Cross-sectional survey of surgical practices among gynecologic oncologists in the United States.

OBJECTIVE: We sought to document current surgical practices among gynecologic oncologists in the United States. METHODS: In March/April 2020, we conducted a cross-sectional survey among members of the Society of Gynecologic Oncology to identify gynecologic oncology practice trends in the United States. The survey collected demographic data and queried participants on types of surgical procedures performed and chemotherapy use. Univariant and multivariant analyses were used to evaluate the association between surgeon practice type, region of practice, working with gynecologic oncology fellows, time in practice, and dominant surgical modality of practice on performance of specific procedures. RESULTS: Among 1199 gynecologic oncology surgeons who were emailed the survey, 724 completed the survey (60.4% response rate). Of these respondents, 170 (23.5%) were within 6 years of fellowship graduation, 368 (50.8%) identified as female; and 479 (66.2%) worked in an academic setting. Surgeons who worked with gynecologic oncology fellows were more likely to perform bowel surgery, upper abdominal surgery, complex upper abdominal surgery, and prescribe chemotherapy. Surgeons who were ≥ 13 years out from fellowship graduation were more likely to perform bowel surgery and complex abdominal surgery and less likely to prescribe chemotherapy and perform sentinel lymph node dissections (P < 0.05). CONCLUSIONS: These findings highlight the variation in surgical procedures performed by gynecologic oncologists in the United States. These data support that there are practice variations that would benefit from further investigation.

Surgical training in gynecologic oncology: Past, present, future.

The purpose of this paper is to review the surgical care related to training in gynecologic oncology, from past, present and future perspectives. A marked decline in the incidence of cervical cancer as well as improvements in radiation therapy have led to a reduction in the numbers of radical hysterectomies and exenterations being performed. Utilization of neoadjuvant chemotherapy is reducing the extent of cytoreductive operations, including intestinal surgery. The incorporation of sentinel lymphatic mapping has reduced the number of pelvic, paraaortic and inguinal lymphadenectomies being performed. Coupled with these changes are other factors limiting time for surgical training including an explosion in targeted anticancer therapies and more individualized options beyond simple cytotoxic therapy. With what is likely to be a sustained impact on training, gynecologic oncologists will still provide a broad range of care for women with gynecologic cancer but may be quite limited in surgical scope and rely on colleagues from other surgical disciplines. Enhancement of surgical training by off-service rotations, simulation, attending advanced surgical training courses and/or a longer duration of training are currently incorporated into some programs. Programs must ensure that fellows take full advantage of the clinical materials available, particularly those related to the potential deficiencies described. Changing required research training to an additional elective year could also be considered. Based on the perspectives noted, we believe it is time for our subspecialty to reevaluate its scope of surgical training and practice.

Cystoscopy at the Time of Hysterectomy for Benign Indications and Delayed Lower Genitourinary Tract Injury.

OBJECTIVE: To compare the rate of delayed 30-day lower genitourinary tract injury in women who underwent cystoscopy at the time of hysterectomy for benign indications to those who did not. METHODS: This was a retrospective cohort study of patients who underwent hysterectomy without a concomitant procedure for prolapse or incontinence for benign pathology with a general obstetrician-gynecologist (ob-gyn) recorded in the National Surgical Quality Improvement Program targeted hysterectomy file between 2015 and 2017. The primary outcome was a delayed lower genitourinary tract injury in the 30 days after hysterectomy. Secondary outcomes included urinary tract infection and operative time. The exposure of interest was cystoscopy at the time of hysterectomy. Stratified analysis was performed by route of surgery. Bivariable tests were used to examine associations. RESULTS: We identified 39,529 women who underwent hysterectomy for benign indications with a general ob-gyn. Surgical approach was open (26%), laparoscopic or robotic assisted laparoscopic (46%), and vaginal or vaginally assisted (28%). Overall, 25% of women underwent cystoscopy at the time of hysterectomy; cystoscopy was more commonly performed in laparoscopic or robotic (32%) and vaginal hysterectomy (25%) as compared with open hysterectomy (11%) (P<.001). There was no difference in delayed lower genitourinary tract injury between patients who underwent cystoscopy at time of hysterectomy compared with those who did not undergo cystoscopy (0.27% vs 0.24%, P=.64). Patients who underwent cystoscopy were more likely to be diagnosed with a urinary tract infection (2.6% vs 2.0%, RR 1.27 95% CI 1.09-1.47). Median operative time was increased by 17 minutes in cases where cystoscopy was performed (132 vs 115 minutes, P<.001). CONCLUSION: Cystoscopy at the time of hysterectomy for benign indications does not result in a lower rate of 30-day delayed lower genitourinary tract injury compared with no cystoscopy.

Prevention of venous thromboembolism in gynecologic oncology surgery.

Gynecologic oncology patients are at a high-risk of postoperative venous thromboembolism and these events are a source of major morbidity and mortality. Given the availability of prophylaxis regimens, a structured comprehensive plan for prophylaxis is necessary to care for this population. There are many prophylaxis strategies and pharmacologic agents available to the practicing gynecologic oncologist. Current venous thromboembolism prophylaxis strategies include mechanical prophylaxis, preoperative pharmacologic prophylaxis, postoperative pharmacologic prophylaxis and extended duration pharmacologic prophylaxis that the patient continues at home after hospital discharge. In this review, we will summarize the available pharmacologic prophylaxis agents and discuss currently used prophylaxis strategies. When available, evidence from the gynecologic oncology patient population will be highlighted.

Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroids: an updated decision analysis following the 2014 Food and Drug Administration safety communications.

Previous decision analyses demonstrate the safety of minimally invasive hysterectomy for presumed benign fibroids, accounting for the risk of occult leiomyosarcoma and the differential mortality risk associated with laparotomy. Studies published since the 2014 Food and Drug Administration safety communications offer updated leiomyosarcoma incidence estimates. Incorporating these studies suggests that mortality rates are low following hysterectomy for presumed benign fibroids overall, and a minimally invasive approach remains a safe option. Risk associated with morcellation, however, increases in women age >50 years due to increased leiomyosarcoma rates, an important finding for patient-centered discussions of treatment options for fibroids.

Venous Thromboembolism in Minimally Invasive Compared With Open Hysterectomy for Endometrial Cancer.

OBJECTIVE: To evaluate whether minimally invasive surgery for endometrial cancer is independently associated with a decreased odds of venous thromboembolism compared with open surgery. METHODS: We performed a secondary analysis cohort study of prospectively collected quality improvement data and examined patients undergoing hysterectomy for endometrial cancer from 2008 to 2013 recorded in the National Surgical Quality Improvement Program database. Patients undergoing minimally invasive (laparoscopic or robotic) surgery were compared with those undergoing open surgery with respect to 30-day postoperative venous thromboembolism. Demographic and procedure variables were examined as potential confounders. Data regarding receipt of perioperative venous thromboembolism prophylaxis were not available. Bivariable tests and logistic regression were used for analysis. RESULTS: Of 9,948 patients who underwent hysterectomy for the treatment of endometrial cancer, 61.9% underwent minimally invasive surgery and 38.1% underwent open surgery. Patients undergoing minimally invasive surgery had a lower venous thromboembolism incidence (0.7%, n=47) than patients undergoing open surgery (2.2%, n=80) (P<.001). In a multivariate model adjusting for age, body mass index, race, operative time, Charlson comorbidity score, and surgical complexity, minimally invasive surgery remained associated with decreased odds of venous thromboembolism (adjusted odds ratio 0.36, 95% confidence interval 0.24-0.53) compared with open surgery. CONCLUSION: Minimally invasive surgery for the treatment of endometrial cancer is independently associated with decreased odds of venous thromboembolism compared with open surgery.

The limited utility of currently available venous thromboembolism risk assessment tools in gynecological oncology patients.

BACKGROUND: Use of risk assessment tools, such as the Caprini score or Rogers score, is recommended by national societies to stratify surgical patients by venous thromboembolism risk and guide prophylaxis. However, these tools were not developed in a gynecological oncology patient population, and their utility in this population is unknown. OBJECTIVE: The objective of the study was to examine the ability of both the Caprini and Rogers scores to stratify gynecological oncology patients by the risk of venous thromboembolism. STUDY DESIGN: Patients undergoing surgery for cervical, ovarian, uterine, vaginal, and vulvar cancers between 2008 and 2013 were identified from the National Surgical Quality Improvement Program Database using International Classification of Diseases, ninth revision, codes. The Caprini and Rogers scores were calculated for each patient based on the recorded demographic and procedure data. Venous thromboembolism events were recorded for 30 days postoperatively. Patients were categorized into risk groups based on the calculated Caprini and Rogers scores and the incidence of venous thromboembolism, and the 95% confidence interval was estimated for each of these groups. The relationship between the risk score and venous thromboembolism incidence was examined with Pearson's correlation coefficient. RESULTS: Of 17,713 patients, 1.8% developed a venous thromboembolism. No patients were classified by the Caprini score as low risk, 0.1% were moderate risk, 3.0% were higher risk (score 4), and 96.9% were highest risk (score ≥5). The Caprini score groupings did not correlate with venous thromboembolism. The high-risk group had a paradoxically higher incidence of venous thromboembolism of 2.5% compared with the highest-risk group, 1.7% (P = .40). However, when the highest-risk group of the Caprini score was substratified, it was highly correlated with venous thromboembolism (R(2) = 0.93). For the Rogers score, only 0.2% of patients were low risk (score <7), 36.9% were medium risk (score 7-10), and 63.0% were high risk (score >10). When the highest risk group of the Rogers score was substratified, it was also highly correlated with venous thromboembolism (R(2) = 0.99). CONCLUSION: Gynecological oncology patients score very high on current venous thromboembolism risk assessment models. The Caprini score is limited in its ability to discriminate relative venous thromboembolism risk among gynecological oncology patients because 97% are in the highest-risk category. Substratification of the highest-risk groups allows for relative venous thromboembolism risk stratification among gynecological oncology patients, suggesting that further evaluation of risk stratification is needed in gynecological oncology surgery.

Technetium Tc 99m sulfur colloid phenotypic probe for the pharmacokinetics and pharmacodynamics of PEGylated liposomal doxorubicin in women with ovarian cancer.

PURPOSE: Significant variability in the pharmacokinetics and pharmacodynamics of PEGylated liposomal doxorubicin (PLD) exists. PLD undergoes clearance via the mononuclear phagocyte system (MPS). Technetium Tc 99m sulfur colloid (TSC) is approved for imaging MPS cells. We investigated TSC as a phenotypic probe of PLD pharmacokinetics and pharmacodynamics in women with epithelial ovarian cancer. METHODS: TSC 10 mCi IVP was administered and followed by dynamic planar and SPECT/CT imaging and blood pharmacokinetics sampling. PLD 30-40 mg/m(2) IV was administered with or without carboplatin, followed by plasma pharmacokinetics sampling. RESULTS: There was a linear relationship between TSC clearance and encapsulated doxorubicin clearance (R(2) = 0.61, p = 0.02), particularly in patients receiving PLD alone (R(2) = 0.81, p = 0.04). There was a positive relationship (ρ = 0.81, p = 0.01) between maximum grade palmar-plantar erythrodysesthesia toxicity developed and estimated encapsulated doxorubicin concentration in hands. CONCLUSIONS: TSC is a phenotypic probe for PLD pharmacokinetics and pharmacodynamics and may be used to individualize PLD therapy in ovarian cancer and for other nanoparticles in development.

Cost-Effectiveness of Laparoscopic Hysterectomy With Morcellation Compared With Abdominal Hysterectomy for Presumed Myomas.

STUDY OBJECTIVE: Hysterectomy for presumed leiomyomata is 1 of the most common surgical procedures performed in nonpregnant women in the United States. Laparoscopic hysterectomy (LH) with morcellation is an appealing alternative to abdominal hysterectomy (AH) but may result in dissemination of malignant cells and worse outcomes in the setting of an occult leiomyosarcoma (LMS). We sought to evaluate the cost-effectiveness of LH versus AH. DESIGN: Decision-analytic model of 100 000 women in the United States assessing the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained (Canadian Task Force classification III). SETTING: U.S. hospitals. PATIENTS: Adult premenopausal women undergoing LH or AH for presumed benign leiomyomata. INTERVENTIONS: We developed a decision-analytic model from a provider perspective across 5 years, comparing the cost-effectiveness of LH to AH in terms of dollar (2014 US dollars) per QALY gained. The model included average total direct medical costs and utilities associated with the procedures, complications, and clinical outcomes. Baseline estimates and ranges for cost and probability data were drawn from the existing literature. MEASUREMENTS AND MAIN RESULTS: Estimated overall deaths were lower in LH versus AH (98 vs 103). Death due to LMS was more common in LH versus AH (86 vs 71). Base-case assumptions estimated that average per person costs were lower in LH versus AH, with a savings of $2193 ($24 181 vs $26 374). Over 5 years, women in the LH group experienced 4.99 QALY versus women in the AH group with 4.91 QALY (incremental gain of .085 QALYs). LH dominated AH in base-case estimates: LH was both less expensive and yielded greater QALY gains. The ICER was sensitive to operative costs for LH and AH. Varying operative costs of AH yielded an ICER of $87 651/QALY gained (minimum) to AH being dominated (maximum). Probabilistic sensitivity analyses, in which all input parameters and costs were varied simultaneously, demonstrated a relatively robust model. The AH approach was dominated 68.9% of the time; 17.4% of simulations fell above the willingness-to-pay threshold of $50 000/QALY gained. CONCLUSION: When considering total direct hospital costs, complications, and morbidity, LH was less costly and yielded more QALYs gained versus AH. Driven by the rarity of occult LMS and the reduced incidence of intra- and postoperative complications, LH with morcellation may be a more cost-effective and less invasive alternative to AH and should remain an option for women needing hysterectomy for leiomyomata.

U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?

The U.S. Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of leiomyomas because of the concern for inadvertent spread of tumor cells if an undiagnosed cancer were present. The authors, representing a 45-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to asses reliable data regarding patient survival after morcellation. The authors disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery.

Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis.

OBJECTIVE: The purpose of this study was to model outcomes in laparoscopic hysterectomy with morcellation compared with abdominal hysterectomy for the presumed fibroid uterus and to examine short- and long-term complications and death. STUDY DESIGN: A decision tree was constructed to compare outcomes for a hypothetical cohort of 100,000 premenopausal women who underwent hysterectomy for presumed fibroid tumors over a 5-year time horizon. Parameter and quality-of-life utility estimates were determined from published literature for postoperative complications, leiomyosarcoma incidence, death related to leiomyosarcoma, and procedure-related death. RESULTS: The decision-tree analysis predicted fewer overall deaths with laparoscopic hysterectomy compared with abdominal hysterectomy (98 vs 103 per 100,000). Although there were more deaths from leiomyosarcoma after laparoscopic hysterectomy (86 vs 71 per 100,000), there were more hysterectomy-related deaths with abdominal hysterectomy (32 vs 12 per 100,000). The laparoscopic group had lower rates of transfusion (2400 vs 4700 per 100,000), wound infection (1500 vs 6300 per 100,000), venous thromboembolism (690 vs 840 per 100,000) and incisional hernia (710 vs 8800 per 100,000), but a higher rate of vaginal cuff dehiscence (640 vs 290 per 100,000). Laparoscopic hysterectomy resulted in more quality-adjusted life years (499,171 vs 490,711 over 5 years). CONCLUSION: The risk of leiomyosarcoma morcellation is balanced by procedure-related complications that are associated with laparotomy, including death. This analysis provides patients and surgeons with estimates of risk and benefit on which patient-centered decisions can be made.

Obesity is associated with worse quality of life in women with gynecologic malignancies: an opportunity to improve patient-centered outcomes.

BACKGROUND: The objective of the current study was to evaluate the effect of obesity on pretreatment quality of life (QoL) in gynecologic oncology patients. METHODS: The authors analyzed collected data from an institution-wide cohort study of women with gynecologic cancers enrolled from August 2012 to June 2013. The Functional Assessment of Cancer Therapy-General, site-specific symptom scales, and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) global mental and physical health tools were administered. Survey results were linked to clinical data abstracted from medical records (demographics and comorbid conditions). Bivariate tests and multivariate linear regression models were used to evaluate factors associated with QoL scores. RESULTS: A total of 182 women with ovarian, uterine, cervical, and vulvar/vaginal cancers were identified; of these, 152 (84%) were assessed before surgery. Mean body mass index was 33.5 kg/m(2) and race included white (120 patients [79%]), black (22 patients [15%]), and other (10 patients [6.5%]). A total of 98 patients (64.5%) were obese (body mass index ≥30). On multivariate analysis, subscales for functional (17 vs 19; P = .04), emotional (16 vs 19; P = .008), and social (22 vs 24; P = .02) well-being as well as overall Functional Assessment of Cancer Therapy-General scores (77 vs 86; P = .002) and Patient-Reported Outcomes Measurement Information System global physical health scores (45 vs 49; P = .003) were found to be significantly lower in obese versus nonobese patients. CONCLUSIONS: Before cancer treatment, obese patients with gynecologic malignancies appear to have worse baseline QoL than their normal-weight counterparts. Emerging models of QoL-based cancer outcome measures may disproportionately affect populations with a high obesity burden. The potential disparate impact of cancer therapy on longitudinal QoL in the obese versus nonobese patients needs to be evaluated.

Uterine morcellation at the time of hysterectomy: techniques, risks, and recommendations.

IMPORTANCE: Uterine leiomyomata or fibroids are the most common pelvic tumor experienced in women. A minimally invasive approach to hysterectomy has proven benefits of cosmesis, lower blood loss, less pain, decreased hospital stay, and faster recovery. The incidence of uterine morcellation, the process of making a uterine specimen smaller for purposes of removal via a minimally invasive approach, has increased for this reason. OBJECTIVE: We review the history, techniques, and direct and indirect risks described in the literature, recommendations for appropriate use, and how to counsel patients regarding this procedure. EVIDENCE ACQUISITION: A thorough search of PubMed for all current literature was performed. Techniques for morcellation were reviewed. We included studies that addressed the type and incidence of morcellator-associated risks including those addressing the incidence of leiomyosarcoma in patients with presumed uterine fibroids. RESULTS: We have summarized several techniques to aid the practitioner in performing morcellation procedures and the risks involved. We have summarized all of the current consensus statements regarding the recommendations for use of morcellation and the approach to proper counseling. CONCLUSIONS AND RELEVANCE: Morcellation is an effective method of specimen removal that can decrease the need for laparotomy in both benign and malignant conditions. Upon analysis of current data and consensus statements, when possible, morcellation should be performed within a contained environment to minimize any potential tumor spread in the event of an undiagnosed malignancy. Patients should be adequately counseled to make an informed decision regarding undergoing a morcellation procedure. Future methods for enclosed specimen extraction will hopefully change the future of morcellation.

Translational studies of phenotypic probes for the mononuclear phagocyte system and liposomal pharmacology.

As nanoparticles (NPs) are cleared via phagocytes of the mononuclear phagocyte system (MPS), we hypothesized that the function of circulating monocytes and dendritic cells (MO/DC) in blood can predict NP clearance (CL). We measured MO/DC phagocytosis and reactive oxygen species (ROS) production in mice, rats, dogs, and patients with refractory solid tumors. Pharmacokinetic studies of polyethylene glycol (PEG)-encapsulated liposomal doxorubicin (PEGylated liposomal doxirubicin [PLD]), CKD-602 (S-CKD602), and cisplatin (SPI-077) were performed at the maximum tolerated dose. MO/DC function was also evaluated in patients with recurrent epithelial ovarian cancer (EOC) administered PLD. Across species, a positive association was observed between cell function and CL of PEGylated liposomes. In patients with EOC, associations were observed between PLD CL and phagocytosis (R(2) = 0.43, P = 0.04) and ROS production (R(2) = 0.61, P = 0.008) in blood MO/DC. These findings suggest that probes of MPS function may help predict PEGylated liposome CL across species and PLD CL in patients with EOC.

Complications of hysterectomy.

Hysterectomy is the most common gynecologic procedure performed in the United States, with more than 600,000 procedures performed each year. Complications of hysterectomy vary based on route of surgery and surgical technique. The objective of this article is to review risk factors associated with specific types of complications associated with benign hysterectomy, methods to prevent and recognize complications, and appropriate management of complications. The most common complications of hysterectomy can be categorized as infectious, venous thromboembolic, genitourinary (GU) and gastrointestinal (GI) tract injury, bleeding, nerve injury, and vaginal cuff dehiscence. Infectious complications after hysterectomy are most common, ranging from 10.5% for abdominal hysterectomy to 13.0% for vaginal hysterectomy and 9.0% for laparoscopic hysterectomy. Venous thromboembolism is less common, ranging from a clinical diagnosis rate of 1% to events detected by more sensitive laboratory methods of up to 12%. Injury to the GU tract is estimated to occur at a rate of 1-2% for all major gynecologic surgeries, with 75% of these injuries occurring during hysterectomy. Injury to the GI tract after hysterectomy is less common, with a range of 0.1-1%. Bleeding complications after hysterectomy also are rare, with a median range of estimated blood loss of 238-660.5 mL for abdominal hysterectomy, 156-568 mL for laparoscopic hysterectomy, and 215-287 mL for vaginal hysterectomy, with transfusion only being more likely after laparoscopic compared to vaginal hysterectomy (odds ratio 2.07, confidence interval 1.12-3.81). Neuropathy after hysterectomy is a rare but significant event, with a rate of 0.2-2% after major pelvic surgery. Vaginal cuff dehiscence is estimated at a rate of 0.39%, and it is more common after total laparoscopic hysterectomy (1.35%) compared with laparoscopic-assisted vaginal hysterectomy (0.28%), total abdominal hysterectomy (0.15%), and total vaginal hysterectomy (0.08%). With an emphasis on optimizing surgical technique, recognition of surgical complications, and timely management, we aim to minimize risk for women undergoing hysterectomy.