Impact of trainees involvement on surgical outcomes of abdominal and laparoscopic myomectomy.

BACKGROUND: To determine the association of trainees involvement with surgical outcomes of abdominal and laparoscopic myomectomy including operative time, rate of transfusion, and complications. METHODS: A retrospective cohort study of 1145 patients who underwent an abdominal or laparoscopic myomectomy from 2008-2012 using the American College of Surgeons National Surgical Quality Improvement Program database (Canadian Task Force Classification II-2). RESULTS: Overall, 64% of myomectomies involved trainees. Trainees involvement was associated with a longer operative time for abdominal myomectomies (mean difference 20.17 minutes, 95% Confidence Interval (CI) [11.37,28.97], p < 0.01) overall and when stratified by fibroid burden. For laparoscopic myomectomy, there was no difference in operative time between trainees vs no trainees involvement (mean difference 4.64 minutes, 95% CI [-18.07,27.35], p = 0.67). There was a higher rate of transfusion with trainees involvement for abdominal myomectomies (10% vs 2%, p < 0.01; Odds Ratio (OR) 5.62, 95% CI [2.53,12.51], p < 0.01). Trainees involvement was not found to be associated with rate of transfusion for laparoscopic myomectomy (4% vs 5%, p = 0.86; OR 0.82, 95% CI [0.16,4.14], p = 0.81). For abdominal myomectomy, there was a higher rate of overall complications (15% vs 5%, p < 0.01; OR 2.96, 95% CI [1.77,4.93], p < 0.01) and minor complications (14% vs 4%, p < 0.01; OR 3.71, 95% CI [2.09,6.57], p < 0.01) with no difference in major complications (3% vs 2%, p = 0.23). For laparoscopic myomectomy, there was no difference in overall (6% vs 10% p = 0.41; OR 0.59, 95% CI [0.18,2.01], p = 0.40), major (2% vs 0%, p = 0.38), or minor (5% vs 10%, p = 0.32; OR 0.52, 95% CI [0.15,1.79], p = 0.30) complications. CONCLUSION: Trainees involvement was associated with increased operative time, rate of transfusion, and complications for abdominal myomectomy, however, did not impact surgical outcomes for laparoscopic myomectomy.

TITLE: Trainees Involvement in MyomectomyThe goal of our study was to determine the association of trainees involvement with surgical outcomes of fibroid excision surgery or myomectomy. We conducted a study of abdominal and laparoscopic myomectomies using an international surgical database. We found that trainees involvement in myomectomy was associated with increased operative time, rate of transfusion, and complications for abdominal myomectomy. However, trainees involvement did not impact surgical outcomes for laparoscopic myomectomy.

Laparoscopic Trocars: Marketed Versus True Dimensions-A Descriptive Study.

STUDY OBJECTIVE: To establish true dimensions of single-use laparoscopic trocars compared with marketed dimensions, calculate corresponding incision sizes, examine what trocar size categories are based on, and outline accessibility of information regarding true dimensions. DESIGN: Descriptive study. SETTING: Laparoscopic disposable trocars available in North America and Europe are marketed in several distinct categories. In practice, trocars in the same-size category exhibit different functionality (ability to introduce instruments/needles and retrieve specimens) and warrant different incision lengths. PATIENTS: Not applicable. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: True dimensions for 125 trocars (bladeless, optical, and balloon) were obtained from 9 vendors covering 8 marketed size categories (3-, 3.5-, 5-, 8-, 10-, 11-, 12-, and 15-mm trocars). On average, true inner cannula diameter was 0.92 mm wider (SD, 0.41 mm; range, 0-2.4 mm) than the marketed size category, with the widest range in the 5 mm category. For 5-mm trocars, mean true inner diameter was 6.1 mm (SD, 0.45; range, 5.5-7.4) and true outer diameter 8.3 mm (SD, 0.71; range, 8.0-10.7). For 12-mm trocars, mean true inner diameter was 13.0 mm (SD, 0.21; range, 12-13.3) and outer diameter 15.3 mm (SD, 0.48; range, 14.4-16.8). Five-mm trocars necessitate a mean incision size of 13.0 mm (SD, 1.1; range, 12.1-16.8) and 12-mm trocars a mean incision of 24.0 mm (SD, 0.75; range, 22.6-26.4). No vendors stated actual diameters on company website or catalog. In one instance the Instructions For Use document contained the true inner diameter. CONCLUSION: Trocar size categories give a false sense of standardization when in actuality there are considerable within-category differences in both inner and outer diameters, corresponding to differences in functionality and required incision sizes. There is no universally applied definition for trocar size categories. Accessibility of information on true dimensions is limited.

Preoperative Hematocrit Level and Associated Risk of Transfusion for Myomectomy Based on Myoma Burden and Surgical Route.

STUDY OBJECTIVE: To determine the association between preoperative hematocrit level and risk of blood transfusion for laparotomic and laparoscopic myomectomy based on myoma burden and surgical route. DESIGN: A cohort study of prospectively collected data. SETTING: American College of Surgeons National Surgical Quality Improvement Program participating institutions. PATIENTS: A total of 26 229 women who underwent a laparotomic or laparoscopic myomectomy from 2010 to 2020. INTERVENTIONS: The primary outcome assessed was the risk of transfusion based on preoperative hematocrit level. This was evaluated with respect to myoma burden and surgical route. MEASUREMENTS AND MAIN RESULTS: There were 26 229 women who underwent a myomectomy during the study interval, 2345 women (9%) of whom required a blood transfusion. Compared with patients who did not require transfusion, those who did had lower median preoperative hematocrit levels (34.7 vs 38.2). Patients were stratified by surgical approach (laparotomic vs laparoscopic) and myoma burden (1-4 myomas/weight ≤250 g or ≥5 myomas/weight >250 g) using Current Procedural Terminology codes (58140, 58146, 58545, 58546). In all categories, there was an inverse relationship between blood transfusion and preoperative hematocrit level with increasing risk depending on preoperative hematocrit range. The odds ratios comparing hematocrit level of 29% with 39% were 6.16 (95% confidence interval [CI], 5.15-7.36), 4.92 (95% CI, 4.19-5.78), 4.85 (95% CI, 3.72-6.33), and 5.2 (95% CI, 3.63-7.43) for patients with laparotomic (1-4 myomas/≤250 g, ≥5 myomas/>250 g) and laparoscopic myomectomy (1-4 myomas/≤250 g, 5 myomas/>250 g), respectively. CONCLUSION: Incremental increases in hematocrit result in a significantly decreased risk of blood transfusion at the time of myomectomy.

Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study.

Study Objective: To examine long-term outcomes from the pivotal study that evaluated the safety and effectiveness of the Cerene® Cryotherapy Device (Channel Medsystems, Berkeley, CA) in premenopausal women with heavy menstrual bleeding due to benign causes who have completed childbearing. Methods: The prospective, multicenter, single-arm, open-label study had eight sites in the USA, one in Mexico, and two in Canada. Inclusion criteria included uterine sound ≤10 cm, endometrial cavity length 2.5 to 6.5 cm, age 25 to 50 years, a pictorial blood loss assessment chart score of ≥150, no submucosal myomata and/or uterine obstruction, distortion, or abnormality. A total of 242 subjects underwent a 2.5-minute cryoablation. Long-term follow-up visits were conducted at Month 24 and Month 36. Data collected included gynecological adverse events, description of last menstrual period, contraception status, self-report of pregnancy, medical or surgical interventions to treat abnormal uterine bleeding, satisfaction, recommendation, and quality of life (QoL). QoL outcomes were measured with the Menorrhagia Impact Questionnaire (MIQ) and the Premenstrual Symptoms Impact Survey (PMSIS™). Results: 201 subjects completed their Month 36 final study visit. Subject outcomes were comparable to those at Month 12. Eighty-nine percent of subjects reported amenorrhea, a lighter-than-normal, or normal period, 91% of subjects had no or slight limitations in MIQ measured activities, and 85% reported premenstrual symptoms at a low frequency. Eighty-five percent of the subjects were satisfied or very satisfied. The cumulative incidence of hysterectomy was 5% and reintervention was 8.7%. Forty-nine gynecologic adverse events (AE) were reported; one non-serious AE, postcoital bleeding, was reported as related to the procedure. No serious device-related or procedure-related AEs were reported. Conclusion: Study data demonstrate that the positive effects of Cerene Cryotherapy Device treatment are sustained through Month 36 and that the risks associated with the device and procedure are low (ClinicalTrials.gov; NCT02842736).

Hysteroscopic Access and Uterine Cavity Evaluation 12 Months after Endometrial Ablation with the Cerene Cryotherapy Device.

STUDY OBJECTIVE: To evaluate whether physical access and the ability to systematically assess the postablation uterine cavity were preserved at 12 months after endometrial ablation with the Cerene cryotherapy device (ChannelMedsystems, Emeryville, CA). DESIGN: A prospective, multicenter, single-arm study. SETTING: In the clinic at 8 US sites and outpatient hospital setting at 2 sites in Canada and 1 site in Mexico. PATIENTS: A total of 230 (of 242) subjects continued in the study at the Month 12 visit after ablation. Two hundred twenty-three subjects were available for a diagnostic hysteroscopic evaluation. INTERVENTIONS: Subjects who had previously been treated with a 2.5-minute cryoablation of the endometrium utilizing the Cerene device underwent a diagnostic hysteroscopy at the Month 12 follow-up visit. MEASUREMENTS AND MAIN RESULTS: The uterine cavity was accessible in 220 of 223 subjects (98.7%) and not accessible in 3 (1.3%) because of pain (n = 2) and cervical stenosis (n = 1). Visualization of the uterine cavity was possible in 204 of 220 subjects (92.7%) with one or both tubal ostia identified in 89.2% (182 of 204) of subjects. Both tubal ostia were visible in 160 of 204 subjects (78.4%) and one ostium in 22 of 204 subjects (10.8%). The cavity was not visualized in the remaining 16 of 220 subjects (7.2%) because of intrauterine adhesions (n = 14), technical difficulties (n = 1), or menstruation (n = 1). In 95.6% (195 of 204) of subjects where the cavity was visualized, the hysteroscopic view was judged adequate to evaluate the uterine cavity for pathologic change. No significant complications occurred during the hysteroscopic evaluations. CONCLUSION: This is the largest study to date conducted to hysteroscopically evaluate the postablation uterine cavity. Uterine cavity assessment with in-office hysteroscopy 1 year after the use of the Cerene cryotherapy device is attainable, enabling both diagnostic and therapeutic procedures within the endometrial cavity.

Don't be STUMPed: description and management of uncommon pathologies encountered on specimens from benign gynecologic surgery.

PURPOSE OF REVIEW: In this review, we aim to describe uncommon pathologies that gynecologic surgeons may reasonably encounter on surgical specimens following benign gynecologic surgery. RECENT FINDINGS: Herein, we describe uncommon pathologic findings of the uterus (e.g. squamous morular metaplasia, fibroid variants, stromal tumor of uncertain malignant potential), peritoneum and adnexa (e.g. endosalpingiosis, serous tubal intraepithelial carcinoma), endometriosis (e.g. stromal endometriosis, atypical endometriosis), and findings of particular interest in postmenopausal women (e.g. ovarian cortical stromal hyperplasia, tubal metaplasia). The majority of pathologic findings presented in this article are inherently benign, although they can present diagnostic challenges. If properly classified, additional treatment and/or extended follow-up is often not required; exceptions are highlighted. SUMMARY: The gynecologic surgeon may encounter uncommon pathologies during a career. Inherent diagnostic difficulties, as well as nonstandardized or outdated terminology, can introduce further uncertainty. Whenever such a situation arises, the surgeon and pathologist should discuss the diagnosis to ensure appropriate treatment options.

A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of a novel cryoablation device (Cerene Cryotherapy Device, Channel Medsystems, Emeryville, CA) in premenopausal women with heavy menstrual bleeding owing to benign causes. DESIGN: A prospective, multi-center, single-arm, open label, non-randomized study. SETTING: At 11 academic and private practices in North America: 8 clinic sites in the United States, and 3 outpatient hospital sites (1 in Mexico and 2 in Canada). PATIENTS: A total of 242 subjects comprise the intent-to-treat population. Subject demographics were similar to other published endometrial ablation studies performed. INTERVENTIONS: Subjects were treated with a single-use disposable cryoablation device (Cerene) which delivers a 2.5-minute treatment to the endometrium. Analgesia and local anesthesia were administered per investigator discretion; intravenous sedation was used in only 3% of subjects and no general anesthesia was used. MEASUREMENTS AND MAIN RESULTS: There were no device or procedure-related serious adverse events, nor unanticipated adverse device effects. Cerene cryoablation was effective in reducing menstrual blood loss, which was measured by pictorial blood loss assessment chart (PBLAC) score. Mean score dropped from 360.6 at pretreatment (±332.1) to 51 at 12 months posttreatment (±64.1), with 81% of 230 evaluable subjects reporting a PBLAC score of ≤75 and 85% of evaluable subjects reporting a PBLAC score of ≤ 100. The median pain rating was ≤2 (mild) throughout the treatment. Of 223 subjects that underwent hysteroscopic evaluation at 12 months, the uterine cavity was visualized in 220 subjects. Quality of life improved with 90% of reporting subjects indicating satisfied or very satisfied at month 12. CONCLUSION: This study demonstrated that Cerene cryoablation is safe and effective, offering the benefits of reduced menstrual blood loss with limited use of pain medication, high patient tolerability, quality of life improvement, and preserved access to the uterine cavity.

Essentials in Minimally Invasive Gynecology Manual Skills Construct Validation Trial.

OBJECTIVE: To establish validity evidence for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems. METHODS: A prospective cohort study was IRB approved and conducted at 15 sites in the United States and Canada. The four participant cohorts based on training status were: 1) novice (postgraduate year [PGY]-1) residents, 2) mid-level (PGY-3) residents, 3) proficient (American Board of Obstetrics and Gynecology [ABOG]-certified specialists without subspecialty training); and 4) expert (ABOG-certified obstetrician-gynecologists who had completed a 2-year fellowship in minimally invasive gynecologic surgery). Qualified participants were oriented to both systems, followed by testing with five laparoscopic exercises (L-1, sleeve-peg transfer; L-2, pattern cut; L-3, extracorporeal tie; L-4, intracorporeal tie; L-5, running suture) and two hysteroscopic exercises (H-1, targeting; H-2, polyp removal). Measured outcomes included accuracy and exercise times, including incompletion rates. RESULTS: Of 227 participants, 77 were novice, 70 were mid-level, 33 were proficient, and 47 were experts. Exercise times, in seconds (±SD), for novice compared with mid-level participants for the seven exercises were as follows, and all were significant (P<.05): L-1, 256 (±59) vs 187 (±45); L-2, 274 (±38) vs 232 (±55); L-3, 344 (±101) vs 284 (±107); L-4, 481 (±126) vs 376 (±141); L-5, 494 (±106) vs 420 (±100); H-1, 176 (±56) vs 141 (±48); and H-2, 200 (±96) vs 150 (±37). Incompletion rates were highest in the novice cohort and lowest in the expert group. Exercise errors were significantly less and accuracy was greater in the expert group compared with all other groups. CONCLUSION: Validity evidence was established for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems by distinguishing PGY-1 from PGY-3 trainees and proficient from expert gynecologic surgeons.

Experience with a novel laparoscopic gynecologic curriculum in Haiti: lessons in implementation.

BACKGROUND: An estimated one-third of the world's burden of disease requires surgical treatment. In many high-income nations, a large proportion of critical surgical procedures are performed laparoscopically due to a number of advantages the technique offers. There is forward progress in the global surgery field to increase access to laparoscopic techniques in low and middle-income settings (LMIC), with potential benefits to both patients and surgeons. METHODS: A week long laparoscopic surgery curriculum for surgeons and hospital staff was designed and implemented in a low-resource setting. An iterative design was used to adapt the curriculum on the ground. RESULTS: The local laparoscopic team was able to independently perform two laparoscopic procedures since the course was administered. CONCLUSIONS: Implementing laparoscopic surgery programs may be feasible in many LMIC settings. Access to this care may benefit patients. Lessons learned for the global laparoscopist are described.

Physician Engagement in Improving Operative Supply Chain Efficiency Through Review of Surgeon Preference Cards.

STUDY OBJECTIVE: To reduce operative costs involved in the purchase, packing, and transport of unnecessary supplies by improving the accuracy of surgeon preference cards. STUDY DESIGN: Quality improvement study (Canadian Task Force classification II-3). SETTING: Gynecologic surgery suite of an academic medical center. PARTICIPANTS: Twenty-one specialized and generalist gynecologic surgeons. INTERVENTIONS: The preference cards of up to the 5 most frequently performed procedures per surgeon were selected. A total of 81 cards were distributed to 21 surgeons for review. Changes to the cards were communicated to the operating room charge nurse and finalized. MEASUREMENTS AND MAIN RESULTS: Fourteen surgeons returned a total of 48 reviewed cards, 39 of which had changes. A total of 109 disposable supplies were removed from these cards, at a total cost savings of $767.67. The cost per card was reduced by $16 on average for disposables alone. Three reusable instrument trays were also eliminated from the cards, resulting in savings of approximately $925 in processing costs over a 3-month period. Twenty-two items were requested by surgeons to be available on request but were not routinely placed in the room at the start of each case, at a total cost of $6,293.54. The rate of return of unused instruments to storage decreased after our intervention, from 10.1 to 9.6 instruments per case. CONCLUSIONS: Surgeon preference cards serve as the basis for economic decision making regarding the purchase, storing, packing, and transport of operative instruments and supplies. A one-time surgeon review of cards resulted in a decrease in the number of disposable and reusable instruments that must be stocked, transported, counted in the operating room, or returned, potentially translating into cost savings. Surgeon involvement in preference card management may reduce waste and provide ongoing cost savings.

Does the uterine cervix become abnormally reinnervated after subtotal hysterectomy and what is the association with future trachelectomy?

STUDY OBJECTIVE: To compare nerve fiber density in the cervices removed by trachelectomy from women with pelvic pain with those cervices removed for nonpain indications. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Two university hospitals. PATIENTS: Subjects who underwent trachelectomy during a 10-year time frame were identified. INTERVENTIONS: Two tissue sections were obtained from each preserved cervix specimen and stained for S100 antibody. The numbers of S100-immunoreactive peripheral nerve fibers were assessed in 6 high-powered fields (HPFs) per tissue section (12 total HPFs per patient). Information collected included patient characteristics and surgical findings. We excluded any patients with dysplasia/cancer and those without an available adequate specimen. MEASUREMENTS AND MAIN RESULTS: We evaluated the cervix specimens from 35 patients who underwent trachelectomy for pain (n = 25, group 1) and nonpain (n = 10, group 2) indications in addition to control cervices (n = 15, group 3) from benign hysterectomies performed for nonpain indications. There were increased numbers of nerve fibers in trachelectomy patients with pain versus those without pain (group 1 vs group 2, p = .02). There were also increased numbers of nerve fibers in both trachelectomy groups compared with the control group (group 1 vs group 3, p < .01; group 2 vs group 3, p = .04). Adjusted average cervical nerve counts/HPF were 17.8 (95% confidence interval [CI], 13.2-22.3) for pain-indicated trachelectomies, 11.5 (95% CI, 4.8-18.2) for nonpain, and 6.3 (95% CI, 0.8-11.8) for controls. Regardless of trachelectomy indication, adjusted average nerve counts/HPF were 17.7 (95% CI, 13.4-22.0) for patients with endometriosis and 14.6 (95% CI, 12.2-17.1) for patients without endometriosis. CONCLUSION: Nerve fibers in the cervical stump after supracervical hysterectomy are significantly increased in women undergoing trachelectomy for pain indications compared with those who underwent trachelectomy for nonpain indications and controls. Although not statistically significant, endometriosis may be an independent risk factor for increased nerve fibers. These histopathologic observations may support the idea that the cervix should be removed in women undergoing hysterectomy for chronic pelvic pain or endometriosis.

Predicting pelvic pain after endometrial ablation: which preoperative patient characteristics are associated?

STUDY OBJECTIVE: To determine which patient characteristics are associated with an increased risk of postablation pelvic pain. DESIGN: Canadian Task Force classification II-2. METHODS: Data were collected from a retrospective cohort of patients who underwent endometrial ablation between January 2006 and September 2010 at a large academic medical center. Patients were identified via Current Procedural Terminology codes (58563, 58353, and 58356) for any type of endometrial ablation (rollerball or global); the sample size was 437 women. Multiple conditions and comorbidities were recorded for each patient. Bivariate analysis of patient demographics and the incidence of pain after endometrial ablation were evaluated using the chi square, Fisher exact, and independent t tests where appropriate. A final multivariate analysis with logistic regression was conducted to determine the exact patient characteristics that are associated with pelvic pain after endometrial ablation. RESULTS: Of 437 women who underwent endometrial ablation, 20.8% reported pain after their ablation. Patients were followed for up to 6.5 years postablation with a median follow-up of 794 days. The median number of days for the development of pain after ablation was 301 days, with 75% of patients who developed pain reporting it within approximately 2 years of their procedure. The median time to hysterectomy for those with pain was 570 days. Other postablation treatments included hormonal therapies in 9.4% of the total population. A total of 20.8% of patients reported postablation pelvic pain, but only 6.3% underwent subsequent hysterectomy for that indication. Preablation patient characteristics significantly associated with the development of postablation pain include dysmenorrhea (aOR = 1.73), smoking status (aOR = 2.31), prior tubal ligation (aOR = 1.68), and age less than 40 (aOR 1.90). Although not statistically significant, a diagnosis of endometriosis appears to be related to postablation pain (aOR = 2.24). Adenomyosis (suggested on ultrasound) and body mass index associations were not statistically significant. A patient with all 4 risk factors for postablation pain (i.e., dysmenorrhea, smoking, prior tubal ligation, and <40 years old) has a 53% (95% confidence interval, 0.40-0.66) chance of experiencing postablation pain. CONCLUSION: The observed incidence of pelvic pain is 20.8% after endometrial ablation and is more frequently observed in women with preablation dysmenorrhea, tobacco use, prior tubal ligation, age less than 40, and possibly endometriosis. One should consider these preexisting conditions when counseling patients regarding outcome expectations after an endometrial ablation procedure.

Single incision laparoscopy for the management of postoperative hemorrhage.

INTRODUCTION: Single incision laparoscopic surgery is being used as an access route for an increasing breadth of surgical cases. However, its use to evaluate and manage postoperative hemorrhage after laparoscopic surgery has not been reported. CASE DESCRIPTION: A patient with recurrent cervical dysplasia who had undergone 2 previous cold knife conizations underwent a single incision total laparoscopic hysterectomy with right salpingectomy and left salpingo-oophorectomy. On postoperative day 1, she developed signs of intraabdominal hemorrhage. She underwent transcatheter arterial embolization of the left uterine artery and received 3U of packed red blood cells. However, on postoperative day 2, she developed signs of persistent bleeding. DISCUSSION: We discuss our management of this case with single incision laparoscopy.