Suture of the Ovary After Enucleation of Ovarian Endometrioma

Официальное название

Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma

Обзор

Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity. According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate). To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation. In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.

Вмешательства

• Процедура Suture of the ovarian cortex
  Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).
• Процедура No suture of the ovarian cortex
  Laparoscopic enucleation of endometriomas without suture of the ovarian cortex

Первичные конечные точки

• Antral Follicle Count (AFC) [Срок оценки: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery]

Вторичные конечные точки (3)

• Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery [Срок оценки: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery]
• Resistive index, evaluated by Doppler flowmetry, of the ovarian artery [Срок оценки: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery]
• Ovarian volume [Срок оценки: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery]

Критерии участия

Критерии включения

• Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;
• Normal AFC at the enrollment (baseline).

Критерии исключения

• Any other disease;
• Bilateral endometriomas;
• Deep infiltrating endometriosis;
• No previous pelvic surgery (even not gynecological);
• Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• "Filippo Del Ponte" Hospital — Varese

Идентификаторы

NCT: NCT03788720 · SOAVE-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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