Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Depth of thermal tissue effects in the ovarian endometrioma cyst wall
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Depth of thermal tissue effects in the ovarian endometrioma cyst wall
时间窗: Immediately after surgery (Day 0)
Histological measurement of the maximum depth of tissue penetration induced by argon plasma coagulation in the ovarian endometrioma capsule after standardized pre-cystectomy application.
次要结局
- Presence of residual endometriotic epithelium(At surgery (Day 0))
- Completeness of cyst lining ablation(Immediately after surgery (Day 0))
- Thermal damage to adjacent ovarian parenchyma(At surgery (Day 0))
- Technical success of argon beam application(During surgery (Day 0))
- Intraoperative complications(During surgery (Day 0))
- Postoperative complications(Up to 30 days after surgery)