Oncological outcomes of unexpected uterine leiomyosarcoma: A single-center retrospective analysis of 5528 consecutive hysterectomies.

BACKGROUND AND METHODS: Uterine leiomyosarcomas (uLMS) are rare malignant tumors, often incidentally discovered, with an estimated annual incidence of five cases per one million women in the United States. This study aimed to compare the oncological outcomes of two groups of patients: those with uLMS incidentally found during surgery and those who underwent surgery due to suspected or confirmed uLMS before the procedure. The study assessed patients who had undergone hysterectomy and were diagnosed with stage I uLMS at a tertiary gynecologic oncology referral center in Italy between January 2000 and December 2019. Data on patients' baseline characteristics, surgical procedures, and oncological outcomes were collected. The patients were classified into two groups based on whether uLMS was unexpectedly discovered or suspected before the surgery. Survival rates and factors influencing recurrence were analyzed. RESULTS: The study included 36 patients meeting the inclusion criteria, with 12 having preoperatively suspected or proven uLMS and 24 having incidentally discovered uLMS. No significant differences were observed between the two groups regarding disease-free survival (23.7 vs. 27.3 months, log rank = 0.28), disease-specific survival (median not reached, log rank = 0.78), or sites of relapse. Notably, among patients who underwent laparoscopic hysterectomy (compared to open surgery), a significantly higher rate of locoregional recurrence was found (78% vs. 33.3%, p = 0.04). Nevertheless, no significant differences in survival were observed based on the surgical approach. CONCLUSIONS: Preoperative suspicion for uLMS did not seem to impact survival outcomes or the pattern of recurrence. Furthermore, although patients who underwent laparoscopic hysterectomy showed a higher rate of locoregional relapse, this did not affect their overall survival.

Predicting the Risk of nOdal disease with histological and Molecular features in Endometrial cancer: the prospective PROME trial.

OBJECTIVE: To assess the role of histopathological and molecular features in predicting the risk of nodal metastases in apparent early-stage endometrial cancer patients undergoing sentinel node mapping. METHODS: This is a prospective trial. Consecutive patients with apparent early-stage endometrial cancer, undergoing laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and sentinel node mapping, were enrolled. Histological and molecular features were used to predict the node positivity. RESULTS: Charts of 223 apparent early-stage endometrial cancer patients were included in this study. Four (1.8%) patients were excluded from this study due to the lack of data about molecular features. Additionally, nine (4%) patients did not meet the inclusion criteria (due to the presence of peritoneal carcinomatosis or bulky nodes (the presence of p53 abnormality correlated with the presence of advanced stage disease (p<0.001)). The study population included 178 (84.8%) and 32 (15.2%) patients with endometrioid and non-endometrioid endometrial cancer, respectively. According to pathological uterine risk factors, 93 (44.3%), 45 (21.4%), 40 (19.1%), and 32 (15.2%) were classified as low, intermediate, intermediate-high, and high-risk, respectively. Using the surrogate molecular classification, 10 (4.8%), 42 (20%), 57 (27.1%), and 101 (48.1%) were included in the POLE mutated, p53 abnormal, MMRd/MSI-H, and NSMP, respectively. Overall, 41 (19.5%) patients were detected with positive nodes. Molecular features were not associated with the risk of having nodal metastases (OR 1.03, 95% CI 0.21 to 5.05, p=0.969 for POLE mutated; OR 0.788, 95% CI 0.32 to 1.98, p=0.602 for p53 abnormal; OR 1.14, 95% CI 0.53 to 2.42, p=0.733 for MMRd/MSI-H). At multivariable analysis, only deep myometrial invasion (OR 3.318, 95% CI 1.357 to 8.150, p=0.009) and lymphovascular space invasion (OR 6.584, 95% CI 2.663 to 16.279, p<0.001) correlated with the increased risk of positive nodes. CONCLUSION: Our data suggest that molecular classification does not seem useful to tailor the need of nodal dissection in apparent early-stage endometrial cancer. p53 abnormality predicts the risk of having advanced disease at presentation. Further external validation is needed. CLINICAL TRIAL REGISTRATION: NCT05793333.

Laparoscopic treatment of early-stage endometrial cancer: benefits of sentinel lymph node mapping and impact on lower extremity lymphedema.

OBJECTIVE: To evaluate the lymphatic-specific morbidity (specifically, lower extremity lymphedema) associated with laparoscopic management of early-stage endometrial cancer using the sentinel lymph node (SLN) algorithm by type of actual nodal assessment. METHODS: An ambispective study was conducted on consecutive patients surgically treated for apparent early-stage endometrial cancer who underwent laparoscopic staging according to the National Comprehensive Cancer Network SLN algorithm at a single institution from January 2020 to August 2023. Data on patient characteristics, surgical details, and post-operative complications were collected. Lymphedema screening was performed using a validated questionnaire. RESULTS: A total of 239 patients were analyzed, with a questionnaire response rate of 85.4%. The study population was grouped based on actual surgical staging: hysterectomy+SLN (54.8%), hysterectomy+systematic pelvic lymphadenectomy (27.2%), and hysterectomy only (18%). The prevalence of lymphedema was significantly lower in the hysterectomy+SLN group compared with the hysterectomy+systematic pelvic lymphadenectomy group (21.4% vs 44.6%, p=0.003). Multivariable analysis showed a threefold increase in the risk of lymphedema for the hysterectomy+systematic pelvic lymphadenectomy group compared with the hysterectomy+SLN group: OR 3.11 (95% CI 1.47 to 6.58). No significant associations were found between lymphedema and other patient or tumor characteristics. CONCLUSION: In the setting of a laparoscopic approach for early-stage endometrial cancer surgery, SLN mapping is associated with a significant reduction in lymphatic complications compared with a systematic lymph node dissection. Our findings provide additional evidence endorsing the adoption of SLN mapping during minimally invasive surgery for endometrial cancer. This technique ensures comparable diagnostic accuracy and also minimizes complications.

A randomized controlled trial on the oncologic outcomes of use of the intrauterine manipulator in the treatment of apparent uterine-confined endometrial carcinoma: the MANEC Trial.

BACKGROUND: The intrauterine manipulator used during a hysterectomy for endometrial cancer has been suggested as a reason for worsening oncologic outcomes. However, only a few non-randomized retrospective studies have investigated this association. PRIMARY OBJECTIVES: To compare 4-year recurrence-free survival in the group of patients who undergo hysterectomy using an intrauterine manipulator with that of those who undergo hysterectomy without it. STUDY HYPOTHESIS: Patients with endometrial cancer who undergo laparoscopic hysterectomy performed with an intrauterine manipulator would have a lower recurrence-free survival than patients who undergo laparoscopic hysterectomy without a manipulator. TRIAL DESIGN: Multicenter, parallel arm, open-label, randomized controlled trial. MAJOR INCLUSION/EXCLUSION CRITERIA: Adult women diagnosed with apparently uterine-confined endometrial cancer of any histology are eligible. We exclude women who had synchronous or previous (<5 years) invasive cancer, had a WHO performance score >2, and had inadequate baseline organ function. PRIMARY ENDPOINTS: 4-Year recurrence-free survival defined as any relapse or death related to endometrial cancer or treatment calculated from randomization to the date of the first recurrence-free survival event. SAMPLE SIZE: With an accrual time of 4 years, a minimum follow-up length of 4 years, and a two-sided type I error of 0.05, we need to enroll 515 women per arm to have a statistical power of 80% to reject the null hypothesis (HR for recurrence=1), assuming that patients who undergo hysterectomy with the use of the intrauterine manipulator have a 3-year recurrence rate of 12.5% and without the use of the intrauterine manipulator of 8.5% (HR for recurrence=1.50), and that 5% of patients are lost at follow-up in each arm, with a median time of 24 months. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is expected in 2028, and result presentation in 2032. TRIAL REGISTRATION: ClinicalTrial.gov ID NCT05687084.

Surgical Outcomes and Complications of Myomectomy: A Prospective Cohort Study.

STUDY OBJECTIVE: To investigate postoperative surgical and non-surgical complications that occur within 30 days following myomectomy procedures, whether laparoscopic or via open surgery. DESIGN: Prospective cohort study SETTING: Del Ponte Women's and Children's Hospital, Varese, Italy. PATIENTS: Women undergoing myomectomy either with laparoscopic or open surgery from July 2020 to June 2023 INTERVENTIONS: Data of consecutive patients who underwent abdominal myomectomy procedures, either via laparoscopy or open abdominal surgery were collected. The study examined patient characteristics, size and location of fibroids, surgical data, and complications. Univariate and multivariable analyses were employed to identify factors contributing to postoperative Clavien-Dindo grade ≥ II complications. MEASUREMENTS AND MAIN RESULTS: Overall 383 patients were included in the study. The univariate analysis showed intramural fibroid type (p = .0009), large fibroid size (p = .03), and extended operative times (p = .05) were associated with postoperative complications. Open surgical approach (p <.001) and uterine cavity opening (p = .02) also contributed to complications. Postoperative anemia emerged as the most prevalent complication. In the multivariable analysis, the open surgical approach emerged as the only independent factor associated with an increased risk of grade ≥ II complications (odds ratio 7.37; p <.0001). CONCLUSION: In this study we found an increased likelihood of complications in case of open myomectomy. While the presence of potential selection bias may have impacted this finding, it could provide valuable insights for clinicians and surgical teams in the strategic planning of myomectomy procedures.

Advanced bipolar vessel sealing devices vs conventional bipolar energy in minimally invasive hysterectomy: a systematic review and meta-analysis.

PURPOSE: To compare conventional bipolar electrosurgery with advanced bipolar vessel sealing (ABVS) devices for total laparoscopic hysterectomy (TLH). METHODS: A systematic review was conducted by searching Scopus, PubMed/MEDLINE, ScienceDirect, and Cochrane Library from January 1989 to November 2021. We identified all studies comparing ABVS devices with conventional bipolar electrosurgery in TLH and reporting at least one of the following outcomes: total blood loss, total operative time, hospital stay, perioperative complications, or costs. Meta-analysis was conducted with a random effect model reporting pooled mean differences and odds ratios (ORs) with related 95% confidence intervals (CIs). RESULTS: Two randomized controlled trials and two retrospective studies encompassing 314 patients were included out of 615 manuscripts. The pooled estimated total blood loss in the ABVS devices group was lower than conventional bipolar electrosurgery of 39 mL (95% CI - 65.8 to - 12.6 mL; p = .004). The use of ABVS devices significantly reduced the total operative time by 8 min (95% CI - 16.7 to - 0.8 min; p = .033). Hospital stay length did not differ between the two groups, and a comparable overall surgical complication rate was observed [OR of 0.9 (95% CI 0.256 - 3.200; p = .878]. CONCLUSIONS: High-quality evidence comparing ABVS devices with conventional bipolar electrosurgery for TLH is lacking. ABVS devices were associated with reduced total blood loss and operative time; however, observed differences seem clinically irrelevant. Further research is required to clarify the advantages of ABVS devices over conventional bipolar electrosurgery and to identify cases that may benefit more from their use.

Ten-year outcomes following laparoscopic and open abdominal radical hysterectomy for "low-risk" early-stage cervical cancer: A propensity-score based analysis.

OBJECTIVE: Accumulating evidence suggested the detrimental effects of adopting minimally invasive surgery in the management of early-stage cervical cancer. However, long-term evidence on the role of minimally invasive radical hysterectomy in "low-risk" patients exists. METHODS: This is multi-institutional retrospective study comparing minimally invasive and open radical hysterectomy in low-risk early-stage cervical cancer patients. A propensity-score matching algorithm (1:2) was used to allocate patients into the study groups. Kaplan-Meir model was used to estimate 10-year progression-free and overall survival. RESULTS: Charts of 224 "low-risk" patients were retrieved. Overall, 50 patients undergoing radical hysterectomy were matched with 100 patients undergoing open radical hysterectomy. Minimally invasive radical hysterectomy was associated with a longer median operative time (224 (range, 100-310) vs. 184 (range, 150-240) minutes; p < 0.001), lower estimated blood loss (10 (10-100) vs. 200 (100-1000) ml, p < 0.001), and shorter length of hospital stay (3.8 (3-6) vs. 5.1 (4-12); p < 0.001). Surgical approach did not influence the risk of having intra-operative (4% vs. 1%; p = 0.257) and 90-day severe (grade 3+) postoperative complication rates (4% vs. 8%; p = 0.497). Ten-year disease-free survival was similar between groups (94% vs. 95%; p = 0.812; HR:1.195; 95%CI:0.275, 5.18). Ten-year overall survival was similar between groups (98% vs. 96%; p = 0.995; HR:0.994; 95%CI:0.182, 5.424). CONCLUSIONS: Our study appears to support emerging evidence suggesting that, for low-risk patients, laparoscopic radical hysterectomy does not result in worse 10-year outcomes compared to the open approach. However, further research is needed and open abdominal radical hysterectomy remains the standard treatment for cervical cancer patients.

When does oasis cause de novo pelvic floor dysfunction? role of the surgeon's skills.

INTRODUCTION AND HYPOTHESIS: Minorly skilled gynecologists are less likely to repair obstetric anal sphincter injuries (OASIS), and this can lead to higher rate of de novo onset of pelvic floor dysfunction (PFD). The aim of this study was to understand the impact of surgeon skills in OASIS repair on de novo incidence of PFDs. METHODS: An observational prospective cohort study performed between January 2019 and December 2020. We included 116 women with OASIS. At 6-weeks from delivery, women were divided into two groups in relation to the onset of PFDs. Characteristics were compared; categorical and continuous variables were assessed with chi-squared test and the Mann-Whitney rank-sum test respectively. Factors involved in PFDs development were analysed with explorative univariate analysis; significant (p<0.05) or approaching significance (p≤0.10) variables were included in multivariable analysis. RESULTS: Seventy-six women (76/116; 65.5%) reported at least one PFD symptom and anal incontinence was the most prevalent (44.73%; 34/76). OASIS management by a skilled gynaecologist resulted protective for PFDs [aOR 0.33 (0.13-0.61)]. Skilled surgeon reported fewer PFDs than less skilled surgeon (4% vs 82.4%; p<0.0001). Operative delivery was more performed (32.5% vs 15.8%; p= 0.03) and severe OASIS resulted more prevalent (60% vs 17.1%; p<0.0001) among women without PDFs, even if these didn't affect the incidence of de novo PFDs [aOR 1.03 (0.23-1.45) and 0.83 (0.13-1.45), respectively]. CONCLUSIONS: Surgeons skilled in OASIS repair resulted the only protective factor for incidence of de novo PFDs in women with OASIS at 6 weeks of follow up. Improvement of training in OASIS repair is necessary.

Evaluation of Peri-Operative Management in Women with Deep Endometriosis Who are Candidates for Bowel Surgery: A Survey from the Italian Society of Gynecologic Endoscopy.

STUDY OBJECTIVE: There is great consensus that the implementation of the enhanced recovery after surgery (ERAS) approach is beneficial for surgical patients, but there is a paucity of data concerning its application in women with deep endometriosis (DE) who are candidates for bowel surgery. The survey described herein was aimed at gathering detailed information on perioperative management of DE patients who were undergoing sigmoid/rectal (discoid or segmental) resection within the Italian Society of Gynecologic Endoscopy (SEGI) group. DESIGN: Baseline survey. SETTING: National survey conducted within the main Italian cooperative group in minimally invasive gynecologic surgery (SEGI). PATIENTS: The study did not involve patients. INTERVENTIONS: A 63-item questionnaire covering ERAS items for gynecologic/elective colorectal surgery was sent to SEGI centers. Only questionnaires from centers that reported performing ≥10 sigmoid/rectal resections per year were considered for this analysis. MEASUREMENTS AND MAIN RESULTS: Thirty-three of 38 (86.8%) of the questionnaires were analyzed. The rates of concordance with the ERAS guidelines were 40.4%, 64.4%, and 62.6% for preoperative, intraoperative, and postoperative items, respectively. The proportion of overall agreement was 56.6%. Preoperative diet, fasting and bowel preparation, correction of anemia, avoidance of peritoneal drains, postoperative feeding, and early mobilization were the most controversial items. Comparative analysis revealed that the referred rates of complete disease removal and conversion to open surgery were significantly different depending on case volume (p = .044 and p = .003, respectively) and gynecologist's/surgeon's experience (p = .042 and p = .022, respectively), with higher chances of obtaining a complete laparoscopic/robotic excision of endometriosis in centers that reported ≥30 DE surgeries performed per year and/or ≥90% of bowel resections performed by a gynecologist/general surgeon specifically dedicated to DE management. In contrast, the rates of concordance with the ERAS guidelines were not significantly different according to case volume (p = .081) or gynecologist's/surgeon's experience (p = .294). CONCLUSION: This is the first study on DE conducted on a national scale. The current survey results revealed suboptimal compliance with the ERAS recommendations and underline the need to improve the quality of perioperative care in DE patients undergoing sigmoid/rectal resection. This study is a first step toward building a consistent, structured reporting platform for the SEGI units and facilitating wide implementation and standardization of the ERAS protocol for DE patients in Italy.

Surgical Outcomes and Complications of Laparoscopic Hysterectomy for Endometriosis: A Multicentric Cohort Study.

STUDY OBJECTIVE: To investigate the postoperative morbidity of laparoscopic hysterectomy (LH) for endometriosis/adenomyosis in terms of operative outcomes and complications. DESIGN: Retrospective multicentric cohort study. SETTING: Eight European minimally invasive referral centers. PATIENTS: Data from 995 patients with pathologically confirmed endometriosis and/or adenomyosis who underwent LH without concomitant urological and/or gastroenterological procedures from January 2010 to December 2020. INTERVENTIONS: Total LH. MEASUREMENTS AND MAIN RESULTS: Demographic patients' characteristics, surgical outcomes, and intraoperative and postoperative complications were evaluated. We considered major postoperative surgical-related complications, any grade 2 or more events (Clavien-Dindo score) that occurred within 30 days from surgery. Univariate analysis and multivariable models fit with logistic regression were used to estimate the adjusted odds ratio (OR) and corresponding 95% confidence interval (CI) for major complications. Median age at surgery was 44 years (28-54), and about half of them (505, 50.7%) were on medical treatment (estro-progestins, progestin, or Gonadotropin hormone-releasing hormone-analogues) at the time of surgery. In association with LH, posterior adhesiolysis was performed in 387 (38.9%) cases and deep nodule resection in 302 (30.0%). Intraoperative complications occurred in 3% of the patients, and major postoperative complications were registered in 93 (9.3%). The multivariable analysis showed an inverse correlation between the occurrence of Clavien-Dindo >2 complications and age (OR 0.94, 95% CI 0.90-0.99), while previous surgery for endometriosis (OR 1.62, 95% CI 1.01-2.60) and intraoperative complications (OR 6.49, 95% CI 2.65-16.87) were found as predictors of major events. Medical treatment at the time of surgery has emerged as a protective factor (OR 0.50, 95% CI 0.31-0.81). CONCLUSION: LH for endometriosis/adenomyosis is associated with non-negligible morbidity. Knowing the factors associated with higher risks of complications might be used for risk stratification and could help clinicians during preoperative counseling. The administration of estro-progestin or progesterone preoperatively might reduce the risks of postoperative complications following surgery.

Hysterectomy for Non-Prolapsed Uterus in Elderly Patients: Predictors of Prolonged Hospital Stay.

OBJECTIVE: The objective of this study was to investigate surgical outcomes and complications of hysterectomy for benign conditions other than prolapse in elderly patients and to define predictors of prolonged hospitalization. DESIGN: Retrospective analysis of prospectively collected data. SETTING: This study was conducted in an academic research center. PATIENTS: We utilized our institution surgical database to identify patients aged 60 years or more ("elderly") who underwent hysterectomy for benign conditions other than pelvic organ prolapse during a 20-year period (January 2000-December 2019). METHODS: Length of stay (LOS) of more than 2 days (90th percentile of LOS) was defined as prolonged hospitalization. Patient demographics, comorbid conditions, and surgical approach (vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), and abdominal hysterectomy (AH)) were identified. Patients treated via LH or VH were also grouped as minimally invasive surgery (MIS). Multivariable logistic regression was used to identify factors associated with prolonged LOS. RESULTS: Overall, 334 patients were included in this study, 262 (78.4%) of whom underwent LH, 42 (12.6%) VH, and 30 (9.0%) AH. Median LOS was 2 days (1-8), and 63 (18.8%) patients required prolonged LOS. Compared to AH, median hospital stay was shorter in MIS group (2 days vs. 3 days, p < 0.001). No admission variables were associated with prolonged LOS. The only independent predictors of prolonged LOS were AH (odds ratio 24.82, 95% CI 4.84-127.16) and operative time (odds ratio for 30 mins increased 11.34, 95% CI 1.63-78.78). Compared to those who underwent VH, patients having LH had a higher rate of concomitant salpingo-oophorectomy (96.6% vs. 61.9%, p < 0.001). LIMITATIONS: Retrospective single-center study design, number of patients with prolonged hospitalization, and the setting (tertiary minimally invasive gynecology referral center), which might have reduced the generalizability of our results are the limitations of this study. CONCLUSIONS: The abdominal route of hysterectomy was found as the main driver of prolonged hospitalization, reinforcing the benefits of MIS for benign hysterectomy in elderly patients with non-prolapsed uteri; the higher chance of performing concomitant salpingo-oophorectomy supports the laparoscopic approach as the first option for these patients.

Practice patterns and 90-day treatment-related morbidity in early-stage cervical cancer.

BACKGROUND: To evaluate the impact of the Laparoscopic Approach to Cervical Cancer (LACC) Trial on patterns of care and surgery-related morbidity in early-stage cervical cancer. METHODS: This is a retrospective, a multi-institutional study evaluating 90-day surgery-related outcomes of patients undergoing treatment for early-stage cervical cancer before (period I: 01/01/2016-06/01/2018) and after (period II: 01/01/2019-06/01/2021) the publication of the results of the LACC trial. RESULTS: Charts of 1295 patients were evaluated: 581 (44.9%) and 714 (55.1%) before and after the publication of the LACC trial, respectively. After the publication of the LACC trial, the number of patients treated with minimally invasive radical hysterectomy decreased from 64.9% to 30.4% (p < 0.001). Overall, 90-day complications occurred in 110 (18.9%) and 119 (16.6%) patients in the period I and period II, respectively (p = 0.795). Similarly, the number of severe (grade 3 or worse) complications did not differ between the two periods (38 (6.5%) vs. 37 (5.1%); p = 0.297). Overall and severe 90-day complications were consistent between periods even evaluating stage IA (p = 0.471), IB1 (p = 0.929), and IB2 (p = 0.074), separately. CONCLUSIONS: The present investigation highlighted that in referral centers the shift from minimally invasive to open radical hysterectomy does not influence 90-day surgery-related morbidity.

Evaluating long-term outcomes of three approaches to retroperitoneal staging in endometrial cancer.

OBJECTIVE: Sentinel lymph node mapping (SNM) has gained popularity in managing apparent early-stage endometrial cancer (EC). Here, we evaluated the long-term survival of three different approaches of nodal assessment. METHODS: This is a multi-institutional retrospective study evaluating long-term outcomes of EC patients having nodal assessment between 01/01/2006 and 12/31/2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm. RESULTS: Overall, 940 patients meeting inclusion criteria were included in the study, of which 174 (18.5%), 187 (19.9%), and 579 (61.6%) underwent SNM, SNM followed by backup lymphadenectomy (LND) and LND alone, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients, including 125 SNM, 125 SNM/backup LND, and 250 LND. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM/backup LND and LND, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p = 0.750) and overall survival (p = 0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification based on uterine risk factors. CONCLUSION: Our study highlighted that SNM provides similar long-term oncologic outcomes than LND.

Overall survival after surgical staging by lymph node dissection versus sentinel lymph node biopsy in endometrial cancer: a national cancer database study.

OBJECTIVE: Substituting lymphadenectomy with sentinel lymph node biopsy for staging purposes in endometrial cancer has raised concerns about incomplete nodal resection and detrimental oncological outcomes. Therefore, this study aimed to investigate the association between the type of lymph node assessment and overall survival in endometrial cancer accounting for node status and histology. METHODS: Women with stage I-III endometrial cancer who underwent hysterectomy and lymph node assessment from January 2012 to December 2015 were identified in the National Cancer Database. Patients who underwent neoadjuvant therapy, had previous cancer, and whose follow-up was less than 90 days were excluded. Multivariable Cox proportional hazards regression analyses were performed to assess factors associated with overall survival. RESULTS: Of 68 614 patients, 64 796 (94.4%) underwent lymphadenectomy, 1777 (2.6%) underwent sentinel node biopsy only, and 2041 (3.0%) underwent both procedures. On multivariable analysis, neither sentinel lymph node biopsy alone nor sentinel node biopsy followed by lymphadenectomy was associated with significantly different overall survival compared with lymphadenectomy alone (HR 0.92, 95% CI 0.73 to 1.17, and HR 0.91, 95% CI 0.77 to 1.08, respectively). When stratified by lymph node status, sentinel node biopsy alone or followed by lymphadenectomy was not associated with different overall survival, both in patients with negative (HR 0.95, 95% CI 0.73 to 1.24, and HR 1.04, 95% CI 0.85 to 1.27, respectively) or positive (HR 0.91, 95% CI 0.54 to 1.52, and HR 0.77, 95% CI 0.57 to 1.04, respectively) lymph nodes. These findings held true when sentinel node biopsy alone and sentinel node biopsy plus lymphadenectomy groups were merged, and on stratification by histotype (type one vs type 2) or inclusion of only complete lymphadenectomy (at least 10 pelvic nodes and at least one para-aortic node removed). In all analyses, age, Charlson-Deyo score, black race, AJCC pathological T stage, grade, lymphovascular invasion, brachytherapy, and adjuvant chemotherapy were independently associated with overall survival. DISCUSSION: No difference in overall survival was found in patients with endometrial cancer who underwent sentinel node biopsy alone, sentinel node biopsy followed by lymphadenectomy, or lymphadenectomy alone. This observation remained regardless of node status, histotype, and lymphadenectomy extent.

Anatomical distribution of sentinel lymph nodes in patients with endometrial cancer: a multicenter study.

OBJECTIVE: Sentinel lymph node (SLN) mapping represents the standard approach in uterine confined endometrial cancer patients. The aim of this study was to evaluate the anatomical distribution of SLNs and the most frequent locations of nodal metastasis. METHODS: This was an observational retrospective multicenter study involving eight high volume gynecologic cancer centers in Italy. We reviewed 1576 patients with a histologically confirmed diagnosis of endometrial cancer from September 2015 to June 2020. All patients underwent total hysterectomy with salpingo-ophorectomy and SLN mapping. RESULTS: A total of 3105 SLNs were mapped and removed, 2809 (90.5%) of these were bilateral and 296 (9.5%) unilateral. The overall detection rate was 93.4% (77.9% bilateral and 15.5% unilateral). The majority of SLNs (80%) and positive SLNs (77.8%) were found at the external iliac and obturator level in both endometrioid and non-endometrioid endometrial cancer. Negative SLNs were more frequent in patients with endometrioid compared with non-endometrioid cancer (91.9% vs 86.1%, p<0.0001). Older patients, a higher body mass index, and non-endometrioid histology were more likely to have 'no mapping' (p<0.0001). Univariate and multivariate analysis showed that higher body mass index and age at surgery were independent predictive factors of empty node packet and fat tissue (p=0.029 and p<0.01, respectively). CONCLUSION: The most frequent sites of SLNs and metastases were located in the pelvic area below the iliac vessel bifurcation. Our findings showed that older age, a higher body mass index, and non-endometrioid histology had a negative impact on mapping.

The subjective and objective very long-term outcomes of TVT in the COVID era: A 20-year follow-up.

INTRODUCTION AND HYPOTHESIS: Few studies in literature have assessed the long-term durability and mesh-related complications of mid-urethral slings (MUSs). The aim of this study is to assess the efficacy and safety of retro-pubic tension-free vaginal tape (TVT) 20 years after implantation for the treatment of female stress urinary incontinence (SUI). METHODS: A prospective observational study was conducted in two urogynaecologic units in two countries. All the patients involved were consecutive women with urodynamically proven pure SUI treated by TVT. The patients underwent preoperative clinical and urodynamic evaluations. Subjective outcomes, objective outcomes and adverse events were recorded during the follow-up period. RESULTS: Fifty-two patients underwent a TVT surgical procedure. Twenty years after surgery, 32 out of 36 patients (88.8%) declared themselves cured (p = 0.98). Similarly, 33 out of these 36 patients (91.7%) were objectively cured (p = 0.98). No significant deterioration of subjective and objective cure rates was observed over time (p for trend 0.50 and 0.48). Fifteen of the 36 patients (41.6%) at the 20-year follow-up reported the onset of de novo overactive bladder (OAB) (p = 0.004). No significant vaginal bladder or urethral erosion or de novo dyspareunia was recorded and no patient required tape release or resection during this period. The cause of death of seven out of ten women who died in the last year of the follow-up period was coronavirus disease 19 (COVID 19). CONCLUSIONS: The 20-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI. The impact of COVID 19 on the mortality rate of elderly women has drastically reduced the number of eligible patients for future evaluations in our region.

Is the Deep Endometriosis or the Surgery the Cause of Postoperative Bladder Dysfunction?

STUDY OBJECTIVE: To assess whether deep endometriosis surgery affects the bladder function. DESIGN: Prospective multicenter observational study (Canadian Task Force classification II-2). SETTING: Academic research centers. PATIENTS: Thirty-two patients with diagnosis of deep endometriosis requiring surgery. INTERVENTIONS: Women were evaluated with urodynamic studies, International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form, and International Consultation on Incontinence Questionnaire Overactive Bladder Module questionnaires before and 3 months after surgery. MEASUREMENTS AND MAIN RESULTS: The main outcome measure was the impact of deep endometriosis surgery on urodynamic parameters. All cystomanometric parameters showed an improvement postoperatively: in particular, the first desire to void (120 vs 204 mL; p <.001) and the bladder capacity (358 vs 409 mL; p = .011) increased significantly after surgery. Of the uroflow parameters, the maximal voiding flow improved significantly postoperatively (19 vs 25 mL/s; p = .026). The International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (2.5 vs 0; p = .0005) and International Consultation on Incontinence Questionnaire Overactive Bladder Module (4.3 vs 1.2; p <.001) questionnaires showed a significant postoperative improvement too. CONCLUSION: Our data show that in a selected population of patients with deep infiltrating endometriosis (not requiring bowel or ureteral resection), the bladder function improves after surgery, both during filling and on voiding urodynamic phases. Postoperatively, patients with deep infiltrating endometriosis become aware of bladder filling later, have a higher bladder capacity, and have a higher maximal flow. The postoperative urodynamic results are corroborated by the improved scores on the bladder questionnaires.

Outcomes of In-bag Transvaginal Extraction in a Series of 692 Laparoscopic Myomectomies: Results from a Large Retrospective Analysis.

STUDY OBJECTIVE: Transvaginal extraction is a feasible method to remove surgical specimen. In this study, we aim to report our experience with in-bag transvaginal specimen retrieval after laparoscopic myomectomy over the past 15 years. DESIGN: Single-center retrospective analysis. SETTING: Academic hospital. PATIENTS: Women who underwent laparoscopic myomectomy from January 2005 to April 2021. INTERVENTION: Posterior colpotomy and in-bag transvaginal extraction of the surgical specimen. MEASUREMENTS AND MAIN RESULTS: We collected and analyzed data about patients' characteristics, main indication for surgery, and intra- and postoperative (within 30 days) complications. RESULTS: A total of 692 women underwent transvaginal specimen retrieval after laparoscopic myomectomy (mean largest myoma diameter: 6.64 ± 2.21 cm; mean specimen weight: 177 ± 140 g; mean operative time: 84.1 ± 37.1 minutes; mean blood loss: 195 ± 191 mL). Within 30-days, we reported the following colpotomy-related complications: a total of 4 cases (0.6%) of vaginal bleeding, 3 of which resolved spontaneously (1 case required readmission with new colporrhaphy under general anesthesia), and 2 cases (0.3%) of vaginal pain, with no underlying cause identified on physical examination and pelvic ultrasound. Specimen weight was positively correlated with longer operative time, intraoperative blood loss, and length of hospital stay. CONCLUSION: Posterior colpotomy and in-bag transvaginal extraction can be considered a feasible option for retrieval of surgical specimens after laparoscopic myomectomy.

Transvaginal versus Port-Site Specimen Retrieval after Laparoscopic Myomectomy: A Systematic Review and Meta-Analysis.

INTRODUCTION: To date, there is no robust evidence suggesting whether transvaginal retrieval (TVSR) or port-site specimen retrieval (PSSR) after laparoscopic myomectomy (LM) may lead to better surgical outcomes. Considering this element, we aimed to compare surgical outcomes of TVSR versus PSSR after LM. METHODS: A search (PROSPERO ID: CRD42020176490) of international databases, from 1980 to 2020, in English language, was conducted. We selected studies that included women who underwent LM with TVSR compared with PSSR. RESULTS: We did not find significant differences for operative time (MD = -8.90; 95% CI: 30.00, 12.20; I2 = 87%), myoma retrieval time (MD = -1.85; 95% CI: 13.55, 9.85; I2 = 98%), blood loss (MD = -27.62; 95% CI: 178.68, 124.43; I2 = 91%), intra-operative complication rate (OR 0.51; 95% CI: 0.01-23.09; I2 = 69%), and hospital stay (MD = -0.14; 95% CI: 0.43, 0.15; I2 = 64%); we found a significant lower postoperative rescue analgesics utilization in the TVSR group compared with the PSSR group (OR 0.31; 95% CI: 0.16-0.61; I2 = 0). CONCLUSION: TVSR and PSSR after LM showed comparable results for operative time and surgery-related complications. However, the need of postoperative rescue analgesics was lower in women who underwent TVSR.

Tranexamic acid for the prevention and the treatment of primary postpartum haemorrhage: a systematic review.

Tranexamic acid (TA) has been proposed for preventing or treating primary postpartum haemorrhage (PPH), which is the leading cause of maternal morbidity and mortality worldwide. We conducted a systematic literature search to the TA role in managing PPH in vaginal and caesarean delivery. Twenty-seven randomised controlled trials (RCTs) (33,302 women) were identified. Three RCTs investigated TA for preventing PPH after vaginal delivery and 22 after caesarean section. None demonstrated a preventive effect on secondary clinical outcomes related to blood loss. Two trials evaluated TA for treating PPH after vaginal and caesarean delivery. Only the WOMAN trial showed that 1 g of TA is effective. In conclusion, TA is considered useful and is recommended or advised for treating PPH. Conversely, available evidence on the prophylactic role is still limited, and this use is not supported. Further investigation is recommended. In this regard, stronger and more reliable outcomes than blood loss should be considered.