Enhanced Myometrial Vascularity
Conditions
Brief summary
This study aims to address this knowledge gap by conducting a randomized active-controlled trial comparing laparoscopic umbilico-uterine trunk clipping with Mirena Intrauterine Device Insertion (an active treatment method chosen and justified based on current clinical practice) in reducing monthly menstrual blood loss in women with enhanced myometrial vascularity. By providing reliable data on clinical efficacy and patient-related outcomes, this study can contribute to guiding clinical decision-making and improving the care of women with this condition.
Interventions
PROCEDURELaparoscopic Umbilico-uterine trunk Clipping Approach
1. Patient preparation. 2. Laparoscopic technique. 3. Identification and clipping of the umbilico-uterine trunk. 4. Post-operative care.
PROCEDUREMirena Intrauterine Device Insertion
Mirena Intrauterine Device Insertion is considered the current standard of care or a relevant alternative
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of Enhanced Myometrial Vascularity. 2. Presence of clinical symptoms related to Enhanced Myometrial Vascularity: Such as menorrhagia affecting quality of life, or abnormal uterine bleeding (AUB) unresponsive to initial medical treatments. 3. Women of reproductive age (18-45 years). 4. Willingness to undergo surgical treatment: Participants must be willing to undergo one of the two surgical procedures under investigation (laparoscopic umbilico-uterine trunk clipping or Mirena Intrauterine Device Insertion). 5. Written informed consent: Participants must be able to understand the study information and provide written informed consent to participate. 6. Adequate general health to undergo anesthesia and laparoscopic surgery: This will be assessed by the responsible physician
Exclusion criteria
1. Presence of other known causes of menorrhagia or abnormal uterine bleeding: Such as large uterine fibroids (\> 3 cm in diameter, or with a location causing distortion of the uterine cavity), large endometrial polyps, untreated endometrial hyperplasia, or known bleeding disorders. 2. History of extensive prior pelvic surgery: That may increase the difficulty or risks of laparoscopic surgery or significantly affect uterine blood supply. 3. Current pregnancy or suspicion of pregnancy: Pregnancy testing will be performed before enrollment. 4. Current breastfeeding. 5. Presence of contraindications to general anesthesia or laparoscopic surgery: This will be assessed by the anesthesiologist. 6. Severe, unstable systemic diseases: Such as uncontrolled cardiovascular disease, pulmonary disease, renal disease, or liver disease. 7. Receiving hormonal therapy that affects the menstrual cycle or uterine blood flow. 8. Participation in another clinical trial that could interfere with the outcomes of this study. 9. Inability to comply with study procedures or follow-up. 10. Any other condition that the principal investigator deems would compromise the safety of the participant or affect the study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| monthly menstrual blood loss | The change in PBAC score within 6 months after procedure | The change in PBAC score |
Outcome results
None listed