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临床试验/NCT03778359
NCT03778359已完成不适用

Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2005年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
5,000
试验地点
1
主要终点
Pain before and after surgery

研究概览

简要总结

Endometriosis (including adenomyosis) is one of the most common gynecological diseases among women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow, infertility, chronic lower abdominal pain, and painful intercourse. According to the literature statistics, the prevalence of endometriosis in women of childbearing age is about 10-20%, while the prevalence of adenomyosis is about 5%. Traditional medical treatments include hormones (danazol, gestrinone, oral lutein). Oral contraceptive, there is a Gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing intrauterine system in the intrauterine administration system. The choice of drugs has many influencing factors, such as the severity of endometriosis in patients (according to the classification of the American Society for Reproductive Medicine), the need for fertility, the convenience of drug use, and the patient's tolerance to drug side effects. Surgery is also one of the treatment options for endometriosis and adenomyosis, including traditional open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion resection; adenomyosis surgery includes traditional methods Open abdominal, transvaginal or minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and cytoreduction surgery (partial adenomyomectomy). For endometriosis, the common treatment consensus of obstetricians and gynecologists is to follow the surgical treatment of the lesions and then follow-up medication. For women with adenomyosis, if they have completed the birth, it is recommended to have a total hysterectomy, so that there is no recurrence. The possibility. However, for women who have not completed birth, conservative uterine preservation surgery is performed. According to research statistics, endometriosis or adenomyosis does not receive follow-up medical treatment after completion of surgical treatment, there is a high probability of recurrence, but the side effects caused by drugs will also affect the patient's compliance with medication.The Department of Women's Medicine of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis. Each year, about 500 cases of endometriosis (including adenomyosis) are performed. This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments.

详细描述

The main purpose: to analyze the prognosis and treatment effect of endometriosis and adenomyosis after surgery and drug treatment.

Secondary objective: Analysis of endometriosis and adenomyosis after surgery and medication, the patient's assessment of drug side effects.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients who underwent endometriosis or adenomyosis-related surgery in the investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up medication.

排除标准

  • 未提供

研究组 & 干预措施

Gonadotropin-releasing hormone agonist treatment

Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment

干预措施: Leuprorelin (Drug)

Intrauterine device treatment

Endometriosis post-operative intrauterine device treatment

干预措施: Levonorgestrel (Device)

Hormone therapy

Endometriosis post-operative hormone therapy

干预措施: Dienogest (Drug)

Oral contraceptive

Endometriosis post-operative oral contraceptive

干预措施: Progestins (Drug)

结局指标

主要结局

Pain before and after surgery

时间窗: 01/2005~12/2015

Visual analogue scale ranges from 0 to 10 points, with higher scores indicative of more pain. We measure it before the surgery and follow it after intervention one month, three months and six months seperately.

次要结局

  • Tumor marker (CA-125)(01/2005~12/2015)
  • Hemoglobin(01/2005~12/2015)
  • Ultrasound image tracking(01/2005~12/2015)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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