S. Chudnoff

Paracervical Block Efficacy in Office Hysteroscopic Sterilization: A Randomized Controlled Trial

OBJECTIVE: To estimate the efficacy of paracervical block compared with saline for pain relief during office hysteroscopic sterilization. METHODS: This study was a randomized, placebo-controlled study of women desiring hysteroscopic sterilization. A paracervical block of 1% lidocaine or normal saline was administered before office hysteroscopic sterilization. Patients and investigators were blinded to assignments. A pre hoc power analysis determined that 40 women would be required per arm to detect a difference of 0.9 cm on a visual analog scale. Pain was recorded on a visual analog scale at multiple procedure time points. Individualized standardized pain scores were constructed by weighted reporting of objective and subjective sensation. RESULTS: A total of 103 consecutive women were eligible, and 80 women were randomized, with 40 per group. Thirty-seven (93%) in each group had successful placement. The lidocaine group showed significantly lower pain scores for tenaculum placement (mean±standard deviation: 0.97±1.28 compared with 3.00±2.41, P<.001) traversing the external cervical os (1.46±1.71 compared with 3.77±2.68, P<.001) and internal os (1.79±2.11 compared with 4.10±2.77, P<.001). There was no significant observed difference with device placement in tubal ostium (3.15±2.69 compared with 3.74±2.73, P=.33). Multivariable linear regression analysis demonstrated a relationship of pain to procedural time (P=.047) and to group assignment (P<.01). CONCLUSION: Paracervical block with 1% lidocaine provides effective pain relief for cervical manipulations during office hysteroscopic sterilization, but does not reduce the pain associated with upper uterine/tubal manipulation when placing the devices. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00811187. LEVEL OF EVIDENCE: I

Analysis of pain and satisfaction with office-based hysteroscopic sterilization

OBJECTIVE To assess pain and patient satisfaction with office-based hysteroscopic sterilization. DESIGN This prospective, observational study was designed to assess patient pain perception and satisfaction with office-based hysteroscopic sterilization using the Essure device (Conceptus, Mountain View, CA). SETTING Faculty practice office at an inner-city urban medical center. PATIENT(S) Women seeking hysteroscopic sterilization. INTERVENTION(S) Office hysteroscopic sterilization under local anesthesia. MAIN OUTCOME MEASURE(S) Pain assessed at the time of the procedure by a 0-10 visual scale and satisfaction by a 1-5 scale. RESULT(S) From June 2003 to June 2006, 209 patients were recruited. The mean scores for average procedural pain, most procedural pain, and average menstrual pain were 2.6+/-2.1, 3.3+/-2.5, and 3.6+/-2.6, respectively. Standardized pain scores revealed that 149 subjects (70%) experienced average pain that was less than or equal to the pain experienced with their menses. Mean satisfaction rating for the procedure was 4.7+/-0.71. CONCLUSION(S) Office-based hysteroscopic sterilization performed with local anesthesia alone is well tolerated, and patients are satisfied with this method for permanent sterilization.

Three-Year Outcome of the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

STUDY OBJECTIVE To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas. DESIGN Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1). SETTING University hospitals and private surgical centers. PATIENTS One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL). INTERVENTIONS Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. CONCLUSION RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.

Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial

BackgroundAlthough most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. Here we analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up.MethodsProspective, multicenter, outpatient interventional clinical trial of fibroid treatment by RFVTA in 124 premenopausal women (mean age, 42.4 ± 4.4 years) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL).Outcome measures included: subject responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months postprocedure. Continuous and categorical variables were summarized using descriptive statistics and means and percentages. Comparisons between visits were based on t-tests using repeated measures models. P-values < 0.05, adjusted for multiplicity, were statistically significant.ResultsOne hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was –35.7 (95% CI, –40.1 to –31.4; p<.001). Change in health-related quality of life (HRQL) was 40.9 (95% CI, 36.2 to 45.6; p < .001). HRQL subscores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function) [p<.001]. Six patients underwent surgical re-intervention for fibroid-related bleeding between 12 and 24 months providing a re-intervention rate of 4.8% (6/124).ConclusionRadiofrequency volumetric thermal ablation of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up.Trial registrationClinicalTrials.gov: NCT00874029

Efficacy of a novel educational curriculum using a simulation laboratory on resident performance of hysteroscopic sterilization.

OBJECTIVE To assess whether a novel educational curriculum using a simulation teaching laboratory improves resident knowledge, comfort with, and surgical performance of hysteroscopic sterilization. DESIGN An educational prospective, pretest/posttest study. SETTING The Montefiore Institute of Minimally Invasive Surgery Laboratory. PATIENT(S)/SUBJECT(S): Thirty-four OB/GYN residents in an academic medical center. INTERVENTION(S) Hysteroscopic sterilization simulation laboratory and a brief didactic lecture. MAIN OUTCOME MEASURE(S) Differences in scores on validated skill assessment tools: Task specific checklist, Global Rating Scale (GRS), pass fail assessment, and a multiple-choice examination to evaluate knowledge and attitude. RESULT(S) In the entire cohort improvements were observed on all evaluation tools after the simulation laboratory, with 31% points (SD+/-11.5, 95% confidence interval [CI] 27.3-35.3) higher score on the written evaluation; 63% points (SD+/-15.7, 95% CI 57.8-68.8) higher score on the task specific checklist; and 54% points (SD+/-13.6, 95% CI 48.8-58.3) higher score on the GRS. Higher PGY status was correlated with better pretest performance, but was not statistically significant in posttest scores. Residents reported an improvement in comfort performing the procedure after the laboratory. CONCLUSION(S) Simulation laboratory teaching significantly improved resident knowledge, comfort level, and technical skill performance of hysteroscopic sterilization.

Group a streptococcus causing necrotizing fasciitis and toxic shock syndrome after medical termination of pregnancy

BACKGROUND: Group A Streptococcus is an aerobic gram-positive bacteria known to cause cutaneous infections. Invasive infections can lead to toxic shock syndrome with multiorgan failure and mortality rates of 25–48%. CASE: A healthy, young woman developed necrotizing fasciitis, myonecrosis, and toxic shock syndrome after an elective medical termination of pregnancy. This patient had confirmed group A Streptococcus on blood cultures and underwent surgical debridement. After aggressive surgical treatment, below–the-knee amputation, and antibiotic therapy, the patient survived. CONCLUSION: This case demonstrates the need for prompt recognition and treatment of necrotizing fasciitis/toxic shock syndrome.

Sensitivity of Myoma Imaging Using Laparoscopic Ultrasound Compared With Magnetic Resonance Imaging and Transvaginal Ultrasound

STUDY OBJECTIVE To determine the efficacy of laparoscopic ultrasound (LUS) as compared with contrast-enhanced magnetic resonance imaging (CE-MRI) and transvaginal ultrasound (TVUS) in detection of uterine myomas. DESIGN Retrospective study of imaging methods used in a trial of LUS-guided radiofrequency volumetric thermal ablation in women with symptomatic myomas (Canadian Task Force classification II-2). SETTING Eleven medical university or private outpatient surgery clinics in the United States (nine sites) and Latin America (two sites). PATIENTS One hundred thirty-five women with symptomatic myomas and objectively confirmed moderate to severe heavy menstrual bleeding. INTERVENTIONS LUS-guided radiofrequency volumetric thermal ablation of myomas. MEASUREMENTS AND MAIN RESULTS Preoperative TVUS scans and CE-MRIs were read at each site, and all CE-MRIs were read by a central reader. LUS-guided scans were obtained intraoperatively by each surgeon by mapping the uterus just before radiofrequency volumetric thermal ablation. The imaging methods and their yields in terms of number of myomas found per subject were as follows: TVUS, 403 myomas (mean [SD] 3 [1.8]; range, 1-8); site CE-MRI, 562 myomas (4.2 [3.8]; range, 1-18); central reader, 619 myomas (4.6 [3.7]; range, 0-20); and LUS, 818 myomas (6.1 [4.9]; range, 1-29) (p < .001). LUS was superior to TVUS, CE-MRI, and the central reader for detection of small (≤1 cm(3)) myomas. Most imaged myomas were intramural: 197 (50.9%) by TVUS, 298 (55.5%) by site CE-MRI, 290 (48.7%) by the central reader, and 386 (48.5%) by LUS. CONCLUSION Compared with CE-MRI and TVUS, LUS demonstrates the most myomas, regardless of size or type.

A 5-day educational program for teaching cervical cancer screening using visual inspection with acetic acid in low-resource settings

To assess the effectiveness of an educational program in visual inspection with acetic acid (VIA) for cervical cancer screening among healthcare providers in 2 low‐resource countries.

Pseudoepitheliomatous hyperplasia mimicking vulvar cancer in a patient with AIDS

Background. Pseudoepitheliomatous hyperplasia (PEH) clinically and histologically mimics squamous cell carcinoma (SCC), specifically in patients with HIV and AIDS. Case. A 51-year-old G3P2 with AIDS and history of vulvar cancer presented with large bilateral exophytic lesions on the vulva, grossly appearing neoplastic. Initial biopsies of the lesions were interpreted as vulvar SCC. After resolution with empiric treatment with acyclovir for possible herpes simplex virus type 2 outbreak, additional slides were reviewed, and cells with viral inclusions were identified, making the final diagnosis PEH in association with herpes simplex virus type 2 infection. Conclusions. Although PEH is infrequently encountered, PEH should be considered in the differential diagnosis of vulvar lesions. A multidisciplinary approach including the gynecologist, pathologist, and infectious disease specialists can optimize patient outcome.

Role of elevated cancer antigen 19-9 in women with mature cystic teratoma.

The objective of this study was to determine how often an elevated cancer antigen (CA) 19-9 (≥ 37 U/mL) was present during the preoperative evaluation of women with a mature cystic teratoma (MCT). This was a retrospective, consecutive case series (N = 139) of histologically proven MCT treated at Montefiore Medical Center from 1997 to 2008. Data were analyzed for patient and tumor characteristics, tumor markers (CA 19-9, CA 125, and carcinoembryonic antigen [CEA]), preoperative imaging, and procedure. CA 19-9 was elevated in 37.4% of patients. Elevated CA 19-9 was not significantly associated with age, race, CA 125 (≥35 U/mL), CEA (≥5 ng/mL), MCT size, or the presence of bilateral MCTs. Of the patients, 59% were ≥40 years old. Age <40 years was associated with cystectomy rather than oophorectomy (P < .001), regardless of CA 19-9 (P = .09). Elevated preoperative CA 19-9 in patients with MCT was associated with increased preoperative computed tomography (P = .04).