View clinical trials related to Leiomyoma.
Filter by:The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF. Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.
Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata through induction of infarction and subsequent hyaline degeneration. This could be followed with variable severity of pain that lasts for several days after the procedure secondary to the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been described as moderate to severe cramping increasing over the first 2 hours after UAE to reach plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The severity of pain after UAE seems unrelated to the uterine or fibroid size which makes the severity of pain is unpredictable.1 Pain management after UAE most often consists of a combination of a non-steroidal anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following embolization of the uterine arteries may require large doses of parenteral opioids for relief with added unwanted effects.2 Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA) after UAE needed considerable amounts of morphine (median [range] 24 mg [0-86 mg]) during the first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce morphine consumption for the first 24 hours after UAE. 2 Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic choice for uterine artery embolization as it improves patients satisfaction and reduces the severity of post-procedural pain. Although some investigators suggest an epidural analgesia for pain control after UAE,4 the use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain management after UAE.5 Thus in an observational study included few patients, the investigators demonstrated considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the catheterization of thoracic epidural space in such low-risk patients has many logistic issues. Up to the best of our knowledge, there is no available comparative randomized clinical trial compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis. Post UFE procedural pain and nausea are expected events. These symptoms are treated with current standard of care medications, including opiates. Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea medications such as ondansetron and prochlorperazine. This study is being conducted to compare two new medications for pain, IV ibuprofen and IV acetaminophen, administered for 24 hours following UFE. The primary safety objective of non-inferiority will be met and the primary efficacy objective of superiority, decreased pain and nausea, will be accessed when compared to current standard of care regimens. This is a 4 arm, double blind, randomized, controlled study. All patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure. The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These medications will be given during the procedure and extended over a 24 hour stay. Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.
The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.
On the basis of empirical evidence and clinical practice, the investigators have developed a formula called Tumor-shrinking Decoction (TSD) used in the treatment of uterine fibroids (UFs). The investigators preliminary clinical observation has demonstrated the benefits of TSD in improving UFs. TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis, Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch. It is hypothesized that TSD can effectively reduce the fibroid size and improve the symptoms associated with UFs and the greater anti-tumor potency of TSD is associated with higher therapeutic doses. To test this hypothesis, one 16-week, double-blind, randomized, two-dose trial will be conducted in patients with symptomatic UFs to determine whether the high dose (217 g/day) of TSD could produce significantly greater effects in reducing the fibroid size and improving its related symptoms and biochemical profiles compared to the lower dose (69 g/day).
The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids