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.
Confirmed diagnosis of Enhanced Myometrial Vascularity.
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.
Women of reproductive age (18-45 years).
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).
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.
History of extensive prior pelvic surgery: That may increase the difficulty or risks of laparoscopic surgery or significantly affect uterine blood supply.
Current pregnancy or suspicion of pregnancy: Pregnancy testing will be performed before enrollment.
Current breastfeeding.
Parallel
Laparoscopic Umbilico-uterine trunk Clipping Approach
Procedure/Surgery1. Patient preparation. 2. Laparoscopic technique. 3. Identification and clipping of the umbilico-uterine trunk. 4. Post-operative care.
Mirena Intrauterine Device Insertion
Procedure/SurgeryMirena Intrauterine Device Insertion is considered the current standard of care or a relevant alternative
monthly menstrual blood loss
The change in PBAC score
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