blinded to the assigned hemostatic technique during transabdominal myomectomy. Randomization will be performed using computer-generated allocation with sequentially numbered opaque sealed envelopes, and the allocation code will be kept by an independent supervisor. Outcome assessment and postoperative data collection will be performed without disclosure of group assignment. The operating surgical team will perform the assigned procedure intraoperatively according to the randomization code.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Model Details: Participants will be randomized into 2 parallel groups undergoing transabdominal myomectomy. One group will receive bilateral uterine artery ligation before myoma enucleation, and the other group will receive pericervical mechanical tourniquet application before myoma enucleation. Outcomes will be compared between the 2 concurrently assigned groups.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 13, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): April 10, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)