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OBJECTIVE: COVID-19 vaccination has been related to menstrual irregularities; however, the effect on postmenopausal women is unknown. The aim of this study was to analyze the prevalence of postmenopausal bleeding (PMB) after COVID-19 vaccination. METHODS: A retrospective study was conducted in the Department of Gynecology in Hospital del Mar. Consecutive postmenopausal women with data available and endometrial biopsy were included between February 2021 and January 2022. Patients were stratified between COVID-19 vaccinated and unvaccinated groups. PMB after 30 days from last vaccine dose was considered unrelated to vaccine. Endometrial pathology diagnoses were stratified into benign or malignant. Univariable and multivariable of regression analysis on variables potentially associated with PMB was performed. RESULTS: A total of 381 patients were included, 91 in the vaccinated group and 290 in the unvaccinated group. Prevalence of PMB in the vaccinated group was 75.8% compared to 59.0% in the unvaccinated group (p < 0.005). No increase in endometrial malignant pathology was observed among the vaccinated group (p = 0.189). Multivariable analysis that correlates factors associated with PMB suggests COVID-19 vaccine and malignant endometrial biopsy as independent risk variables. CONCLUSIONS: A higher prevalence of PMB was associated with COVID-19 vaccine. Endometrial histological results showed no association with COVID-19 vaccination, but endometrial biopsy should be performed for PMB.
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OBJECTIVE: Incisional hernias are a common complication of midline laparotomies. The aim of this study was to determine the impact of prophylactic mesh placement after midline laparotomy for ovarian tumors on the incidence of incisional hernia. METHODS: We collected retrospective data from patients undergoing midline laparotomy for borderline or ovarian cancer with at least 12 months of follow-up, including those with and without mesh. Patient demographics, preoperative characteristics and risk factors for hernia were reported and grouped according to prophylactic mesh placement. A multivariate analysis was conducted to identify independent risk factors for incisional hernia. Kaplan-Meier curves illustrating the cumulative incidence of incisional hernia based on mesh placement were performed. RESULTS: A total of 139 consecutive patients with available data were included, 58 in the non-mesh group and 81 in the mesh group, with high body mass index (BMI) as the most common reason for mesh placement. The mean (SD)) age was 60 years (13.97). A total of 11 patients (7.9%) had borderline tumors while 128 (92.1%) had invasive cancer. After clinical and radiological examination, 18.7% (26/139) of patients developed incisional hernia at a median follow-up of 35.8 months (IQR) 43.8): 31% (18/58) were detected in the non-mesh group, and 9.9% (8/81) in the mesh group (p<0.002). Multivariate analysis showed no-mesh placement (OR) 10; 95% CI) 2.8 to 35.919; p<0.001) as a significant risk factor for incisional hernia. Age ≥70 (OR 4.3; 95% CI 1.24 to 15; p=0.02) and BMI ≥29 (OR 4.4; 95% CI 1.27 to 14.93; p=0.019) were also identified as independent risk factors for hernia development. According to Kaplan-Meier curves, the cumulative incidence of incisional hernia was higher in the non-mesh group (p=0.002). CONCLUSION: The incidence of incisional hernia was high in patients undergoing midline laparotomy for ovarian tumors. The addition of a prophylactic mesh may reduce this incidence, therefore there is a need to consider it as an option for high-risk patients, particularly those aged over 70 years or with a BMI ≥29 kg/m2.
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Human Papillomavirus (HPV) prophylactic vaccination has proven effective in preventing new infections, but it does not treat existing HPV infections or associated diseases. Hence, there is still an important reservoir of HPV in adults, as vaccination programs are mainly focused on young women. The primary objective of this non-randomized, open-label trial is to evaluate if a 3-dose regimen of Gardasil-9 in HPV16/18-positive women could reduce the infective capacity of their body fluids. We aim to assess if vaccine-induced antibodies could neutralize virions present in the mucosa, thus preventing the release of infective particles and HPV transmission to sexual partners. As our main endpoint, the E1^E4-HaCaT model will be used to assess the infectivity rate of cervical, anal and oral samples, obtained from women before and after vaccination. HPV DNA positivity, virion production, seroconversion, and the presence of antibodies in the exudates, will be evaluated to attribute infectivity reduction to vaccination. Our study will recruit two different cohorts (RIFT-HPV1 and RIFT-HPV2) of non-vaccinated adult women. RIFT-HPV1 will include subjects with an HPV16/18 positive cervical test and no apparent cervical lesions or cervical lesions eligible for conservative treatment. RIFT-HPV2 will include subjects with an HPV16/18 positive anal test and no apparent anal lesions or anal lesions eligible for conservative treatment, as well as women with an HPV16/18 positive cervical test and HPV-associated vulvar lesions. Subjects complying with inclusion criteria for both cohorts will be recruited to the main cohort, RIFT-HPV1. Three doses of Gardasil-9 will be administered intramuscularly at visit 1 (0 months), visit 2 (2 months) and visit 3 (6 months). Even though prophylactic HPV vaccines would not eliminate a pre-existing infection, our results will determine if HPV vaccination could be considered as a new complementary strategy to prevent HPV-associated diseases by reducing viral spread. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05334706.
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Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18 , Papillomavirus Humano 16 , Papillomavirus Humano 18 , Infecções por Papillomavirus , Adolescente , Adulto , Feminino , Humanos , Adulto Jovem , Anticorpos Antivirais/imunologia , Colo do Útero/virologia , DNA Viral , Papillomavirus Humano 16/imunologia , Papillomavirus Humano 18/imunologia , Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18/administração & dosagem , Vacina Quadrivalente Recombinante contra HPV tipos 6, 11, 16, 18/imunologia , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/virologia , Infecções por Papillomavirus/imunologia , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/imunologia , Vacinação/métodos , Ensaios Clínicos como Assunto , Estudos de Avaliação como AssuntoRESUMO
OBJECTIVES: Enhanced recovery after surgery (ERAS) and prehabilitation programs are multidisciplinary care pathways that aim to reduce stress response and improve perioperative outcomes. However, literature is limited regarding the impact of ERAS and prehabilitation in gynecologic oncology surgery. The aim of this study was to assess the impact of implementing an ERAS and prehabilitation program on post-operative outcomes of endometrial cancer patients undergoing laparoscopic surgery. METHODS: We evaluated consecutive patients undergoing laparoscopy for endometrial cancer that followed ERAS and the prehabilitation program at a single center. A pre-intervention cohort that followed the ERAS program alone was identified. The primary outcome was length of stay, and secondary outcomes were normal oral diet restart, post-operative complications and readmissions. RESULTS: A total of 128 patients were included: 60 patients in the ERAS group and 68 patients in the prehabilitation group. The prehabilitation group had a shorter length of hospital stay of 1 day (p<0.001) and earlier normal oral diet restart of 3.6 hours (p=0.005) in comparison with the ERAS group. The rate of post-operative complications (5% in the ERAS group and 7.4% in the prehabilitation group, p=0.58) and readmissions (1.7% in the ERAS group and 2.9% in the prehabilitation group, p=0.63) were similar between groups. CONCLUSIONS: The integration of ERAS and a prehabilitation program in endometrial cancer patients undergoing laparoscopy significantly reduced hospital stay and time to first oral diet as compared with ERAS alone, without increasing overall complications or the readmissions rate.
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Neoplasias do Endométrio , Recuperação Pós-Cirúrgica Melhorada , Humanos , Feminino , Exercício Pré-Operatório , Complicações Pós-Operatórias/prevenção & controle , Procedimentos Cirúrgicos em Ginecologia , Tempo de Internação , Neoplasias do Endométrio/cirurgiaRESUMO
BACKGROUND: Cytoreductive surgery followed by systemic chemotherapy is the standard of treatment in advanced ovarian cancer where feasible. Neoadjuvant chemotherapy (NACT) followed by surgery is applicable where upfront cytoreductive surgery is not feasible because of few certain reasons. Nevertheless, surgical interventions and the chemotherapy itself may be associated with postoperative complications usually entailing slow postoperative recovery. Prehabilitation programs consist of the patient's preparation before surgery to improve the patient's functional capacity. The aim of this study was to evaluate the impact of a prehabilitation program during neoadjuvant treatment and interval cytoreductive surgery for ovarian cancer patients. METHODS: A retrospective observational pilot study of patients with advanced ovarian cancer treated with NACT and interval cytoreductive surgery was conducted. The prehabilitation group received a structured intervention based on physical exercise, nutritional counseling, and psychological support. Nutritional parameters were assessed preoperatively and postoperatively, and functional parameters and perioperative and postoperative complications were also recorded. RESULTS: A total of 29 patients were included in the study: 14 in the prehabilitation group and 15 in the control group. The patients in the prehabilitation program showed higher mean total protein levels in both preoperative (7.4 vs. 6.8, p = 0.004) and postoperative (4.9 vs. 4.3, p = 0.005) assessments. Up to 40% of controls showed intraoperative complications vs. 14.3% of patients in the prehabilitation group, and the requirement of intraoperative blood transfusion was significantly lower in the prehabilitation group (14.3% vs. 53.3%, p = 0.027). The day of the first ambulation, rate of postoperative complications, and length of hospital stay were similar between the groups. Finally, trends towards shorter time between diagnosis and interval cytoreductive surgery (p = 0.097) and earlier postoperative diet restart (p = 0.169) were observed in the prehabilitation group. CONCLUSION: Prehabilitation during NACT in women with ovarian cancer candidates to interval cytoreductive surgery may improve nutritional parameters and thereby increase postoperative recovery. Nevertheless, the results of this pilot study are preliminary, and further studies are needed to determine the clinical impact of prehabilitation programs.
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Terapia Neoadjuvante , Neoplasias Ovarianas , Quimioterapia Adjuvante/métodos , Procedimentos Cirúrgicos de Citorredução/métodos , Feminino , Humanos , Terapia Neoadjuvante/métodos , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/cirurgia , Projetos Piloto , Exercício Pré-Operatório , Estudos RetrospectivosRESUMO
OBJECTIVE: Invasive cervical cancer is considered a young women's disease, however up to 20 % of cases develop cervical cancer at advanced ages. The aim was to characterize invasive cervical cancer in women aged 65 and older assessing age-specific survival differences. STUDY DESIGN: A retrospective study including cervical cancer patients was conducted at Hospital del Mar Barcelona from July-2007 to December-2016. Women were stratified: <65 or ≥65years. Clinical and pathological data were collected. Multivariate analysis was used to compare outcomes. Adjusted hazard ratios with 95 % confidence intervals for disease-free survival, and overall survival were estimated using Cox proportional hazards models. RESULTS: 124 patients with invasive cervical cancer (n = 87 < 65years and n = 37 ≥ 65years) were included. At diagnosis, 48.3 % of <65years patients were diagnosed at advanced stages, while 64.9 % in ≥65years (p = 0.018). Standard treatment was given to 83.9 % of patients in <65years group compared to 62.2 % in ≥65years (p = 0.015). Disease-free survival and overall survival showed no significant differences between groups. Age ≥65 did not predict worse disease-free survival (HR: 0.3 95 %CI, 0.04-3.1, p = 0.347) or overall survival (HR: 0.82 95 %CI, 0.3-2.3, p = 0.729). CONCLUSION: Invasive cervical cancer was diagnosed at advanced stages and was treated less frequently with radical intention in patients ≥65years; overall survival and disease-free survival were similar to those cervical cancer diagnosed at younger ages.
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Neoplasias do Colo do Útero , Intervalo Livre de Doença , Feminino , Humanos , Estadiamento de Neoplasias , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Neoplasias do Colo do Útero/patologiaRESUMO
The SARS-CoV-2 (COVID-19) pandemic has significantly impacted the management of patients with gynecologic cancers. Many centers have reduced access to routine visits to avoid crowded waiting areas and specially to reduce the infection risk for oncologic patients. The goal of this review is to propose a surveillance algorithm for patients with gynecologic cancers during the COVID-19 pandemic based on existing evidence and established guidelines. It is time to consider strategies based on telemedicine and to adapt protocols in this new era. We hereby propose a strategy for routine surveillance both during and beyond the pandemic.
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COVID-19/epidemiologia , Neoplasias dos Genitais Femininos/epidemiologia , Telemedicina/métodos , Algoritmos , Feminino , Neoplasias dos Genitais Femininos/diagnóstico , Neoplasias dos Genitais Femininos/terapia , Humanos , SARS-CoV-2/isolamento & purificaçãoRESUMO
Patients undergoing major surgery are predisposed to a decrease in functional capacity as a response to surgical stress that can delay post-operative recovery. A prehabilitation program consists of patient preparation strategies before surgery, and include pre-operative measures to improve functional capacity and enhance post-operative recovery. Multimodal prehabilitation may include exercise, nutritional counseling, psychological support, and optimization of underlying medical conditions, as well as cessation of unfavorable health behaviors such as smoking and drinking. Currently, there are no standardized guidelines for prehabilitation, and the existent studies are heterogeneous; however, multimodal approaches are likely to have a greater impact on functional outcomes than single management programs. We have reviewed the literature on prehabilitation in general, and in gynecologic surgery in particular, to identify tools to establish an optimal prehabilitation program within an Enhanced Recovery After Surgery (ERAS) protocol for gynecologic oncology patients. We suggest a safe, reproducible, functional, and easy-to-apply multimodal prehabilitation program for gynecologic oncology practice based on patient-tailored pre-operative medical optimization, physical training, nutritional counseling, and psychological support. The analysis of the prehabilitation program implementation in an ERAS protocol should undergo further research in order to test the efficacy on surgical outcome and recovery after surgery.
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Recuperação Pós-Cirúrgica Melhorada , Neoplasias dos Genitais Femininos/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Cuidados Pré-Operatórios/métodos , Feminino , Neoplasias dos Genitais Femininos/reabilitação , Procedimentos Cirúrgicos em Ginecologia/normas , Humanos , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To evaluate the spontaneous progression of cervical intraepithelial neoplasia grade 2 (CIN2) in accordance with Chlamydia trachomatis (chlamydia) serology. METHODS: A prospective observational study included women diagnosed with CIN2 by cervical biopsy and managed conservatively for 24 months at Hospital del Mar, Barcelona, between December 2011 and October 2013. Serum anti-chlamydia immunoglobulin G (IgG), previous cytology, and high-risk human papillomavirus (HPV) genotyping were recorded at baseline. The outcome was regression, persistence, or progression of CIN2. RESULTS: Overall, 93 women aged 18-56 years were enrolled. Spontaneous regression was observed for 61 (66%) women, and 21 (23%) progressed to CIN3. Eight (9%) women had chlamydia seropositivity at baseline. Multivariate analysis showed that anti-chlamydia IgG seropositivity (odds ratio [OR], 19.1; 95% confidence interval [CI], 1.9-189.7), previous high-grade squamous intraepithelial lesion cytology (OR, 5.0; 95% CI, 1.7-14.6), and HPV16 (OR, 4.8; 95% CI, 1.7-13.7) increased the risk of CIN2 persistence or progression. CONCLUSION: Women with CIN2 and chlamydia IgG seropositivity had increased risk of progression to CIN2+ and immediate treatment may be recommended for these women. Larger clinical studies are needed to confirm the results, but chlamydia serology might be introduced into CIN2 management to better individualize treatment.