Laparoscopic Umbilico-uterine Trunk Clipping Approach in the Management of Enhanced Myometrial Vascularity

Обзор

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.

Вмешательства

• Процедура Laparoscopic Umbilico-uterine trunk Clipping Approach
  1. Patient preparation. 2. Laparoscopic technique. 3. Identification and clipping of the umbilico-uterine trunk. 4. Post-operative care.
• Процедура Mirena Intrauterine Device Insertion
  Mirena Intrauterine Device Insertion is considered the current standard of care or a relevant alternative

Первичные конечные точки

• monthly menstrual blood loss [Срок оценки: The change in PBAC score within 6 months after procedure]

Критерии участия

Критерии включения

• 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).
• Written informed consent: Participants must be able to understand the study information and provide written informed consent to participate.
• Adequate general health to undergo anesthesia and laparoscopic surgery: This will be assessed by the responsible physician

Критерии исключения

• 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.
• Presence of contraindications to general anesthesia or laparoscopic surgery: This will be assessed by the anesthesiologist.
• Severe, unstable systemic diseases: Such as uncontrolled cardiovascular disease, pulmonary disease, renal disease, or liver disease.
• Receiving hormonal therapy that affects the menstrual cycle or uterine blood flow.
• Participation in another clinical trial that could interfere with the outcomes of this study.
• Inability to comply with study procedures or follow-up.
• Any other condition that the principal investigator deems would compromise the safety of the participant or affect the study outcomes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07529587 · 1647-8-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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