Transcervical resection of myoma(TCRM) has a good therapeutic effect while the probability of complete resection of type I and II fibroids is only 55% per procedure on average and a significant number of patients have fibroid remained.At present, there is no standardized treatment option for reducing the remaining submucous fibroids volume and preventing its recurrence after TCRM.The present prospective,multicentre,randomised controlled clinical trial will enrol women after TCRM and treat them with mifepristone(10mg)or GnRHa(3.60mg)for 3 to 6 months,investigating the effective and cost-effective treatment options after fibroids with TCRM,thus to provide evidence and effectual regiments for reducing remaining fibroids volume and preventing its recurrence.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
294
Patients with fibroid remained will be enrolled and divided into three groups. one group wii be administrated with Zoladex (3.60mg/28 days) for three to six months.
Patients with fibroid remained will be enrolled and divided into three groups. one group will be administrated with mifepristone(10.0mg/d) for three to six months.
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
the remaining submucous fibroids volume
The change of residual fibroid volume is compared to residual fibroid volume measured by ultrasound and /or MRI one month after surgery;
Time frame: one to three years after TCRM
the recurrence rate of remaining submucous fibroids and time
recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids.
Time frame: one to three years after TCRM
the recurrence time of remaining submucous fibroids
the time interval between recurrent submucosal fibroids and TCRM
Time frame: one to three years after TCRM
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