Scheduled Hysterectomy Research Articles

High-Volume Surgeons and Reducing Racial Disparities in Route of Hysterectomy

Study ObjectiveTo examine racial disparities in route of hysterectomy and perioperative outcomes before and after expansion of high-volume minimally invasive surgeons (>10 minimally invasive hysterectomies (MIH)/year) DesignRetrospective cohort study SettingMulti-center academic teaching institution PatientsAll patients who underwent a scheduled hysterectomy for benign indications during 2018 (pre-intervention) and 2022 (post-intervention) InterventionsRecruitment of Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS)- trained faculty and increased surgical training for academic specialists in obstetrics and gynecology occurred in 2020. Measurements and Main ResultsPatients in the pre-intervention cohort (n=171) were older (median age 45 years vs. 43 years, p=0.003) while patients in the post-intervention cohort (n=234) had a higher burden of comorbidities (26% ASA class III vs. 19%, p=0.03). Uterine weight was not significantly different between cohorts (p=0.328). Between the pre-intervention and post-intervention cohorts, high-volume minimally invasive surgeons increased from 27% (n=4) to 44% (n=7) of those performing hysterectomies within the division and percentage of hysterectomies performed via minimally invasive route increased (63% vs. 82%, p<0.001). In the pre-intervention cohort, Black patients had a lower percentage of hysterectomies performed via minimally invasive route compared to White patients (Black = 56% MIH vs. White = 76% MIH, p=0.014). In the post-intervention cohort, differences by race were no longer significant (Black = 78% MIH vs. White = 87% MIH, p= 0.127). There was a significant increase (22%) in MIH for Black patients between cohorts (p<0.001). After adjusting for age, BMI, ASA class, prior surgery, and uterine weight, disparities by race were no longer present in the post-intervention cohort. Perioperative outcomes including length of stay (p<0.001), infection rates (p=0.002) and blood loss (p=0.01) improved post-intervention. ConclusionIncreasing FMIGs-trained gynecologic surgeons and providing more opportunities in robotic/laparoscopic training for academic specialists may improve access to MIH for Black patients and reduce disparities.

(094) Evaluation of Female Sexuality After Vaginal Hysterectomy in a Cohort of Tunisian Women

Abstract Introduction Researchers indicate that hysterectomy might adversely affect pelvic anatomy and therefore female sexuality. However, only a few studies focused on evaluating female sexuality after vaginal hysterectomy. Objective This study aimed to evaluate female sexual function after a vaginal hysterectomy. Methods This was a monocentric prospective study conducted in the gynecology-obstetrics department of Ben Arous regional hospital over a period of 5 years [January 2016-December 2020]. We included all patients who underwent vaginal hysterectomy. Selected women received a preoperative evaluation of their sexual function using the Female sexual function index (FSFI). They were invited for two follow-ups at 12 and 24 months after surgery. The main outcomes measured were frequency of sexual intercourse, dyspareunia, orgasm, vaginal dryness, sexual desire, and FSFI scores. Results A total number of 109 women underwent vaginal hysterectomy over the study period. The mean age was 41 years ranging from 31 to 69 years. Only 79 patients completed the required follow-ups in order to evaluate their satisfaction and the impact of surgery on their sexuality. The percentage of women engaging in sexual intercourse increased significantly from 70.8% before vaginal hysterectomy (VH) to 77.21% and 75.9% at 12 and 24 months after respectively. The rate of dyspareunia dropped significantly from 40.5% before surgery to 5% and 3.8 % at 12 and 14 months after VH. The rate of women experiencing orgasm increased significantly from 63.2% before VH to 72.1% and 70.8 % after 12 and 24 months. Low sexual desire also decreased significantly from 10.1% before VH to 6.3% and 5% respectively at 12 and 24 months. The percentage of women experiencing satisfactory vaginal lubrication increased from 36.7% to 46.8% and 45.5%. Average FSFI significantly increased from 24.58 prior to the surgery to 26.82 and 27.55 at the 12 months and 24 months follow-ups respectively. Conclusions Female sexual function is a major cause of women's concern for scheduled hysterectomy. Our results showed a significant improvement in female sexual function after a vaginal hysterectomy. Therefore, the vaginal route for hysterectomy should be encouraged among middle-aged women as a minimally invasive technique that does not affect female sexual function or feminine shape. Disclosure No.

Assessment of the self-confidence of obstetrics & gynecology fellows to perform a postpartum hemostasis hysterectomy.

Hemostasis Hysterectomy (HH) is a last resort surgical procedure performed in situations of uncontrolled post-partum hemorrhage in maternity wards. The chances of being confronted with this situation are scarce during residency, and the situation is not well suited for teaching. Nevertheless, every obstetrician-gynecologist can be confronted with this stressful situation, and should therefore possess the surgical competence required, regardless of his routine practice. The aim of the present study is to evaluate clinical exposure and self-awareness concerning HH amongst obstetrics and gynecology residents and fellows. We performed a survey amongst French obstetrics and gynecology fellows. An anonymous survey was sent by email between December 1, 2020 to July 1, 2021. Half of the interrogated fellows had practiced (as operator) an HH during residency with a senior and only 22,6% in post-residency. During the last year of residency 70% of them had performed less than 10 scheduled hysterectomies as primary operator. The laparoscopic approach was the most frequently practiced. Very few hysterectomies were performed as primary operator. Fellows with a surgical or mixed activity (both gynecological surgery and obstetrical activity in current practice) felt significantly more capable of performing HH compared to those with exclusive obstetrical or reproductive medicine activity; respectively 60% vs 36%, p=0.008; Odds Ratio: 2.629 (95% CI 1.2214; 5.8094). The number of scheduled hysterectomies or HH performed as primary operator is very low during residency or fellowship. It remains largely inferior to the number deemed necessary in previous publications about the learning curve for scheduled hysterectomy, which varies from 18 to 80 interventions. Nowadays, the increasing number of residents, added to the decrease of hemostasis hysterectomies through better management of post-partum hemorrhage, pushes towards the development of specific training, such as "damage control simulation".

The Effect of Clonidine and Tramadol on Post-spinal Anaesthesia Shivering in Hysterectomy Patients: A Comparative Study

Introduction: Spinal anaesthesia is most commonly used as a secure anaesthetic method in elective and emergency operations. Shivering is noted in 40%–70% of patients undergoing surgery under spinal anaesthesia. The study aims to compare the efficacy, haemodynamic effects and side effects of clonidine with tramadol for the control of shivering. Materials and Methods: This prospective study was conducted from April 2016 to November 2016. Using a convenient sampling technique, a total of 60 adult patients of the American Society of Anaesthesiologists (ASA) physical status Grade I or II, aged ≥18 years, of either sex who were scheduled hysterectomy administered with clonidine vis-à-vis tramadol for spinal anaesthesia were selected for the study after informed consent. All the patients were randomly allocated into one of the two groups using computer generated random number table: Group C: Injection clonidine 75 µg slow intravenous (IV) injection and Group T: Injection tramadol 1 mg/kg slow IV injection. Results: Non-significant association was found between age, ASA grade, level of sensory block, shivering grade and mean systolic blood pressure amongst the participants of group clonidine and tramadol. Group C had significantly early control of shivering, less time for complete loss of shivering and fewer adverse events were noted compared to the tramadol group. Conclusion: Both clonidine (75 µg) and tramadol (1 mg/kg) effectively treat patients with post-spinal anaesthesia shivering, but tramadol takes longer time for complete cessation of shivering than clonidine. Clonidine offers better thermodynamics than tramadol, with fewer side effects. The more frequent incidence of the side effects of tramadol, such as nausea, vomiting and dizziness, may limit its use as an anti-shivering drug.

A Comparison Study Quantifying Environmental Impact of All Surgical Modalities of Hysterectomies

<h3>Study Objective</h3> Compare carbon dioxide emissions generated from operating room waste from all types of hysterectomies. Improving provider awareness on the environmental impact of hysterectomies may facilitate interventions to minimize our carbon footprint. <h3>Design</h3> A prospective cohort study was conducted, including patients who had a hysterectomy for any indication. Surgical waste in pounds (lbs), procedure data, and patient demographics was collected for each case. The formula below was used to identify the emissions generated for each procedure: <i>CO2 emissions = Waste in pounds (lbs) x 1 short ton/2000 lbs x EPA emission factor (kg CO2 per short ton) x global warming potential</i> <h3>Setting</h3> A 305-bed Level II Trauma center and academic teaching hospital, 11/2021 – present. <h3>Patients or Participants</h3> A total of 81 women ≥ 18 years of age underwent a scheduled hysterectomy (robotic assisted, laparoscopic, vaginal, abdominal) for benign or malignant indications at one institution. We excluded women < 18 years of age and emergent hysterectomies (i.e., postpartum hysterectomy). Data collection is ongoing with the goal of reaching a sample size of 100. <h3>Interventions</h3> Waste that was generated for every hysterectomy was weighed by the Primary Investigator. <h3>Measurements and Main Results</h3> Among the 81 cases analyzed, there was no significant difference between groups in age, ethnicity, and BMI. The total waste generated by each type of hysterectomy ranges from lowest (vaginal, 3 lbs.) to highest (robotic, 46 lbs.). CO2 emissions was significantly higher for robotic hysterectomies (57%, <0.0001) when compared to the other types. 100% of robotic hysterectomy waste contributed more than the mean CO2 emission of our sample. There was no significant association between duration of surgical case and amount of waste generated. Additional analysis in progress. <h3>Conclusion</h3> Robotic hysterectomies were found to generate a statistically significant majority of CO2 emissions. Additional studies are needed to determine the environmental impact and strategies to reduce our carbon footprint.

Evaluation of the impact of an enhanced recovery after surgery (ERAS) programme on the quality of recovery in patients undergoing a scheduled hysterectomy: a prospective single-centre before-after study protocol (RAACHYS study)

IntroductionThe enhanced recovery after surgery (ERAS) programmes following hysterectomies have been studied since 2010, and their positive effects on clinical or economic criteria are now well established. However, the benefits...

The Relationship between Increasing Patient Body Mass Index and Operating Room Scheduling Inaccuracies at the Time of Hysterectomy

<h3>Study Objective</h3> To assess the relationship between patient body mass index (BMI) and operating room (OR) scheduling inaccuracies at the time of hysterectomy. <h3>Design</h3> Retrospective cohort study. <h3>Setting</h3> Academic medical center. <h3>Patients or Participants</h3> Scheduled hysterectomies (n=951) performed from 11/2017 through 02/2020 for any gynecologic indication. <h3>Interventions</h3> Hysterectomy by any route. <h3>Measurements and Main Results</h3> The primary outcome was operating room time scheduling inaccuracy in minutes, defined as the difference between the scheduled and the actual operating room time. The mean scheduling inaccuracy for women with normal weight, overweight, and class I, II, and III obesity was 22.2, 28.4, 33.5, 38.3, and 48.2 minutes, respectively (p<0.001). Multivariable linear regression analysis adjusted for patient age, the presence of major cardiopulmonary comorbidities, ASA category, anesthetic type, abdominal surgical history, number of procedures performed, procedure route, and uterine weight. Normal and overweight women were similarly under-scheduled. Compared with normal-weight women, those with class 1 and 3 obesity were, on average, 12.7 (95% CI 2.1-23.3, p=0.019) and 18.9 (95% CI 4.4-33.3, p=0.010), respectively, more minutes under-scheduled. (The average scheduling inaccuracy of women with class 2 obesity did not differ significantly from women with normal weight.) Obese women whose surgeries were under-scheduled, compared to those who were not, spent a significantly greater proportion of their operating room time in operative time (82.6% vs. 74.6%, p<0.001) as compared to pre-operative positioning time (12.1% vs. 18.3%, p<0.001) or non-operative anesthetic time (15.6% vs. 21.0%, p<0.001). <h3>Conclusion</h3> When adjusted for key factors that may affect operating room time, obese women were significantly more under-scheduled than women of normal weight. Obese women with under-scheduled cases spent proportionally more OR time in operative as opposed to non-operative time. Future studies can assess whether awareness of this tendency helps surgeons more accurately predict operating room time required for hysterectomy for obese women.

Retrospective comparison of emergent versus scheduled peripartum hysterectomies: a single institution experience

Objectives: The objective of this study was to compare outcomes between scheduled and emergent peripartum hysterectomies at our institution, particularly those completed for abnormal placentation, to provide insight for perioperative optimization. Methods: Retrospective analysis of all peripartum hysterectomies completed at a single center over a five-year period. Antepartum, intraoperative, and post-operative courses were reviewed. Patients were categorized based on whether surgery was performed urgently/emergently or scheduled. Bivariate analysis was performed to compare demographic, pre-, intra-, and post-operative outcomes between urgent/emergent and scheduled hysterectomy groups. Results: Among 49 peripartum hysterectomies completed between 2015-2019, 13 (26.5%) were emergent and 36 (73.5%) were scheduled. All were completed following a cesarean delivery. Baseline demographic characteristics were not different between the groups. Surgical indication included abnormal placentation (86.1%) and carcinoma (11.1%) for scheduled cases and abnormal placentation (46.2%), uterine atony (30.7%), uterine rupture (7.7%), and surgical complication (23.1%) for emergent cases. A gynecologic oncologist was involved in 34 cases (69.4%) with their presence significantly more common in scheduled cases (80.7% vs 38.5%, p=0.005). Of cases completed for abnormal placentation, 30 were scheduled and 5 were emergent. Rate of gynecologic oncology involvement was similar between these two groups (80.0% vs 60.0%, p=0.57). Thirty-four (97%) of these cases were complicated by intra-operative hemorrhage with emergent cases having higher average blood loss (7.2L vs 3.0L, p=0.30). There were two bladder injuries and one vascular injury (all occurred in scheduled cases). There were no ureteral of bowel injuries. Emergent cases had higher rates of ICU stay (80.0% vs 55.2%, p=0.38), while scheduled cases had higher rates of post-operative transfusion (30% vs 0%, p=0.30) and immediate postoperative complications (26.7% vs 0%, p=0.32, Table 1). Six-week post-operative complication rates were similar between the two groups (36.7% vs 40.0%). Download : Download high-res image (60KB) Download : Download full-size image Conclusions: Scheduled peripartum hysterectomies are more common than emergent peripartum hysterectomies at our institution. Involvement of a gynecologic oncologist is common, particularly for scheduled and abnormal placentation cases. Amongst abnormal placentation cases, we observed high rates of intra-operative and post-operative complications. Abnormal placentation cases completed in an emergent setting had intra-operative blood loos as well as need for ICU stay. Implementation of multidisciplinary protocols, particularly in the emergent setting, may help to address these differences and minimize morbidity.

Does Shifting Surgeries from Inpatient to Outpatient Settings Save Money? The Case of Hysterectomy in Massachusetts

Research ObjectiveTechnological advances have allowed for the shifting of many surgeries from hospital inpatient to outpatient settings. This shift should lead to net cost savings as fewer resources are required. There could also be distributional and other market consequences due to differences in referral patterns, individual hospital resources, and benefit design. Scheduled hysterectomies (eg, those that are unrelated to maternity episodes) represent an example of this trend. The objective of this study is to analyze the impact of shifting surgeries from inpatient to outpatient settings of care on the distribution of surgeries across types of hospitals and on overall costs.Study DesignWe identified hysterectomies performed in Massachusetts in both inpatient and outpatient settings among members of five large private insurers in the state’s all‐payer claims database from 2015 to 2017. We further subset these procedures to define “shiftable” hysterectomies as procedures that were not maternity related or related to cancer and did not involve major complications. We estimated the average payment for the hysterectomy episode which was defined to include all claims taking place on the same day as the procedure and included both hospital and professional payments. We grouped hospitals by type and system to evaluate the distributional effects of inpatient to outpatient shifts.Population StudiedCommercially insured inpatient stays and outpatient surgery encounters for hysterectomies in Massachusetts during 2015‐2017 period.Principal FindingsDespite shifting of about one‐fifth of inpatient hysterectomies to outpatient settings, the average system‐wide payment per hysterectomy in our commercially insured population increased 9.5% over the study period. When examined in more detail, this paradox appears to be partly explained by a shift from hospitals with lower‐than‐average‐priced inpatient and outpatient surgeries to hospitals with higher‐than‐average priced outpatient surgeries. Absent such a shift, total spending would have increased only 6.3% due to price increases within settings. For example, the average payment for an outpatient hysterectomy procedure at one of the AMCs with highest increase in outpatient hysterectomies, while lower than the cost of a procedure on their own inpatient wards, was 37% higher than the inpatient cost of the procedure at a local community hospital that lost the most inpatient volume. Overall, nonteaching hospitals, especially those with a high mix of public payers, lost commercial hysterectomy volume, and consequently revenue, while outpatient hysterectomies accumulated in a handful of academic hospital systems.ConclusionsThe promise of shifting surgeries to outpatient settings to reduce total spending has not materialized for hysterectomy—a surgery that underwent a dramatic shift in just 2 years. However, there are winners and losers among providers. The financial well‐being of community hospitals may partly depend on their ability to retain their commercial volume in their own outpatient settings.Implications for Policy or PracticeHysterectomy as a case study suggests that the promise of more efficient modes of care delivery may not yield net savings to consumers if high‐priced systems capture a large share of the shifted volume.Primary Funding SourceXxxx.

Analysis of SCN9A Gene Variants for Acute and Chronic Postoperative Pain and Morphine Consumption After Total Hysterectomy.

Single nucleotide polymorphisms (SNPs) of the voltage-gated sodium channel alpha subunit gene (SCN9A) have been associated with pain in various settings. The aim of this study was to investigate the association of the SNPs to evaluate the influence of common gene variants on chronic postoperative pain (CPSP) and other related pain variables in a cohort of patients who underwent a scheduled hysterectomy. DNA samples from a cohort of 1,075 patients who underwent a scheduled total hysterectomy in our hospital were genotyped for three common SCN9A SNPs using TaqMan assays. Multivariate logistic regression models were used to quantify the association between independent covariates such as pain threshold, pain endurance, pain scores, morphine use, and the presence of chronic pain. Frequencies of the minor alleles were different between the different ethnic groups. There was a statistically significant association of rs16851799 with morphine consumption and self-reported postoperative pain for the 1,038 subjects genotyped, with the TT genotype reporting higher pain and using more morphine. For the subpopulation of 446 subjects with chronic pain data, there was a similar association with self-reported postoperative pain and tolerance of pressure pain. Univariate analysis also showed a statistically significant association of rs16851799 with CPSP, whereas multivariable analysis revealed a similar association of rs4387806 with this outcome. There were three haplotypes with different relative frequencies for the CPSP and non-CPSP groups. Our results showed that SCN9A polymorphisms could play a role in acute pain perception and the susceptibility to chronic pain.

Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.

Perioperative outcomes using LigaSure compared with conventional technique in peripartum hysterectomy.

To evaluate the use of new bipolar vessel sealing system like LigaSure™ compared to the standard surgical technique (suture) during emergency peripartum hysterectomy (EPH). A retrospective observational bicentric study was conducted from February 2005 to August 2018 in the maternity wards of the University Hospital of Toulouse and Angers. All EPHs performed up to 24h after delivery were included. The main outcome was the total blood loss. Secondary outcomes were operating time, number of blood transfusions, per and postoperative complications. A subgroup analysis was performed between hysterectomies performed in emergency and scheduled hysterectomies. Among 111,266 deliveries, 86 women (0.07%) underwent EPH, 29 were operated upon with LigaSure™, 57 with the traditional technique. In the LigaSure™ arm, there were statistically lower blood loss (3198mL vs 4223mL, p = 0.02), fewer blood transfusions (62.1% vs 94.7%, p = 0.0003, confirmed in subgroup analysis), and fewer perioperative complications (8.3% vs 45.5%, p = 0.04) for scheduled hysterectomies. Bipolar vessel sealing systems such as LigaSure™ are a surgical instrument, easy to use for the surgeon, with an interest in the management of EPH, particularly for total blood loss, transfusions, and intraoperative complications.

43: Evaluation of a bundled checklist in decreasing hysterectomy surgical site infections

To compare surgical site infection (SSI) rates prior to and after implementation of a SSI bundle and checklist for scheduled hysterectomies at Prentice Women’s Hospital. Components are based on prior SSI bundles described in the literature and include patient use of chlorhexidine gluconate (CHG) at home prior to the surgery, surgical site hair clipping in the preoperative area, CHG vaginal prep, use of a plastic retractor when appropriate, and the changing of personal protective equipment (PPE) prior to skin closure. Eligibility criteria included any open, laparoscopic and robotic hysterectomies performed at Prentice Women’s Hospital from February 1 to July 31, 2017. Patients were 18 years of age or older. Exclusion criteria included non-scheduled, emergency hysterectomies or hysterectomy done at the time of cesarean section. The Healthcare Epidemiology and Infection Prevention department data was used to measure the surgical site infection rates both before and after implementation of the SSI bundle. Compliance with the individual components of the checklist was gathered through nursing-completed forms (“Checklists”) for all patients undergoing scheduled hysterectomies. These forms were completed both in the pre-operative holding area and in the operating room. The study was submitted to the Institutional Review Board and deemed to not require review. Compared to surgical site infections before implementation of the bundle and checklist, infections dropped from 2/209 to 0/281, representing a significant decrease (P = 0.01). Checklists were completed in 65% of cases overall, with an increase from 60% at the beginning of the intervention to 70% currently. Of the cases with a completed checklist, 29% of patients used CHG at home prior to the surgery, and of those who did not, 96% were given a CHG wipe in the preoperative area prior to the surgery. Compliance with surgical site hair clipping and CHG vaginal prep were 60% and 97%, respectively. The compliance rates for hair clipping increased from 41% to 75% through the implementation period. Prior to skin closure, gloves were changed in 63% of cases while gowns were changed in 23% of cases. Of non-oncologic abdominal hysterectomies during this time, 55% recorded use of metal retractors while 9% recorded use of plastic retractors. After implementation of the SSI bundle for scheduled hysterectomies, surgical site infection rates significantly decreased from historical values. Over the course of a 6-month data gathering period, we found that patients tend to not complete the requested CHG wipe at home. However, for those patients who have not performed the prerequisite wipe, nursing staff nearly always performed the wipe prior to surgery. Of the interventions implemented, the highest compliance items were nursing-led activities including preoperative CHG wipe and hair clipping, and intraoperative vaginal CHG prep. On the other hand, surgeon-directed items including PPE change and retractor use had low compliance throughout the intervention period. Overall, we have shown that implementation of a few simple, cost-efficient techniques can significantly affect an institution’s SSI rates.

Pilot Study of the Mirabilis System Prototype for Rapid Noninvasive Uterine Myoma Treatment Using an Ultrasound-Guided Volumetric Shell Ablation Technique

Study ObjectiveThe primary objective of this pilot study was to evaluate the safety and acute tissue ablation efficacy of a transabdominal high-intensity focused ultrasound (HIFU) prototype device that uses ultrasound imaging guidance for rapid noninvasive ablation of uterine myomas. The secondary objective was to assess preliminary myoma-related symptom improvement and myoma volume reduction at 3 to 6 months post-treatment in subsets of patients. DesignMulticenter prospective single-arm pilot study (Canadian Task Force classification II-2). SettingUniversity-affiliated teaching hospital and private community hospital. PatientsWomen with a diagnosis of symptomatic uterine myomas planning to undergo hysterectomy. InterventionsSeventy-three women underwent transabdominal ultrasound-guided HIFU treatment using a volumetric ablation technique referred to as “shell ablation,” in which the HIFU energy is deposited in patterns that partially encapsulate the peripheral region of the targeted myoma(s). Patients were divided into 2 sequential cohorts, the development cohort (the first 37 patients treated) and the validation cohort (the final 36 patients treated). Development cohort treatments were performed for dose-ranging purposes to identify the optimum HIFU treatment parameters, whereas the validation cohort treatments were performed to validate these final settings. Sixty-five patients (89.0%) received only prophylactic oral, sublingual, or intramuscular analgesia before treatment, sometimes with oral anxiolytics. The remaining 8 patients (11.0%) were anesthetized before treatment. Sixty-seven patients (91.8%) then had scheduled hysterectomies between 0 and 179 days after treatment completion. Adverse events were monitored until study exit, which ranged from 10 to 191 days post-treatment. Measurements and Main ResultsThe primary efficacy endpoint measured in all 73 patients was the nonperfused volume (NPV) of tissue produced, which was assessed between 0 and 7 days post-treatment either by tissue sectioning after hysterectomy or by gadolinium-enhanced magnetic resonance imaging. Secondary efficacy endpoints were also measured in subsets of patients who were prospectively scheduled for delayed hysterectomies: Changes in menstrual blood loss (MBL), symptom severity (SS), and quality of life (QOL) scores were assessed using validated techniques at 3 months post-treatment in 10 patients and changes in treated myoma volume were assessed using magnetic resonance imaging at 3 to 6 months post-treatment in 14 patients. In all 73 patients, there were no reports of any serious adverse device effects, including no damage to any extrauterine collateral tissues or the abdominal skin. In the development cohort, a mean NPV of 17.9 ± 24.9 cm3 (range, 0–123.0) was produced in a mean total treatment time of 4.9 ± 2.4 minutes (range, 1.1–11.3). These metrics improved in the validation cohort, where a mean NPV of 44.9 ± 58.5 cm3 (range, 0–284.7) was produced in a mean total treatment time of 3.6 ± 2.1 minutes (range, 1.5–9.5). In the subsets of patients with data available, there was a significant improvement in QOL score (median, 16.5 point increase; p = .011), an improving trend in SS score (median, 13.5 point decrease; p = .254), and a significant improvement in treated myoma volume (mean, 24.0% decrease; p = .013). In 8 patients who had above-average MBL scores at baseline and regular menstrual cycle lengths during follow-up, there was also a significant improvement in MBL score (median, 40.8% decrease; p = .035). ConclusionUltrasound-guided HIFU ablation with the prototype device demonstrated an excellent safety profile and produced clinically relevant NPVs in a mean total treatment time of under 4 minutes using the final validated treatment settings. Short-term clinical efficacy metrics assessed in subsets of patients were encouraging, and larger studies should be conducted to confirm these results (ClinicalTrials.gov, NCT01946178).

Color Doppler ultrasound to improve the diagnostic accuracy of the transvaginal ultrasound in the diagnosis of adenomyosis

Objectives To measure the accuracy of combined two-dimensional (2D) transvaginal ultrasound (TVS) and color Doppler in the diagnosis of adenomyosis and to assess the role of Doppler indices of the uterine artery and the intramyometrial blood vessels in the diagnosis of adenomyosis. Study design This was a cross-sectional observational study. Setting This study was carried out at the Women Health Hospital, Faculty of Medicine, Assiut University. Patients and methods One hundred women complaining of pelvic pain and/or uterine bleeding, clinically and sonographically diagnosed with adenomyosis, and scheduled for hysterectomy were approached for participation. Eighty patients were recruited and subjected to color Doppler examination in a trial to obtain a more accurate diagnosis of adenomyosis. In addition, uterine artery and intramyometrial Doppler studies (systolic/diastolic ratio, resistance, and pulsatility index) were measured before the scheduled hysterectomy to detect its role in diagnosis. The findings of 2D-TVS and color Doppler were compared with a gold standard of histopathology of the uterine specimens retrieved. Sensitivity, specificity, positive and negative predictive values, and overall accuracy were measured. Results Fifty specimens out of 80 uteri were histologically confirmed to have adenomyosis by histopathology. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of the 2D-TVS in the diagnosis of adenomyosis were 76.0, 83.3, 88.4, 67.6, and 78.8%, respectively. However, for combined 2D-TVS and the color Doppler ultrasound, the values were 86.0, 86.67, 91.5, 78.8, and 86.3%, respectively. Myometrial cysts were the most commonly diagnosed (53.8%) ultrasonographic criteria. Neither uterine artery nor intramyometrial vessels systolic/diastolic ratio, resistance index, and pulsatility index showed a significant association with adenomyosis. Conclusion Combined 2D-TVS and color Doppler ultrasound is superior to 2D-TVS alone in the diagnosis of adenomyosis. Uterine artery and intramyometrial Doppler studies were of no diagnostic value in adenomyosis.

Loss of stiffness in collagen-rich uterine fibroids after digestion with purified collagenase Clostridium histolyticum

Uterine fibroids are a significant health problem. These common benign tumors occur in 70-80% of women before age 50years and often cause bleeding and pain and can interfere considerably with daily life. Current treatment options are limited. Fibroids contain substantial amounts of altered and disordered collagens, which contribute to their bulk. Targeting these collagens directly presents a novel treatment approach. We sought to test the hypothesis that a highly purified collagenase Clostridium histolyticum will digest interstitial collagen in uterine fibroids and reduce their stiffness and thereby evaluate the feasibility that this collagenase C histolyticum can be developed into an alternative treatment for fibroids. A secondary objective was to describe the collagen content of the fibroid tissue. Fibroid tissue cubes (1 cm3; n= 154) were cut from 17 uterine fibroids that were obtained from 7 consented subjects undergoing scheduled hysterectomies. Tissue cubes were injected with diluent, placebo, or highly purified collagenase C histolyticum (0.05, 0.1, or 0.2 mg/cube) and incubated at 37°C for 24, 48, 72, or 96 hours. At each time point, 6 noninjected control cubes were also evaluated. Tissue cubes were photographed before and after incubation. Myometrial samples (n= 21) were alsoevaluated. Stiffness was quantified through rheometry by measuring complex shear moduli of the tissues. Percent fibrosis was determined by computerized analysis of Masson-trichrome-stained slides. Digestion of collagen fibrils was confirmed by transmission electron microscopy. Fibrosis in untreated fibroids ranged from 37% to 77%, reflecting the collagen-rich nature of these tumors. After treatment with collagenase for 96 hours, fibrosis ranged from 5.3% to 2.4%. Transmission electron microscopy confirmed complete digestion of collagen fibrils. Tissue stiffness was reduced with all 3 doses of collagenase treatment and at all 4 time points. Longer incubation times with collagenase caused greater reduction in stiffness, and treated cubes lost their cuboidal shape and had gelatinous/liquefied centers. At 96 hours the stiffness in tissues treated with the lowest dose was reduced to 966 ± 106 Pascal compared with the diluent-treated control at the same time (5323 ± 903 Pascal; P < .0001; by analysis of variance with Tukey-Kramer). Uterine fibroids have a high content of collagen that can be effectively digested by highly purified collagenase C histolyticum, resulting in reduced tissue stiffness. Loss of stiffness may decrease bulk symptoms invivo and possibly lead to shrinkage of fibroids through changed mechanotransduction, leading ultimately to reduced fibroid symptoms of pain and bleeding. Clinical trials are necessary to evaluate the safety and efficacy of collagenase C histolyticum including the rate ofregrowth of fibroids. The data of this study provide a strong rationale forusing this purified collagenase in clinical trials as a local treatment for women with fibroids.

Scheduled hysterectomy vs. urgent hysterectomy in patients with placenta accreta in a high specialty medical unit

Abstract Background Patients with placenta accreta have a high frequency of complications and death risk. Objective The aim of this study was to compare the results of scheduled hysterectomy vs. urgent hysterectomy in patients with placenta accreta in a high specialty medical unit. Material and methods An observational, comparative, cross-sectional study was conducted by reviewing patient records with confirmed diagnostic of placenta accreta, who attended in a one year period. They were divided into 2 groups based on the type of surgery, scheduled or urgent. Descriptive statistics were applied, with comparisons using Student t-test and chi squared tests. A value of P Results There were 4592 births in the period of study, and 125 obstetric hysterectomies were performed, with 40 confirmed cases of accreta (8.7 per thousand births) with 20 in scheduled and 20 in urgent surgeries, with the most frequent type being placenta accreta. The mean maternal age was 32 years, with a mean of 5 h operating time, total bleeding 3135 ml, and 3.5 units of packed cells transfused. There was no statistical difference when comparing these variables with re-interventions, hypovolaemic shock, and intensive care unit admission. Caesarean-hysterectomy with hypogastric artery ligation was the most frequent surgery performed. Conclusions In this hospital, scheduled and urgent surgical treatment of patients with placenta accreta show similar results, probably because the constant availability of resources and the experience obtained by the multidisciplinary team in all shifts. Nevertheless, make absolutely sure to perform elective surgery while having all the necessary resources.

Histerectomía programada vs. histerectomía de urgencia en pacientes con placenta acreta, en una unidad médica de alta especialidad

BackgroundPatients with placenta accreta have a high frequency of complications and death risk. ObjectiveThe aim of this study was to compare the results of scheduled hysterectomy vs. urgent hysterectomy in patients with placenta accreta in a high specialty medical unit. Material and methodsAn observational, comparative, cross-sectional study was conducted by reviewing patient records with confirmed diagnostic of placenta accreta, who attended in a one year period. They were divided into 2 groups based on the type of surgery, scheduled or urgent. Descriptive statistics were applied, with comparisons using Student t-test and chi squared tests. A value of P<.05 was considered significant. ResultsThere were 4,592 births in the period of study, and 125 obstetric hysterectomies were performed, with 40 confirmed cases of accreta (8.7 per thousand births) with 20 in scheduled and 20 in urgent surgeries, with the most frequent type being placenta accreta. The mean maternal age was 32 years, with a mean of 5 hours operating time, total bleeding 3135 ml, and 3.5 units of packed cells transfused. There was no statistical difference when comparing these variables with re-interventions, hypovolaemic shock, and intensive care unit admission. Caesarean-hysterectomy with hypogastric artery ligation was the most frequent surgery performed. ConclusionsIn this hospital, scheduled and urgent surgical treatment of patients with placenta accreta show similar results, probably because the constant availability of resources and the experience obtained by the multidisciplinary team in all shifts. Nevertheless, make absolutely sure to perform elective surgery while having all the necessary resources.

Effect of body mass index on maternal morbidity following peripartum hysterectomy.

The objective of this study was to estimate the impact of maternal body mass index (BMI) on maternal morbidity following unscheduled peripartum hysterectomy. A retrospective cohort study of consecutive peripartum hysterectomies at our institution from 1988 through 2012; scheduled hysterectomies were excluded. Medical records were reviewed and maternal, foetal and surgical data collected for each subject. Maternal BMI was categorized by the National Institute of Health classifications for overweight and obese. Statistical analyses included evaluation for trend. A total of 360,774 women delivered at Parkland Hospital during the study period with 665 (1.8 per 1000 deliveries) unscheduled peripartum hysterectomies performed. BMI was available for 635 women. Gestational diabetes, chronic hypertension and pregnancy-related hypertension were significantly higher in all three obesity categories, P = < 0.01. Post-partum complications, such as venous thrombosis and composite surgical morbidity did not differ among BMI groups. Estimated blood loss and units transfused did not differ across the BMI categories, P = 0.42 and P = 0.38, respectively. Increasing BMI was associated with longer surgical times and more wound infections, P = 0.01. These complications should be considered when approaching a peripartum hysterectomy in patients with obesity.

Pre-hysterectomy Assessment of Immediate Tubal Occlusion With the Third-Generation ESSURE Insert (ESS505)

Study ObjectiveTo assess the ability of a new iteration of the ESSURE insert (ESS505) to achieve short-term fallopian tube occlusion. DesignProspective, single center, interventional cohort (Canadian Task Force classification II-1). SettingTertiary care hospital. PatientsWomen scheduled to undergo hysterectomy. InterventionPatients underwent placement of the ESS505 in the right fallopian tube and ESS305 (the commercially approved previous version of the device) in the left fallopian tube at 30 (n = 10), 60 (n = 10), or 90 (n = 10) days before a planned hysterectomy. Tubal occlusion was assessed via hysterosalpingography (HSG) both at the time of placement and just before hysterectomy. Ultrasound was used to evaluate acute device placement. Measurements and Main ResultsThirty-five women (mean age, 39.7 years) were enrolled from July 2012 to January 2013, and 30 underwent both ESSURE placement and scheduled hysterectomy. Mean (SD) placement time for the ESS305 and ESS505 devices was 1.4 (0.65) minutes and 1.3 (0.42) minutes, respectively (p = .36). At 1 hour after ESS505 placement, 29 of 30 tubes (97%) exhibited complete occlusion at HSG, compared with only 4 of 30 tubes (13%) after ESS305 placement (p < .001 for difference in occlusion rates). At hysterectomy, the tubal occlusion rate was high in both groups: 97% for ESS505 and 100% for ESS305 tubes. High occlusion rates were observed in each of the 3 duration groups (30, 60, and 90 days). Five women experienced only minor adverse effects. ConclusionESS505, a modification to the commercially available ESS305 designed to cause immediate tubal occlusion, demonstrated a high rate of both immediate-term and intermediate-term tubal occlusion. Early tubal occlusion may obviate the need for interim alternative contraceptive methods after ESSURE placement.