PDF(Pubmed)
Abstract：
BACKGROUND: The oral gonadotropin-releasing hormone antagonist relugolix, which temporarily stops menstruation, is used to treat heavy menstrual bleeding, pelvic pressure, and low back pain in women with uterine fibroids. Treatment can also help women recover from low hemoglobin levels and possibly shrink the fibroids. However, evidence of preoperative use of relugolix before laparoscopic myomectomy is limited. Nevertheless, the treatment could reduce interoperative blood loss, decrease the risk of developing postoperative anemia, and shorten the operative time. Thus, we aim to test whether 12-week preoperative treatment with relugolix (40 mg orally, once daily) is similar to or not worse than leuprorelin (one injection every 4 weeks) to reduce intraoperative blood loss.
METHODS: Efficacy and safety of preoperative administration of drugs will be studied in a multi-center, randomized, open-label, parallel-group, noninferiority trial enrolling premenopausal women ≥ 20 years of age, diagnosed with uterine fibroids and scheduled for laparoscopic myomectomy. Participants (n = 80) will be recruited in the clinical setting of participating institutions. The minimization method (predefined factors: presence or absence of fibroids ≥ 9 cm and the International Federation of Gynecology and Obstetrics [FIGO] type 1-5 fibroids) with randomization is used in a 1:1 allocation. Relugolix is a 40-mg oral tablet taken once a day before a meal, for 12 weeks, up to the day before surgery. Leuprorelin is a 1.88 mg, or 3.75 mg subcutaneous injection, given in three 4-week intervals during patient visits before the surgery. For the primary outcome measure of intraoperative bleeding, the blood flow is collected from the body cavity, surgical sponges, and collection bag and measured in milliliters. Secondary outcome measures are hemoglobin levels, myoma size, other surgical outcomes, and quality-of-life questionnaire responses (Kupperman Konenki Shogai Index and Uterine Fibroid Symptoms-Quality of Life).
CONCLUSIONS: Real-world evidence will be collected in a clinical setting to use pre-treatment with an oral gonadotropin-releasing hormone antagonist to reduce intraoperative bleeding in women who undergo laparoscopic myomectomy.
BACKGROUND: jRCTs031210564 was registered on 19 January 2022 in the Japan Registry of Clinical Trials ( https://jrct.niph.go.jp ).
METHODS: Efficacy and safety of preoperative administration of drugs will be studied in a multi-center, randomized, open-label, parallel-group, noninferiority trial enrolling premenopausal women ≥ 20 years of age, diagnosed with uterine fibroids and scheduled for laparoscopic myomectomy. Participants (n = 80) will be recruited in the clinical setting of participating institutions. The minimization method (predefined factors: presence or absence of fibroids ≥ 9 cm and the International Federation of Gynecology and Obstetrics [FIGO] type 1-5 fibroids) with randomization is used in a 1:1 allocation. Relugolix is a 40-mg oral tablet taken once a day before a meal, for 12 weeks, up to the day before surgery. Leuprorelin is a 1.88 mg, or 3.75 mg subcutaneous injection, given in three 4-week intervals during patient visits before the surgery. For the primary outcome measure of intraoperative bleeding, the blood flow is collected from the body cavity, surgical sponges, and collection bag and measured in milliliters. Secondary outcome measures are hemoglobin levels, myoma size, other surgical outcomes, and quality-of-life questionnaire responses (Kupperman Konenki Shogai Index and Uterine Fibroid Symptoms-Quality of Life).
CONCLUSIONS: Real-world evidence will be collected in a clinical setting to use pre-treatment with an oral gonadotropin-releasing hormone antagonist to reduce intraoperative bleeding in women who undergo laparoscopic myomectomy.
BACKGROUND: jRCTs031210564 was registered on 19 January 2022 in the Japan Registry of Clinical Trials ( https://jrct.niph.go.jp ).
摘要：
背景：口服促性腺激素释放激素拮抗剂relugolix，暂时停止月经，用于治疗大量月经出血，骨盆压力,子宫肌瘤女性的腰背痛。治疗还可以帮助女性从低血红蛋白水平中恢复，并可能缩小肌瘤。然而,腹腔镜子宫肌瘤切除术前使用relugolix的证据有限.然而，治疗可以减少手术间失血，降低术后贫血的风险，缩短手术时间。因此，我们的目的是测试12周术前治疗是否使用relugolix（口服40毫克，每天一次）与亮丙瑞林（每4周注射一次）相似或不差于亮丙瑞林（每4周注射一次），以减少术中失血。
方法：术前用药的有效性和安全性将在多中心进行研究，随机化，开放标签，平行组，非劣效性试验招募年龄≥20岁的绝经前妇女，诊断为子宫肌瘤，并计划进行腹腔镜子宫肌瘤切除术。参与者（n=80）将在参与机构的临床环境中招募。在1：1分配中使用随机化的最小化方法（预定义的因素：是否存在≥9cm的肌瘤以及国际妇产科联合会[FIGO]1-5型肌瘤）。Relugolix是一种40毫克的口服片剂，每天饭前服用一次，12周,直到手术前一天。亮丙瑞林是1.88毫克，或3.75毫克皮下注射，在手术前患者访视期间间隔3个4周给予。对于术中出血的主要结果测量，从体腔收集血流，手术海绵,和收集袋，以毫升为单位。次要结果指标是血红蛋白水平，肌瘤大小,其他手术结果，和生活质量问卷回答（KuppermanKonenkiShogai指数和子宫肌瘤症状-生活质量）。
结论：将在临床环境中收集使用口服促性腺激素释放激素拮抗剂的预治疗以减少腹腔镜子宫肌瘤切除术妇女的术中出血的真实世界证据。
背景：jRCTs031210564于2022年1月19日在日本临床试验注册中心注册（https://jrct。尼夫.走吧。jp)。
方法：术前用药的有效性和安全性将在多中心进行研究，随机化，开放标签，平行组，非劣效性试验招募年龄≥20岁的绝经前妇女，诊断为子宫肌瘤，并计划进行腹腔镜子宫肌瘤切除术。参与者（n=80）将在参与机构的临床环境中招募。在1：1分配中使用随机化的最小化方法（预定义的因素：是否存在≥9cm的肌瘤以及国际妇产科联合会[FIGO]1-5型肌瘤）。Relugolix是一种40毫克的口服片剂，每天饭前服用一次，12周,直到手术前一天。亮丙瑞林是1.88毫克，或3.75毫克皮下注射，在手术前患者访视期间间隔3个4周给予。对于术中出血的主要结果测量，从体腔收集血流，手术海绵,和收集袋，以毫升为单位。次要结果指标是血红蛋白水平，肌瘤大小,其他手术结果，和生活质量问卷回答（KuppermanKonenkiShogai指数和子宫肌瘤症状-生活质量）。
结论：将在临床环境中收集使用口服促性腺激素释放激素拮抗剂的预治疗以减少腹腔镜子宫肌瘤切除术妇女的术中出血的真实世界证据。
背景：jRCTs031210564于2022年1月19日在日本临床试验注册中心注册（https://jrct。尼夫.走吧。jp)。
