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Clinical Trial on Dysfunctional Uterine Bleeding
Thomas L. Lyons, MD, Conducting Clinical Trial On Dysfunctional Uterine Bleeding (DUB) The Center for Women’s Care & Reproductive Surgery, headed by laparoscopic pioneer Thomas L. Lyons, MD, is conducting a placebo controlled FDA clinical trial on a drug used to control dysfunctional uterine bleeding (DUB). The anti-fibrinolytic medication stops the body from breaking down clots in the blood, causing heavy bleeding to diminish. It has been demonstrated in Europe to decrease bleeding after being administered during the acute phase of the cycle. Some women enrolled in the clinical trial will take the drug sporadically through their cycle, whereas some participants will receive the placebo. It is a randomized double-blind study, meaning neither the physician nor the patient knows who is receiving the drug and who is receiving the placebo, to ensure unbiased clinical results. Patients who qualify will receive study drug and related physical exams, electrocardiograms, eye exams and laboratory tests at no cost. They will also receive compensation for their time and travel. “We’ve conducted numerous clinical trials in the past, and remain very clinically active because we deal with issues that many pharmacological companies are testing,” said Dr. Lyons, known for developing the laparoscopic supracervical hysterectomy, or LSH, a procedure which leaves the woman’s cervix intact as a keystone support for the anatomy. It has also been shown in studies to help improve sexual function post-surgery. Study CriteriaWomen who experience heavy menstrual bleeding on two to five days of their cycle, and who have to alter their normal social and work activities due to heavy bleeding may be qualified for the study. Women must be generally healthy, and between the ages of 18 and 49; have regular menstrual cycles with heavy bleeding; and not have any other bleeding disorder. Evolution of a World-Class SurgeonDr. Lyons began teaching surgeons from around the world in the late 1980s as he trained others on laparoscopic gallbladder removal. From there he began exploration and training on tubal pregnancies, ovarian cysts, fibroids, hysterectomy and endometriosis. At the present time, even certain cancers can be removed laparoscopically.In the early 1990s, telesurgery revolutionized the field and Dr. Lyons began performing procedures in his customary operating environment while surgeons in Europe or Asia watched, asked questions and learned remotely.A video news feature about Dr. Lyons’ pioneering in the field of gynecologic laparoscopy is featured on www.ElifeMagazine.net during July 2007. What Your Doctor Doesn’t Tell YouAlthough Dr. Lyons has trained thousands of surgeons on the LSH technique he developed, most doctors don't perform it. Some surgeons refuse to perform laparoscopic procedures on a large uterus, and say it can’t be done. Left out in that explanation is, “because I can’t do it.” The size of the uterus is not an issue or a problem for Dr. Lyons. "It's especially important that patients choose a surgeon who is experienced in working with lasers and laparoscopy. LSH requires more skill than open abdominal hysterectomy. It's easier on the patient, but more challenging for the surgeon," explained Dr. Lyons. One of the most important factors in helping people choose appropriate medical care is a comprehensive understanding of the reasons for treatment, the risks, and the potential benefits. This especially applies to hysterectomy. If hysterectomy has been suggested as an option, women should carefully weigh the pros and cons, the alternative treatments, the potential benefits and risks, and the physician's track record. Many surgeons will attempt a laparoscopic procedure and feel it necessary to convert to an open surgery with a long incision during the procedure. Make sure to ask your surgeon about his or her conversion ratio. Dr. Lyons' conversion ratio is less than one percent. For information about participation in the trial contact the Center for Women’s Care & Reproductive Surgery in Atlanta at 770-352-0037 or toll-free 888-545-0400.
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