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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.
Severance Hospital
Seoul, South Korea
Pain intensity by numerical rating scale
0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable
Time frame: 0-24 hours after embolization
Fentanyl and analgesic usage volume
Fentanyl and analgesic usage volume within 24 hours after embolization
Time frame: 24 hours
Symptom severity score
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.
Time frame: 3 months
Postoperative inflammation
Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization
Time frame: 24 hours
Tumor necrosis degree
Assessment of tumor necrosis degree in MR after embolization
Time frame: 3 months
Fluoroscopy and procedure time
Fluoroscopy and procedure time taken for embolization to achieved
Time frame: procedure time
Serum Anti-Mullerian Hormone (AMH)
Residual ovarian function before and after embolization
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.