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临床试验/NCT01092494
NCT01092494Unknown不适用

Efficacy of Postoperative Cyclic Oral Contraceptive Use After Gonadotropin-releasing Hormone Agonist for the Prevention of Endometrioma Recurrence

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
232
试验地点
1
主要终点
recurrence rate of endometrioma

研究概览

简要总结

Ovarian endometriotic cyst (endometrioma) is one of the most common endometriotic lesions, and conservative laparoscopic surgery is the treatment of choice. However, the recurrence after surgery is common.

As repetitive surgery leads to morbidities and ovarian function decrease, recurrence after surgery frustrates both patients and clinicians. In this aspect, medical treatments have been offered after surgery to prevent or delay the recurrence. Gonadotropin-releasing hormone agonist (GnRHa) is frequently used in women with advanced endometriosis, but the efficacy is rather controversial. On the other hand, it has been demonstrated that oral contraceptives (OCs) could reduce or delay endometrioma recurrence, but data are still limited. Consequently, no one type of postoperative medical therapy has been shown to be superior in reducing the recurrence of endometrioma.

The rationale of postoperative medical therapy is that it could eradicate microscopic lesions which were not found and not treated sufficiently during surgery. Therefore, the maintenance of strongly suppressed condition induced by postoperative GnRHa treatment by addition of OCs could be a promising treatment to prevent the recurrence, but it has not been widely investigated.

We performed this retrospective cohort study to evaluate the efficacy of cyclic monophasic low-dose OCs as a maintenance therapy after GnRHa treatment for the suppression of endometrioma recurrence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • reproductive aged women who underwent conservative laparoscopic ovarian surgery for endometrioma (ASRM stage III/IV) which was confirmed by pathologic inspection
  • women who were given postoperative GnRHa injections every 28 days for 3 or 6 months
  • women with no residual lesion confirmed by ultrasonography after surgery
  • women who were followed up for over 12 months after surgery.

排除标准

  • if they had
  • undergone hysterectomy during an operation
  • been given GnRHa injections more than 6 times
  • been given other types of postoperative treatment (progestin or intrauterine device)
  • a history of previous pelvic surgery for endometriosis
  • a history of hormonal treatment before surgery
  • been diagnosed as menopause after surgery
  • contraindications to OCs
  • been identified ovarian endometriomas within 6 months of postoperative evaluation

结局指标

主要结局

recurrence rate of endometrioma

时间窗: 60 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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