Reducing Operative Blood Loss in Laparoscopic Myomectomy With Umbilico-uterine Trunk Clipping
1 other identifier
interventional
66
1 country
1
Brief Summary
the purpose of this study is to examine how Umbilico-uterine trunk occlusion reduces surgery-associated blood loss in Laparoscopic Myomectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2025
CompletedFirst Submitted
Initial submission to the registry
September 23, 2025
CompletedFirst Posted
Study publicly available on registry
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2026
CompletedOctober 7, 2025
October 1, 2025
6 months
September 23, 2025
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Operative Blood Loss
The difference between the total amount of irrigation and suction will be used to compute operational blood loss
during operation
Hemoglobin drop
The difference between the preoperative and postoperative hemoglobin levels will be used to define the hemoglobin change.
24 hours postoperative
Study Arms (2)
Group A
EXPERIMENTALparticipants will undergo umbilico-uterine trunk occlusion
Group B
ACTIVE COMPARATORparticipants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision
Interventions
participants will undergo umbilico-uterine trunk occlusion during laparoscopic myomectomy
participants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision during laparoscopic myomectomy
Eligibility Criteria
You may qualify if:
- Age between 19 and 45
- Symptoms of menorrhagia, pelvic pain, or infertility
- Plan to have a laparoscopic myomectomy
- Number of myomas ≤ 4, with the largest myoma measuring ≤ 9 cm
You may not qualify if:
- Postmenopausal status
- Dominant pedunculated subserosal FIGO classification (6-7)
- Submucosal type of myoma FIGO classification (0-2)
- Suspicion of malignant uterine or adnexal diseases
- Major medical comorbidities or psychiatric illnesses that could affect follow-up and/or compliance
- Refusal to participate or provide consent to the procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Minia advanced laparoscopy unit
Minya, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Obstetrics and Gynecology
Study Record Dates
First Submitted
September 23, 2025
First Posted
October 1, 2025
Study Start
September 11, 2025
Primary Completion
March 11, 2026
Study Completion
March 11, 2026
Last Updated
October 7, 2025
Record last verified: 2025-10