Short- and long-term outcomes for single-port risk-reducing salpingo-oophorectomy with and without hysterectomy for women at risk for gynecologic cancer.

INTRODUCTION: Risk-reducing salpingo-oophorectomy has been established as one of the most effective strategies in risk reduction for ovarian and breast cancers among women at increased genetic risk. However, there are limited data regarding the single-port laparoscopic platform in the field of risk-reducing surgery. Our objective was to describe outcomes after single-port risk-reducing salpingo-oophorectomy with or without hysterectomy for reduction of ovarian, breast, or endometrial cancer risk. METHODS: A retrospective, single institution (Canadian Task Force Classification II.2) analysis was performed in women at high genetic or familial risk for ovarian/tubal/primary peritoneal cancer or with personal history of breast cancer who underwent single-port laparoscopic risk-reducing salpingo-oophorectomy with or without hysterectomy between October 2009 and December 2015. Data were collected on patient demographics, surgical procedure and characteristics, intra-operative findings, and post-operative outcomes. RESULTS: In total, 187 single-port laparoscopic surgeries were performed with a median follow-up of 204 (IQR 25-749) days. BRCA1/2, Lynch syndrome, or Cowden syndrome was diagnosed in 64.0% of patients. Additionally, 32.1% had a personal history of breast cancer, and 3.2% reported strong family history of ovarian and/or breast cancer. Single-port risk-reducing salpingo-oophorectomy with hysterectomy was performed in 53.5% of patients. The rate of adverse outcomes, including conversion to multiport laparoscopy or laparotomy (1.6%), intra-operative injury (1.6%), deep vein thrombosis (0.5%), urinary tract infection (2.7%), and/or incisional cellulitis (4.3%) were low. Three patients (1.6%) were diagnosed with malignancy on final pathology. All three patients were BRCA1-positive and their CA125 values were significantly lower than those without malignancy (p=<0.0001). CONCLUSIONS: Single-port laparoscopy is a safe option for patients undergoing risk-reducing salpingo-oophorectomy with or without hysterectomy. Standardized pre-operative evaluation criteria are needed to determine absolute risk of incidental malignancy, and the risk of identifying a malignancy should be reiterated to patients during pre-operative counseling.

Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial.

BACKGROUND: Accurate identification of sentinel lymph nodes in patients with cancer improves detection of metastatic disease and decreases surgical morbidity. We sought to establish whether indocyanine green fluorescent dye is non-inferior to isosulfan blue dye in detecting sentinel lymph nodes in women with cervical and uterine cancers. METHODS: In this non-inferiority, within-patient comparison study, patients aged 18 years or older with clinical stage I endometrial or cervical cancer undergoing curative surgery were randomly assigned 1:1 to lymphatic mapping with isosulfan blue dye (visualised by white light) followed by indocyanine green (visualised by near-infrared imaging), or indocyanine green followed by isosulfan blue dye. Permuted block randomisation with stratification by study site was done with a computerised random number generator. All participants were masked to their randomisation assignment until after the procedure; however, investigators were not masked to the procedure used. Laparoscopic surgery with the PINPOINT near-infrared fluorescence imaging system (Stryker, Kalamazoo, MI, USA) was used in all cases. The primary outcome was efficacy of intraoperative indocyanine green with near-infrared fluorescence imaging versus that of isosulfan blue dye in the identification of lymph nodes, defined as the number of lymph nodes identified by indocyanine green and isosulfan blue dye, respectively (and confirmed as lymphoid tissue by histology), divided by the number of lymph nodes identified intraoperatively and excised. The study had a 5% non-inferiority margin needed to show non-inferiority of the frequency of lymph node detection with indocyanine green to that with isosulfan blue dye with 80% power at a 5% two-sided significance level. Analyses were done in both per-protocol and modified intention-to-treat populations. The trial was registered with ClinicalTrials.gov, number NCT02209532, and is completed and closed. FINDINGS: Between Dec 21, 2015, and June 19, 2017, 180 patients were enrolled and randomly assigned to the two groups (90 to each group); 176 patients received the intervention and were evaluable (modified intention-to-treat population). 13 patients with major protocol violations were subsequently excluded from the per-protocol population. 517 sentinel nodes were identified in the per-protocol population (n=163), of which 478 (92%) were confirmed to be lymph nodes on pathological processing: 219 (92%) of 238 nodes that were both blue and green, all seven nodes that were blue only, and 252 (95%) of 265 nodes that were green only (p=0·33). Seven sentinel lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. In total, 471 (97%) of 485 lymph nodes were identified with the green dye and 226 (47%) with the blue dye (difference 50%, 95% CI 39-62; p<0·0001). In the modified intention-to-treat population (n=176), 545 nodes were identified, of which 513 (94%) were confirmed to be lymph nodes on pathological processing: 229 (92%) of 248 nodes that were both blue and green, all nine nodes that were blue only, and 266 (95%) of 279 nodes that were green only (p=0·30). Nine sentinal lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. 495 (96%) of 513 nodes were identified with the green dye and 238 (46%) with the blue dye (50%, 39-61; p<0·0001). INTERPRETATION: Indocyanine green dye with near-infrared fluorescence imaging identified more sentinel nodes than isosulfan blue dye in women with cervical and uterine cancers, with no difference in the pathological confirmation of nodal tissue between the two mapping substances. FUNDING: Novadaq.

Single-port laparoscopy in gynecologic oncology: seven years of experience at a single institution.

BACKGROUND: Single-port laparoscopy has gained popularity within minimally invasive gynecologic surgery for its feasibility, cosmetic outcomes, and safety. However, within gynecologic oncology, there are limited data regarding short-term adverse outcomes and long-term hernia risk in patients undergoing single-port laparoscopic surgery. OBJECTIVE: The objective of the study was to describe short-term outcomes and hernia rates in patients after single-port laparoscopy in a gynecologic oncology practice. STUDY DESIGN: A retrospective, single-institution study was performed for patients who underwent single-port laparoscopy from 2009 to 2015. A univariate analysis was performed with χ2 tests and Student t tests; Kaplan-Meier and Cox proportional hazards determined time to hernia development. RESULTS: A total of 898 patients underwent 908 surgeries with a median follow-up of 37.2 months. The mean age and body mass index were 55.7 years and 29.6 kg/m2, respectively. The majority were white (87.9%) and American Society of Anesthesiologists class II/III (95.5%). The majority of patients underwent surgery for adnexal masses (36.9%) and endometrial hyperplasia/cancer (37.3%). Most women underwent hysterectomy (62.7%) and removal of 1 or both fallopian tubes and/or ovaries (86%). Rate of adverse outcomes within 30 days, including reoperation (0.1%), intraoperative injury (1.4%), intensive care unit admission (0.4%), venous thromboembolism (0.3%), and blood transfusion, were low (0.8%). The rate of urinary tract infection was 2.8%; higher body mass index (P = .02), longer operative time (P = .02), smoking (P = .01), hysterectomy (P = .01), and cystoscopy (P = .02) increased the risk. The rate of incisional cellulitis was 3.5%. Increased estimated blood loss (P = .03) and endometrial cancer (P = .02) were independent predictors of incisional cellulitis. The rate for surgical readmissions was 3.4%; higher estimated blood loss (P = .03), longer operative time (P = .02), chemotherapy alone (P = .03), and combined chemotherapy and radiation (P < .05) increased risk. The rate of incisional hernia rate was 5.5% (n = 50) with a mean occurrence at 570.2 ± 553.3 days. Higher American Society of Anesthesiologists class (P = .04), diabetes (P < .001), hypertension (P = .043), increasing age (P = .017; hazard ratio [HR], 1.03), and body mass index (P < .001; HR, 1.08) were independent predictors for incisional hernia development. Previous abdominal surgeries (P = .24) and hand assist (P = .64) were not associated with increased risk for incisional hernia. Patients with American Society of Anesthesiologists class III/IV had a 3 year hernia rate of 12.8% (HR, 1.81). Patients with diabetes mellitus had a 3 year hernia rate of 23.0% (HR, 3.60). CONCLUSION: In this large cohort of patients undergoing single-port laparoscopy, the incidence of short-term adverse outcomes is low. While the rate of incisional hernia was 5.5%, incidence reached 23.0% at 3 years in high-risk groups. Previous studies with short follow-up duration may underestimate the risk of hernia, especially in patients with significant comorbidities.

Utility of indocyanine green (ICG) intra-operative angiography to determine uterine vascular perfusion at the time of radical trachelectomy.

OBJECTIVES: The aim of our study was to measure and analyze uterine perfusion utilizing laser angiography with ICG during uterine artery sparing and non-sparing radical trachelectomy. METHODS: Data were collected from all patients diagnosed with early-stage cervical cancer that underwent laser angiography with ICG during open or laparoscopic radical trachelectomy from June 2012 to December 2015. Regression analysis was use to determine the p values and R-squares on fluorescence, surgical time, hospital stay, age and BMI; a p-value<0.05 was considered statistically significant. RESULTS: A total of 20 patients met the inclusion criteria and were included in this study. Ten patients underwent uterine artery-sparing surgery, and ten patients underwent uterine artery non-sparing surgery. The most frequent stage for the entire cohort was IA2 (55%), and the most common histologic subtype was squamous cell carcinoma (49%). Lymph-vascular invasion was noted in 30% of the patients. There was no statistical significance difference in the mean ICG fundal fluorescence intensity between the uterine artery-sparing group 162.5 (range, 137-188) and the uterine artery non-sparing group 160.5 (range, 135-186), p=0.22. In both groups, 100% of the patients regained their menstrual function by postoperative week 8. A total of 4 (40%) pregnancies have occurred in the uterine artery-sparing group and 3 (30%) in the non-uterine artery-sparing group. CONCLUSIONS: Based on our real-time intraoperative angiography observations, there is no need to preserve the uterine artery during radical trachelectomy to maintain uterine viability.

Role of Indocyanine Green in Sentinel Node Mapping in Gynecologic Cancer: Is Fluorescence Imaging the New Standard?

Sentinel lymph node biopsy has proven safe and feasible in a number of gynecologic cancers such as vulvar cancer, cervical cancer, and endometrial cancer. The proposed aim of lymphatic mapping and sentinel node identification is to decrease the associated morbidity of a complete lymphadenectomy, particularly the rate of lymphedema, while also increasing the detection of small tumor deposits in the node. Different tracers have been shown to be useful, including technetium-99 and blue dye, with a detection reported in 66% to 86%. Recently, there has been increasing interest in the use of fluorescent dies such as indocyanine green (ICG). In this report we provide a review of the existing literature regarding the use of ICG in cervical or endometrial cancer with the goal to provide details on its utility and compare it with other tracers.

A phase II trial of paclitaxel, carboplatin, and bevacizumab in advanced and recurrent endometrial carcinoma (EMCA).

OBJECTIVE: To evaluate the effect of adding bevacizumab to adjuvant paclitaxel and carboplatin and as maintenance on progression-free survival (PFS) in advanced or recurrent endometrial carcinoma (EMCA). METHODS: A phase II trial was conducted in patients with measurable disease. Paclitaxel (175mg/m(2)/3h), carboplatin (AUC 5) and bevacizumab (15mg/kg) were administered q 21 days. Patients with a complete response after 6-8cycles received maintenance therapy with bevacizumab 15mg/kg q 21 days for 16cycles. Based on GOG 177 which had a 6-month PFS rate of 59%, an increase in 6-month PFS to 72% with the treatment regimen was considered of clinical interest. RESULTS: 15 patients were enrolled on protocol when accrual to the study was discontinued due to the initiation of a national randomized phase II trial. A total of 127 courses (median 8, range 1-20) of carboplatin, paclitaxel, and bevacizumab combination therapy were administered. One patient suffered a bowel perforation after her first course of therapy and was inevaluable for response. Fourteen of the 15 patients (93%, 95% CI: 82-100) were progression free at 6months. The median follow-up was 36months (7-58+). The median PFS was 18months (CI: 11-25). Five complete responses and 6 partial responses were seen for an overall response rate of 73% (CI: 45-91). The median overall survival was 58months (CI: 48-68). CONCLUSIONS: The bevacizumab, paclitaxel, and carboplatin regimen is active and tolerable in advanced and recurrent EMCA. Its impact awaits results of the recently completed randomized phase II trial.

Radical trachelectomy in early-stage cervical cancer: A comparison of laparotomy and minimally invasive surgery.

OBJECTIVES: Radical trachelectomy is considered standard of care in patients with early-stage cervical cancer interested in future fertility. The goal of this study was to compare operative, oncologic, and fertility outcomes in patients with early-stage cervical cancer undergoing open vs. minimally invasive radical trachelectomy. METHODS: A retrospective review was performed of patients from four institutions who underwent radical trachelectomy for early-stage cervical cancer from June 2002 to July 2013. Perioperative, oncologic, and fertility outcomes were compared between patients undergoing open vs. minimally invasive surgery. RESULTS: A total of 100 patients were included in the analysis. Fifty-eight patients underwent open radical trachelectomy and 42 patients underwent minimally invasive surgery (MIS=laparoscopic or robotic). There were no differences in patient age, body mass index, race, histology, lymph vascular space invasion, or stage between the two groups. The median surgical time for MIS was 272min [range, 130-441min] compared with 270min [range, 150-373min] for open surgery (p=0.78). Blood loss was significantly lower for MIS vs. laparotomy (50mL [range, 10-225mL] vs. 300mL [50-1100mL]) (p<0.0001). Nine patients required blood transfusion, all in the open surgery group (p=0.010). Length of hospitalization was shorter for MIS than for laparotomy (1day [1-3 days] vs. 4days [1-9 days]) (p<0.0001). Three intraoperative complications occurred (3%): 1 bladder injury, and 1 fallopian tube injury requiring unilateral salpingectomy in the MIS group and 1 vascular injury in the open surgery group. The median lymph node count was 17 (range, 5-47) for MIS vs. 22 (range, 7-48) for open surgery (p=0.03). There were no differences in the rate of postoperative complications (30% MIS vs. 31% open surgery). Among 83 patients who preserved their fertility (33 MIS vs. 50 open surgery), 34 (41%) patients attempted to get pregnant. Sixteen (47%) patients were able to do so (MIS: 2 vs. laparotomy: 14, p=0.01). The pregnancy rate was higher in the open surgery group when compared to the MIS group (51% vs. 28%, p=0.018). However, median follow-up was shorter is the MIS group compared with the open surgery group (25months [range, 10-69] vs. 66months [range, 11-147]). To date, there has been one recurrence in the laparotomy group and none in the MIS group. CONCLUSIONS: Our results suggest that radical trachelectomy via MIS results in less blood loss and a shorter hospital stay. Fertility rates appear higher in patients undergoing open radical trachelectomy.

Laparoendoscopic single-site surgery for benign ovarian cystectomies.

BACKGROUND: Single-port laparoscopy (LESS) utilizes a single, multichannel port in an attempt to decrease postoperative pain, while enhancing cosmesis and minimizing the potential risks and morbidities associated with the multiple ports used in conventional laparoscopy. METHODS: We performed a retrospective study examining three tertiary care referral centers. From September 2009 until March 2013, 31 patients with ovarian cystic lesions were treated using the LESS technique. A control group of 57 patients who underwent conventional laparoscopic ovarian cystectomy was included for comparison. RESULTS: All patients underwent a technically successful cystectomy. There were no statistically significant differences in the mean operative time or estimated blood loss between the two groups. Narcotic use during the recovery period was reported in less patients in the LESS group than in the laparoscopic group (p = 0.05). CONCLUSIONS: The LESS technique can be used to safely perform cystectomies on women with benign ovarian cysts. Additional investigation is needed to evaluate the safety, cost-effectiveness and long-term outcomes of this new approach.

Small cell carcinoma of the uterine cervix: a case report and literature review.

Small cell carcinoma of the uterine cervix is a rare and aggressive extra-pulmonary variant of small cell tumors. This carcinoma of the cervix comprises less than 5% of all cervical carcinomas and is know to be highly undifferentiated. It is associated with a poor prognosis and characterized by premature distant nodal involvement. The survival rate at all stages ranges from 17% to 67%. We describe the case of a 41 year old female patient with a rare, and aggressive, clinical stage IB1 small cell neuroendocrine carcinoma of the cervix. The goal of this case report is to describe this rare pathology and contribute information to the scant available data.

Feasibility and perioperative outcomes of robotic-assisted surgery in the management of recurrent ovarian cancer: a multi-institutional study.

OBJECTIVES: Minimally invasive surgery for recurrent ovarian cancer is generally not performed. The aim of this study was to assess the feasibility and surgical outcomes of robotic-assisted surgery in the management of recurrent ovarian cancer. METHODS: Eligible patients included those with confirmed recurrent ovarian cancer amenable to surgical resection and in which a complete resection was thought to be feasible with the use of the robotic platform. Patients with evidence of carcinomatosis were not considered for a robotic approach. Clinical and pathologic data were abstracted from the medical records. Appropriate statistical tests were performed using SPSS statistical software program (SPSS 20.0 Inc., Chicago, IL). RESULTS: A total of 48 patients were identified. Thirty-six (75%) patients had a recurrent mass or masses isolated to one anatomic region (pelvis or abdomen). Conversion to laparotomy was necessary in 4 (8.3%) cases. In cases not requiring conversion to laparotomy, the median operative time, EBL, and length of stay were 179.5 min, 50 cc, and 1 day, respectively. An optimal debulking was achieved in 36 (82%) cases. Complications occurred in 6 (13.6%) cases. The median operative time, EBL, length of stay, and complications were all statistically significantly lower in the cases not converted to laparotomy compared to those that were (p<0.001). CONCLUSIONS: This study suggests that select patients with recurrent ovarian cancer in the absence of carcinomatosis may be candidates for secondary surgical cytoreduction via a robotic approach. Surgical and postoperative outcomes appear to be favorable compared to reports of laparotomy in recurrent ovarian cancer.

Laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy: initial multi-institutional experience for treatment of invasive cervical cancer.

STUDY OBJECTIVE: To describe the feasibility, safety, and outcomes of women with stage I cervical cancer treated with laparoendoscopic single-site surgery radical hysterectomy (LESS-RH). DESIGN: A retrospective descriptive study (Canadian Task Force classification III). SETTING: Multiple academic teaching hospitals. PATIENTS: Women with Fédération Internationale de Gynécologie et d'Obstétrique FIGO stage IA1 to IB1 cervical cancer. INTERVENTIONS: LESS-RH as the primary therapy for cervical cancer performed by a gynecologic oncologist with expertise in LESS. A multichannel, single-port access device; a flexible-tipped 5-mm laparoscope; and a multifunctional instrument were used in all cases. Clinicopathologic, surgical, and perioperative outcomes were analyzed. MEASUREMENTS AND MAIN RESULTS: Twenty-two women were identified in whom a LESS-RH was attempted; 20 (91%) successfully underwent the procedure, including 19 in whom pelvic lymphadenectomy (PLND) was completed. Of the 2 converted procedures, 1 patient underwent 2-port laparoscopy secondary to truncal obesity, and 1 patient underwent conversion to laparotomy secondary to external iliac vein laceration during PLND. The median age and body mass index were 46 years and 23.3 kg/m(2), respectively. The median number of pelvic lymph nodes removed was 22. One patient experienced an intraoperative complication, and no patient required reoperation. The margins of excision were negative. One patient with 2 positive pelvic nodes and 1 patient with microscopic parametrial disease received adjuvant chemosensitized radiation; 3 additional patients received adjuvant radiation therapy secondary to an intermediate risk for recurrence. After a median follow up of 11 months, no recurrences were detected. CONCLUSION: LESS-RH/PLND is feasible and safe for select patients with stage I cervical cancer. Larger studies are needed to confirm whether the increased technical difficulty of this procedure justifies its use in routine gynecologic oncology practice.

Cost and robotic surgery in gynecology.

Since the introduction of robotic technology, there have been significant changes to the field of gynecology. The number of minimally invasive procedures has drastically increased, with robotic procedures rising remarkably. To date several authors have published cost analyses demonstrating that robotic hysterectomy for benign and oncologic indications is more costly compared to the laparoscopic approach. Despite being more expensive than laparoscopy, other studies have found robotics to be less expensive and more effective than laparotomy. In this review, controversies surrounding cost-effectiveness studies are explored.

Feasibility and optimal dosage of indocyanine green fluorescence for sentinel lymph node detection using robotic single-site instrumentation: preclinical study.

The present study was performed to determine the optimal dosage of indocyanine green (ICG) to accurately differentiate the sentinel node from surrounding tissue and then to test this dosage using novel single-port robotic instrumentation. The study was performed in healthy female pigs. After induction of anesthesia, all pigs underwent exploratory laparotomy, dissection of the bladder, and colpotomy to reveal the cervical os. With use of a 21-gauge needle, 0.5 mL normal saline solution was injected at the 3- and 9-o'clock positions as control. Four concentrations of ICG were constituted for doses of 1000, 500, 250, and 175 µg per 0.5 mL. ICG was then injected at the 3- and 9-o'clock positions on the cervix. The SPY camera was used to track ICG into the sentinel nodes and to quantify the intensity of light emitted. SPY technology uses an intensity scale of 1 to 256; this scale was used to determine the difference in intensity between the sentinel node and surrounding tissues. The optimal dosage was tested using single-port robotic instrumentation with the same injection techniques. A sentinel node was identified at all doses except 175 µg, at which ICG stayed in the cervix and vasculature only. For both the 500- and 250-µg doses, the sentinel node was identified before reaching maximum intensity. At maximum intensity, the difference between the surrounding tissue and the node was 207 (251 vs 44) for the 500-µg dose and 159 (251 vs 92) for the 250-µg dose. Sentinel lymph node (SLN) biopsy was successfully performed using single-port robotic technology with both the 250- and 500-µg doses. For SLN detection, the dose of ICG is related to the ability to differentiate the sentinel node from the surrounding tissue. An ICG dose of 250 to 500 µg enables identification of a SLN with more distinction from the surrounding tissues, and this procedure is feasible using single-port robotics instrumentation.

Is sentinel lymph node dissection an appropriate standard of care for low-stage endometrial cancers? A review of the literature.

BACKGROUND/AIMS: To review the literature and compare detection rates, false negative (FN) rates, and negative predictive values (NPVs) of sentinel lymph node (SLN) biopsy in endometrial cancer to those in breast and vulvar cancer. Secondary objectives were to evaluate techniques of SLN biopsy in endometrial cancer. METHODS: The PubMed database was searched for applicable scientific articles. Detection rates, FN rates, and NPVs were calculated for all studies. Studies were stratified by techniques and compared. RESULTS: Nineteen articles met criteria for this review. The overall detection rates ranged from 62 to 100%, the FN rate ranged from 0 to 50%, and the NPVs ranged from 95 to 100%. There is no technique that is definitively superior to any other with regard to surgical modality, injectant used, injection site, or pathologic techniques. CONCLUSIONS: Studies on SLN biopsy in endometrial cancer have a large range of detection rates and FN rates, and larger studies including more patients with metastatic disease are needed for comparison with breast and vulvar cancers. While no techniques are definitively superior to others, minimally invasive surgery, cervical injection, and pathologic analysis utilizing HE staining, immunohistochemistry, and ultrastaging may be clinically advantageous.

Comparison of single-port laparoscopy, standard laparoscopy, and robotic surgery in patients with endometrial cancer.

BACKGROUND: The aim of this study was to evaluate single-port laparoscopy (SPL) for the surgical treatment of presumed early-stage endometrial cancer and to compare surgical outcomes to laparoscopy and robotics. METHODS: A multi-institutional, matched retrospective cohort study was performed. All patients with clinical stage I or occult stage II endometrial cancer who underwent SPL hysterectomy, bilateral salpingo-oophorectomy +/- lymphadenectomy from April 2009 to September 2010 were identified. Outcomes were compared with patients matched by age, body mass index (BMI), tumor histology, and grade, who underwent laparoscopy or robotic surgery. Data was analyzed using Kruskal-Wallis 1-way analysis of variance and chi-square test for frequency data. A P value of <.05 was considered significant. RESULTS: A total of 90 matched patients (30 SPL, 30 LSC, and 30 robotic) were included in the study. There were no significant differences in median operating time or estimated blood loss between the 3 groups. The median number of pelvic lymph nodes obtained was significantly higher in the robotic (17.0 [8-36] and SPL group (16.0 [11-21]) compared with the laparoscopy group (13.0 [3-18]) P = .04. However, there was no significant difference in the median number of para-aortic nodes obtained between the 3 groups. There was no significant difference between the groups in length of hospital stay, comorbid conditions, complication rates, or operative times. CONCLUSIONS: Our findings suggest SPL surgery for endometrial carcinoma is feasible with similar operating times, hospital length of stay, complication rates, and estimated blood loss when compared with laparoscopy and robotics.

Primary radiation therapy for medically inoperable patients with clinical stage I and II endometrial carcinoma.

OBJECTIVE: To determine the outcomes associated with primary radiation therapy for medically inoperable, clinical stage I and II, endometrial adenocarcinoma (EAC). METHODS: A multi-institution, retrospective chart review from January 1997 to January 2009 was performed. Overall survival (OS), disease-specific survival (DSS), progression-free survival (PFS) and time to progression (TTP) were assessed using the Kaplan-Meier method. Disease-specific survival was analyzed using a competing risks approach. RESULTS: Seventy-four patients were evaluable. The median age and BMI were 65 years (range 36-92 years) and 46 kg/m(2) (range 23-111 kg/m(2)), respectively. 85.1% had severe systemic disease, most frequently cardiopulmonary risk and morbid obesity. With a mean follow-up of 31 months, 13 patients (17.6%) experienced a recurrence. The median PFS and OS were 43.5 months and 47.2 months, respectively. Overall, 35 women died, including 4 women who died of unknown cause. Of the remaining 31 women, 7 patients (9.5%) died of disease, while 24 died of other causes (32.4%). The hazard ratio comparing the risk of death due to other causes to the risk of death due to disease was 3.4 (95% CI 1.4-9.4, p=0.003). Among patients who are alive three years after diagnosis, 14% recurred and the conditional recurrence estimate did not exceed 16%. CONCLUSIONS: Primary radiation therapy for clinical stage I and II EAC is a feasible option for medically inoperable patients and provides disease control, with fewer than 16% of surviving patients experiencing recurrence.

Minimally invasive surgery versus laparotomy in women with high grade endometrial cancer: a multi-site study performed at high volume cancer centers.

OBJECTIVE: The study aim was to compare outcomes in women with high-grade endometrial cancer (EC) who underwent surgical staging via minimally invasive surgery (MIS) versus laparotomy. METHODS: This is a retrospective, multi-institutional cohort study of patients with high-grade EC who were comprehensively surgically staged by either MIS or laparotomy. Demographic, surgical variables, complications, and survival were analyzed. RESULTS: Three hundred and eighty-three patients met criteria: 191 underwent laparotomy and 192 MIS (65% robotic, 35% laparoscopy). Subgroups were well matched by age (mean 66 years), stage, body mass index, histology and adjuvant therapies. Median operative time was longer in the MIS group (191 vs. 135 min; p<.001). However, the MIS cohort had a higher mean lymph node count (39.0 vs. 34.0; p=.03), shorter hospital stay (1 vs. 4 days) and significantly fewer complications (8.4% vs. 31.3%; p<.001). There was no significant difference in lymph node count with laparoscopic versus robotic staging. With a median follow-up time of 44 months, progression-free (PFS) and overall survival were not significantly different between the surgical cohorts. On multivariable analysis, stage, treatment were associated with PFS. CONCLUSIONS: Women with high grade endometrial cancers staged by minimally invasive techniques experienced fewer complications and similar survival outcomes compared to those staged by laparotomy. As this population is elderly and most will receive adjuvant therapies, minimization of surgical morbidity is of interest. When managed by expert laparoscopists or robotic surgeons, a high-risk histologic subtype is not a contraindication to minimally invasive surgery in women with apparent early-stage disease.

First 100 early endometrial cancer cases treated with laparoendoscopic single-site surgery: a multicentric retrospective study.

OBJECTIVE: We sought to assess feasibility and perioperative outcomes for laparoendoscopic single-site surgery (LESS) in early endometrial cancer. STUDY DESIGN: This was a retrospective multicentric study of 100 early endometrial cancer cases undergoing LESS from July 2009 through July 2011. RESULTS: All patients underwent total hysterectomy and bilateral salpingo-oophorectomy by LESS. Pelvic and paraaortic lymphadenectomy were performed in 48 and 27 patients, respectively. A median of 16 pelvic lymph nodes (range, 1-33) and 7 paraaortic lymph nodes (range, 2-28) were retrieved. Both median operative time (129 minutes; range, 45-321) and estimated blood loss (70 mL; range, 10-500) were greater when staging lymphadenectomy was performed (P values = .001). Four intraoperative and 4 postoperative complications were observed. Conversion to standard laparoscopy and laparotomy was necessary for completion of 1 case each. Patients responded positively regarding cosmetic result and minimal postoperative pain control. CONCLUSION: LESS further minimizes the invasive nature of surgery and is feasible for treatment of early-stage endometrial cancer.

The risk of umbilical hernia and other complications with laparoendoscopic single-site surgery.

STUDY OBJECTIVE: To estimate the risk of umbilical hernia and other latent complications in women who underwent laparoendoscopic single-site surgery (LESS) for a gynecologic indication. DESIGN: Retrospective, nonrandomized clinical study (Canadian Task Force classification II-2). SETTING: Four tertiary care academic medical centers. PATIENTS: Women undergoing LESS for a benign or malignant gynecologic indication from 2009 to 2011. INTERVENTIONS: A total of 211 women underwent LESS via a single 1.5- to 2.0-cm umbilical incision. All surgeries were performed by advanced gynecologic laparoscopists. Incisions were repaired with a running, delayed absorbable suture. Subject demographics and clinical variables were collected and surgical outcomes analyzed. MEASUREMENTS AND MAIN RESULTS: Median age and body mass index were 45 years and 30 kg/m(2), respectively. Approximately half of study subjects underwent a hysterectomy with or without salpingo-oophorectomy, and 15% had a diagnosis of cancer. Overall, 0.9% of women were diagnosed with a preoperative umbilical hernia, and 2.4% of women experienced a major perioperative complication. After a median postoperative follow-up time of 16 months, 2.4% had development of an umbilical hernia. However, 4/5 of these women had significant risk factors for fascial weakening independent of LESS, including requirement for a second abdominal surgery in 1 subject and a cancer diagnosis with postoperative chemotherapy administration in 2 subjects. When these subjects deemed "high risk" for incisional disruption were excluded from the analysis, the umbilical hernia rate was 0.5% (1/207). On univariable analysis, obesity was the only factor associated with complications (p = .04). CONCLUSION: When performed by advanced laparoscopic surgeons, laparoendoscopic single-site gynecologic surgery is associated with a low risk of major adverse events. Additionally, the overall umbilical hernia rate was 2.4% and was lower (0.5%) in subjects without significant comorbidities.