Correlation of surgical case volume and fellowship training with performance on simulated procedural tasks.

BACKGROUND: High-volume and fellowship-trained surgeons have superior outcomes. However, in gynecology, a large proportion of cases are performed by low-volume surgeons. Simulation has been shown to be useful in assessing surgical skill and may be a useful tool in hospital credentialing and maintenance of privileges. OBJECTIVE: To determine the correlation between a surgical case volume and fellowship training with performance on simulated procedural tasks. STUDY DESIGN: A total of 108 obstetricians and gynecologists with laparoscopic privileges at 2 academic institutions completed a pre-test survey and performed 3 tasks on the LapSim laparoscopic virtual reality simulator. The pre-test survey inquired about the monthly laparoscopic case volume and prior training. Simulations included a basic skills task (peg transfer) followed by a procedural task (salpingectomy) of 2 difficulty levels (low and moderate). Spearman correlation and Wilcoxon tests were used to determine correlations between the survey responses and performance metrics. RESULTS: Participants included 67 generalists (62%) and 41 fellowship-trained specialists (38%). There was an observed weak correlation among surgical volume (more than 6 cases per month), time to completion, and the amount of blood loss when performing the low-difficulty level salpingectomy (r=-0.32, P=.0007 and r=-0.29, P=.002, respectively). The economy of movement (instrument path length) was correlated to high surgical volume (r=-0.35, P=.0002). Compared with generalists, surgeons with fellowship training performed tasks faster (410.8 seconds [interquartile range, 309.7-595.2]) vs 530.2 seconds (interquartile range, 406.2-605.0; P=.0009), more efficiently at 6.1 m (interquartile range, 4.8-7.3) vs 8.1 m (interquartile range, 5.8-10.7; P=.0003), and with less blood loss at 21.7 mL (interquartile range, 11.8-37.7) vs 42.9 mL (interquartile range, 18.1-70.6; P=.002). Regarding the case volume and fellowship background, there was no difference in ovarian diathermy damage. In addition, there was no difference among most performance parameters for the peg transfer task and the moderate-difficulty salpingectomy procedure. CONCLUSION: Surgical experience obtained through higher case volume and fellowship training correlate with higher performance scores during simulated procedural tasks. In a previous study, we found a similar correlation with simulated basic skills tasks. The current study is a continuation of an ongoing quality initiative to establish a summative assessment of laparoscopic surgical skills using virtual reality simulator for the maintenance of credentials among obstetrical and gynecologic surgeons. Future studies will compare the performance metrics from laparoscopic procedures performed on virtual reality simulator with the performance in the operating room and clinical outcomes.

A Retrospective Study of Risk Factors for Small Bowel Obstruction After Hysterectomy.

BACKGROUND AND OBJECTIVES: The purpose of this study was to evaluate the incidence of small bowel obstruction (SBO) following hysterectomy and to identify factors that may increase the risk of SBO by route of hysterectomy. METHODS: A retrospective review of the electronic medical records of all hysterectomies completed between January 2011 through July 2013 at our institution was performed. Information on patient demographics, comorbid conditions, and surgical characteristics were collected. All cases were reviewed for documentation of SBO in the immediate or remote postoperative period, up to 5 years post-hysterectomy. RESULTS: Between January 2011 and July 2013, 1630 hysterectomies were performed at Montefiore Medical Center. A minimally invasive technique was employed for 49.8%, including 15.7% vaginal and 33.9% laparoscopic hysterectomies. Of these 1630 cases, 40 SBO's were documented; 30 after an abdominal approach and 10 after a minimally invasive approach. The overall incidence of SBO was 2.4%. A multivariable analysis adjusting for potential confounders demonstrated lower odds of SBO for the minimally invasive approaches combined, compared to abdominal hysterectomy (0.44, 95% confidence interval, 0.20, 0.98, p = .0444). Additional variables independently associated with development of SBO included intra-operative bowel injury and malignancy, whereas intra-operative blood loss and lysis of adhesions were not independently associated with SBO. CONCLUSIONS: After adjusting for confounders including malignancy, abdominal hysterectomy was associated with a significantly higher risk for SBO when compared to minimally invasive hysterectomy. Our study adds to the body of literature supporting a minimally invasive approach to hysterectomy when feasible.

Methotrexate Administration to Patients With Presumed Ectopic Pregnancy Leads to Methotrexate Exposure of Intrauterine Pregnancies.

OBJECTIVE: To report clinical experience with methotrexate (MTX) treatment for suspected but not definite ectopic pregnancy (EP). METHODS: This was a retrospective cohort study. All patients treated with MTX for presumed EP between 2000 and 2016 were included. Demographic, clinical, sonographic, and outcome data were collected and analyzed. RESULTS: A total of 820 patients were treated with MTX, 692 (84.4%) of which were lacking definitive features of EP; 155 (22.4%) failed to follow up until complete resolution and were excluded. Retrospective sonographic categorization was applied to 537 patients; of those patients, 393 (73.2%) were categorized as probable EPs, 136 (25.3%) pregnancies of unknown location (PULs), and 8 (1.5%) probable intrauterine pregnancies (IUPs). Sixteen were eventually diagnosed with IUP: 6 from the probable EPs, 9 from the PULs, and 1 from the probable IUP group. Patients with final diagnosis of IUP had higher values of ß-human chorionic gonadotropin as well as lower prevalence of adnexal mass (38% versus 74%; P = .003), higher prevalence of intracavitary fluid (44% versus 9%; P = .0004) and thicker endometrium (17.1 ± 11.8 versus 9.7 ± 5.6; P = .04). None of the sonographic parameters were able to distinguish patients with IUP. One patient of the 16 with IUP was diagnosed with a viable pregnancy, and 7 additional patients had a possible viable pregnancy. None of them elected to continue the pregnancy. CONCLUSIONS: Most patients with suspected EP who are eligible for medical treatment lack definitive sonographic features of EP. Treatment with MTX in such cases should be delayed, as clinically reasonable, to improve the diagnosis and prevent inadvertent administration of MTX to patients with a viable IUP.

A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of the AEGEA Vapor System (Aegea Medical System, Menlo Park, CA) for the treatment of heavy menstrual bleeding (HMB). DESIGN: A prospective, multicenter, single-arm, open-label, clinical trial. Follow-up assessments were conducted at 24 hours; 2 weeks; and 3, 6, and 12 months after the endometrial ablation procedure (Canadian Task Force Classification II-1). SETTING: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. PATIENTS: One hundred fifty-five premenopausal women aged 30 to 50years with HMB as determined by a pictorial blood loss assessment score ≥150. Preoperative evaluation included ultrasound, sonohysterography or hysteroscopy, and endometrial biopsy. Screening inclusion allowed treatment of up to 12-cm uterine sound lengths and nonobstructing myomata. INTERVENTIONS: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. MEASUREMENTS AND MAIN RESULTS: The primary effectiveness end point was the reduction of menstrual blood loss to a pictorial blood loss assessment score ≤75. Success was judged based on the Food and Drug Administration's objective performance criteria, derived from the success rates of the first 5 global endometrial ablation pivotal clinical trials. The secondary effectiveness end points included quality of life and patient satisfaction as assessed using the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score as well as the need for surgical or medical intervention to treat abnormal bleeding at any time within the first 12 months after treatment. All adverse events, including device- and procedure-related events, were recorded. At 12 months, the primary effectiveness end point was achieved in 78.7% of subjects exceeding the OPC (p = .0004); 90.8% of subjects were satisfied or very satisfied with the treatment. Ninety-nine percent of subjects showed improvement in quality of life scores with an average decrease in the Menorrhagia Impact Questionnaire score by 8.1, 72% had less dysmenorrhea, and 85% of women whose sex lives were affected by their menses reported improvement in their sex lives. There were no reported serious adverse device effects or any reported serious adverse events that were procedure related. CONCLUSION: The AEGEA Vapor System is a safe, effective, and minimally invasive option for performing in-office endometrial ablation under minimal anesthesia for the purpose of treating women who suffer from HMB.

Pregnancy Outcomes After Direct Uterine Myoma Thermal Ablation: Review of the Literature.

The objective of this review is to describe the reproductive outcomes of women after radiofrequency volumetric thermal ablation (RFVTA) of myomas or magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU). This is a literature review of the current case reports of reproductive outcomes after direct myoma thermal ablation at multiple academic and private centers throughout the world. A literature search was performed using PubMed and Medline. All publications that included data of women who underwent radiofrequency myoma ablation or MRgHIFU of myomas and subsequently conceived were included. There were 122 pregnancies after direct uterine myoma thermal ablation, and 20 pregnancies were reported after RFVTA. Of these cases, there was 1 spontaneous abortion and 7 elective terminations. The remaining 12 pregnancies went on to have live full-term deliveries, 9 (75%) by cesarean section and 3 (25%) by vaginal delivery. There were no reports of uterine abnormalities at delivery and 1 delayed postpartum hemorrhage with expulsion of a degenerated myoma. There are 102 reported pregnancies after MRgHIFU. There were 21 spontaneous abortions and 22 elective terminations, 48 deliveries, and 11 ongoing pregnancies at the time of report. There was 1 preterm delivery at 36 weeks due to placenta previa, and the remaining deliveries were full term. The complications reported included vaginal spotting (12.5%), delayed placental separation (4%), and placenta previa (4%). There were no cases of uterine rupture. In summary, RFVTA and MRgHIFU are new minimally invasive alternatives for the treatment of myomas. Further investigation into the reproductive outcomes after these myoma therapies is crucial to determine whether these are appropriate treatment options for women with symptomatic myomas who desire future fertility.

Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.

OBJECTIVE: To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. DESIGN: Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). SETTING: Thirteen clinical study centers in the United States, Europe, and Australia. PATIENTS: A total of 518 previously fertile women seeking permanent contraception. INTERVENTION: The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. MEASUREMENTS AND MAIN RESULTS: The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during follow-up as being "possibly" related to the procedure or the inserts. CONCLUSION: The findings from extended follow-up of this Phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional option for permanent contraception.

Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database.

STUDY OBJECTIVE: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. DESIGN: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). SETTING N/A PATIENTS: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. INTERVENTIONS: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. MEASUREMENTS AND MAIN RESULTS: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. CONCLUSIONS: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.

Image-guided drainage versus antibiotic-only treatment of pelvic abscesses: short-term and long-term outcomes.

OBJECTIVE: To determine the efficacy of image-guided drainage versus antibiotic-only treatment of pelvic abscesses. DESIGN: Retrospective cohort analysis. SETTING: An academic, inner-city medical center. PATIENT(S): Women ages 11-49, admitted between 1998 and 2008 with ICD9 code 614.x (inflammatory diseases of ovary, fallopian tube, pelvic cellular tissue, and peritoneum). INTERVENTION(S): Medical records search, chart review, and phone survey. MAIN OUTCOME MEASURE(S): Surgical intervention. RESULT(S): We identified 6,151 initial patients, of whom 240 patients met inclusion criteria. Of the included patients, 199 women received antibiotic-only treatment, and 41 received additional image-guided drainage. There was no statistically significant difference between the two groups in terms of age, body mass index, parity, incidence of diabetes, obesity, endometriosis, or history of sexually transmitted infection excluding human immunodeficiency virus (HIV). Abscesses in the drainage cohort were noted to be larger in dimension (5.9 cm vs. 8.5 cm); 16.1% of patients who received antibiotics alone required surgical intervention versus only 2.4% of the drainage cohort. Patients who received drainage had longer hospital stays, but the time from treatment to discharge was similar in both groups (7.4 days vs. 6.7 days). We successfully contacted 150 patients, and the differences in long-term pregnancy outcomes, pain, or infertility were not statistically significant. CONCLUSION(S): Patients who received antibiotics alone were more likely to require further surgical intervention when compared with patients who additionally received image-guided drainage. There were no observable long-term differences.

Global endometrial ablation in the presence of essure® microinserts.

Abnormal uterine bleeding (AUB) affects 30% of women at some time during their reproductive years and is one of the most common reasons a woman sees a gynecologist. Many women are turning to endometrial ablation to manage their AUB. This article reviews the data relating to the available endometrial ablation techniques performed with hysteroscopic sterilization, and focuses on data from patients who had Essure® (Conceptus, San Carlos, CA) coils placed prior to performance of endometrial ablation. Reviewed specifically are data regarding safety and efficacy of these two procedures when combined. Data submitted to the US Food and Drug Administration for the three devices currently approved are reviewed, as well as all published case series. Articles included were selected based on a PubMed search for endometrial ablation (also using the brand names of the different techniques currently available), hysteroscopic sterilization, and Essure.

Review of vasopressin use in gynecologic surgery.

Vasopressin has been used in gynecologic surgery since the 1950s. Since its initial introduction, multiple applications of vasopressin have been explored. The expansion of vasopressin usage in gynecologic surgery is being fueled in part by the increase in minimally invasive surgical techniques, in which alternative methods of temporary hemostasis are in high demand. Nevertheless, much criticism has been directed toward use of vasopressin because of reports of serious complications including cardiac arrest. These concerns have caused several countries to restrict or prohibit the use of this valuable drug. This review explores the mechanisms of vasopressin, the current literature on vasopressin use in gynecologic surgery, and evaluates the reported complications associated with vasopressin use.

A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA-mandated trial.

OBJECTIVE: To assess the placement rates for experienced users versus newly trained physicians using the new ESS 305 delivery catheter for the Essure microinsert hysteroscopic sterilization system. DESIGN: Multicenter prospective cohort study. SETTING: Seventy-six sites throughout the U.S. comprising community hospitals, teaching institutions, surgery centers, and office-based practices. PATIENT(S): A total of 578 women seeking hysteroscopic sterilization. INTERVENTION(S): Hysteroscopic sterilization with the ESS 305 device by either experienced or novice physicians. MAIN OUTCOME MEASURE(S): Successful bilateral placement of the Essure 305 device. RESULT(S): A total of 625 patients were recruited with 578 eligible cases performed by 37 newly trained and 39 experienced physicians: 562/578 (97.2%) overall had successful placement, with 98% successful placement rate versus 96.1% for experienced versus novice physicians, respectively. Mean procedural time was 9 minutes (±7 SD), with experienced physicians completing it on average quicker at 7.9 minutes (±5.8 SD) and novices completing it in 10.7 minutes (±8.3 SD). There was no significant association between successful placement with patient characteristics such as body mass index, surgical history, parity, or prior vaginal deliveries observed. CONCLUSION(S): The Essure procedure can be performed quickly and safely with high bilateral placement rates regardless of physician experience or patient characteristics.

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.

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.

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.

A summary of reported pregnancies after hysteroscopic sterilization.

The purpose of this article is to describe 64 unintended pregnancies reported by patients who had undergone hysteroscopic sterilization and to provide recommendations for avoiding post-procedure pregnancies. Sixty-four pregnancies out of an estimated 50,000 procedures were reported to the device manufacturer from 1997 through December 2005. Most occurred in patients without appropriate follow-up. Other causes included misread hysterosalpingograms, undetected preprocedure pregnancies, and failure to follow product-labeling guidelines. The risk of pregnancy with hysteroscopic sterilization may be reduced by educating patients about the necessity of follow-up, ensuring that patients use effective contraception before and after placement, following the instructions for use, and adhering to the hysterosalpingography protocol.

Prospective analysis of office-based hysteroscopic sterilization.

STUDY OBJECTIVES: To evaluate the efficacy of performing the Essure hysteroscopic sterilization in an office-based setting. DESIGN: Prospective, longitudinal analysis (Canadian Task Force classification II-3). SETTING: University out-patient office. PATIENTS: All patients undergoing permanent sterilization in our outpatient office who opted for hysteroscopic sterilization were included. INTERVENTIONS: Hysteroscopic placement of the Essure device in an office-based setting with only non-steroidal antiinflammatory drugs and paracervical block. MEASUREMENTS AND MAIN RESULTS: Multiple data points were collected on each patient including demographic data, specific procedural information, and 12-week hysterosalpingogram data. Most of our patients were Hispanic and had an average body mass index of 30.3. Average time to perform the procedure was 12.4 minutes, with the steepest improvement in the first 13 cases. Bilateral placement of the device was successful in 98 (96%) of 102 patients. Of these patients 92 have 12-week hysterosalpingography results (6 patients were lost to follow-up), with 90 (98%) showing bilateral tubal occlusion. There were no intraprocedural or postprocedural complications. CONCLUSION: In our institution and in our experience, office-hysteroscopic placement of the Essure device is a feasible and effective approach for permanent sterilization.

Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis.

STUDY OBJECTIVE: To evaluate the actual cost difference in performing Essure hysteroscopic sterilization in the office compared with ambulatory surgery using laparoscopic sterilization in the operating room. DESIGN: Cost-comparison analysis (Canadian Task Force classification III). SETTING: University hospital and affiliated outpatient office. INTERVENTIONS: Hysteroscopic placement of Essure device in an office setting and laparoscopic tubal ligation for permanent sterilization. MEASUREMENTS AND MAIN RESULTS: The various costs associated with the two procedures at our institution were compiled, and a direct cost comparison was made. We used actual institutional costs of the procedures, not billing or reimbursement. We found laparoscopic tubal ligations to cost 3449 dollars compared with hysteroscopic placement of the Essure device that costs 1374 dollars yielding a 2075 dollars difference between the procedures. CONCLUSION: In our institution and in our experience, office-hysteroscopic placement of the Essure device is a more cost-effective method than laparoscopic tubal ligation.