Submucous Leiomyoma of Uterus
Conditions
Keywords
Submucous leiomyoma, Transcervical resection of myoma, GnRH analogues
Brief summary
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.
Interventions
DRUGZoladex
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.
DRUGMifepristone Oral Tablet
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.
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years; 2. Type I and II submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm; 3. Type I or II submucosal fibroids confirmed by TCRM and no degeneration confirmed pathologically; 4. A MRI test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery; 5. Patients would not had used drugs such as mifepristone and GnRHa 3 months before surgery; 6. Participate in this trial and sign the informed consent form voluntarily .
Exclusion criteria
1. Combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc; 2. Have fertility requirements within 3 years after surgery; 3. Estrogen-dependent diseases such as adenomyosis and endometriosis; 4. Drugs such as mifepristone or GnRHa have been used before surgery; 5. Mifepristone or GnRHa drug treatment is contraindicated or cannot tolerate TCRM surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the remaining submucous fibroids volume | one to three years after TCRM | The change of residual fibroid volume is compared to residual fibroid volume measured by ultrasound and /or MRI one month after surgery; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the recurrence rate of remaining submucous fibroids and time | one to three years after TCRM | recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids. |
| the recurrence time of remaining submucous fibroids | one to three years after TCRM | the time interval between recurrent submucosal fibroids and TCRM |
Countries
China
Contacts
Primary ContactWU zaigui
Backup ContactRUAN fei
Outcome results
None listed