Reducing Blood Loss During Myomectomy:Uterine Artery Ligation Vs Pericervical Tourniquet
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-48
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bilateral Uterine Artery Ligation
Procedure/SurgeryA 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.
Pericervical Mechanical Tourniquet Application
Procedure/SurgeryA 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Bilateral Uterine Artery LigationExperimental treatment 1 intervention
Group B: Pericervical Mechanical TourniquetExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
During surgery and until drain removal on the second postoperative daySecondary outcomes
1
Need for blood transfusion
Number of participants requiring blood transfusion as an indicator of significant perioperative hemorrhage.
Time frame
From surgery until hospital discharge, assessed up to 3 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cairo University
Lead sponsor
Kafrelsheikh University
Collaborator
Source ClinicalTrials.gov