Uterine Fibroid, Uterine Myoma
Conditions
Brief summary
This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.
Detailed description
This investigational study is designed to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids. The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS) score obtained for each time points within 24 hours after embolization. Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (Serum AMH). This study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.
Interventions
DEVICEGelatin microsphere (Nexsphere™)
Gelatin microsphere (Nexsphere™) is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for gelatin microsphere are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.
DEVICEEmbosphere
Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.
Sponsors
Next Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma.
Exclusion criteria
* Bradycardia on electrocardiogram (\< 45 bpm) * Ventricular conduction abnormalities * Liver failure * Kidney failure * Uncontrolled high blood pressure * Obesity (BMI ≥ 30 ㎏/㎡) * Patients who are allergic to drugs * Patients who cannot read consent forms such as illiterate or foreigners * Pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity by numerical rating scale | 0-24 hours after embolization | 0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity score | 3 months | Comparison of symptom severity score before and 3 months after embolization Symptom was scored on a scale of 0-10, with 0 being no symptoms and 10 being the baseline, or initial symptoms. |
| Postoperative inflammation | 24 hours | Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization |
| Fentanyl and analgesic usage volume | 24 hours | Fentanyl and analgesic usage volume within 24 hours after embolization |
| Fluoroscopy and procedure time | procedure time | Fluoroscopy and procedure time taken for embolization to achieved |
| Serum Anti-Mullerian Hormone (AMH) | 3 months | Residual ovarian function before and after embolization |
| Tumor necrosis degree | 3 months | Assessment of tumor necrosis degree in MR after embolization |
Countries
South Korea
Outcome results
None listed