Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma: a Pilot, Prospective, Randomized Study Comparing Stripping With CO2 Laser Vaporization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Microparticle levels after two laparoscopic treatments of ovarian endometriomas
研究概览
简要总结
Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in surgical treatment of patients with ovarian endometrioma (OE).
Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting: Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
Measurements and Main results: Blood samples were collected before surgery, and at 2 hours, 24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian endometrioma surgery was performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •age between 18 and 40 years and unilateral symptomatic OEs ≥3 cm.
排除标准
- •previous pelvic surgery, history of cancer, suspected malignancy, presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral contraceptives, GnRH-agonists, progestins, or danazol in the preceding 3 months. We excluded patients with suspicion of deep endometriosis according to an extensive preoperative work-up (including magnetic resonance imaging when necessary) routinely performed in such patients.
研究组 & 干预措施
Laparoscopic stripping ovarian endometriomas
干预措施: Stripping versus laser CO2 (Procedure)
Laser CO2 treatment ovarian endometriomas
干预措施: Stripping versus laser CO2 (Procedure)
结局指标
主要结局
Microparticle levels after two laparoscopic treatments of ovarian endometriomas
时间窗: 1 month
次要结局
未报告次要终点
研究者
Francisco Carmona
Professor
Hospital Clinic of Barcelona