Higher Rates of Cesarean Sections Found in Somali Immigrant Women in Minnesota.

OBJECTIVE: The purpose of this study was to compare prenatal characteristics and postpartum outcomes among Somali and non-Somali women residing in Olmsted County. METHODS: We reviewed the medical records for a cohort of Somali women (≥18 years old; N= 298) who had singleton births between January 2009 and December 2014 and for an age-matched non-Somali cohort (N= 298) of women residing in Olmsted County, Minnesota. Logistic regression models which accounted for repeated measures were used to assess differences in prenatal and postpartum outcomes between Somali and non-Somali women. RESULTS: Somali women had a significantly higher odds of cesarean section (adjusted OR=1.81; 95% CI=1.15, 2.84). Additionally, Somali women had a significantly lower odds of postpartum depression (adjusted OR=0.27; 95% CI=0.12, 0.63). CONCLUSION: The reported adverse postpartum outcomes have implications for interventions aimed at addressing perinatal care disparity gaps for Somali women immigrant and refugee populations.

Prospective Implementation and Evaluation of a Decision-Tree Algorithm for Route of Hysterectomy.

OBJECTIVE: To evaluate the rate of vaginal hysterectomy and outcomes after initiation of a prospective decision-tree algorithm to determine the optimal surgical route of hysterectomy. METHODS: A prospective algorithm to determine optimal route of hysterectomy was developed, which uses the following factors: history of laparotomy, uterine size, and vaginal access. The algorithm was implemented at our institution from November 24, 2015, to December 31, 2017, for patients requiring hysterectomy for benign indications. Expected route of hysterectomy was assigned by the algorithm and was compared with the actual route performed to identify compliance compared with deviation. Surgical outcomes were analyzed. RESULTS: Of 365 patients who met inclusion criteria, 202 (55.3%) were expected to have a total vaginal hysterectomy, 57 (15.6%) were expected to have an examination under anesthesia followed by total vaginal hysterectomy, 52 (14.2%) were expected to have an examination under anesthesia followed by robotic-assisted total laparoscopic hysterectomy, and 54 (14.8%) were expected to have an abdominal or robotic-laparoscopic route of hysterectomy. Forty-six procedures (12.6%) deviated from the algorithm to a more invasive route (44 robotic, two abdominal). Seven patients had total vaginal hysterectomy when robotic-assisted total laparoscopic hysterectomy or abdominal hysterectomy was expected by the algorithm. Overall, 71% of patients were expected to have a vaginal route of hysterectomy per the algorithm, of whom 81.5% had a total vaginal hysterectomy performed; more than 99% of the total vaginal hysterectomies attempted were successfully completed. CONCLUSION: Vaginal surgery is feasible, carries a low complication rate with excellent outcomes, and should have a place in gynecologic surgery. National use of this prospective algorithm may increase the rate of total vaginal hysterectomy and decrease health care costs.

Multicenter study comparing oncologic outcomes after lymph node assessment via a sentinel lymph node algorithm versus comprehensive pelvic and paraaortic lymphadenectomy in patients with serous and clear cell endometrial carcinoma.

OBJECTIVES: To compare survival after nodal assessment using a sentinel lymph node (SLN) algorithm versus comprehensive pelvic and paraaortic lymphadenectomy (LND) in serous or clear cell endometrial carcinoma, and to compare survival in node-negative cases. METHODS: Three-year recurrence-free survival (RFS) and overall survival were compared between one institution that used comprehensive LND to the renal veins and a second institution that used an SLN algorithm with ultra-staging with inverse-probability of treatment weighting (IPTW) derived from propensity scores to adjust for covariate imbalance between cohorts. RESULTS: 214 patients were identified (118 SLN cohort, 96 LND cohort). Adjuvant therapy differed between the cohorts; 84% and 40% in the SLN and LND cohorts, respectively, received chemotherapy ± radiation therapy. The IPTW-adjusted 3-year RFS rates were 69% and 80%, respectively. The IPTW-adjusted 3-year OS rates were 88% and 77%, respectively. The IPTW-adjusted hazard ratio (HR) for the association of surgical approach (SLN vs LND) with progression and death was 1.46 (95% CI: 0.70-3.04) and 0.44 (95% CI: 0.19-1.02), respectively. In the 168 node-negative cases, the IPTW-adjusted 3-year RFS rates were 73% and 91%, respectively. The IPTW-adjusted 3-year OS rates were 88% and 86%, respectively. In this subgroup, IPTW-adjusted HR for the association of surgical approach (SLN vs LND) with progression and death was 3.12 (95% CI: 1.02-9.57) and 0.69 (95% CI: 0.24-1.95), respectively. CONCLUSION: OS was not compromised with the SLN algorithm. SLN may be associated with a decreased RFS but similar OS in node-negative cases despite the majority receiving chemotherapy. This may be due to differences in surveillance.

Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis.

BACKGROUND: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. METHODS: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients' satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. RESULTS: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0-4] vs. 15 [0-131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100-100] vs. 100 [87-100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs.$2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). CONCLUSION: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. CLINICAL TRIAL REGISTRATION: NCT01165307.

Prospective assessment of the prevalence of pelvic, paraaortic and high paraaortic lymph node metastasis in endometrial cancer.

OBJECTIVE: To prospectively define the prevalence of lymph node metastasis (LNM) in at risk endometrial cancer (EC). METHODS: From 2004 to 2008, frozen section based Mayo Criteria prospectively identified patients "not at-risk" of LNM (30% EC population; grade I/II, <50% myometrial invasion and tumor diameter ≤ 2 cm) where lymphadenectomy was not recommended. The remaining 70% EC cohort was considered "at-risk" of LNM; where a systematic pelvic and infrarenal paraaortic lymphadenectomy was recommended. Patients were prospectively followed. The area between renal vein and inferior mesenteric artery (IMA) was labeled as high paraaortic area. For calculating the prevalence of LNM in high paraaortic area, the denominator was the population with known anatomic location of nodal tissue in relation to the IMA. RESULTS: Of the 742 patients, 514 were at risk; of which 89% underwent recommended lymphadenectomy. A mean (± standard deviation) of 36 (± 14) pelvic and 18 (± 9) paraaortic nodes were harvested. The prevalence of pelvic and paraaortic LNM was 17% and 12%, respectively. In presence of pelvic LNM, 51% had paraaortic LNM. In absence of pelvic LNM, 3% had paraaortic LNM; of which 67% was located exclusively in high paraaortic area. Among patients with paraaortic LNM, 88% had high paraaortic LNM; and 35% had only high paraaortic LNM. The cases of paraaortic LNM with negative pelvic nodes seemed to cluster in moderate to high grade endometrioid EC with ≥ 50% myometrial invasion. CONCLUSION: We present reference data for the prevalence of LNM in at-risk EC patients to guide lymphadenectomy decisions for clinical and research purposes.

Predictors and costs of surgical site infections in patients with endometrial cancer.

OBJECTIVE: Technological advances in surgical management of endometrial cancer (EC) may allow for novel risk modification in surgical site infection (SSI). METHODS: Perioperative variables were abstracted from EC cases surgically staged between January 1, 1999, and December 31, 2008. Primary outcome was SSI, as defined by American College of Surgeons National Surgical Quality Improvement Program. Counseling and global models were built to assess perioperative predictors of superficial incisional SSI and organ/space SSI. Thirty-day cost of SSI was calculated. RESULTS: Among 1369 EC patients, 136 (9.9%) had SSI. In the counseling model, significant predictors of superficial incisional SSI were obesity, American Society of Anesthesiologists (ASA) score >2, preoperative anemia (hematocrit <36%), and laparotomy. In the global model, significant predictors of superficial incisional SSI were obesity, ASA score >2, smoking, laparotomy, and intraoperative transfusion. Counseling model predictors of organ/space SSI were older age, smoking, preoperative glucose >110 mg/dL, and prior methicillin-resistant Staphylococcus aureus (MRSA) infection. Global predictors of organ/space SSI were older age, smoking, vascular disease, prior MRSA infection, greater estimated blood loss, and lymphadenectomy or bowel resection. SSI resulted in a $5447 median increase in 30-day cost. CONCLUSIONS: Our findings are useful to individualize preoperative risk counseling. Hyperglycemia and smoking are modifiable, and minimally invasive surgical approaches should be the preferred surgical route because they decrease SSI events. Judicious use of lymphadenectomy may decrease SSI. Thirty-day postoperative costs are considerably increased when SSI occurs.

Comparative outcomes assessment of uterine grade 3 endometrioid, serous, and clear cell carcinomas.

OBJECTIVE: The objective of this study is to assess effects of clinicopathologic risk factors and contemporary therapeutic interventions on high-risk uterine epithelial carcinoma outcomes. METHODS: Patient-, disease-, and treatment-specific variables were annotated. Survival was estimated via the Kaplan-Meier method. Associations were evaluated with Cox proportional hazard regression and summarized using hazard ratios. RESULTS: From 1999 through 2008, therapy with curative intent was initiated for 119 grade 3 endometrioid (G3EC), 211 serous (USC), and 40 clear cell (CCC) carcinomas. Although clinicopathologic risk factors varied among the histologic subtypes, overall survival (OS) did not differ statistically between subtypes (P=.10) or in stage-for-stage comparative analyses (stage I/II, P=.45; stage III, P=.46; stage IV, P=.65). The 5-year cause-specific survival in stage I/II was 84.8%, 89.8%, and 83.9% for G3EC, USC, and CCC, respectively; multivariable modeling identified lymphovascular space involvement (LVSI) as the only independent prognostic factor (P=.02). For stage III, 5-year OS was 49.2% and 40.0% for G3EC and USC, respectively; multivariable modeling identified age (P<.001), LVSI (P<.001), unresectable nodal disease (P=.03), and regional radiotherapy (P=.01) as independent prognostic factors. For stage IV, 5-year OS was 8.7% and 12.1% for G3EC and USC, respectively; multivariable modeling identified LVSI (P=.002), cervical stromal invasion (P=.02), and adjuvant chemotherapy (P=.02) but not residual disease as independent prognostic factors. CONCLUSIONS: When controlled for disease stage, outcomes did not differ among high-risk histologic subtypes. LVSI was a significant adverse prognostic factor within all stages. The lack of improved outcomes with contemporary therapy suggests that more innovative therapeutic approaches should be given higher priority.

Factors predictive of postoperative morbidity and cost in patients with endometrial cancer.

OBJECTIVE: To identify patient characteristics and perioperative factors predictive of 30-day morbidity and cost in patients with endometrial carcinoma. METHODS: Data of consecutive patients treated with hysterectomy for endometrial carcinoma between 1999 and 2008 were collected prospectively. Thirty predictors were chosen from more than 130 collected based on anticipated clinical relevance and prevalence (more than 3%). Complications were graded per the Accordion Classification. Multivariable models were developed using stepwise and backward variable selection methods. Thirty-day cost analyses were expressed in 2010 Medicare dollars. RESULTS: Of 1,369 patients, significant predictors (P<.01) of grade 2 and higher morbidity included American Society of Anesthesiologists physical status classification system class higher than 2 (odds ratio [OR] 2.1), preoperative white blood count (OR 2.1 per doubling), history of deep vein thrombosis (OR 2.1), pelvic and para-aortic lymphadenectomy (OR 2.3 compared with no lymphadenectomy), laparotomy (OR 2.8 compared with minimally invasive surgery), myometrial invasion more than 50% (OR 2.4), operating time (OR 1.9 per doubling), and grade 4 surgical complexity (OR 2.7 compared with grade 1). After controlling for patient factors in a multivariable model, laparotomy, pelvic, and para-aortic lymphadenectomy were associated with significant increases in cost compared with the use of minimally invasive surgery or hysterectomy alone. CONCLUSION: This analysis identifies patient and perioperative care factors predictive of 30-day morbidity and cost. These data are useful for preoperative counseling, for defining equitable reimbursement and factors critical for risk-adjustment when comparing outcomes, and for identifying areas for quality improvement in patients with endometrial carcinoma. Given the marked increases in morbidity and cost associated with laparotomy and lymphadenectomy, minimally invasive surgery and selective lymphadenectomy should be standard treatment for patients with endometrial carcinoma.

The impact of surgical guidelines and periodic quality assessment on the staging of endometrial cancer.

OBJECTIVE: To determine the impact of surgical guidelines and transparent periodic assessment of surgical quality on endometrial cancer (EC) staging by gynecologic oncologists in a single institution and to identify process-of-care, patient-specific, and disease-specific risk factors that influence surgical quality. METHODS: In January 2004, a prospective treatment algorithm was implemented for EC at our institution. The number of nodes harvested was a surrogate, and staging quality from 2004 to 2008 (quality assessment [QA] interval) was compared with the previous 5 years (pre-QA interval). Since 2004, low-risk cases based on frozen section examination had not undergone lymphadenectomy and were excluded. Independent patient-specific, disease-specific, and surgery-related risk factors influencing lymphadenectomy quality during both intervals were identified with multivariable logistic regression analysis. RESULTS: Pelvic and para-aortic lymph node dissection (LND) in surgical EC management before QA (n=420) were 77.9% and 48.8% vs 89.3% and 83.4% during the QA (n=561) (P<.001). The median number of pelvic and para-aortic nodes harvested in LND was 29 and 10 before QA vs 34 and 16 during the QA interval (P<.001). With acceptance of stringent criteria for defining systematic LND (mean node count-1 SD) during the QA, systematic pelvic (≥22 nodes) and para-aortic (≥10 nodes) LNDs occurred in 57.4% and 25.7% of cases before QA vs 77.9% and 70.7% during the QA interval (P<.001). In patients with LND, rates of systematic pelvic and para-aortic LND were 73.7% and 53.0% before vs 87.2% and 84.8% after QA (P<.001). Multivariable logistic regression analysis showed independent factors influencing systematic pelvic and para-aortic LND (P<.01): surgeon and stage during the pre-QA interval vs surgical approach; intraoperative ascites; body mass index; surgeon; patient age; and myometrial invasion after QA implementation. CONCLUSION: Inclusion of detailed surgical guidelines and transparent periodic assessment of surgical quality translated to dramatic improvement in quality of surgical EC staging. This implementation was associated with a transition to more patient-specific risk factors influencing systematic LND. Although surgical quality metrics were markedly enhanced during QA, persistent variability observed among surgeons and the change in surgical approach render continuous QA and improvement obligatory.