Menopause in adult women with human papillomavirus: health-related quality of life and determinants.

OBJECTIVE: Human papillomavirus (HPV) infection and menopause entail a considerable impairment in health-related quality of life (HRQoL). The objective of the present study was to analyze the impact of the menopause status on HRQoL in women with HPV infection. METHODS: A cross-sectional, nationwide, multicenter sample of women with HPV infection was conducted throughout clinics of gynecology representative of the Spanish population with regard to age, geographic density, and autonomous regions. Demographic and clinical characteristics and the specific HPV-QoL questionnaire score with its domains were compared according to reproductive status: premenopausal and peri-/postmenopausal. Correlation with other validated patient-reported outcomes measurements was also tested, including General Health Questionnaire-12 (GHQ-12), Female Sexual Function Index (FSFI), and Hospital Anxiety and Depression Scale (HADS). RESULTS: A sample of 1,016 noninstitutionalized women, aged 18-80 y, was recorded, 191 (18.8%) peri-/postmenopausal and 825 (81.2%) premenopausal. Total HPV-QoL scoring was significantly lower in peri-/postmenopausal (38.8, 95% CI [35.2-42.4]) compared to premenopausal (46.4, 95% CI [45.0-47.8]) women, and also in every domain of the scale (P < 0.05), except in social well-being and health domains, with a small effect size of 0.39. In women with sexual dysfunction according to FSFI, adjusted total scoring and domains sexuality, general well-being, and psychological well-being scored significantly higher in premenopause women (P < 0.01), although the magnitude of differences were of small to moderate size. CONCLUSIONS: HRQoL was impaired during menopause in women with HPV infection according to HPV-QoL questionnaire. The sexuality domain was the most differentiating dimension between these populations.

Clinical challenges and considerations in pharmacotherapy of osteoporosis due to menopause.

INTRODUCTION: Osteoporosis is a chronic systemic skeletal disorder characterized by compromised bone strength and an increased risk of fracture, with a high prevalence worldwide. It is associated with a negative quality of life and an increased morbidity and mortality. Postmenopausal women are more prone to develop osteoporosis, and many of them will suffer at least one fragility fracture along their lifetime. AREAS COVERED: This review starts by summarizing the pathogenesis of postmenopausal osteoporosis (PMO), with focus on the estrogen deficiency-associated bone loss. It continues with the current PMO diagnostic and fracture risk prediction tools, and it finally addresses management of PMO. All the efficacy and safety profiles of the current and future osteoporosis medications are reviewed. Furthermore, strategies to optimize the long-term disease management are discussed. For this review, only publications in English language were selected. References were extracted from PubMed, Embase, and Medline. EXPERT OPINION: PMO disease management is far from being ideal. Educational and communication programs with the goal of improving disease knowledge and awareness, as well as reducing the health-care gap, should be implemented. In addition, most effective sequential prevention and treatment strategies should be initiated from the early menopause.

POESIT recommendations on management of body-identical hormones in menopausal symptoms.

Many women seek treatment to improve menopausal vasomotor symptoms (VMS). The selection of women most likely to benefit from menopause hormone therapy (MHT) is crucial in clinical practice. There is general agreement that women younger than 60 years or who initiate MHT within the first 10 years of menopause, with no contraindications, have greater benefits considering symptomatic relief and additional advantages. This group may have the advantage of protection from osteoporosis and from other chronic diseases that affect postmenopausal women, namely cardiovascular disease (CVD). Cumulating evidence supports MHT for symptomatic women. However, inadequate use according to the needs of symptomatic women led to a burden of suffering worldwide. In recent years, the emergent use of non-regulated body-identical hormones (non-rBHT) can expose patients to potential harms. These hormone preparations are not regulated through the same tests of safety, efficacy or dosing consistency as regulated-BHT (r-BHT). The POESIT (Portugal + Spain + Italy) recommendations highlight the use of 17ß-estradiol (E2) and micronized progesterone (P4) as the real r-BHT. In addition, the group emphasizes as an example the data from the REPLENISH study with 1 mg E2/100 mg P4. The combination of the two hormones in one convenient pill showed a clear reduction or elimination of hot flashes and an improvement in sleep quality and, consequently, quality of life. At the same time, this combination has shown high rates of amenorrhea and no significant impact on lipid, glucose or coagulation parameters. Both the REPLENISH study and a real-life retrospective study pointed to the possibility of a lower risk of venous thromboembolism (VTE) with this formulation than with other combinations.

Eligibility criteria for using menopausal hormone therapy in breast cancer survivors: a safety report based on a systematic review and meta-analysis.

IMPORTANCE: Menopause hormone therapy (MHT) effectively alleviates menopausal symptoms. However, it is generally not recommended for breast cancer survivors, although the scientific evidence is scarce. OBJECTIVE: This study aimed to establish eligibility criteria for use of the MHT in breast cancer survivors based on a systematic review and meta-analysis of the literature. EVIDENCE REVIEW: We conducted exhaustive literature searches until June 2022 in MEDLINE, The Cochrane Library, and EMBASE, using a tailored strategy with a combination of controlled vocabulary and search terms related to breast cancer survivors and MHT. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and assessed the risk of bias using the Cochrane and Risk of Bias in Non-randomized Studies - of Interventions tools. The quality of the evidence was graded according to grading quality of evidence and strength of recommendations criteria (A, high; B, moderate; C, low; and D, very low). We categorized MHT use into four levels: category 1 (no restrictions on use), category 2 (the benefits outweigh the risks), category 3 (the risks generally outweigh the benefits), and category 4 (MHT should not be used). FINDINGS: A total of 12 studies met the eligibility criteria. Analysis of the three randomized clinical trials using combined MHT or tibolone revealed no significant differences concerning tumor recurrence (relative risk [RR], 1.46; 95% CI, 0.99-2.24). A combined analysis of randomized clinical trials, prospective, and retrospective trials found no elevated risk of recurrence (RR, 0.85; 95% CI, 0.54-1.33) or death (RR, 0.91; 95% CI, 0.38-2.19). The eligibility criteria for patients with hormone receptor (HR)-positive tumors fell into categories 3B and 3C for combined MHT or estrogen alone and 4A for tibolone. For HR-negative tumors, the category was 2B and 2C. CONCLUSIONS AND RELEVANCE: Our findings suggest that MHT could be a viable treatment alternative for breast cancer survivors experiencing menopausal symptoms, especially those with HR-negative tumors. Personalized management is recommended for each peri/postmenopausal woman facing a diminished quality of life because of menopause symptoms. Further randomized trials are needed before considering changes to current standards of care.

Pharmacological interactions and menopausal hormone therapy: a review.

IMPORTANCE AND OBJECTIVE: Menopausal hormone therapy (HT) is widely used, and there are several statements of international scientific societies to guide prescribers; however, a summary of existing literature about possible drug interactions with HT does not exist, although many midlife women take medications for other conditions. Therefore, our objective was to create a document that presents and synthesizes the most relevant interactions. The impact of the interaction itself and the number of candidates for HT who are likely to use other treatments are considered based on the best available evidence. METHODS: A systematic review was performed to determine the best evidence of interaction effects on relevant outcomes of interest for decision making. A working framework was developed to formulate explicit and reasoned recommendations according to four predefined categories for coadministration: (1) can be used without expected risks, (2) acceptable use (no evidence of negative interaction), (3) alternative treatment should be considered, and (4) nonuse without express justification. The project protocol was registered in the Open Science Framework platform (doi: 10.17605/OSF.IO/J6WBC ) and in PROSPERO (registration number CRD42020166658). RESULTS: Studies targeting our objective are scarce, but 23 pharmacological groups were assigned to one of the predefined categories of recommendation for concomitant use of HT. Vaginal HT was assigned to category 1 for 21 of the analyzed pharmacological groups. For oral and transdermal HT (estrogen-only or combined) and tibolone, there were 12 pharmacological groups assigned to category 1, 12 to category 2, 5 to category 3, and 4 to category 4. Results are shown in crossed-tables that are useful for counseling and prescription. DISCUSSION AND CONCLUSIONS: Available evidence of HT interactions with other drugs is scarce and mainly indirect. It comes from biological plausibility, knowledge of extensive concomitant use without reported incidents, and/or extrapolation from hormonal contraception, but there are pharmacological groups in all categories showing that information is useful. These eligibility criteria summarize it and can help in the decision process of HT coadministration with other drugs. Decisions should be taken based on these recommendations but also individualized risk/benefit evaluation, according to underlying pathology, patient's clinical requirements, and the existence or nonexistence of alternatives.

Impact of vulvovaginal atrophy therapies on postmenopausal women's quality of life in the CRETA study measured by the Cervantes scale.

OBJECTIVE: To assess the correlation of different vulvovaginal atrophy therapeutic options with the quality of life of postmenopausal women. STUDY DESIGN: The CRETA study is a descriptive, observational, cross-sectional, multicenter study designed to measure, besides treatment satisfaction and adherence, the quality of life of postmenopausal women diagnosed with vulvovaginal atrophy in 29 hospitals and centers across Spain. MAIN OUTCOME MEASURES: The study enrolled postmenopausal women currently receiving treatment with vaginal moisturizers, local estrogen therapy or ospemifene. Clinical features and treatment perceptions were collected by self-report questionnaire and quality of life was evaluated using the Cervantes scale. RESULTS: Among the 752 women included, the ospemifene cohort showed a statistically significant lower global score (44.9 ± 21.7) on the Cervantes scale (and therefore, a better quality of life) than the cohorts treated with moisturizers (52.5 ± 21.6, p = 0.003) or local estrogen therapy (49.2 ± 23.8, p = 0.0473). In the analysis by domains, ospemifene-treated women showed statistically significant better scores in menopause & health and psychological status than moisturizers-treated women (p < 0.05). In the domains of sexuality and couple relations, the score for the quality of life of the ospemifene cohort was statistically significantly better than the scores in either of the cohorts treated with moisturizers (p < 0.001) or local estrogen therapy (p < 0.05). CONCLUSIONS: Postmenopausal women diagnosed with vulvovaginal atrophy and treated with ospemifene have better quality of life than women treated with vaginal moisturizers or local estrogen therapy. The improvement observed with ospemifene is more remarkable in those aspects related to sex life and couple relations. CLINCIALTRIALS. GOV NUMBER: NCT04607707.

Eligibility criteria for Menopausal Hormone Therapy (MHT): a position statement from a consortium of scientific societies for the use of MHT in women with medical conditions. MHT Eligibility Criteria Group.

This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms.

Development and psychometric properties of the human papillomavirus-quality of life (HPV-QoL) questionnaire to assess the impact of HPV on women health-related-quality-of-life.

PURPOSE: The HPV-Quality-of-Life (HPV-QoL) questionnaire was developed to determine the impact of Human-Papillomavirus (HPV) infection and related interventions on women health-related quality-of-life. This study provides the development and preliminary psychometric properties of a novel HPV-QoL questionnaire for adult women with HPV. METHODS: After reviewing literature and cognitive debriefing interviews in women who had experienced HPV-related conditions, instrument items and domains were developed. A draft questionnaire was pilot tested for comprehension and ease of completion. Psychometric evaluation of the final HPV-QoL scale was conducted in a psychometric study including 252 adult women derived to our centre by a positive HPV test in the cervical cancer screening program and/or presenting genital warts. RESULTS: The present study reveals that the HPV-QoL questionnaire, structured in four domains: general well-being [including psychological well-being and social well-being subdomains], health, contagiousness and sexuality, showed good metric properties of feasibility irrespective of age or educational level, and time to administer was less than 5 min. Internal consistency and temporal stability (reliability) showed values above the acceptable standards. The instrument showed its concurrent validity by means of a significant correlation with mental and sexual existing instruments; GHQ-12 and FSFI questionnaires, respectively, and also known groups validity showing significant differences among the subgroups regarding either sexual dysfunction or mental deterioration. CONCLUSION: This study provides an HPV-QoL questionnaire with an innovative patient-reported outcomes specific measurement tool to assess HRQoL in women with HPV infection. The present study suggests this questionnaire has satisfactory psychometric properties, including validity and reliability. Results support the use of the HPV-QoL questionnaire as a HRQoL measurement instrument for daily medical practice and clinical research.

A higher quality of life by the Cervantes Short-Form Scale is related to a better sexual desire in postmenopausal women.

OBJECTIVE: Evaluate the association between health relate quality of life and sexual desire in postmenopausal women and the influence of demographic descriptors on sexual desire. METHODS: A observational-cross-sectional study was conducted in 521 postmenopausal women in La Zarzuela Hospital between 2018-2020. Cervantes-short form (Cervantes-SF) scale and Brief profile female sexual function (B-PFSF) scale were filled out in the consultation. High score in Cervantes-SF implies worse health-related quality of life (HR-QoL). If score is lower or equal to 20 in B-PFSF implies diagnosis of hypoactive sexual desire disorder. RESULTS: There is a positive relationship between HR-QoL measured by Cervantes-SF and sexual desire measured by B-PFSF (p < .001; correlation coefficient: .223). The mean score on Cervantes-SF was 30.8 ± 14.9 and on B-PFSF was 18.7 ± 7.4. The B-PFSF score was worse in those women using systemic or vaginal hormonal treatment versus using non-hormonal treatment (18.7 ± 7.8 or 17.2 ± 7.4 vs 19.7 ± 6.5; p = .033. Smoking (b exp: .384; p = .029) and using vaginal hormonal treatment (b exp: 1.759; p = .033) are independent factors related to sexual desire. No difference was found in the wellbeing perceived by women in the different treatments (mean of minimal clinically important difference score was 2.9 in systemic vs. 3.0 in vaginal hormonal treatment). CONCLUSIONS: Improvement on HR-QoL is related to improvement on sexual desire. Sexual desire is better in women with non-hormonal treatment than in women with systemic or vaginal hormonal treatment. The vaginal hormonal treatment and being current smoker are independent factors of low and high sexual desire, respectively.

Tumoral volume measured preoperatively by magnetic resonance imaging is related to survival in endometrial cancer.

BACKGROUND: The aim of the study was to determine if the endometrial tumor volume (TV) measured by magnetic resonance imaging (MRI-TV) is associated with survival in endometrial cancer and lymph nodes metastases (LN+). PATIENTS AND METHODS: We evaluated the MRI imaging and records of 341 women with endometrial cancer and preoperative MRI from 2008 to 2018. The MRI-TV was calculated using the ellipsoid formula measuring three perpendicular tumor diameters. Tumor myometrial invasion was also analyzed. RESULTS: Higher MRI-TV was associated with age ≥ 65y, non-endometrioid tumors, grade-3, deep-myometrial invasion, LN+ and advanced FIGO stage. There were 37 patients with LN+ (8.8%). Non-endometrioid tumors, deep-myometrial invasion, grade-3 and MRI-TV ≥ 10 cm3 were the factors associated with LN+. Using a receiver operating characteristic [ROC] curve, the MRI-TV cut-off for survival was 10 cm3 (area under curve [AUC] = 0.70; 95% CI: 0.61-0.73). 5 years disease-free (DFS) and overall survival (OS) was significantly lower in MRI-TV ≥ 10 cm3 (69.3% vs. 84.5%, and 75.4% vs. 96.1%, respectively). MRI-TV was considered an independent factor of DFS (HR: 2.20, 95% CI: 1.09-4.45, p = 0.029) and OS (HR: 3.88, 95% CI: 1.34-11.24, p = 0.012) in multivariate analysis. CONCLUSIONS: MRI-TV was associated with LN+, and MRI-TV ≥ 10 cm3 was an independent prognostic factor of lower DFS and OS. The MRI-TV can be auxiliary information to plan the surgery strategy and predict the adjuvant treatment in women with endometrial cancer.

Beliefs, knowledge and the impact of COVID19 on menopause therapies in Spanish women: COMEM-treatment study.

OBJECTIVE: To study what women think about menopause treatments and assess their knowledge about them. To analyze adherence to treatment during COVID-19 confinement as a secondary objective. METHODS: A multi-center cross-sectional observational study was conducted using a survey of 2500 women between January and June 2019. This was administered following a non-probability sampling procedure including women between 35 and 75 years. An extension study was conducted during the coronavirus pandemic, between March and June 2020. RESULTS: The responses of 2355 surveyed women were analyzed. Of this sample, 42% knew about menopause hormone therapy (MHT). The most frequently identified indication was the treatment of hot flashes (65.6%). The MHT risks most frequently perceived were weight gain (24.2%) and breast cancer (21.7%); the main reason for rejecting MHT was a lack of information (96.1%). Comparative analyses were conducted according to age, menopausal status, type of menopause, place of residence, type of health care and level of education. During the coronavirus confinement period, 85 women using MHT were located, of which 84.7% continued it. CONCLUSIONS: Women hold certain false beliefs about menopause, and their knowledge of the available treatments is somewhat limited. Adherence to MHT during the COVID-19 confinement in Spain has been high.

Women with low quality of life by cervantes-short form scale choose menopausal hormone therapy.

OBJECTIVES: The aim of the study is to assess whether women who choose to use menopausal hormone therapy (MHT) have lower quality of life (QoL) than those who do not initiate it using Cervantes short form scale (C-SF), and analyze sociodemographic factors associated with lower QoL in women. STUDY DESIGN: A cross-sectional descriptive observational study was made in four hundred and eighty women with climacteric symptoms. RESULTS: Mean age was 51.1 years. Two hundred and sixty-one women (54.3 %) started MHT. The sample´s global mean in C-SF score was 51.3 ± 13.9. Women who choose to use MHT have higher score in C-SF (lower QoL) than women who reject it (58.7 ± 15.9 vs 46.7 ± 12.8; p < 0.001). We found higher score in women with early menopause (53.7 ± 15.9 vs 49.7 ± 13.1; p = 0.037); with no obesity (<30 vs >30 BMI) (52.8 ± 13.5 vs 41.0 ± 8.2; p = 0.002); with previous malignancies (56.2 ± 18.2 vs 50.2 ± 13.5; p = 0.020) and without sexual activity (58.0 ± 25.4 vs 50.4 ± 13.1; p = 0.009. No differences were found in C-SF score with respect to tobacco habits or physical activity. In the multivariate analysis, the variable independently associated to lower QoL by C-SF (high score) was to be a woman who want to initiate MHT (p = 0.004). CONCLUSIONS: Women who choose to use MHT due to menopausal symptoms have lower quality of life measured by C-SF scale. Women with early menopause, with no obesity (<30 BMI), without sexual activity and with previous malignances have lower quality of life measured by C-SF scale. Women with early menopause have more psychic symptoms like nervousness, fatigue and sleep complaints by C-SF scale than women with natural menopause.

Role of lymphadenectomy in intermediate-risk endometrial cancer: a matched-pair study.

OBJECTIVE: To assess the impact of lymph node dissection (LND) on morbidity, survival, and cost for intermediate-risk endometrial cancers (IREC). METHODS: A multicenter retrospective cohort of 720 women with IREC (endometrioid histology with myometrial invasion <50% and grade 3; or myometrial invasion ≥50% and grades 1-2; or cervical involvement and grades 1-2) was carried out. All patients underwent hysterectomy and bilateral salpingo-oophorectomy. A matched pair analysis identified 178 pairs (178 with LND and 178 without it) equal in age, body mass index, co-morbidities, American Society of Anesthesiologist score, myometrial invasion, and surgical approach. Demographic data, pathology results, perioperative morbidity, and survival were abstracted from medical records. Disease-free survival (DFS) and overall survival (OS) was analyzed using Kaplan-Meier curves and multivariate Cox regression analysis. Cost analysis was carried out between both groups. RESULTS: Both study groups were homogeneous in demographic data and pathologic results. The mean follow-up in patients free of disease was 61.7 months (range, 12.0-275.5). DFS (hazard ratio [HR]=1.34; 95% confidence interval [CI]=0.79-2.28) and OS (HR=0.72; 95% CI=0.42-1.23) were similar in both groups, independently of nodes count. In LND group, positive nodes were found in 10 cases (5.6%). Operating time and late postoperative complications were higher in LND group (p<0.05). Infection rate was significantly higher in no-LND group (p=0.035). There were no statistical differences between both groups regarding operative morbidity and hospital stay. The global cost was similar for both groups. CONCLUSION: Systematic LND in IREC has no benefit on survival, although it does not show an increase in perioperative morbidity or global cost.

Colposcopy combined with dynamic spectral imaging. A prospective clinical study.

OBJECTIVE: To analyze the value of dynamic spectral imaging (DSI) compared to, and as an adjunct to, conventional colposcopy (CC) in the diagnosis of cervical intraepithelial neoplasia (CIN). STUDY DESIGN: Four hundred seventy-nine women referred for colposcopy after an abnormal Pap-smear (≥ASC-US) to the Low Genital Tract Unit of the San Carlos Clinical Hospital in Madrid, Spain during the years 2012-2014 were examined simultaneously by CC and DSI. Thirty-six cases (8.1%) were excluded because the DSI map was not calculated. The gold standard for comparisons was the final histological diagnosis performed by punch biopsy or LEEP. RESULTS: Out of the 443 cases, 293 were found to be negative for CIN, 109 had CIN1 and 41 were found with CIN2+. The sensitivity of CC to detect those with CIN2+ lesions was 73.2% and the specificity 92.3%. Using the DSI map as an adjunct, led to a statistically significant increase of the sensitivity to 87.8% with a concomitant drop in specificity to 85.6%. The adjunctive use of DSI increased the sensitivity for CIN2+ also in the high-risk group of the 65 cases with an identified HPV16/18 infection; CC had a sensitivity of 88.9%, which increased to 100%. The specificity dropped from 91.1% to 87.5%. CONCLUSIONS: Combining conventional colposcopy with DSI mapping improves the capability to detect cervical lesions.

Correlating the accuracy of colposcopy with practitioner experience when diagnosing cervical pathology using the dynamic spectral imaging system.

BACKGROUND/AIMS: To assess the performance of colposcopists and correlate it with their experience when diagnosing cervical pathology by reviewing conventional colposcopy (CC) digital images and the Dynamic Spectral Imaging System (DySIS) cervical map. METHODS: Images from 50 women with normal and abnormal cervix collected during CC and the corresponding DySIS maps were projected consecutively to 63 participating colposcopists. Participants were asked for their diagnosis (normal, abnormal findings or cancer). The clinical experience of the participants was divided into low (n = 27), medium (n = 18) and high (n = 18), considering the number of colposcopies each one performed routinely. RESULTS: The mean of overall correct diagnoses was significantly higher with DySIS than CC for the low and medium experience group (20.4 vs. 24.4, and 21.9 vs. 26.0, respectively; p < 0.001), but not in the high experience group. The correct diagnosis was significantly higher with DySIS than CC for all experience groups in cases with a normal cervix and cervical intraepithelial neoplasia 2+ (CIN2+), but not for those with CIN1. All groups agreed that DySIS guides biopsies better, offers more information and allows performing colposcopy even without extensive experience. CONCLUSIONS: The results of evaluating projected colposcopy images were more successful with DySIS than with CC in the diagnosis of cervical pathology, especially among less experienced colposcopists.

Impact of the lymphadenectomy in high-risk histologic types of endometrial cancer: a matched-pair study.

OBJECTIVE: The aim of this study is to assess the impact of lymphadenectomy (LND) on morbidity, survival, and cost for high-risk histologic types of endometrial cancer (EC). MATERIALS AND METHODS: We analyzed a multicenter retrospective cohort of 389 women with high-risk histotypes of EC (poor differenced tumors [G3], clear cell, serous papillary, and mixed mesodermal tumors) preoperatively confined to the corpus and diagnosed between 2000 and 2013. All patients underwent hysterectomy and bilateral salpingo-oophorectomy. A matched-pair analysis identified 97 pairs (97 with LDN and 97 without) equal in age, body mass index, comorbidities, International Federation of Gynecology and Obstetrics stage, and adjuvant treatment. Demographic data, pathologic examination results, perioperative morbidity, and survival were abstracted from medical records. Cost was provided by the cost unit of the local hospital. Disease-free and overall survival were analyzed using the Kaplan-Meier curves and Cox multivariable regression analysis. RESULTS: Both study groups were homogeneous in demographic data and pathologic examination results. At a median follow-up of 24.5 months (range, 5.4-146.3), disease-free survival (hazard ratio, 1.09; 95% confidence interval, 0.70-1.90) and overall survival (hazard ratio, 0.86; 95% confidence interval, 0.56-1.33) were similar in both groups regardless of nodal count. Positive nodes were found in 23.7%. Predictor factors of nodal involvement were advanced age (P = 0.024), deep myometrial invasion (P < 0.001), and high CA 125 levels (P = 0.003). In the LDN group, operating time, late postoperative complications, and surgical cost were higher (P < 0.05). There were no statistical differences between both groups relative to surgical morbidity. Early postoperative complications and hospital stay were lower in the LDN group. The global cost was similar for both groups (6027&OV0556; for the LND group and 5772&OV0556; for the no-LND group). CONCLUSIONS: Lymphadenectomy in high-risk histotypes of EC does not increase perioperative morbidity or global cost and has not benefit on survival.

Comparison of perioperative outcomes and cost between robotic-assisted and conventional laparoscopy for transperitoneal infrarenal para-aortic lymphadenectomy (TIPAL).

STUDY OBJECTIVE: To compare perioperative outcomes and cost of robotic-assisted and laparoscopic transperitoneal infrarenal para-aortic lymphadenectomy (TIPAL) for treatment of gynecologic malignant conditions. DESIGN: Prospective non-randomized study (Canadian Task Force classification II-2). SETTING: Tertiary center for women's health. PATIENTS: Sixty-two patients with gynecologic cancer operated on by the same surgical team. INTERVENTIONS: Thirty-two patients underwent TIPAL via robotic-assisted laparoscopy, and 30 via conventional laparoscopy. Comparison analyses of perioperative outcomes and estimated costs were performed. MEASUREMENTS AND MAIN RESULTS: There were no differences between robotic-assisted and laparoscopy insofar as age, body mass index, presurgical morbidity, operating time (92.5 minutes for robotics vs 96.6 minutes for laparoscopy), number of aortic nodes (12 vs. 12), hospitalization stay (2 vs. 2 days), or rate of complications (12.5% vs. 13.3%). Blood loss tended to be lower in the robotic group (75.0 vs. 92.5 mL; p = .08). Surgical cost was higher in the robotic group ($3.42 vs. $2.55; p < .001), although hospitalization cost was similar. CONCLUSION: Robotic-assisted and laparoscopy provide similar perioperative outcomes. However, the robotic-assisted approach is associated with higher surgical cost.

Comparison of perioperative outcomes and cost of robotic-assisted laparoscopy, laparoscopy and laparotomy for endometrial cancer.

OBJECTIVE: To analyze the perioperative outcomes and cost of three surgical approaches in the treatment of endometrial cancer: robotic, laparoscopy and laparotomy. STUDY DESIGN: We studied 347 patients with endometrial cancer treated in a single institution: 71 patients were operated by robotics, 84 by conventional laparoscopy and 192 by laparotomy. All patients underwent total hysterectomy, bilateral salpingoophorectomy and pelvic and para-aortic lymphadenectomy depending on the pathological features. RESULTS: Operative time was longer in the laparoscopy group as compared to robotics and laparotomy (218.2 min, 189.2 min, and 157.4 min respectively, p=0.000). The estimated blood loss was lower in the robotic group relative to the other groups (99.4 ml in robotic, 190.0 ml in laparoscopy and 231.5 ml in laparotomy, p=0.000). Similar findings were observed for the pre- and post-operative mean hemoglobin levels (-1.3g/dl, -2.3g/dl and -2.5 g/dl respectively, p=0.000), and transfusion rate (4.2%, 7.1% and 14.1% respectively, p=0.036). The length of hospital stay was higher in the laparotomy group compared to robotics and laparoscopy (8.1, 3.5 and 4.6 days respectively; p=0.000). The conversion rate to laparotomy was lower for robotics (2.4% for robotics and 8.1% for laparoscopy, p=0.181). Overall complications were similar for robotics and laparoscopy (21.1%, 28.5%) (p=0.079). Robotic complications were significantly lower as compared to laparotomy (21.2 vs 34.9% (p=0.036). No differences were found relative to disease-free or overall survival among the three groups. The global costs were similar for the three approaches (p=0.566). CONCLUSION: Robotics is a safe alternative to laparoscopy and laparotomy for endometrial cancer patients, offering improved perioperative outcomes and similar cost as compared to the other two surgical approaches.