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2.
Int J Gynecol Cancer ; 2024 Sep 11.
Artículo en Inglés | MEDLINE | ID: mdl-39266205

RESUMEN

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.

3.
Healthcare (Basel) ; 12(16)2024 Aug 13.
Artículo en Inglés | MEDLINE | ID: mdl-39201172

RESUMEN

The operating room is the environment where harm to the patient is most likely. Robotic surgery was listed as one of the top 10 health hazards as late as 2020. Taking inspiration from other fields of application, such as aeronautics, checklists have been increasingly implemented in medical practice over the years, becoming essential components of the operating theatre. In addition to checklists, simulation has taken on a fundamental importance in reducing errors. This paper aims to provide a narrative review to assess the importance of checklists and training in robotic surgery and how they improve the outcome. A comprehensive literature search from January 2000 to September 2023 was conducted. A total of 97 articles were included in the initial search. Eleven studies were deemed relevant and were considered eligible for full-text reading. Among these, ten studies focused on the analysis of training effectiveness. An article in our review assessed the benefits of introducing checklists in the operating room. Innovations created in aviation, such as checklists and simulation, have entered the medical field to prevent human error. Developing dedicated checklist and surgical teams, through theoretical and practical training, has become essential in modern medicine. Tools such as checklists, training, and simulation are among the best methods to reduce adverse medical events.

4.
Front Public Health ; 12: 1417250, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39171296

RESUMEN

Introduction: Surgical-related injuries are frequent, in fact the reported percentage of musculoskeletal disorders in surgeons is between 47% and 87%. These conditions are caused by long periods of standing, incorrect postures, repeated movements, little rest between operations, the lack of integrated operator rooms, the correct number and arrangement of monitors and the use of non-ergonomic instruments. This survey aims to assess the Italian overview both highlighting how prevalent surgical-related injury is in our surgeons and whether there is an operating room ergonomics education program in Italian surgical specialty schools. Methods: An anonymous questionnaire was designed through SurveyMonkey© web application. This survey was composed of 3 different sections concerning the general characteristics of the participants, their surgical background and any training performed, and any injuries or ailments related to the surgical activity. The survey was carried out in the period 1th of December 2022 and the 6th of February 2023. Results: At the close of our survey, 300 responses were collected. Among the participants, the two most represented specialties were Gynecology and Obstetrics (42.3%) and General Surgery (39.7%) and surgeons were mainly employed in the Northern regions of Italy (54.8%). Analyzing the participants' background, 61.7% of the respondents had laparoscopic training during their training and only 53.1% had a pelvic trainer during their residency. In accordance with 98.7% of the respondents, during surgery we have the feeling of being in an uncomfortable position that causes discomfort or muscle pain, and regarding the frequency of these discomforts, the majority of our study population experiences these problems monthly (46.2%), while in 29.6% it is experienced weekly, 12.1% annually and finally 12.1% daily. The surgical approach that is most correlated with these disorders is laparoscopy (62.7%) while the one that causes the least discomfort is robotic surgery (1.4%). These discomforts cause 43.9% of our population to take a break or do short exercises to reduce pain during surgery, and the body areas most affected are the back (61.6%), neck (40.6%) and shoulders (37.8%). Conclusion: Despite this, our survey allows us to highlight some now-known gaps present in the surgical training program of our schools and the lack of protection toward our surgeons during their long career.


Asunto(s)
Ergonomía , Enfermedades Musculoesqueléticas , Quirófanos , Humanos , Italia , Quirófanos/estadística & datos numéricos , Encuestas y Cuestionarios , Femenino , Masculino , Adulto , Enfermedades Musculoesqueléticas/prevención & control , Persona de Mediana Edad , Cirujanos/educación , Cirujanos/estadística & datos numéricos , Enfermedades Profesionales/prevención & control , Enfermedades Profesionales/epidemiología
5.
Eur J Surg Oncol ; 50(9): 108526, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39024693

RESUMEN

INTRODUCTION: Although the management of gynecological cancers recurrences may be challenging, due to the heterogeneity of recurrent disease, the aim of this work is to present a descriptive analysis of gynecological malignancies recurrences in our institution treated by robotic approach. MATERIALS AND METHODS: We performed a retrospective review and analysis of data of patients who underwent robotic surgery for recurrent gynecological malignancies at Catholic University of the Sacred Hearth, Rome, from January 2013 to January 2024. RESULTS: A total of 54 patients underwent successful robotic cytoreductive surgery. The median age was 63 years; the median BMI was 33 kg/m2 and most of the patients (59 %) were obese. In 12 cases (22 %) the relapse presented was the second or third relapse. The most frequent patterns of recurrence were represented by lymph nodes (41 %), followed by peritoneal (26 %), pelvic (22 %) and parenchymal (11 %). In all patients complete cytoreduction was achieved. In 29 patients (54 %) the surgical field was previous treated. The median operative time and estimated blood loss were, respectively, 270 min and 100 ml. There were 2 intraoperative complications, managed endoscopically; 10 early postoperative complications, and 3 late postoperative complications. The 2-year progression-free-survival and overall survival were, respectively, 39.8 % and 72.3 %. CONCLUSION: Robotic approach in the treatment of recurrent gynecological cancers should be considered in selected patients with oligometastatic disease, in high-volume centers with expert surgeons, particularly in obese patients.


Asunto(s)
Procedimientos Quirúrgicos de Citorreducción , Neoplasias de los Genitales Femeninos , Recurrencia Local de Neoplasia , Procedimientos Quirúrgicos Robotizados , Humanos , Femenino , Procedimientos Quirúrgicos Robotizados/métodos , Persona de Mediana Edad , Estudios Retrospectivos , Anciano , Neoplasias de los Genitales Femeninos/cirugía , Neoplasias de los Genitales Femeninos/patología , Procedimientos Quirúrgicos de Citorreducción/métodos , Adulto , Tempo Operativo , Neoplasias Endometriales/cirugía , Neoplasias Endometriales/patología , Complicaciones Posoperatorias/epidemiología , Neoplasias Peritoneales/secundario , Neoplasias Peritoneales/cirugía , Neoplasias Ováricas/cirugía , Neoplasias Ováricas/patología , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Metástasis Linfática , Obesidad/complicaciones , Anciano de 80 o más Años
6.
Eur J Obstet Gynecol Reprod Biol ; 300: 287-295, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39053089

RESUMEN

BACKGROUND: Endometriosis has been associated with sleep disorders, and hyperarousal appears to be involved in their pathogenesis; however, the presence of hyperarousal in the endometriosis population was never investigated. METHODS: We conducted a case-control survey study by sending a questionnaire to all endometriosis patients followed up at our Centers. Controls were recruited among the general population. The questionnaire included demographic information, symptoms and history of endometriosis, the Hyperarousal Scale (H-Scale), the Pittsburgh Sleep Quality Index (PSQI), and the Insomnia Severity Index (ISI). RESULTS: A total of 847 women completed the questionnaires: 430 (50.8 %) had endometriosis, and 417 (49.2 %) were controls. Endometriosis was associated with higher H-scale score (OR 2.9, 95 % CI 2.4-3.8, p = 0.000), higher PSQI score (OR 4.3, 95 % CI 3.2-5.7, p = 0.000), and higher ISI score (OR 4.6, 95 % CI 3.5-6.1, p = 0.000) in multivariable ordinal logistic regressions analysis. With path analysis, hyperarousal (H-Scale) reported a partial mediating role in the association between endometriosis and sleep disorders. The mediation effect represented 22.3-27.8 % of the entire association between endometriosis and sleep disturbances. CONCLUSION: Endometriosis patients complaining sleep disorders may benefit by investigating the presence of hyperarousal given cognitive behavioral therapy was reported effective in improving hyperarousal and associated sleep disorders.


Asunto(s)
Endometriosis , Trastornos del Sueño-Vigilia , Humanos , Femenino , Endometriosis/complicaciones , Adulto , Estudios de Casos y Controles , Trastornos del Sueño-Vigilia/epidemiología , Encuestas y Cuestionarios , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Nivel de Alerta/fisiología , Calidad del Sueño
7.
Eur J Obstet Gynecol Reprod Biol ; 299: 322-328, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38968783

RESUMEN

BACKGROUND: Tubal ectopic pregnancy (EP) is a life-threatening condition, especially if undiagnosed or misdiagnosed, tipically in low income countries and/or where women have limited access to health care. The current management protocol of tubal EP consists of either surgical management, or medical management with methotrexate. Recent studies, while few, have suggested that letrozole, an aromatase inhibitor, may play a role in the medical treatment of tubal EP. OBJECTIVES: To evaluate the effectiveness of letrozole alone in the medical treatment of tubal EP. SEARCH STRATEGY: Electronic databases were searched until 31 December 2023. SELECTION CRITERIA: Retrospective or prospective studies reporting the treatment of tubal EP with letrozole alone were considered eligible for inclusion. DATA COLLECTION AND ANALYSIS: Pooled results were expressed as OR with 95 %CI. Heterogeneity was assessed using Higgins I2. Subgroup analysis was performed to compare outcomes according to time after intervention. Subgroup differences were checked through χ2 test. RESULTS: A total of 152 patients were included. Seventy-nine patients (51.97 %) were treated with letrozole, 39 patients (16.54 %) with methotrexate, and 34 patients (31.49 %) underwent surgical treatment. Pooled data analysis supports the consistency of the effect of letrozole in reducing ß-hCG over time at a comparable rate among studies, and that treatment with letrozole is superior to surgery and has the same efficacy as methotrexate. However, all the included studies were judged at high risk of bias in terms of study design, sample representativeness, and sampling technique. Furthermore, short and long term side effects were not reported in any of the included studies. CONCLUSIONS: Letrozole is a promising alternative to methotrexate and surgical therapy in the treatment of tubal EP. Although this meta-analysis suggests efficacy and low hazard of the drug and encourages its application, the data available today remain extremely sparse, which weakens any claims that can be made, and is not sufficient to assert that letrozole is safe and effective in the treatment of EPs. There is an absolute need for randomized studies with accurate patient selection, fixed doses, large sample sizes, and reporting of short- and long-term side effects to refute or confirm this assumption.


Asunto(s)
Inhibidores de la Aromatasa , Letrozol , Metotrexato , Embarazo Tubario , Humanos , Letrozol/uso terapéutico , Femenino , Embarazo , Metotrexato/uso terapéutico , Inhibidores de la Aromatasa/uso terapéutico , Embarazo Tubario/tratamiento farmacológico , Embarazo Tubario/cirugía , Abortivos no Esteroideos/uso terapéutico , Resultado del Tratamiento
8.
Int J Gynecol Cancer ; 34(8): 1133-1139, 2024 Aug 05.
Artículo en Inglés | MEDLINE | ID: mdl-39002981

RESUMEN

OBJECTIVE: To assess if the use of a V-Y reconstructive flap after excisional radical surgery positively influences the surgical outcomes in patients with vulvar cancer. METHODS: This was a multicenter, retrospective, controlled study. Surgical outcomes and complication rates of women with invasive vulvar cancer who underwent radical surgery and vulvar reconstruction and those who underwent radical surgery without the reconstruction step were compared. Only patients who underwent bilateral or unilateral V-Y advancement fascio-cutaneous flaps were included in the reconstruction group. Univariate and multivariate logistic regression models were used to analyze predicting variables for their association with complication rates. RESULTS: Overall, 361 patients were included: 190 (52%) underwent the reconstructive step after the excisional radical procedure and were compared with 171 (47.4%) who did not undergo the reconstructive step. At multivariate analysis, body mass index >30 kg/m2 (odds ratio (OR) 3.36, p=0.007) and diabetes (OR 2.62, p<0.022) were independently correlated with wound infection. Moreover, increasing age (OR 1.52, p=0.009), body mass index >30 kg/m2 (OR 3.21, p=0.002,) and International Federation of Gynecology and Obstetrics (FIGO) stages III-IV (OR 2.25, p=0.017) were independent predictors of wound dehiscence. A significant reduction in the incidence of postoperative wound complications among patients who underwent V-Y reconstructive flaps was demonstrated. This was correlated more significantly in women with lesions >4 cm. CONCLUSIONS: The adoption of V-Y flaps in vulvar surgery was correlated with reduced surgical related complications, particularly in vulnerable patients involving large surgical defects following excisional radical procedures.


Asunto(s)
Procedimientos de Cirugía Plástica , Colgajos Quirúrgicos , Neoplasias de la Vulva , Humanos , Femenino , Neoplasias de la Vulva/cirugía , Neoplasias de la Vulva/patología , Estudios Retrospectivos , Persona de Mediana Edad , Procedimientos de Cirugía Plástica/métodos , Anciano , Adulto , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Anciano de 80 o más Años , Carcinoma de Células Escamosas/cirugía , Carcinoma de Células Escamosas/patología
9.
Artículo en Inglés | MEDLINE | ID: mdl-39031095

RESUMEN

OBJECTIVE: To evaluate complication rate and functional outcomes of nerve-sparing parametrectomy for deep endometriosis in relation to the extension of the surgical procedure, based on recognizable anatomical landmarks. METHODS: This was a prospective single-center study including all patients undergoing parametrectomy for deep endometriosis from September 2020 to June 2023 at our tertiary center. Dorsolateral parametrectomies were divided into parametrectomies medial to the presacral fascia and cranial to the medial rectal artery (superficial parametrectomy), and parametrectomies in which one of the two landmarks was overcome during the surgical procedure, leading to the excision of tissue lateral to the presacral fascia (deep parametrectomy type 1, or DP1) or caudal to the medial rectal artery (DP2). Finally, we used the hypogastric fascia as landmark to define type 3 deep parametrectomy (DP3), when the procedure was deeply lateral to the fascia. RESULTS: Bladder voiding deficit occurred in 9.7% of cases, with higher rates in DP2 (20.8%) and DP3 (30%) groups. Regarding postoperative gastrointestinal function, our data showed a significant improvement over time in all groups, with the exception of DP2; instead an improvement in postoperative bladder function was only shown in DP3. Parametrectomy was not associated with a simultaneous improvement in sexual function expressed with the female sexual function index, in any of the four groups. CONCLUSION: Our classification constitutes a concrete approach for comparing, in a standardized way, the complications and functional outcomes of parametrectomy, which, even if carried out by expert surgeons, demonstrates a non-negligible rate of bladder voiding deficit.

10.
Taiwan J Obstet Gynecol ; 63(4): 500-505, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-39004476

RESUMEN

Lower extremity lymphedema (LEL) is a common complication following surgical staging of endometrial cancer. LEL is a chronic condition associated with significant impact on patient morbidity and quality of life (QoL). This review aimed to report the current evidence in the literature on secondary LEL after surgical staging for endometrial cancer, focusing on the incidence based on different approaches to lymph node staging, diagnosis, risk factors, and the impact on QoL. Due to the absence of a standardized agreement regarding the methodology for evaluating LEL, the documented frequency of occurrence fluctuates across different studies, ranging from 0% to 50%. Systematic pelvic lymphadenectomy appears to be the primary determinant associated with the emergence of LEL, whereas the implementation of sentinel lymph node biopsy has notably diminished the occurrence of this lymphatic complication after endometrial cancer staging. LEL is strongly associated with decreased QoL, lower limb function, and negative body image, and has a detrimental impact on cancer-related distress reported by survivors. Standardization of lymphedema assessment is needed, along with cross-cultural adaptation of subjective outcome measures for self-reported LEL. The advent of sentinel lymph node mapping represents the ideal approach for accurate nodal assessment with less short- and long-term morbidity. Further research is needed to definitively assess the prevalence and risk factors of LEL and to identify strategies to improve limb function and QoL in cancer survivors with this chronic condition.


Asunto(s)
Neoplasias Endometriales , Extremidad Inferior , Escisión del Ganglio Linfático , Linfedema , Estadificación de Neoplasias , Calidad de Vida , Humanos , Femenino , Linfedema/etiología , Neoplasias Endometriales/cirugía , Neoplasias Endometriales/patología , Extremidad Inferior/cirugía , Escisión del Ganglio Linfático/efectos adversos , Factores de Riesgo , Biopsia del Ganglio Linfático Centinela/efectos adversos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Incidencia
11.
Cancers (Basel) ; 16(14)2024 07 15.
Artículo en Inglés | MEDLINE | ID: mdl-39061181

RESUMEN

Cervical cancer continues to have a significant incidence, despite global efforts in HPV vaccination campaigns. Managing this condition involves a diverse team of healthcare professionals. Research in this field is undergoing a period of great revolution in multiple areas, and international guidelines will soon have to adapt to new scientific evidence. This could be true mainly in locally advanced stages, and it could also be true for minimal invasive surgery. This paper aims to summarize and compare the most recent recommendations published by international gynecological oncological societies for patients with cervical cancer. From their comparison, common aspects and disagreements emerged, especially in the diagnostic pathway and follow-up strategies. Several issues that remain to be debated in the literature were addressed and compared, highlighting similarities and differences, from the role of the sentinel lymph node in early stages to that of the adjuvant hysterectomy in locally advanced tumors. On the surgical side, for this last subset of patients, currently, a laparotomic approach is recommended. At the same time, the advent of immunotherapy has just opened up new and promising scenarios in systemic treatment for locally advanced cervical cancer, and international guidelines will soon introduce it into their algorithms.

12.
Artículo en Inglés | MEDLINE | ID: mdl-38995862

RESUMEN

BACKGROUND: Indocyanine green (ICG) is a visible near-infrared fluorescent dye. Several studies have reported its benefit in identifying important anatomical structures, tissue vascularization, and sentinel lymph nodes in the case of tumors. Studies have shown that ICG is critical and safe in gynecologic surgeries. However, research on how ICG dye can help surgeons in laparoscopic surgeries correctly identify the course of the ureter has yet to be further investigated. METHOD: This cross-sectional study enrolled 62 gynecology attending and resident surgeons who were asked to identify the course of the ureter on images of laparoscopic surgeries. The results were then compared with images in which ICG dye highlighted the course of the ureter. The purpose of this study was to detect the ability of surgical assistants and residents to adequately identify the course of the ureter in laparoscopic pelvic surgeries. RESULTS: No statistically significant differences were found in terms of year of residency, years of experience, number of laparoscopic procedures attended, and correct identification of ureter course. ICG proved useful in identifying the correct ureteral trajectory. CONCLUSIONS: ICG can be a valuable tool to improve the correct identification of ureters and improve surgical outcomes.

13.
Eur J Surg Oncol ; 50(9): 108467, 2024 09.
Artículo en Inglés | MEDLINE | ID: mdl-38901291

RESUMEN

OBJECTIVE: To investigate the safety of sentinel node mapping for patients with early-stage cervical cancer undergoing cervical conization plus nodal evaluation. METHODS: The ETERNITY project is a retrospective, multi-institutional study collecting data of patients with early-stage cervical cancer undergoing fertility-sparing treatment. Here, we compared outcomes related to three methods of nodal assessment: sentinel node mapping (SNM), SNM plus backup lymphadenectomy (SNM + LND); pelvic lymphadenectomy (LND). RESULTS: Charts of 123 patients (with stage IA1-IB1 cervical cancer) were evaluated. Median patients' age was 34 (range, 22-44) years. SNM, SNM + LND, and LND were performed in 32 (26 %), 31 (25.2 %), and 60 (48.8 %) patients, respectively. Overall, eight (6.5 %) patients were diagnosed with positive nodes. Two (3.3 %), three (9.7 %), and three (9.4 %) patients were detected in patients who had LND, SNM + LND, and SNM respectively. Considering the 63 patients undergoing SNM (31 SNM + LND and 32 SNM alone), macrometastases, micrometastases, and isolated tumor cells were detected in four (3.2 %), three (2.4 %), and one (0.8 %) patients, respectively. All patients with positive nodes discontinued the fertility sparing treatment. Other two patients (one (1.7 %) in the LND group and one (3.1 %) in the SNM group) required hysterectomy even after negative nodal evaluation. After a median follow-up of 53.6 (range, 1.3, 158.0) months, nine (7.3 %) and two (1.6 %) patients developed cervical and pelvic nodes recurrences, respectively. Disease-free (p = 0.332, log-rank test) and overall survival (p = 0.769, log-rank test) were similar among groups. CONCLUSIONS: In this retrospective experience, SNM upholds long-term oncologic effectiveness of LND, reducing morbidity.


Asunto(s)
Preservación de la Fertilidad , Escisión del Ganglio Linfático , Estadificación de Neoplasias , Biopsia del Ganglio Linfático Centinela , Neoplasias del Cuello Uterino , Humanos , Femenino , Neoplasias del Cuello Uterino/patología , Neoplasias del Cuello Uterino/cirugía , Adulto , Escisión del Ganglio Linfático/métodos , Estudios Retrospectivos , Preservación de la Fertilidad/métodos , Biopsia del Ganglio Linfático Centinela/métodos , Metástasis Linfática , Ganglio Linfático Centinela/patología , Conización/métodos , Adulto Joven , Carcinoma de Células Escamosas/cirugía , Carcinoma de Células Escamosas/patología
14.
Artículo en Inglés | MEDLINE | ID: mdl-38910100

RESUMEN

In women with proven infertility and deep endometriosis (DE), optimal management is controversial. To date, there is no clear evidence on the association between infertility and different stages of rASRM, nor is there clear guidance from leading scientific societies for surgical treatment of DE patients. A comprehensive literature search was conducted on the main databases for English-language trials describing the effectiveness of surgery for DE in patients with proven infertility; 16 studies were deemed eligible for inclusion in this systematic review (CRD42024498888). Quantitative analysis was not possible because of the heterogeneity of the data. A descriptive summary of the results according to location of pathology, surgical technique used, and whether assisted reproductive technology (ART) was needed or not was provided. A total of 947 infertile women were identified, 486 of whom became pregnant, with an average pregnancy rate of 51.3%. Our review suggests that surgery can be of valuable help in improving reproductive outcomes by improving the results of ART. It has not been possible to reach robust conclusions on the outcomes of surgery based on the location of DE because of the heterogeneity of evidence available to date. Overall, although some data encourage first-line surgical management, further investigation is needed to determine its effective application before or after ART failure.


Asunto(s)
Endometriosis , Infertilidad Femenina , Índice de Embarazo , Técnicas Reproductivas Asistidas , Humanos , Femenino , Endometriosis/cirugía , Endometriosis/complicaciones , Infertilidad Femenina/cirugía , Infertilidad Femenina/etiología , Embarazo
15.
Eur J Obstet Gynecol Reprod Biol ; 299: 213-218, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38897097

RESUMEN

OBJECTIVE: To evaluate the use of oral nomegestrol acetate/estradiol in random start rapid preparation of endometrium before office hysteroscopic polypectomy. STUDY DESIGN: Multicenter, prospective, randomized controlled trial. SETTING: University hospitals. PARTICIPANTS: 80 adult women undergoing office hysteroscopic polypectomy between January 2023 and March 2024 were randomized to intervention (n = 40) or control (n = 40). Exclusion criteria included the presence of endouterine pathology other than endometrial polyps solely. METHODS: Subjects in the intervention group were treated with oral nomegestrol acetate/estradiol 1.5 mg/2.5 mg/day started taking the drug from an indefinite time in the menstrual cycle (random start) for 14 days. Subjects in the control group did not receive any pharmaceutical treatment and underwent polypectomy between days 8 and 11 of the menstrual cycle. RESULTS: On the day of the procedure, the difference in pre- and post-office hysteroscopic polypectomy endometrial ultrasound thickness was statistically significant between the two groups, with endometrial thickness in both measurements being thinner for the intervention group (p < 0.001). In the nomegestrol acetate/estradiol-treated group, compared with the control, there was also a statistically significant difference in the physician's assessment of the quality of endometrial preparation (p < 0.001), the quality of visualization of the uterine cavity (p < 0.001), and satisfaction with the performance of the procedure (p < 0.001). Finally, all surgical outcomes analyzed were better in the treatment group. CONCLUSION: Treatment with nomegestrol acetate/estradiol could provide rapid, satisfactory and low-cost preparation of the endometrium before office polypectomy, thus improving surgical performance and woman's compliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT06316219.


Asunto(s)
Endometrio , Estradiol , Histeroscopía , Megestrol , Norpregnadienos , Pólipos , Humanos , Femenino , Histeroscopía/métodos , Estradiol/administración & dosificación , Endometrio/cirugía , Endometrio/efectos de los fármacos , Endometrio/diagnóstico por imagen , Endometrio/patología , Adulto , Norpregnadienos/administración & dosificación , Norpregnadienos/uso terapéutico , Megestrol/administración & dosificación , Megestrol/uso terapéutico , Pólipos/cirugía , Pólipos/diagnóstico por imagen , Persona de Mediana Edad , Estudios Prospectivos , Administración Oral , Enfermedades Uterinas/cirugía , Enfermedades Uterinas/tratamiento farmacológico , Cuidados Preoperatorios/métodos
16.
Eur J Surg Oncol ; 50(7): 108436, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38820923

RESUMEN

INTRODUCTION: The study aimed to validate the Betella algorithm, focusing on molecular analyses exclusively for endometrial cancer patients, where molecular classification alters risk assessment based on ESGO/ESTRO/ESP 2020 guidelines. MATERIALS AND METHODS: Conducted between March 2021 and March 2023, the retrospective research involved endometrial cancer patients undergoing surgery and comprehensive molecular analyses. These included p53 and mismatch repair proteins immunohistochemistry, as well as DNA sequencing for POLE exonuclease domain. We applied the Betella algorithm to our population and evaluated the proportion of patients in which the molecular analysis changed the risk class attribution. RESULTS: Out of 102 patients, 97 % obtained complete molecular analyses. The cohort exhibited varying molecular classifications: 10.1 % as POLE ultra-mutated, 30.3 % as mismatch repair deficient, 11.1 % as p53 abnormal, and 48.5 % as non-specified molecular classification. Multiple classifiers were present in 3 % of cases. Integrating molecular classification into risk group calculation led to risk group migration in 11.1 % of patients: 7 moved to lower risk classes due to POLE mutations, while 4 shifted to higher risk due to p53 alterations. Applying the Betella algorithm, we can spare the POLE sequencing in 65 cases (65.7 %) and p53 immunochemistry in 17 cases (17.2 %). CONCLUSION: In conclusion, we externally validated the Betella algorithm in our population. The application of this new proposed algorithm enables assignment of the proper risk class and, consequently, the appropriate indication for adjuvant treatment, allowing for the rationalization of the resources that can be allocated otherwise, not only for the benefit of settings with low resources, but of all settings in general.


Asunto(s)
Algoritmos , ADN Polimerasa II , Neoplasias Endometriales , Proteína p53 Supresora de Tumor , Humanos , Neoplasias Endometriales/genética , Neoplasias Endometriales/patología , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Proteína p53 Supresora de Tumor/genética , ADN Polimerasa II/genética , Mutación , Inmunohistoquímica , Proteínas de Unión a Poli-ADP-Ribosa/genética , Medición de Riesgo/métodos , Reparación de la Incompatibilidad de ADN , Anciano de 80 o más Años , Adulto , Análisis de Secuencia de ADN/métodos
17.
Gynecol Obstet Invest ; : 1-11, 2024 May 08.
Artículo en Inglés | MEDLINE | ID: mdl-38718761

RESUMEN

OBJECTIVES: The objective of the study was to evaluate the prevalence and impact of impaired thyroid-stimulating hormone (TSH) levels on the reproductive outcomes of in vitro fertilization patients diagnosed with endometriosis and compared to controls without endometriosis. DESIGN: This is a retrospective cohort study on prospectively collected data. SETTING: The study was conducted at tertiary care university hospital. PARTICIPANTS: Participants were infertile women with histopathological diagnosis of endometriosis. METHODS: For 12 months (January 2018 to January 2019), women were deemed suitable and subsequently divided according to serum TSH levels above or below 2.5 mIU/L and compared to patients without endometriosis. Needed sample size was at least 41 patients for each cohort of women. Co-primary outcomes were the live birth rate (LBR), clinical pregnancy rate (CPR), and pregnancy loss rate (PLR). RESULTS: Overall, 226 women (45 with endometriosis and 181 controls without endometriosis) were included. Diagnoses of Hashimoto thyroiditis were significantly more frequent in women with rather than without endometriosis (14/45 [31.1%] vs. 27/181 [14.9%]; p = 0.012). Similarly, in women with endometriosis, Hashimoto diagnosis rates were higher with TSH ≥2.5 mIU/L compared to TSH <2.5 mIU/L (9/15 [60%] vs.5/30 [16.6%]; p = 0.001) so were the Hashimoto diagnosis rates in control group (women without endometriosis) with TSH ≥2.5 mIU/L compared to TSH <2.5 mIU/L (17/48 [35.4%] vs. 10/133 [7.5%], respectively; p = 0.001). Effect size analysis confirmed an increased risk of Hashimoto thyroiditis in women with endometriosis and TSH ≥2.5 mIU/L compared to women with endometriosis and TSH <2.5 mIU/L (risk ratio [RR] 3.60 [95% CI 1.46-8.86]) and in women with endometriosis and TSH ≥2.5 mIU/L compared to non-endometriotic euthyroid patients (RR 7.98 [95% CI 3.86-16.48]). Dysmenorrhea risk was higher in endometriotic euthyroid women compared to euthyroid patients with no endometriosis (RR 1.87 [95% CI 1.21-2.87]). The risk was still increased in euthyroid women with endometriosis relative to dysthyroid women with no endometriosis (RR 1.97 [95% CI 1.11-3.50]). There were no significant differences between the four groups for CPR, LBR, PLR and retrieved oocytes, immature oocytes, degenerated and unfertilized oocytes, cultured blastocysts, embryos and transferred embryos. LIMITATIONS: Limitations of the study were retrospective design, limited sample size, and use of different ovarian stimulation protocol. CONCLUSIONS: Thyroid autoimmunity seems more common in women with endometriosis and TSH over 2.5 mIU/L. However, there was no significant impact on in vitro fertilization and reproductive outcomes related to the coexistence of endometriosis, Hashimoto disease, and higher TSH levels. Due to limitations of the study, additional evidence is required to validate the abovementioned findings.

18.
Curr Oncol ; 31(5): 2796-2804, 2024 05 14.
Artículo en Inglés | MEDLINE | ID: mdl-38785493

RESUMEN

INTRODUCTION: In recent years, generative Artificial Intelligence models, such as ChatGPT, have increasingly been utilized in healthcare. Despite acknowledging the high potential of AI models in terms of quick access to sources and formulating responses to a clinical question, the results obtained using these models still require validation through comparison with established clinical guidelines. This study compares the responses of the AI model to eight clinical questions with the Italian Association of Medical Oncology (AIOM) guidelines for ovarian cancer. MATERIALS AND METHODS: The authors used the Delphi method to evaluate responses from ChatGPT and the AIOM guidelines. An expert panel of healthcare professionals assessed responses based on clarity, consistency, comprehensiveness, usability, and quality using a five-point Likert scale. The GRADE methodology assessed the evidence quality and the recommendations' strength. RESULTS: A survey involving 14 physicians revealed that the AIOM guidelines consistently scored higher averages compared to the AI models, with a statistically significant difference. Post hoc tests showed that AIOM guidelines significantly differed from all AI models, with no significant difference among the AI models. CONCLUSIONS: While AI models can provide rapid responses, they must match established clinical guidelines regarding clarity, consistency, comprehensiveness, usability, and quality. These findings underscore the importance of relying on expert-developed guidelines in clinical decision-making and highlight potential areas for AI model improvement.


Asunto(s)
Técnica Delphi , Neoplasias Ováricas , Guías de Práctica Clínica como Asunto , Humanos , Femenino , Inteligencia Artificial , Oncología Médica/métodos , Oncología Médica/normas
19.
Int J Gynecol Cancer ; 34(8): 1232-1239, 2024 Aug 05.
Artículo en Inglés | MEDLINE | ID: mdl-38821546

RESUMEN

OBJECTIVE: Poly (ADP-ribose) polymerase inhibitors (PARPi) have become a new standard of care for the maintenance treatment of advanced epithelial ovarian cancer. This study aims to evaluate the efficacy and safety of combining stereotactic body radiotherapy with PARPi continuation as a strategy to treat ovarian cancer oligoprogression on PARPi. METHODS: This is a multicenter retrospective study including ovarian cancer patients treated with stereotactic body radiotherapy and PARPi continuation for oligoprogression under PARPi maintenance therapy between June 2012 and May 2023 in three Italian centers. PARPi treatment was continued until further disease progression or unacceptable toxicity. The primary endpoint was the next-line systemic therapy-free interval. The Kaplan-Meier method was used to assess local control, progression-free survival, and overall survival. Univariate and multivariate Cox regression analyses were performed to evaluate potential clinical outcomes predictors. RESULTS: 46 patients were included, with a total of 89 lesions treated over 63 radiotherapy treatments. Lymph nodes were the most frequently treated lesions (80, 89.9%), followed by visceral lesions (8, 9%) and one case with a bone lesion (1.1%). Median follow-up was 25.9 months (range 2.8-122). The median next-line systemic therapy-free interval was 12.4 months (95% CI 8.3 to 19.5). A number of prior chemotherapy lines greater than five was significantly associated with a reduced next-line systemic therapy-free interval (HR 3.21, 95% CI 1.11 to 9.32, p=0.032). At the time of analysis, 32 (69.6%) patients started a new systemic therapy regimen, while 14 (30.4%) remained on the PARPi regimen. The 2-year progression-free survival, local failure-free survival, and overall survival rates were 10.7%, 78.1%, and 76.5%, respectively. Four patients (8.7%) experienced acute toxicity with G1 gastrointestinal events. CONCLUSION: Stereotactic body radiotherapy combined with PARPi continuation may be an effective and safe strategy for managing ovarian cancer patients with oligoprogression on PARPi maintenance therapy. Prospective research is warranted to shed more light on this approach.


Asunto(s)
Neoplasias Ováricas , Inhibidores de Poli(ADP-Ribosa) Polimerasas , Radiocirugia , Humanos , Femenino , Inhibidores de Poli(ADP-Ribosa) Polimerasas/administración & dosificación , Estudios Retrospectivos , Persona de Mediana Edad , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/patología , Neoplasias Ováricas/terapia , Neoplasias Ováricas/radioterapia , Anciano , Radiocirugia/métodos , Radiocirugia/efectos adversos , Adulto , Progresión de la Enfermedad , Anciano de 80 o más Años , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Carcinoma Epitelial de Ovario/radioterapia , Carcinoma Epitelial de Ovario/terapia , Supervivencia sin Progresión
20.
J Pers Med ; 14(4)2024 Apr 19.
Artículo en Inglés | MEDLINE | ID: mdl-38673060

RESUMEN

BACKGROUND: Despite pregnancy's hypercoagulable state, the correlation between inherited thrombophilia and thrombotic adverse pregnancy outcomes remains uncertain. The objective of this study was to determine the prevalence of inherited thrombophilic polymorphisms among asymptomatic pregnant individuals and to examine their potential correlation with adverse perinatal outcomes. METHODS: in this single-center prospective study, 105 healthy pregnant women were included. Genotyping was conducted for factor V Leiden (FVL), prothrombin gene mutation, methylenetetrahydrofolate reductase enzyme (MTHFR) C677T, MTHFR A1298C, and plasminogen activator inhibitor-1 (PAI-1), alongside the assessment of protein C (PC), protein S (PS), and antithrombin (AT) levels. The study analyzed the association between inherited thrombophilic polymorphisms and pregnancy complications linked to placental insufficiency, such as gestational hypertension (GH), preeclampsia (PE), intrauterine death (IUD), fetal growth restriction (FGR), and placental abruption. RESULTS: The prevalence of identifiable thrombophilic polymorphism mutations was 61.9% (95% confidence interval-CI 52.4-70.8%), with the most common single mutation being PAI-1 4G/5G (12/105, 11.4%, 95% CI 6.4-18.5). The most frequent combined mutation was heterozygosity for MTHFR C677T and PAI-1 (12/105, 11.4%, 95% CI 6.4-18.5). Notably, no FVL homozygous carriers or single homozygous and heterozygous carriers for prothrombin polymorphisms were found. Additionally, no deficiencies in PC and AT were detected among participants. Except for homozygosity for PAI-1, none of the studied polymorphisms demonstrated a significant association with pregnancy complications linked to placental insufficiency. CONCLUSIONS: The asymptomatic carriers of inherited thrombophilic polymorphisms do not have an increased risk of adverse perinatal outcomes.

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