Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: APC, Lap bipolar forceps.
- Кому может быть актуально
- Состояния в реестре: Endometriosis. Базовые параметры: 18 лет — 40 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy: A Prospective Controlled Randomized Pilot Study
Обзор
The study is a prospective, monocentric, randomized controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany. In this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment. Seventy-two (72) patients who meet all eligibility criteria will undergo surgical procedure. The patients will be randomized into the group with standard cystectomy treatment or with APC treatment. Per group n=36 patients will be treated i.e., 1:1 randomization. A pre-specified primary endpoint analysis is planned after the last patient has undergo Visit 4 (Follow-up after 6 months) to analyze the primary endpoint. Screening takes place during the first visit (V1). During the second visit (V2) the participants will receive the ovarian endometriosis treatment procedure either with the APC or the standard cystectomy. Standard procedure (standard cystectomy) will be performed for additional endometriosis lesions. The follow up visits (V3 - V5) will take place after three, six and twelve months. Visit 3 and Visit 4 will take place at the study site and AMH will be measured. Whereas Visit 5 will take place via telemedical contact, i.e. phone call.
Вмешательства
- Устройство APC
For the surgical procedure for ovarian endometrioma treatment APCapplicator will be used - Устройство Lap bipolar forceps
For ovarian endometrioma treatment the standard of care treatment will be performed.
Первичные конечные точки
- Concentration of AMH (Anti-Müller hormone) level [Срок оценки: Screening Visit 1 (up to -28 days before day 0); Visit 3 (day 0 +3 months +/- 14 days; Visit 4 (day 0 + 6 months +/- 14 days)]
Критерии участия
Критерии включения
- Indication for surgical endometrioma treatment according to patient symptoms
- Signed informed consent
Критерии исключения
- Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
- Prior procedures at the ovaries
- Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included)
- Pregnant or breastfeeding patients
- Participation in any other clinical study that could affect the AMH level or pregnancy
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
Германия · 1 центр
- Department for Women's Health — Tübingen
Публикации
- Younis JS, Shapso N, Ben-Sira Y, Nelson SM, Izhaki I. Endometrioma surgery-a systematic review and meta-analysis of the effect on antral follicle count and anti-Mullerian hormone. Am J Obstet Gynecol. 2022 Jan;226(1):33-51.e7. doi: 10.1016/j.ajog.2021.06.102. Epub 2021 Jul 13. PMID 34265271
- Stefanovic S, Sutterlin M, Gaiser T, Scharff C, Neumann M, Berger L, Froemmel N, Tuschy B, Berlit S. Microscopic, Macroscopic and Thermal Impact of Argon Plasma, Diode Laser, and Electrocoagulation on Ovarian Tissue. In Vivo. 2023 Mar-Apr;37(2):531-538. doi: 10.21873/invivo.13111. PMID 36881055
- Lockyer EK, Schreurs A, Lier M, Dekker J, Melgers I, Mijatovic V. Treatment of ovarian endometriomas using plasma energy in endometriosis surgery: effect on pelvic pain, return to work, pregnancy and cyst recurrence. Facts Views Vis Obgyn. 2019 Mar;11(1):49-55. PMID 31695857
- Working group of ESGE, ESHRE, and WES; Saridogan E, Becker CM, Feki A, Grimbizis GF, Hummelshoj L, Keckstein J, Nisolle M, Tanos V, Ulrich UA, Vermeulen N, De Wilde RL. Recommendations for the surgical treatment of endometriosis-part 1: ovarian endometrioma. Gynecol Surg. 2017;14(1):27. doi: 10.1186/s10397-017-1029-x. Epub 2017 Dec 19. PMID 29285022
- Muzii L, Achilli C, Bergamini V, Candiani M, Garavaglia E, Lazzeri L, Lecce F, Maiorana A, Maneschi F, Marana R, Perandini A, Porpora MG, Seracchioli R, Spagnolo E, Vignali M, Benedetti Panici P. Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: a multicentre RCT. Hum Reprod. 2016 Feb;31(2):339-44. doi: 1 PMID 26682578
Идентификаторы
NCT: NCT07065214 · OVAPLAS