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Идёт набор NCT07711743

Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas

Без фазы С лечением Ovarian Endometrioma Endometriosis

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: Argon Plasma Coagulation.
Кому может быть актуально
Состояния в реестре: Ovarian Endometrioma, 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
Швейцария
Следующий шаг
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Официальное название

Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas: A Prospective Pilot Study

Обзор

The goal of this clinical trial is to evaluate the depth of tissue penetration of Argon Beam Coagulation (ABC) during laparoscopic surgery for ovarian endometriomas. Researchers want to determine how deeply ABC affects ovarian tissue and to generate data on the safety of this surgical technique. Participants will undergo standard laparoscopic surgery for ovarian endometriomas. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to the study protocol. The treated tissue will subsequently be excised as part of the planned surgery and analyzed histologically to measure the depth of tissue penetration.

Подробное описание

Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age. Ovarian endometriomas are a common manifestation of the disease and frequently require surgical treatment. Conventional cystectomy may unintentionally remove healthy ovarian tissue, potentially reducing ovarian reserve and affecting future fertility. Tissue-preserving surgical techniques are therefore of increasing clinical interest.

Argon Beam Coagulation (ABC) is an energy-based surgical technology that allows non-contact coagulation using ionized argon gas. Although ABC is increasingly used in endometriosis surgery, limited histological evidence is available regarding the depth of tissue penetration produced by this technique.

This prospective, single-center interventional study will enroll women undergoing laparoscopic surgery for ovarian endometriomas at the University Hospital Bern. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to a standardized protocol. The treated tissue will subsequently be excised during the same operation and processed for histological examination.

The primary objective of the study is to quantify the histological depth of tissue penetration of Argon Beam Coagulation in ovarian tissue. Secondary objectives include evaluating the consistency of tissue penetration and generating data that may support the safe use of ABC as a tissue-preserving surgical technique in the management of ovarian endometriomas.

Вмешательства

  • Процедура Argon Plasma Coagulation
    Standardized argon plasma coagulation (APC) is applied to the outer surface of the ovarian endometrioma capsule immediately before laparoscopic cystectomy. The resected tissue is subsequently processed for histological analysis to assess the depth of APC tissue penetration.

Первичные конечные точки

  • Depth of thermal tissue effects in the ovarian endometrioma cyst wall [Срок оценки: Immediately after surgery (Day 0)]
Вторичные конечные точки (6)
  • Presence of residual endometriotic epithelium [Срок оценки: At surgery (Day 0)]
  • Completeness of cyst lining ablation [Срок оценки: Immediately after surgery (Day 0)]
  • Thermal damage to adjacent ovarian parenchyma [Срок оценки: At surgery (Day 0)]
  • Technical success of argon beam application [Срок оценки: During surgery (Day 0)]
  • Intraoperative complications [Срок оценки: During surgery (Day 0)]
  • Postoperative complications [Срок оценки: Up to 30 days after surgery]

Критерии участия

Критерии включения

  • Female patients aged 18-40 years.
  • Indication for surgical treatment of ovarian endometrioma based on clinical symptoms and/or imaging findings.
  • Diagnosis of ovarian endometrioma ≥3 cm confirmed by preoperative imaging (ultrasound and/or MRI).
  • Planned laparoscopic cystectomy.
  • Written informed consent.

Критерии исключения

  • Expected lack of compliance or inability to understand the study procedures.
  • Previous surgical procedures on the affected ovary.
  • Recurrent ovarian endometrioma.
  • Pregnancy or breastfeeding.
  • Participation in another interventional clinical study that may influence study outcomes, such as anti-Müllerian hormone (AMH) levels or pregnancy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швейцария · 1 центр
  • University Hospital of Obstetrics and Gynecology, Inselspital Bern — Bern

Идентификаторы

NCT: NCT07711743 · ENDO-ARGON-01 · Protocol ID

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗