Daryoosh Samimi, MD, says he has developed a new surgical procedure for hysterectomy, of which there are about 600,000 performed with a variety of methods each year in the U.S. for the treatment of both benign and malignant disease.
Samimi, director of the U.S. Women Institute (Fountain Valley, California), said the new procedure prevents blood loss and preserves nerves in the abdomen that can prevent later complications from the surgery for women.
“[Using my procedure], we could [save] 240,000 units of blood [from being used] each year, and we can save more than 270,000 days of hospitalization per year,“ Samimi told Medical Device Daily.
This new “bloodless/nerve-sparing hysterectomy keeps the cardinal, uterosacral ligmanet and vaginal apex safe and secure,“ according to Samimi, “without cutting.“
However, he said the entire cervix, along with the uterus, is removed through the pericervical ring by bikini cut. Samimi maintains that removal of the uterus, along with the cervix, is “helpful in the prevention of future cervical cancer.“
Samimi said his procedure avoids the dissection of the cardinal ligament, uterosacral ligament and puboviseco-cervical fascia.
“It is the cardinal ligament which provides major support of the uterus and cervix,“ Samimi said in a statement. “Additionally, the uterosacral ligament is composed primarily of nerve bundles, which contain fibers communicating primarily to the uterus, cervix urinary bladder and vagina. It also serves as anatomic support for the cervix.“
Ultimately, he said the procedure results in minimal complications, such as urinary problems, sexual dysfunction and ureteric injury, as well as in less blood loss.
Samimi said that there are various kinds of procedures utilized to remove the uterus from the pelvic cavity.
“Traditionally, this procedure may be performed using the following methods: conventional abdominal, vaging or laparascopy-assisted vaginal hysterectomy; intrafascial, extrafascial hysterectomy; and lastly, the subtotal or supracervical hysterectomy,“ he said.
Samimi said the supracervical hysterectomy “has been criticized in medical literature due to a significant number of patients developing cancer of the cervical stump,“ resulting in the patient's death.
“The procedure is also expensive because of costs incurred as a result of preventive measures considered for cancer,“ he said.
Samimi said he has completed a total of 80 procedures of this type since beginning them in the year 2000, on women ranging in age from 35 to 74, and no complications have been reported. Also, there has been “minimal estimated blood loss during surgery,“ and follow-up care ranges from two to 63 months.
“Post-operative care and patient improvement following surgery was excellent,“ he said.
After completing the initial 20 procedures, Samimi presented a paper during the 2003 annual meeting of the American College of Obstetricians and Gynecologists (ACOG; Washington).
At the time of the presentation, Bryan Cowan, MD, professor and chairman of obstetrics and gynecology at the University of Mississippi Medical Center (Jackson, Mississippi), told Medscape Medical News that “20 patients are just not enough to make this claim“ about the procedure. “You need at least 60 patients in each arm to really show a difference.“ In addition, a study of that nature would normally “call in other centers, maybe three centers in all, to broaden the results.“
Samimi told MDD that after presenting the paper at ACOG, he realized that he needed to perform the procedure on more patients to prove its success.
In addition to the 600,000 hysterectomies performed in the U.S. each year, Samimi said there are more than 20 million performed annually around the world. Of the number in the U.S., he said 70% are abdominal procedures and the remaining 30% are vaginal.