Perioperative Outcomes of Robotic-Assisted Hysterectomy Compared With Open Hysterectomy.

BACKGROUND: Increasing numbers of robotic hysterectomies (RH) are being performed. To provide ventilation (with pneumoperitoneum and steep Trendelenburg position) for these procedures, utilization of lung protective strategies with limiting airway pressures and tidal volumes is difficult. Little is known about the effects of intraoperative mechanical ventilation and high peak airway pressures on perioperative complications. We performed a retrospective review to determine whether patients undergoing RH had increased pulmonary complications compared to total abdominal hysterectomy (TAH). METHODS: We performed a single center retrospective review comparing the intraoperative, anesthetic, and immediate and 30-day postoperative course of patients undergoing RH to TAH, including intraoperative ventilatory parameters and respiratory complications. Patients undergoing TAH (201) from 2004 to 2006 were compared to RH (251) from 2009 to 2012. It was our hypothesis that patients undergoing RH would have increased incidence of postoperative pulmonary complications. A secondary hypothesis was that morbid obesity predicts pulmonary complications in patients undergoing RH. Complications were compared between groups using Fisher's exact test. To account for potential confounders, the primary analysis was performed for a subgroup of patients matched on the propensity for RH. RESULTS: A total of 351 RH and 201 TAH procedures are included. Higher inspiratory pressures were required in ventilation of the RH group (median [25th, 75th] 31 [26, 36] cm H2O) than the TAH group (23 [19, 27] cm H2O) (P < .001) at 30 minutes after incision. Peak inspiratory pressures at 30 minutes after incision for RH increased according to increasing body mass index group (P < .001). There were 163 RH and 163 TAH procedures included in the propensity matched analysis. From this analysis, there were no significant differences in cardiopulmonary complications between RH and TAH (0.6% vs 1.2%; odds ratio = 2.0, 95% confidence interval = 0.2-2.4; P = 1.00). Surgical site infection was significantly lower in the RH compared to TAH group (0.6% vs 8.6%; P < .001). Hospital length of stay was longer for those who underwent TAH versus RH (median [25th, 75th] 2 [2, 3] vs 1 [0, 2] days; P < .001). CONCLUSIONS: There was no significant difference in perioperative complications in obese and morbidly obese women compared to nonobese undergoing RH. Patients undergoing RH had shorter hospital stays, fewer infectious complications, and no increase in overall complications compared to TAH. Higher ventilatory airway pressures (RH versus TAH and obese versus nonobese) did not result in an increase in cardiopulmonary or overall complications. We believe that peritoneal insufflation attenuates the effect of high airway pressures by raising intrapleural pressure and reducing the gradient across terminal bronchioles and alveoli. Thus, we propose that lung protective strategies for patients undergoing RH account for the markedly elevated intraperitoneal and intrapleural pressures, whereas transpulmonary airway pressures remain static. This reduced transpulmonary gradient attenuates the strain on lung tissue that would otherwise be imposed by ventilation at high pressures.

Incorporating robotic-assisted surgery for endometrial cancer staging: Analysis of morbidity and costs.

OBJECTIVE: To evaluate how the introduction of robotic-assisted surgery affects treatment-related morbidity and cost of endometrial cancer (EC) staging. METHODS: We retrospectively reviewed the records of consecutive patients with stage I-III EC undergoing surgical staging between 2007 and 2012 at our institution. Costs (from surgery to 30days after surgery) were set based on the Medicare cost-to-charge ratio for each year and inflated to 2014 values. Inverse probability weighting (IPW) was used to decrease the allocation bias when comparing outcomes between surgical groups. RESULTS: We focused our analysis on the 251 EC patients who had robotic-assisted surgery and the 384 who had open staging. During the study period, the use of robotic-assisted surgery increased and open staging decreased (P<0.001). Correcting group imbalances by using IPW methodology, we observed that patients undergoing robotic-assisted staging had a significantly lower postoperative complication rate, lower blood transfusion rate, longer median operating time, shorter median length of stay, and lower readmission rate than patients undergoing open staging (all P<0.001). Overall 30-day costs were similar between the 2 groups, with robotic-assisted surgery having significantly higher median operating room costs ($2820 difference; P<0.001) but lower median room and board costs ($2929 difference; P<0.001) than open surgery. Increasing experience with robotic-assisted staging was significantly associated with a decrease in median operating time (P=0.002) and length of stay (P=0.003). CONCLUSIONS: The implementation of robotic-assisted surgery for EC staging improves patient outcomes. It provides women the benefits of minimally invasive surgery without increasing costs and potentially improves patient turnover.

A hemangioma of the cervix in childhood can be a harbinger of menorrhagia and infertility as an adult.

Early diagnosis of uterine hemangiomas may direct management decisions improving long-term outcome in children, adolescents and adulthood.

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.

Phase I trial of intraperitoneal administration of an oncolytic measles virus strain engineered to express carcinoembryonic antigen for recurrent ovarian cancer.

Edmonston vaccine strains of measles virus (MV) have shown significant antitumor activity in preclinical models of ovarian cancer. We engineered MV to express the marker peptide carcinoembryonic antigen (MV-CEA virus) to also permit real-time monitoring of viral gene expression in tumors in the clinical setting. Patients with Taxol and platinum-refractory recurrent ovarian cancer and normal CEA levels were eligible for this phase I trial. Twenty-one patients were treated with MV-CEA i.p. every 4 weeks for up to 6 cycles at seven different dose levels (10(3)-10(9) TCID(50)). We observed no dose-limiting toxicity, treatment-induced immunosuppression, development of anti-CEA antibodies, increase in anti-MV antibody titers, or virus shedding in urine or saliva. Dose-dependent CEA elevation in peritoneal fluid and serum was observed. Immunohistochemical analysis of patient tumor specimens revealed overexpression of measles receptor CD46 in 13 of 15 patients. Best objective response was dose-dependent disease stabilization in 14 of 21 patients with a median duration of 92.5 days (range, 54-277 days). Five patients had significant decreases in CA-125 levels. Median survival of patients on study was 12.15 months (range, 1.3-38.4 months), comparing favorably to an expected median survival of 6 months in this patient population. Our findings indicate that i.p. administration of MV-CEA is well tolerated and results in dose-dependent biological activity in a cohort of heavily pretreated recurrent ovarian cancer patients.

Quality improvement in the surgical approach to advanced ovarian cancer: the Mayo Clinic experience.

BACKGROUND: After observing disparate rates of cytoreduction, we initiated efforts to improve outcomes through feedback and education, and we reassessed outcomes. STUDY DESIGN: Outcomes from group A (2006 and 2007, n=105) were compared with those from the cohort predating quality-improvement efforts (group B, 2000 to 2003, n=132). All stage IIIC ovarian cancer patients at our institution were evaluated for tumor dissemination, age, performance status, surgical complexity, residual disease (RD), morbidity, and mortality. A surgical complexity score previously described was used to categorize extent of operation. RESULTS: No significant differences in age, performance status, or extent of disease were observed between cohorts. Surgical complexity increased after initiation of quality improvement (mean surgical complexity score, 5.5 to 7.1; p < 0.001), rates of optimal RD (< 1 cm) improved from 77% to 85% (p=0.157), and rates of complete resection of all gross disease rose from 31% to 43% (p=0.188). In the subset of patients with carcinomatosis most likely to benefit from extended surgical resection, radical procedures were used more frequently (63% versus 79%; p=0.028), rates of optimal debulking (RD<1 cm) increased (64% to 79%), and the rate of RD=0 increased from 6% to 24% (p=0.006). When disease was noted on the diaphragm, procedures to remove the disease were more frequently used (38% to 64%; p=0.001). The rates of major perioperative morbidity (group B, 21% versus group A, 20%; p=0.819) and 3-month mortality (8% versus 6%; p=0.475) were not affected despite this more aggressive surgical approach. CONCLUSIONS: Analysis of outcomes with appropriate feedback and education is a powerful tool for quality improvement. We observed improvements in rates of cytoreduction and use of specific radical procedures, with no increase in morbidity as a result of this process.

Pattern of retroperitoneal dissemination of primary peritoneum cancer: basis for rational use of lymphadenectomy.

INTRODUCTION: The rationale for lymphadenectomy in primary peritoneal cancer (PPC) is unclear. We sought to define the pattern of lymphatic metastasis in PPC and propose evidence-based rationale for lymphadenectomy in relevant cases. METHODS: Patients with PPC undergoing primary surgery at Mayo Clinic were identified. Demographics, tumor characteristics, procedures performed and follow up were analyzed. RESULTS: Forty eight patients with PPC were identified; 39 had stage IIIC (81.2%) and 9 (18.8%) had stage IV. Residual disease (RD) after primary surgery was microscopic in 6 cases (12.5%), less than 1 cm in 33 (68.8%), more than 1 cm in 9 patient (18.7%) with median survivals of 5.8, 3.2 and 1.3 years, respectively. Overall, 24 patients had lymphadenectomy performed (pelvic (PND) or paraortic (PAND) or both). Pelvic nodes were involved in 12/23 (52.7%) cases, while para-aortic nodes were involved in 5/21 (23.8%) of cases. The rate of simultaneously positive pelvic and para-aortic nodes was 20% (4/20). Nodal involvement was a poor prognostic factor with 5 year overall survival 63% vs. 25% (p=0.014) in node positive vs. negative cases. Compared to patients with primary ovarian cancer (OC), OC cases had a higher rate of positive para-aortic nodes (57.6%: 77/132; p=0.004). CONCLUSIONS: Retroperitoneal lymph nodes are a common site of metastases in PPC, therefore it is logically consistent to perform PND and PAND if a patient can be cytoreduced to microscopic RD in other sites or remove grossly positive nodes in patients with RD<1 cm.

Prospective assessment of lymphatic dissemination in endometrial cancer: a paradigm shift in surgical staging.

OBJECTIVE: To prospectively assess pelvic and para-aortic lymph node metastases in endometrial cancer with lymphatic dissemination, emphasizing the examination of para-aortic metastases relative to the inferior mesenteric artery (IMA). METHODS: Over 36 months, 422 consecutive patients were managed by predefined surgical guidelines differentiating low-risk patients from patients at risk for dissemination requiring systematic lymphadenectomy. Low risk was defined as grade 1 or 2 endometrioid type with myometrial invasion (MI) < or = 50% and primary tumor diameter (PTD) < or = 2 cm. Pelvic and para-aortic lymph nodes were submitted separately, with nodes identified from all 8 pelvic and 4 para-aortic node-bearing basins. Surgical quality assessments examined median node counts (primary surrogate for quality) and nodes harvested above and below the IMA and excised gonadal veins (secondary surrogates). RESULTS: Lymphadenectomy was not required in 27% of patients (all low risk) and in 33% (n=112) of endometrioid cases. However, 22 patients (20%) of this latter cohort had lymphadenectomy and all lymph nodes were negative. Sixty-three (22%) of 281 patients undergoing lymphadenectomy had lymph node metastases: both pelvic and para-aortic in 51%, only pelvic in 33%, and isolated to the para-aortic area in 16%. Therefore, 67% of patients with lymphatic dissemination had para-aortic lymph node metastases. Furthermore, 77% of patients with para-aortic node involvement had metastases above the IMA, whereas nodes in the ipsilateral para-aortic area below the IMA and ipsilateral common iliac basin were declared negative in 60% and 71%, respectively. Gonadal veins were excised in 25 patients with para-aortic node metastases; 7 patients (28%) had documented metastatic involvement of gonadal veins or surrounding soft tissue. CONCLUSIONS: The high rate of lymphatic metastasis above the IMA indicates the need for systematic pelvic and para-aortic lymphadenectomy (vs sampling) up to the renal vessels. The latter should include consideration of excision of the gonadal veins. Conversely, lymphadenectomy does not benefit patients with grade 1 and 2 endometrioid lesions with MI < or = 50% and PTD < or = 2 cm.

Colorectal cancer screening education, prioritization, and self-perceived preparedness among primary care residents: data from a national survey.

BACKGROUND: Colorectal cancer (CRC) screening remains underutilized in the United States. We conducted a national survey of CRC screening education, prioritization, and self-perceived preparedness among resident physicians in Family Practice (FP), Internal Medicine (IM), and Obstetrics and Gynecology (OB/GYN) training programs. METHODS: Directors/administrators from 1085 FP, IM, and OB/GYN training programs were contacted by e-mail with a request to forward an invitation to participate in our Web-based CRC screening education survey to all residents in their program. Willing residents submitted responses in anonymous fashion. Data were analyzed using chi2 tests and analysis of variance methods. RESULTS: In total, 243 program directors/administrators forwarded our invitation, and 835 residents responded (384 FP, 266 IM, 177 OB/GYN, 8 undesignated specialty). Nearly all resident responders (89%) had received CRC screening education, but few content delivery methods were reported. Most felt at least somewhat comfortable or somewhat knowledgeable with respect to advising patients about CRC screening (90%), currently endorsed CRC screening guidelines (89%), and criteria used to identify familial CRC syndromes (50%). However, substantially fewer respondents reported feeling very comfortable or very knowledgeable in these areas (45%, 23%, and 5%, respectively). Program specialty, level of training, and gender were the strongest indicators of self-perceived preparedness. CONCLUSIONS: Although based on a relatively small sample of all FP, IM, and OB/GYN residents, these data suggest tangible opportunities to improve the CRC screening curriculum in primary care residency programs.

Is it justified to classify patients to Stage IIIC epithelial ovarian cancer based on nodal involvement only?

BACKGROUND: Stage IIIC epithelial ovarian cancer is generally associated with upper abdominal tumor implants of greater than 2 cm and carries a grave prognosis. A subset of patients is upstaged to Stage IIIC because of lymph node metastases, in which prognosis is not well defined. We undertook this study to describe the clinical behavior of occult Stage IIIC. METHODS: All consecutive patients found to have Stage IIIC epithelial ovarian cancer during a 9-year period (1994-2002) were analyzed for surgical procedures, pathology, and disease-free (DFS) and overall survival (OS). RESULTS: Thirty-six patients were upstaged to Stage IIIC by virtue of positive nodes. Nine had small volume upper abdominal disease (IIIA/B before upstaging), 15 had disease limited to the pelvis and 12 had disease confined to the ovaries. 32/36 patients had no gross residual disease at the conclusion of surgery. The 5-year DFS and OS survivals were 52% and 76% respectively, for all patients. We observed no significant difference in outcomes between patients upstaged from IIIA/B versus I-II stage disease. The outcomes were superior to a control group of patients cytoreduced to either no gross RD or RD<1 cm, who had large volume upper abdominal disease at beginning of surgery (p<0.001). CONCLUSIONS: Patients upstaged to Stage IIIC epithelial ovarian cancer for node involvement have an excellent 5-year OS relative to all patients with Stage IIIC disease. These data demonstrate the necessity for stratifying patients classified as having Stage IIIC disease based solely on nodal disease when comparing outcomes. This information is particularly valuable when counseling patients regarding prognosis.

Aggressive surgical effort and improved survival in advanced-stage ovarian cancer.

OBJECTIVE: Residual disease after initial surgery for ovarian cancer is the strongest prognostic factor for survival. However, the extent of surgical resection required to achieve optimal cytoreduction is controversial. Our goal was to estimate the effect of aggressive surgical resection on ovarian cancer patient survival. METHODS: A retrospective cohort study of consecutive patients with International Federation of Gynecology and Obstetrics stage IIIC ovarian cancer undergoing primary surgery was conducted between January 1, 1994, and December 31, 1998. The main outcome measures were residual disease after cytoreduction, frequency of radical surgical resection, and 5-year disease-specific survival. RESULTS: The study comprised 194 patients, including 144 with carcinomatosis. The mean patient age and follow-up time were 64.4 and 3.5 years, respectively. After surgery, 131 (67.5%) of the 194 patients had less than 1 cm of residual disease (definition of optimal cytoreduction). Considering all patients, residual disease was the only independent predictor of survival; the need to perform radical procedures to achieve optimal cytoreduction was not associated with a decrease in survival. For the subgroup of patients with carcinomatosis, residual disease and the performance of radical surgical procedures were the only independent predictors. Disease-specific survival was markedly improved for patients with carcinomatosis operated on by surgeons who most frequently used radical procedures compared with those least likely to use radical procedures (44% versus 17%, P < .001). CONCLUSION: Overall, residual disease was the only independent predictor of survival. Minimizing residual disease through aggressive surgical resection was beneficial, especially in patients with carcinomatosis. LEVEL OF EVIDENCE: II-2.

Efficacy of thermal balloon ablation in patients with abnormal uterine bleeding.

OBJECTIVE: The purpose of this study was to assess changes in menstrual pattern, quality of life, and patient satisfaction after thermal balloon ablation for abnormal uterine bleeding. STUDY DESIGN: One hundred forty-one women who underwent thermal balloon ablation in our institution initially had their charts reviewed for demographics, procedure data, clinical history, and follow-up. Thereafter, a telephone interview was conducted to assess postprocedural menstrual pattern, quality of life, and patient satisfaction. Data were compared with the use of appropriate tests for categoric or continuous variables and logistic regression. RESULTS: The median follow-up time was 18 months, and a telephone interview was obtained for 119 of 141 patients. A reduction in days per cycle (9.6 vs 3.1 days, P<.0001) and in pads per day (12.8 vs 2.5 pads/d, P<.0001) and an improvement in self-reported quality of life scores (2.8 vs 9.0, P<.0001) were observed after thermal balloon ablation. Hysterectomy was required in 21 of 141 patients (15%). Assessment of the level of satisfaction showed that 96% of patients were satisfied or very satisfied with the procedure. No major complications or deaths were related to thermal balloon ablation. CONCLUSION: Thermal balloon ablation is a safe and efficient method to treat abnormal uterine bleeding. It reduces the menstrual flow, improves the quality of life, and remarkably fulfills expectations in selected patients.

Laparoscopy versus laparotomy in the management of benign unilateral adnexal masses.

STUDY OBJECTIVE: To compare operative characteristics and charges of laparoscopy and laparotomy for women with a benign unilateral adnexal mass 7 cm or less in greatest diameter. DESIGN: Historical cohort study (Canadian Task Force classification II-2). SETTING: Clinic department of obstetrics and gynecology. PATIENTS: One hundred six women. INTERVENTION: Unilateral oophorectomy or unilateral salpingo-oophorectomy performed by laparoscopy or laparotomy. MEASUREMENTS AND MAIN RESULTS: When patients were compared on an intent to treat basis, no differences in greatest mass diameter (4.2 vs 4.5 cm), patient age (49.2 vs 46.4 yrs), or body mass index (26.0 vs 27.0 kg/m(2)) were found between 62 laparoscopies and 44 laparotomies. Laparoscopy was associated with longer operating times (94 vs 63 min, p <0.001), shorter hospital stay (1.6 vs 2.5 days, p <0.001), higher sterile supply charges ($1031 vs $40, p <0.001), and lower hospital room charges ($672 vs $1351, p <0.0001). No significant differences in total hospital charges, febrile morbidity, or transfusion rates were identified. CONCLUSION: Patient charges and early operative morbidity are similar for laparoscopy and laparotomy. Therefore, patient and surgeon preference should be a primary consideration when deciding on operative approach in carefully selected women with a unilateral adnexal mass.

Multimodal therapy including neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) for stage IIB to IV cervical cancer.

OBJECTIVE: The purpose of this study was to determine the survival rates and toxicity levels that are associated with multimodal therapy (including neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC]) in patients with stage IIB to IVB cervical cancer. STUDY DESIGN: We retrospectively reviewed the cases of 49 patients who were treated between 1989 and 1997 with neoadjuvant MVAC for advanced cervical cancer. RESULTS: The clinical response rate was 90% (27 partial responders, 17 complete responders). Grade 3 or greater toxicity was mostly limited to neutropenia; no deaths were attributed to MVAC. Combined therapy after MVAC included operation in 34 patients (69%) and radiation in 41 patients (84%). Twenty-one patients (43%) had <2 cm residual tumor at histologic evaluation. Pelvic control was achieved in 86% of patients. Five-year disease-specific survival for patients with stage III disease was 60%. CONCLUSION: For patients with advanced cervical cancer, neoadjuvant MVAC had a high response rate (90%) and an acceptable toxicity level. Compared with historic control subjects, multimodal treatment may be associated with improved rates of pelvic control.

Atypical glandular cells of undetermined significance. Review of final histologic diagnoses.

OBJECTIVE: To review recent literature that examines the histologic characterization of women with atypical glandular cells of undermined significance (AGUS) on a Pap smear. STUDY DESIGN: The English-language literature published between January 1995 and April 2000 was reviewed. The MEDLINE database and the search terms atypical glandular cells of undetermined significance and AGUS were used. The references cited in the studies were reviewed to identify additional publications. Studies that reported data from patients with a cytologic diagnosis of AGUS without an associated squamous lesion identified by Pap smear were used to summarize the final histologic diagnoses. RESULTS: Eight percent of women with the diagnosis of an AGUS Pap smear without a concurrent squamous lesion had a malignancy. CONCLUSION: A thorough initial evaluation is recommended for all women with a cytologic diagnosis of AGUS.