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Leiomyoma clinical trials

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NCT ID: NCT00860002 Recruiting - Uterine Fibroids Clinical Trials

The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids

Start date: January 2009
Phase: N/A
Study type: Observational

Uterine leiomyomas (i.e., fibroids, myomas) are the most common gynecologic tumors in women of reproductive age (1). Clearly, the majority of such lesions are asymptomatic (2). Symptoms directly attributable to these benign tumors represent the most common reason for laparotomy in non-pregnant women in the United States (3,4), and also in Taiwan (5). Whereas in decades past, hysterectomy was seen almost as a panacea for uterine leiomyomas, more recently attention has been paid to the development of pharmaceutical agents and less-invasive procedures (6). Frequently, such procedures are designed to retain the uterus (6). Of these, myomectomy may be a choice among the uterine-sparing treatments for symptomatic uterine myoma (7,8). The surgical mode of access usually employed in myomectomy is traditional exploratory laparotomy or its modification—mini-laparotomy (MLT) (9) or ultra-mini laparotomy (UMLT) (10,11), though recently, laparoscopy (12-14) or a combination of laparoscopy and MLT (9), vaginal surgery (15), and hysteroscopic myomectomy (16-21) have represented valid alternatives. However, myomectomy alone provides varying degrees of symptom control and a high percentage of recurrence, not only for the tumors themselves, but also for the symptoms. For example, one study reported that symptom resolution varied from 84.0% to 100% depending on different items and 21 (19.4%) of 108 patients experienced a recurrence after an average interval of 16 months (range, 1.8-47.4 months) (22). Therefore, an alternative or additional therapy might be required to provide longer durable symptom control and minimize tumor recurrence. One of the strategies is laparoscopic uterine vessel occlusion (LUVO), also known as laparoscopic uterine artery occlusion (LUAO) (23,24). The rationale for using LUVO in the management of symptomatic myomas is found in the successful experience with uterine-artery embolization (UAE), which was introduced in 1995 as an alternative technique for treating fibroids (25). Since then it has become increasingly accepted as a minimally invasive, uterine-sparing procedure, and studies have reported the relief of excessive menstrual bleeding or pressure in 80-90% of patients (26-32). LUVO provided similar relief of symptoms (89.4% with symptomatic improvement and 21.2% with complete resolution of symptoms) in 2001 in a 7- to 12-month follow-up of 87 patients after LUVO (33). Since that time there has been rapid growth in the use of this treatment with various modifications, such as simultaneous accompaniment with myomectomy either through laparoscopy or ML, and there has been considerable research into its outcome (22,34-42). However, in our previous data, we found that a combination of LUVO and myomectomy provided definite effectiveness in symptom control for these women with symptomatic uterine myomas (98.1% to 100% symptom resolution depending on various kinds of items), minimized tumor recurrence, and rendered the vast majority of re-interventions unnecessary (22). Myomectomy can be performed by the laparoscopic approach or by ML when patients are undergoing the LUVO procedure. Before 2002, we often used ML to perform myomectomy (22). However, we have shortened the incision to less than 4 cm, creating ultramini-laparotomy (UMLT) to perform myomectomy (10,11,43). Since many conservative therapies might provide less or more therapeutic effects on the symptom control and disease status, the aim of this prospective study tries to evaluate the therapeutic outcomes of these symptomatic uterine myomas after different kinds of therapies in the coming 5 years at Taipei Veterans General Hospital.

NCT ID: NCT00299481 Recruiting - Ovarian Neoplasms Clinical Trials

Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

Start date: March 2006
Phase: N/A
Study type: Observational

The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue for the study of cancer in order to better understand the changes occurring on a molecular level (DNA, RNA, protein) that lead to the development of cancer.

NCT ID: NCT00163930 Recruiting - Uterine Fibroids Clinical Trials

Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata

Start date: January 2005
Phase: N/A
Study type: Observational

This project seeks to evaluate the effectiveness of a new post-operative pain relief program for women who have undergone uterine artery embolisation (UAE). UAE is performed by an interventional radiologist as a treatment of uterine fibroids (non-cancerous growths of the uterus.) UAE can be associated with a high level of post-procedural pain and it is the purpose of this study to evaluate a new relief regimen for dealing with this acute pain. There will be two treatment groups into which patients will be randomly assigned. One will receive the current post-operative therapy (dose-on-demand) and the other will receive the new therapy (pre-emptive dosing). Otherwise patients will receive standard management protocol for this procedure. Only patients that are scheduled for UAE will be enrolled (up to 40 patients). The new treatment involves giving the patient their morphine dose orally and sixty minutes before the procedure begins (pre-emptive dosing) as opposed to current standard treatment which involves giving the patient a dose of morphine intravenously once they feel pain. Information to be collected directly from patients includes pain and nausea levels, indicated on a visual scale (a 10 centimetre line showing a spectrum of no pain to worst pain imaginable) as well as their opinions of the effectiveness of the pain relief program and the procedure itself. This information is to be collected immediately post-procedure and at 2, 4, 6 and 24 hours post procedure. Each VAS will take the patient approximately 20 seconds to complete. Information about concurrent medication and procedure complications, post-operative vomiting and respiratory depression will be collected from the patient’s history.

NCT ID: NCT00155870 Recruiting - Leiomyoma Clinical Trials

Health-Related QoL Among Women Receiving Hysterectomy in NTUH

Start date: June 2005
Phase: N/A
Study type: Observational

Laparoscopic assisted vaginal hysterectomy (LAVH)has become the most prevalent operation method in woman suffering from uterine myoma or adenomyosis nowadays. The operation decisions for these women are always due to symptoms such as pain, anemia and mass effect. However, there is a lack of measurement for these symptoms and therefore highlight the need to validate these symptom by health-related quality of life (QOL) assessments. Patients usually recovered better by LAVH comparing to traditional open surgeries. However, LAVH was restricted to cases with small size uteri and most QOL reported neglected uterine weight or were based on small uteri size. We recently intervened a new surgical procedure called RULU during LAVH and thus released this limitation. This will give a more unbiased study on the effect of QOL in patients receiving LAVH. In this study, we plan to use two questionnaires: the disease specific UFS-QOL and the WHO-QOL Taiwan version questionnaires for patients receiving LAVH. Assessment will be performed before operation; and 3 days, 7 days, 3 months and 18 months after operation. From these assessments, we plan to determine which QOL variables will be useful as operation guidelines for patients suffering from leiomyoma or adenomyosis, and for the assessment of appropriates and outcomes of LAVH.

NCT ID: NCT00050752 Recruiting - Kidney Cancer Clinical Trials

Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer

Start date: February 24, 2003
Phase:
Study type: Observational

This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer, or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are benign (non-cancerous) tumors arising from smooth muscle. HLRCC can cause various health problems. Some people develop red bumps on their skin that can be painful at times. Some women with HLRCC can develop leiomyomas of the uterus. In some families, people with HLRCC develop kidney tumors. This study will try to determine: - What gene changes (mutations) cause HLRCC - What kind of kidney tumors develop in HLRCC and how they grow - What the chance is that a person with HLRCC will develop a kidney tumor People with known or suspected HLRCC (and their family members of any age) may be eligible for this study. This includes people in families in which one or more members has skin leiomyoma and kidney cancer; skin leiomyoma and uterine leiomyoma; multiple skin leiomyomas; kidney cancer and uterine leiomyomas, or kidney cancer consistent with HLRCC, including, but not limited to, collecting duct or papillary, type II. Candidates will be screened with a physical examination, family history, and, for affected family members, a review of medical records, including pathology slides and computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will undergo tests and procedures that may include the following: - Review of medical records, x-rays, and tissue slides - Physical examination and family history - Skin examination - Gynecological examination for women - Interviews with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor - Blood tests for: 1. Genetic research to identify the gene responsible for HLRCC 2. Evaluation of liver, kidney, heart, pancreas, and thyroid function 3. Complete blood count and clotting profile 4. Pregnancy test for pre-menopausal women 5. PSA test for prostate cancer in men over age 40 - CT or MRI scans (for participants 15 years of age and older only) - Skin biopsy (surgical removal of a small sample of skin tissue) - Cheek swab or mouth rinse to collect cells for genetic analysis - Medical photographs of lesions - Questionnaire When the tests are completed, participants will discuss the results with a doctor and possibly a genetic nurse or genetic counselor. The genetic findings will not be revealed to participants because their meaning and implications may not yet be understood. Participants may be asked to return to NIH from every 3 months to every 3 years, depending on their condition, for follow-up examinations and tests.

NCT ID: NCT00005095 Recruiting - Ovarian Cancer Clinical Trials

Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Start date: March 2000
Phase:
Study type: Observational

RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.