Jay M. Cooper

A Randomized, Multicenter Trial of Safety and Efficacy of the NovaSure System in the Treatment of Menorrhagia

STUDY OBJECTIVE To compare the safety and effectiveness of the NovaSure impedance-controlled endometrial ablation system with hysteroscopic wire loop resection plus rollerball ablation for treatment of excessive uterine bleeding in premenopausal women. DESIGN Randomized, multicenter, double-arm study (Canadian Task Force classification I). SETTING Nine academic medical centers and private offices. PATIENTS Two hundred sixty-five premenopausal women with symptomatic menorrhagia. INTERVENTION Ablation performed with the NovaSure system or wire loop resection and rollerball. MEASUREMENTS AND MAIN RESULTS Success [pictorial blood loss-assessment chart (PBLAC) score < or =75] was achieved in 88.3% of NovaSure-treated and 81.7% of rollerball-treated patients. One year after treatment 90.9% and 87.8%, respectively, reported normal bleeding or less (PBLAC < or =100) and 41% and 35%, respectively, experienced amenorrhea (PBLAC = 0). Mean procedure time was 4.2 minutes (average 84 sec) in the NovaSure group and 24.2 minutes in the rollerball group. Local and/or intravenous sedation was administered in 73% of NovaSure patients and 18% of rollerball patients. Intraoperative adverse events occurred less frequently with NovaSure (0.6%) than with rollerball (6.7%). Postoperative adverse events occurred in 13% and 25.3% of patients, respectively. CONCLUSION The NovaSure system was safe and effective in treatment of women with menorrhagia. The procedure is both quick and effective, and eliminates the expense and side effects of endometrial pretreatment.

The AAGL classification system for laparoscopic hysterectomy

Reich first reported total laparoscopic hysterectomy in 1989.1 Since that time many variations of the procedure have been described, that vary principally by the relative portions of the surgery performed via the vaginal and laparoscopically directed routes. The variations have potential impact on clinical outcomes such as complication rates, and resource utilization outcomes such as the cost of surgical care. In addition, training and credentialing of surgeons may vary depending upon the type of laparoscopic hysterectomy performed. Unfortunately, critical and rigorous evaluation of the technique has been impaired by the varied and inconsistent nomenclature used in the gynecologic literature to describe the spectrum of operations that comprise laparoscopic hysterectomy, including laparoscopically assisted vaginal hysterectomy (LAVH), laparoscopic-directed hysterectomy, laparoscopic hysterectomy and laparoscopicallyassisted hysterectomy. In addition, the rediscovery of subtotal or supracervical hysterectomy and its adaptation to the laparoscopic route has introduced such terms as classic intrafascial Semm hysterectomy (CISH), laparoscopic assisted subtotal hysterectomy (LASH) and others. These procedures, while generally performed under laparoscopic direction, vary both by the amount of dissection performed and by the treatment of the columnar epithelium and the transformation zone of the cervix. These differences may have an impact not only on resource utilization and complications, but also on the long-term incidence of post procedural cervical neoplasia. Such information is important for patients, providers, and health care organizations. A historically useful solution to the problem is the creation of a classification system that is easily reproducible and capable of stratifying cases in a way that allows critical evaluation of procedures performed in different clinical environments by a variety of surgeons. Many attempts have been made to design a classification system for laparoscopic hysterectomy and each has been different in its approach. 2-5 Consequently, the goals of standardized classification have yet to be achieved. The AAGL believes that it is important to develop and support a standard nomenclature for the classification of laparoscopic hysterectomy. The AAGL Classification Committee was charged with designing an acceptable system, or selecting one that has been previously published. The result of the deliberation was the selection of a previously published system 2 accompanied by an abbreviated form of the same system designed for everyday use. The full system, reprinted here with permission, is designed principally for clinical and resource outcomes use by investigators but could be used in whole or in part by practitioners, investigators or provider organizations. It is detailed,

Intraoperative and early postoperative complications of operative hysteroscopy

With preoperative evaluation, meticulous technique, and vigilance for impending problems, intraoperative and early postoperative complications of operative hysteroscopy are largely preventable. Fluid overload is the most common serious complication. The hysteroscopist must understand the significant differences between hypotonic, electrolyte-free distention media and isotonic, electrolyte-containing media and their respective sequelae. As new operative tools become available, hypotonic and electrolyte-free distention media may become obsolete. The physiology and management of air embolism, the most grave intraoperative complication, are essential to the knowledge base of any active hysteroscopist. Mechanical accidents, anesthetic complications, laser and electrical injury, and infections can be reduced by knowledge and preparation. Technologic advances, ongoing research, and postgraduate training in hysteroscopic technique continue to expand the safe and beneficial applications of hysteroscopy into the next century.

Microwave Endometrial Ablation vs. Rollerball Electroablation for Menorrhagia: A Multicenter Randomized Trial

STUDY OBJECTIVE To compare the effectiveness, safety, and acceptability of microwave endometrial ablation (MEA) with those of rollerball electroablation (REA) for the treatment of menorrhagia. DESIGN Randomized clinical trial (Canadian Task Force classification I). SETTING Eight academic medical centers and private medical practices. PATIENTS Three hundred twenty-two women with documented menorrhagia due to benign causes. INTERVENTION MEA or REA. MEASUREMENTS AND MAIN RESULTS By intent-to-treat analysis, the success rate of MEA at 12 months (87.0%; CI 81.7%-91.2%) did not differ significantly (p = .40) from that of REA (83.2%; CI 74.7%-89.7%). Among evaluable patients, success rate was also similar (p = .24) in the MEA (96.4%; CI 92.7%-98.5%) and REA (92.7%; CI 85.6%-97%) groups. The amenorrhea rate in evaluable patients after MEA was 61.3% (CI 54.1 %-68.2%). In patients with myomas, the success and amenorrhea rates in evaluable patients after MEA were 90.3% (CI 74.2%-98%) and 61.3% (CI 42.2%-78.2%), respectively. In evaluable patients with body mass index of 30 kg/m2 or greater, MEA success rate was 96.7% (CI 88.5%-99.6%) compared with 81.8% (CI 59.7%-94.8%) for REA (p = .042). The ablation procedure was performed under IV sedation in 62% of patients in the MEA group versus 18% of patients in the REA group (p <.001); whereas, general anesthesia was employed more often in patients undergoing REA (37% vs. 76%, p <.001). No major complications were encountered. Patient satisfaction with results of treatment was high (98.5% of the MEA and 99.0% of the REA group). CONCLUSIONS Microwave endometrial ablation is an efficacious and safe procedure for the treatment of menorrhagia. Over half of patients treated with MEA achieve amenorrhea, and the procedure is suitable for women with myomas and irregular uterine cavities. The procedure is easily learned and can be performed rapidly, under IV sedation in most cases.

Hysteroscopic training guidelines

Safety and outcome of surgical procedures are clearly linked to adequate training. The criteria suggested below are minimal requirements and not absolute requirements as determined by the Board of Trustees of the American Association of Gynecologic Laparoscopists. Surgeons are responsible for obtaining adequate training. Surgeons should not request privileges for procedures or the use of new technologies in which they have not received adequate training. This is especially true when new technologies are used. The burden for satisfying the adequacy of training and surgical competence of the surgeon before allowing direct patient care ultimately falls on the hospital/facility medical staff. Physicians seeking hysteroscopic training should: a. Be board eligible/certified in gynecology, b. Have unsupervised gynecologic privileges for patient care, OR c. Be in an accredited residency program in obstetrics and gynecology. The components of hysteroscopic training ideally will include: a. Didactic training. b. Hands-on laboratory training. c. Case observation (highly recommended). d. Preceptorship (highly recommended). The didactic portion should initially include diagnostic and operative hysteroscopy and be a minimum of 6 hours. It should be a CME-approved program and include: 1. Uterine anatomy 2. Options of distention media 3. Management of distention media 4. Energy sources 5. Instrumentation 6. Surgical indications and techniques for: a. diagnostic hysteroscopy b. adhesiolysis c. metroplasty d. polycystic ovary e. fibroid resection/vaporization f. endometrial ablation 7. Prevention and management ofhysteroscopic complications.

Late complications of operative hysteroscopy

The late complications of operative hysteroscopy result from either persistent endometrium after ablation or myometrial damage during surgery. Residual endometrium can become neoplastic, cause pain, or support a pregnancy. Myometrial damage can produce catastrophic consequences during a later pregnancy. These long-term problems place the impetus on the operating physician to select patients carefully, prepare the endometrium, and operate in such a way as to minimize the likelihood of residual endometrium and unnecessary myometrial damage. The value of operative hysteroscopy for infertility secondary to adhesions and uterine septa is unequivocal. Hysteroscopic surgery offers increased fertility rates while avoiding the risks of open surgery. For the treatment of abnormal uterine bleeding, endometrial ablation can be performed safely, and the long-term benefits are durable. As more operative hysteroscopy is performed, more delayed complications will arise. Easy-to-perform global ablation techniques and multifunctional operative hysteroscopes have enticed more gynecologists to test the waters of endometrial ablation and operative hysteroscopy. Although they empower the hysteroscopist to offer more advanced and more valuable minimally invasive options to patients, these tools simultaneously can tempt the surgeon to forego meticulous preoperative evaluation. Evidence exists that too often women undergo surgery without complete diagnostic assessment. In one study, 50% of women underwent hysterectomy without any diagnostic evaluation of the endometrium. Hysterectomy possesses a saving grace in that it provides cover for many missed diagnoses. Conservative, nonextirpative procedures offer no such life raft. Meticulous diagnostic assessment and preoperative consideration of risk factors for residual endometrium and future pregnancy remain the keys to minimizing late complications.

Complications of fluid overload from resectoscopic surgery

Excess absorption of liquid distending media is one of the most frequent complications of operative hysteroscopy. Although most women recover uneventfully, we are seeing cases of permanent morbidity or death resulting from this complication.

One-year results of the Vesta system for endometrial ablation

STUDY OBJECTIVE To compare a distensible multielectrode balloon for endometrial ablation with electrosurgical ablation performed by a combined resection-coagulation technique. DESIGN Randomized, prospective trial (Canadian Task Force classification I). Setting. Eight centers. PATIENTS Women with menorrhagia validated with a standardized pictorial blood loss assessment chart (PBAC), without intracavitary organic uterine disease, who failed or poorly tolerated medical therapy. Intervention. Results in 122 patients treated by Vesta and 112 treated surgically, evaluable at 1 year, were compared, with success defined as monthly blood loss of less than 80 ml and avoidance of additional therapy. MEASUREMENTS AND MAIN RESULTS Pretreatment PBAC scores for patients treated by Vesta and resection or rollerball were 535+/-612 and 445 +/- 313, respectively; at 1 year they were 18+/-37 and 28+/-60, respectively. With PBAC below 75 as the definition of success, 86.9% of Vesta-treated patients were successful compared with 83.0% treated by rollerball or resection. Total amenorrhea, defined as no visible bleeding and no use of protective products, was 31.1% and 34. 8%, respectively. None of the outcome comparisons between treatments showed statistical difference. Complications in both groups were few and minor. Most (86.6%) Vesta procedures were carried out with paracervical block with or without intravenous sedation in an office or outpatient setting, compared with 79.7% epidural or general anesthesia for rollerball or resection. CONCLUSION The Vesta system of endometrial ablation is equally effective and safe as classic resectoscopic methods. Potential advantages include avoidance of fluid and electrolyte disturbance associated with intravasation of distending media, and ability to perform the procedure under local anesthesia in an office setting with less total operating time.

Endometrial sampling techniques in the diagnosis of abnormal uterine bleeding

There have been many advances in sampling of the endometrium. Ideas and technologies have evolved, increasing our ability to gather adequate specimens that provide reliable information about uterine cavity pathologies. No technique surpasses the sensitivity and specificity of hysteroscopy with directed biopsy. Owing to its superior diagnostic potential, hysteroscopy, even when performed in the office with narrow scopes (not significantly larger in diameter than the Pipelle catheter), leads to precise diagnosis and appropriate management of intrauterine pathologic conditions. For physicians who are untrained or lacking the equipment to perform diagnostic hysteroscopy with directed biopsy, simple in-office endometrial sampling techniques with no visual control provide a means to obtain reasonably reliable samples with negligible patient discomfort.

Global endometrial ablation technologies

The value of extirpative surgery for excessive uterine bleeding is questionable. A number of technologies have been developed that destroy the endometrial lining while preserving the uterus. This article compares and contrasts multiple modalities of global endometrial ablation technology.