Comparing catheter mediated uterine vessel occlusion with uterine removal by surgery for treatment of uterine fibroids
- Conditions
- Health Condition 1: null- Patients presenting with menorrhagia(PBAC score 100) and pelvic pain, pressure symptoms attributable to uterine fibroids.
- Registration Number
- CTRI/2017/11/010501
- Lead Sponsor
- Department of Radiodiagnosis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Menstruating women with symptomatic uterine fibroids who have completed their family
Uterus size<= 24 weeks on bimanual examination. Ultrasonography suggestive ofat least one uterine myoma of >= 3 cm diameter in size
1.Uterine size > 24 weeks on clinical examination.
2. Any single myoma size > 12 cm on ultrasonography. Patients can also be taken up for UAE post trial of GnRH agonists if the fibroid 3. size at presentation is more than 12 cm at initial presentation
4.Active pelvic infection or pregnancy
5.Suspected or known case of gynecological cancer/atypical endometrial hyperplasia.
6. Known case of uncontrolled coagulation disorder, renal insufficiency, severe contrast allergy
7. Large uterine polyp ( >2 cm), Submucosal fibroid (class 0 & 1 under myoma sub-classification system)
8. Large subserosal fibroids with narrow stalk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fibroid size as assessed by USG or MRI <br/ ><br>Uterine fibroid Quality of life assessment score <br/ ><br>Timepoint: 6 months after treatment <br/ ><br>
- Secondary Outcome Measures
Name Time Method Relief of symptoms like pain, pressure symptoms and menorrhagia <br/ ><br>Percentage necrosis of myoma on post embolization MRITimepoint: Relief of symptoms in 6 months <br/ ><br>Percentage necrosis on post embolisation MRI in 6 weeks