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BACKGROUND: A strong correlation between breast cancer (BC) molecular subtypes and axillary status has been shown. It would be useful to predict the probability of lymph node (LN) positivity. OBJECTIVE: To develop the performance of multivariable models to predict LN metastases, including nomograms derived from logistic regression with clinical, pathologic variables provided by tumor surgical results or only by biopsy. METHODS: A retrospective cohort was randomly divided into two separate patient sets: a training set and a validation set. In the training set, we used multivariable logistic regression techniques to build different predictive nomograms for the risk of developing LN metastases. The discrimination ability and calibration accuracy of the resulting nomograms were evaluated on the training and validation set. RESULTS: Consecutive sample of 12,572 early BC patients with sentinel node biopsies and no neoadjuvant therapy. In our predictive macro metastases LN model, the areas under curve (AUC) values were 0.780 and 0.717 respectively for pathologic and pre-operative model, with a good calibration, and results with validation data set were similar: AUC respectively of 0.796 and 0.725. Among the list of candidate's regression variables, on the training set we identified age, tumor size, LVI, and molecular subtype as statistically significant factors for predicting the risk of LN metastases. CONCLUSIONS: Several nomograms were reported to predict risk of SLN involvement and NSN involvement. We propose a new calculation model to assess this risk of positive LN with similar performance which could be useful to choose management strategies, to avoid axillary LN staging or to propose ALND for patients with high level probability of major axillary LN involvement but also to propose immediate breast reconstruction when post mastectomy radiotherapy is not required for patients without LN macro metastasis.
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Neoplasias de la Mama/diagnóstico , Ganglios Linfáticos/patología , Modelos Biológicos , Fenotipo , Adulto , Anciano , Anciano de 80 o más Años , Biomarcadores de Tumor , Neoplasias de la Mama/genética , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/terapia , Femenino , Humanos , Ganglios Linfáticos/metabolismo , Metástasis Linfática , Persona de Mediana Edad , Clasificación del Tumor , Nomogramas , Estudios Retrospectivos , Biopsia del Ganglio Linfático Centinela , Carga TumoralRESUMEN
PURPOSE: The prevalence of pelvic organ prolapse (POP) is increasing. The number of women aged 70-80 years requiring surgical management for POP is also increasing. The purpose of this study was to compare the complications associated with three pelvic organ prolapse repair methods, sacrocolpopexy (SCP), native tissue repair (NTR), and vaginal mesh repair (VMR), in women aged 70-80 years. METHODS: We performed a multi-institutional retrospective analysis of 213 women who underwent POP surgical repairs between December 2012 and December 2017. Treatment-related complications were classified using the ClavienDindo grading system and compared among the three groups. Perioperative data, anatomical success rates, patient satisfaction, and postoperative complication data were collected during the follow-up period, which lasted up to 12 months. RESULTS: Of 213 patients, 70 (33%) underwent SCP, 85 (40%) underwent NTR, and 58 (28%) underwent VMR. By postoperative day 30, the all-inclusive complication rate was lower in the SCP group than in the NTR or VMR group; however, there was no between-group difference in complication grade. The VMR group underwent fewer concomitant hysterectomies than the other groups, and operative time was the longest for SCP. Overall, recovery time, anatomical success rate, and patient satisfaction were comparable for all three repairs. CONCLUSIONS: All three surgical techniques were equivalent in patient satisfaction, anatomical success rate, and complication rate. SCP should be recommended to elderly women who meet criteria for prolonged general anesthesia, as it was associated with fewer perioperative complications than NTR and VMR.
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Procedimientos Quirúrgicos Ginecológicos/métodos , Diafragma Pélvico/cirugía , Prolapso de Órgano Pélvico/cirugía , Anciano , Femenino , Humanos , Estudios RetrospectivosRESUMEN
BACKGROUND: Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial ( ClinicalTrials.gov , number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included. METHODS: SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement. RESULTS: Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy. CONCLUSION: The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov , number NCT01717131 October 19, 2012.
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Neoplasias de la Mama/terapia , Escisión del Ganglio Linfático/métodos , Evaluación de Resultado en la Atención de Salud/métodos , Ganglio Linfático Centinela/patología , Adulto , Anciano , Anciano de 80 o más Años , Axila , Neoplasias de la Mama/patología , Quimioterapia Adyuvante/métodos , Femenino , Humanos , Modelos Logísticos , Persona de Mediana Edad , Análisis Multivariante , Micrometástasis de Neoplasia , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Biopsia del Ganglio Linfático CentinelaRESUMEN
PURPOSE: Benefit of adjuvant trastuzumab-based chemotherapy for node-positive and/or >1 cm human epidermal growth factor receptor 2-positive (HER2+) breast carcinomas has been clearly demonstrated in randomized clinical trials. Yet, evidence that adjuvant chemotherapy with or without trastuzumab is effective in pT1abN0 HER2+ tumors is still limited. The primary objective of this study was to investigate the impact of adjuvant chemotherapy ± trastuzumab on outcome in this subpopulation. PATIENTS AND METHODS: A total of 356 cases of pT1abN0M0 HER2 + breast cancers were retrospectively identified from a large cohort of 22,334 patients, including 1248 HER2+ patients who underwent primary surgery at 17 French centers, between December 1994 and January 2014. The primary end point was disease-free survival (DFS). A multivariate Cox model was built, including adjuvant chemotherapy, tumor size, hormone receptor status, and Scarff Bloom Richardson (SBR) grade. RESULTS: A total of 138 cases (39%) were treated with trastuzumab-based chemotherapy, 29 (8%) with chemotherapy alone, and 189 (53%) received neither trastuzumab nor chemotherapy. Adjuvant chemotherapy ± trastuzumab was associated with a significant DFS benefit (3-year 99 vs. 90%, and 5-year 96 vs. 84%, Hazard ratio, HR 0.26 [0.10-0.67]; p = 0.003, logrank test) which was maintained in multivariate analysis (HR 0.19 [0.07-0.52]; p = 0.001). Metastasis-free survival was also increased (HR 0.25 [0.07-0.86]; p = 0.018, logrank test) at 3-year (99 vs. 95%) and 5-year (98 vs. 89%) censoring. Exploratory subgroup analysis found DFS benefit to be significant in hormone receptor-negative, hormone receptor-positive, and pT1b tumors, but not in pT1a tumors. CONCLUSIONS: Adjuvant chemotherapy ± trastuzumab is associated with a significantly reduced risk of recurrence in subcentimeter node-negative HER2+ breast cancers. Most of the benefit may be driven by pT1b tumors.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/metabolismo , Receptor ErbB-2/metabolismo , Adulto , Anciano , Anciano de 80 o más Años , Biomarcadores de Tumor , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Quimioterapia Adyuvante , Femenino , Humanos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Clasificación del Tumor , Estadificación de Neoplasias , Trastuzumab/administración & dosificación , Resultado del Tratamiento , Carga Tumoral , Adulto JovenRESUMEN
BACKGROUND: To estimate the proportion of elderly patients (>70 years) with breast cancer eligible for an Exclusive IntraOperative RadioTherapy (E-IORT) and to evaluate their local recurrence-free survival rate. METHODS: This retrospective study examining two cohorts focuses on patients over 70 years old: a multi-centric cohort of 1411 elderly patients and a mono-centric cohort of 592 elderly patients. All patients underwent conservative surgery followed by external radiotherapy for T0-T3 N0-N1 invasive breast cancer, between 1980 and 2008. RESULTS: Within each cohort two groups were identified according to the inclusion criteria of the RIOP trial (R group) and TARGIT E study (T group). Each group was divided into two sub-groups, patients eligible (E) or non-eligible (nE) for IORT. The population of patients that were eligible in the TARGIT E study but not in the RIOP trial were also studied in both cohorts. The proportion of patients eligible for IORT was calculated, according to the eligibility criteria of each study. A comparison of the 5-year local or locoregional recurrence-free survival rate between eligible vs non-eligible patients was made. In both cohorts, the proportion of patients eligible according to the RIOP trial's eligibility criteria was 35.4 and 19.3%, and according to the TARGIT E study criteria was 60.9 and 45.3%. The 5-year locoregional recurrence-free survival rate was not significantly different between RE and RnE groups, TE and TnE groups. In both cohorts RE and (TE-RE) groups were not significantly different. CONCLUSIONS: Our results encourage further necessary studies to define and to extend the eligibility criteria for per operative exclusive radiotherapy.
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Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Carcinoma Ductal de Mama/radioterapia , Carcinoma Ductal de Mama/cirugía , Mastectomía , Radioterapia Adyuvante , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Carcinoma Ductal de Mama/mortalidad , Supervivencia sin Enfermedad , Femenino , Humanos , Cuidados Intraoperatorios , Persona de Mediana Edad , Selección de Paciente , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
PURPOSE: Persistent urinary retention (UR) is a complication of 3.5-14.3% of patients having undergone deep pelvic endometriosis (DPE) surgery of posterior compartment, and it is prone to persist. The purpose of this study is to identify surgical procedures and clinical circumstances associated with persistent UR, and consider its treatment. METHODS: We undertook a multi-center retrospective study studying medical records of patients who had surgery for DPE between January 2005 and December 2012. Patients who suffered from UR defined as a post-void residual (PVR) volume >100 mL needing intermittent self-catheterizations more than 30 days after surgery were included. Preoperative data (functional complaints, clinical examination, imaging, medical treatment) were recorded. Types of surgery and detailed postoperative urinary symptoms were noted. RESULTS: 881 patients had surgery for DPE and 16 patients were included (1.8%). In 93.8% of cases, a lesion of posterior compartment was clinically significant. Mean lesion size was 28.8 ± 7.3 mm. Colorectal resection and colpectomy were necessary in 93.8 and 87.5% of cases, respectively. Loss of bladder sensation and straining during urination were the two most common post-operative symptoms. 11 patients still required self-catheterization up to 1 year after the intervention. CONCLUSIONS: Patients with increased risks of UR present with a symptomatic and clinically palpable deep pelvic endometriotic lesion of the posterior compartment. Treatment implies surgery with colorectal resection. Bilateral resection of utero-sacral ligaments and posterior colpectomy tend to increase that risk. Complications due to PVR volume and straining during urination may be prevented by self-catheterization.
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Cateterismo/efectos adversos , Endometriosis/cirugía , Enfermedades del Recto/cirugía , Retención Urinaria/etiología , Adulto , Anciano , Endometriosis/diagnóstico , Femenino , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Trastornos Urinarios/epidemiología , Trastornos Urinarios/etiologíaRESUMEN
BACKGROUND: We wished to estimate the proportion of patients with breast cancer eligible for an exclusive targeted intraoperative radiotherapy (TARGIT) and to evaluate their survival without local recurrence. METHODS: We undertook a retrospective study examining two cohorts. The first cohort was multicentric (G3S) and contained 7580 patients. The second cohort was monocentric (cohort 2) comprising 4445 patients. All patients underwent conservative surgery followed by external radiotherapy for invasive breast cancer (T0-T3, N0-N1) between 1980 and 2005. Within each cohort, two groups were isolated according to the inclusion criteria of the TARGIT A study (T group) and RIOP trial (R group).In the multicentric cohort (G3S) eligible patients for TARGIT A and RIOP trials were T1E and R1E subgroups, respectively. In cohort number 2, the corresponding subgroups were T2E and R2E. Similarly, non-eligible patients were T1nE, R1nE and T2nE, and R2nE.The eligible groups in the TARGIT A study that were not eligible in the RIOP trial (TE-RE) were also studied. The proportion of patients eligible for TARGIT was calculated according to the criteria of each study. A comparison was made of the 5-year survival without local or locoregional recurrence between the TE versus TnE, RE versus RnE, and RE versus (TE-RE) groups. RESULTS: In G3S and cohort 2, the proportion of patients eligible for TARGIT was, respectively, 53.2% and 33.9% according the criteria of the TARGIT A study, and 21% and 8% according the criteria of the RIOP trial. Survival without five-year locoregional recurrence was significantly different between T1E and T1nE groups (97.6% versus 97% [log rank=0.009]), R1E and R1nE groups (98% versus 97.1% [log rank=0.011]), T2E and T2nE groups (96.6% versus 93.1% [log rank<0. 0001]) and R2E and R2nE groups (98.6% versus 94% [log rank=0.001]). In both cohorts, no significant difference was found between RE and (TE-RE) groups. CONCLUSIONS: Almost 50% of T0-2 N0 patients could be eligible for TARGIT.
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Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/diagnóstico , Estudios de Cohortes , Terapia Combinada , Femenino , Humanos , Persona de Mediana Edad , Recurrencia Local de Neoplasia/diagnóstico , Recurrencia Local de Neoplasia/radioterapia , Recurrencia Local de Neoplasia/cirugía , Estudios Retrospectivos , Análisis de Supervivencia , Adulto JovenRESUMEN
Although benign, pelvic organ prolapse is a real public health problem, affecting mostly women above sixty-five. Eighty-year-old women have an 11.1% lifetime risk of undergoing surgery for prolapse or stress urinary incontinence and 29% will need a second procedure. Surgical approach may be abdominal (sacrocolpopexy by laparotomy, laparoscopy or robot-assisted) or vaginal (autologous, or prosthetic reinforcement). In addition to anatomical correction, surgical objectives include: improvement of the patient's quality of life, prolapse symptoms relief, normal urinary, digestive and sexual functions and especially, avoiding iatrogenic sequelae. Thus, the choice of the surgical approach does not only depend upon the site and the severity of the prolapse. Urogynecological surgeons should take into consideration the patient's expectations and life style, her age--a determinant factor in deciding upon the best approach -, and her relapse risk factors. They should master both approaches, and the management of surgical complications. Therefore, an apprenticeship in a reference pelviperineology center is a must. In addition, surgeons should be aware of and consider contraindications to each procedure, for instance contraindications to transvaginal prosthesis reinforcement like risk factors of bad healing or infection. Urogynecology specialists have to take into consideration known anatomical and functional results of each technique as cited in the medical literature and act in accordance with international recommendations. The surgery's main objective is to ameliorate the patient's discomfort and her quality of life without causing iatrogenic dysfunctional symptoms (urinary, digestive, sexual). The pelvic organ prolapse being a benign pathology, the patient's satisfaction is the main marker of the procedure success. In short, regarding the surgical management of pelvic organ prolapse in women the answer to the question How to choose the best approach? is not binary. It depends on several factors, and regardless of the choice, it must
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Toma de Decisiones , Procedimientos Quirúrgicos Ginecológicos/métodos , Participación del Paciente , Prolapso de Órgano Pélvico/cirugía , Femenino , HumanosRESUMEN
Genital prolapse is a frequent functional pathology in women. Its surgical treatment depends specially upon the suspension and fixation of the vaginal vault. Thus, sacrocolpopexy has become a gold standard technique to correct genital prolapse. Laparoscopy is a procedure resulting in less bleeding and decreased hospital stay than open sacrocolpopexy and is presently the approach of choice. Its objective and subjective correction rates are > 90%. Some authors proposed a dual abdominal and perineal approach to help fixing the posterior mesh and repairing the perineal body. Robotics is the actual surgeons' gadget.Its results are similar to laparoscopic sacrocolpopexy albeit a higher cost and a longer operating time. The ideal mesh is monofilamentous with large pores. Sacrocolpopexy consists in fixing two meshes, one on the anterior vaginal wall and one on the posterior vaginal wall, on the anterior sacral ligament, without tension for the posterior mesh, with or without subtotal hysterectomy, and with closure of the peritoneum at the end. In the case of associated stress urinary incontinence, proved on the clinical exam or urodynamical exam, appropriate surgical treatment is done with sacrocolpopexy. In the near future, robotics will replace laparoscopy when costs will be reduced and medical staff well trained to perform robotic or robot-assisted sacrocolpopexy.
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Procedimientos Quirúrgicos Ginecológicos/métodos , Laparoscopía , Prolapso de Órgano Pélvico/cirugía , Femenino , HumanosRESUMEN
BACKGROUND: Results of IBCSG-23-01-trial which included breast cancer patients with involved sentinel nodes (SN) by isolated-tumor-cells or micro-metastases supported the non-inferiority of completion axillary-lymph-node-dissection (cALND) omission. However, current data are considered insufficient to avoid cALND for all patients with SN-micro-metastases. METHODS: To investigate the impact of cALND omission on disease-free-survival (DFS) and overall survival (OS), we analyzed a cohort of 1421 patients <75 years old with SN-micro-metastases who underwent breast conservative surgery (BCS). We used inverse probability of treatment weighting (IPTW) to obtain adjusted Kaplan-Meier estimators representing the experience in the analysis cohort, based on whether all or none had been subject to cALND omission. RESULTS: Weighted log-rank tests comparing adjusted Kaplan-Meier survival curves showed significant differences in OS (p-value = 0.002) and borderline significant differences in DFS (p-value = 0.090) between cALND omission versus cALND. Cox's regression using stabilized IPTW evidenced an average increase in the risk of death associated with cALND omission (HR = 2.77, CI95% = 1.36-5.66). Subgroup analyses suggest that the rates of recurrence and death associated with cALND omission increase substantially after a large period of time in the half sample of women less likely to miss cALND. CONCLUSIONS: Using IPTW to estimate the causal treatment effect of cALND in a large retrospective cohort, we concluded cALND omission is associated with an increased risk of recurrence and death in women of <75 years old treated by BCS in the absence of a large consensus in favor of omitting cALND. These results are particularly contributive for patients treated by BCS where cALND omission rates increase over time.
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Neoplasias de la Mama , Ganglio Linfático Centinela , Humanos , Femenino , Anciano , Biopsia del Ganglio Linfático Centinela , Metástasis Linfática/patología , Estudios Retrospectivos , Escisión del Ganglio Linfático/métodos , Ganglio Linfático Centinela/cirugía , Ganglio Linfático Centinela/patología , Neoplasias de la Mama/patología , Supervivencia sin Enfermedad , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patologíaRESUMEN
We report a case of a pregnancy and follow the delivery of a young woman who previously underwent a laparoscopic sacral colpopexy (LSC) for pelvic organ prolapse (POP). A 38-year-old woman with POP desires pregnancy who after unsuccessful medical treatment with pessary underwent a laparoscopic uterine ventrosuspension (LUV). However, this procedure also failed and there was an immediate relapse. Thus, LSC was then performed. After which, she became pregnant culminating in elective caesarean delivery. The LUV failure was documented by a POP-Q classification and dynamic pelvic magnetic resonance (PMR) which was carried out 1 month after the surgery. When the same assessment was conducted after the LSC, it showed an optimal POP correction. The short-term post-delivery follow-up exhibited a small prolapse relapse, which remained stable 48 months after surgery as confirmed by a new PMR. Surgical correction of POP is possible in women with pregnancy desires. The result is variable and links to the POP stage and other surgical interventions.
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Colposcopía/métodos , Procedimientos Quirúrgicos Ginecológicos/métodos , Laparoscopía/métodos , Prolapso de Órgano Pélvico/cirugía , Resultado del Embarazo , Adulto , Femenino , Humanos , Embarazo , Región Sacrococcígea , Suturas , Resultado del TratamientoRESUMEN
OBJECTIVE: Pelvic organ prolapse is a common condition among post-menopausal women, and surgery is often the standard treatment proposed. Native tissue vaginal surgery is burdened by a high rate of recurrence, and mesh vaginal surgery has become current practice. The purpose of this study was to evaluate the safety and the effectiveness of the vaginal kit Anterior/Apical single incision mesh Elevate™ for the correction of anterior and apical compartment prolapse. STUDY DESIGN: Data of patients with symptomatic anterior vaginal prolapse stage ≥ II, receiving mesh repair with the Anterior/Apical Elevate single incision system between January 2010 and January 2015 were retrieved. Prolapse was classified according to the POP-Q system. The main outcome measure was anatomical success, while subjective and safety outcomes were secondary outcomes. RESULTS: Anatomical success rate was 87.2 % for anterior compartment prolapse and 84.6 % for combined anterior and apical prolapse, while overall functional success rate was 96.2 % after a median follow-up of 33.6 months. The most frequent short-term complications were urinary bladder injury (3.0 %) and transient urinary retention (6.9 %). The most common long-term complications were de novo or persistent symptomatic stress urinary incontinence (10.8 %) and vaginal mesh extrusion (3.8 %). CONCLUSION: Mesh vaginal surgery with Anterior/Apical single incision mesh Elevate™ is a well-tolerated procedure with a very high anatomical and functional success rate. Short and long-term complications rate seem to be acceptable, and in most of cases, solvable. Further studies are needed to confirm our promising data.
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Prolapso de Órgano Pélvico , Incontinencia Urinaria de Esfuerzo , Femenino , Estudios de Seguimiento , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Humanos , Prolapso de Órgano Pélvico/cirugía , Mallas Quirúrgicas/efectos adversos , Resultado del Tratamiento , Incontinencia Urinaria de Esfuerzo/cirugía , Vagina/cirugíaRESUMEN
Based on results of clinical trials, completion ALND (cALND) is frequently not performed for patients with breast conservation therapy and one or two involved sentinel nodes (SN) by micro- or macro-metastases. However, there were limitations despite a conclusion of non-inferiority for cALND omission. No trial had included patients with SN macro-metastases and total mastectomy or with >2 SN macro-metastases. The aim of the study was too analyze treatment delivered and pathologic results of patients included in SERC trial. SERC trial is a multicenter randomized non-inferiority phase-3 trial comparing no cALND with cALND in cT0-1-2, cN0 patients with SN ITC (isolated tumor cells) or micro-metastases or macro-metastases, mastectomy or breast conservative surgery. We randomized 1855 patients, 929 to receive cALND and 926 SLNB alone. No significant differences in patient's and tumor characteristics, type of surgery, and adjuvant chemotherapy (AC) were observed between the two arms. Rates of involved SN nodes by ITC, micro-metastases, and macro-metastases were 5.91%, 28.12%, and 65.97%, respectively, without significant difference between two arms for all criteria. In multivariate analysis, two factors were associated with higher positive non-SN rate: no AC versus AC administered after ALND (OR = 3.32, p < 0.0001) and >2 involved SN versus ≤2 (OR = 3.45, p = 0.0258). Crude rates of positive NSN were 17.62% (74/420) and 26.45% (73/276) for patient's eligible and non-eligible to ACOSOG-Z0011 trial. No significant differences in patient's and tumor characteristics and treatment delivered were observed between the two arms. Higher positive-NSN rate was observed for patients with AC performed after ALND (17.65% for SN micro-metastases, 35.22% for SN macro-metastases) in comparison with AC administered before ALND.
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INTRODUCTION AND HYPOTHESIS: To evaluate clinical outcomes at 3 years following total transvaginal mesh (TVM) technique to treat vaginal prolapse. METHODS: Prospective, observational study in patients with prolapse ≥ stage II. Success was defined as POP-Q-stage 0-I and absence of surgical re-intervention for prolapse. Secondary outcome measures were: quality of life (QOL), prolapse-specific inventory (PSI), impact on sexual activity and complications. RESULTS: Ninety women underwent TVM repair, 72 a hysterectomy. Anatomical failure rate was 20.0% at 3 years. Three patients required re-intervention for prolapse. Improvements in QOL- and PSI-scores were observed at 1 and 3 years. Vaginal mesh extrusion occurred in 14.4% patients. After 3 years, 4.7% asymptomatic extrusions remained present. Of 61 sexually active women at baseline, a significant number of patients (41%) ceased sexual activity by 3 years; de novo dyspareunia was reported by 8.8%. One vesico-vaginal fistula resolved after surgery. CONCLUSION: Medium-term results demonstrate that the TVM technique provides a durable prolapse repair.
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Procedimientos Quirúrgicos Ginecológicos/métodos , Prolapso de Órgano Pélvico/cirugía , Mallas Quirúrgicas , Anciano , Femenino , Estudios de Seguimiento , Procedimientos Quirúrgicos Ginecológicos/instrumentación , Humanos , Estudios Longitudinales , Persona de Mediana Edad , Satisfacción del Paciente , Estudios Prospectivos , Calidad de Vida , Conducta Sexual , Resultado del TratamientoRESUMEN
Iliac and lumboaortic lymphadenectomy is a frequent component of surgical treatment for ovarian carcinomas. These procedures carry specific risks and have poorly known immunological consequences. Two prospective randomized studies, one informs limited to the pelvis and the other in advanced disease, suggest that lymphadenectomy improves disease-free survival but not overall survival, although these findings are controversial. Modern imaging techniques (CT MRI, PET scan) and per-operative palpation are less sensitive than exhaustive histological examination of excised nodes. If lymphadenectomy is performed, it must be complete, including the external and primary iliac and lumboaortic chains up to the left renal vein, independently of the tumor location, as the lymphatic drainage pathway is difficult to predict in this setting In addition to their diagnostic value, node clearance also has therapeutic value. The risk of lymphatic invasion depends on the disease stage, grade, and histological type. Lymphadenectomy is not necessary for early-stage disease and is only warranted in advanced stages if the surgery is complete or the tumor residue is smaller than one centimeter.
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Carcinoma/secundario , Escisión del Ganglio Linfático , Metástasis Linfática , Neoplasias Ováricas/cirugía , Carcinoma/mortalidad , Carcinoma/cirugía , Diagnóstico por Imagen , Supervivencia sin Enfermedad , Femenino , Humanos , Escisión del Ganglio Linfático/efectos adversos , Escisión del Ganglio Linfático/métodos , Metástasis Linfática/diagnóstico , Estadificación de Neoplasias , Neoplasias Ováricas/mortalidad , Neoplasias Ováricas/patología , Pelvis , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Sensibilidad y Especificidad , Análisis de SupervivenciaRESUMEN
PURPOSE: This study was designed to assess the safety and outcomes achieved with stapled transanal rectal resection vs. biofeedback training in obstructed defecation patients. METHODS: A total of 119 women patients who suffered from obstructed defecation with associated rectocele and rectal intussusception were randomized to stapled transanal rectal resection or biofeedback training. Stapled transanal rectal resection was performed by using two circular staplers to produce transanal full-thickness rectal resection. Primary outcome was symptoms of obstructed defecation resolution at 12 months; secondary outcomes included safety, change in quality of life score, and anatomic correction of rectocele and rectal intussusception. RESULTS: Fourteen percent (8/59) stapled transanal rectal resection and 50 percent (30/60) biofeedback training patients withdrew early. Eight (15 percent) patients treated with stapled transanal rectal resection and 1 (2 percent) biofeedback patient experienced adverse events. One serious adverse event (bleeding) occurred after stapled transanal rectal resection. Scores of obstructed defecation improved significantly in both groups as did quality of life (both P < 0.0001). Successful treatment was observed in 44 (81.5 percent) stapled transanal rectal resection vs. 13 (33.3 percent) evaluable biofeedback training patients (P < 0.0001). Functional benefit was observed early and remained stable during the study. CONCLUSIONS: In this controlled trial, stapled transanal rectal resection was well tolerated, was more effective than biofeedback training for the resolution of obstructed defecation symptoms, and improved quality of life, with minimal risk of impaired continence. Thus, stapled transanal rectal resection offers a new treatment alternative for obstructed defecation after failure of conservative measures including biofeedback training, a noninvasive approach.
Asunto(s)
Biorretroalimentación Psicológica , Intususcepción/terapia , Rectocele/terapia , Grapado Quirúrgico , Adulto , Anciano , Anciano de 80 o más Años , Canal Anal/cirugía , Estudios de Cohortes , Europa (Continente) , Femenino , Humanos , Intususcepción/complicaciones , Intususcepción/patología , Persona de Mediana Edad , Satisfacción del Paciente , Calidad de Vida , Recuperación de la Función , Rectocele/complicaciones , Rectocele/patología , Resultado del TratamientoRESUMEN
Introduction and hypothesis: Descending Perineum Syndrome (DPS) is a coloproctologic disease and the best treatment for it is yet to be defined. DPS is frequently associated with pelvic organ prolapse (POP) and it is reasonable to postulate, that treatment of POP will also have an impact on DPS. We aimed to evaluate the subjective satisfaction and improvement of DPS for patients who have undergone a sacral colpoperineopexy associated with retrorectal mesh for concomitant POP. Methods: This retrospective cohort study, conducted between February 2010 and May 2016 included all women who had undergone surgery to treat POP and DPS. Improvement of POP was assessed clinically and subjective satisfaction was assessed with a survey. Results: Among the 37 operated patients, 31 responded to the questionnaire and 77.4% were satisfied with this surgical procedure. 94.6% were objectively cured for POP. There was a 60% improvement rate for constipation, 63.5 and 68% were cured or improved for ODS and the need for digital maneuvers respectively. Conclusion: Sacral colpoperineopexy associated with retrorectal dorsal mesh appears to objectively and subjectively improve POP associated with DPS.
RESUMEN
BACKGROUND: Vaginal mesh safety information is limited, especially concerning single incision techniques using ultra lightweight meshes for the treatment of anterior pelvic organ prolapse (POP). OBJECTIVE: To determine the intraoperative and postoperative complication rates after anterior POP repair involving an ultralight mesh (19g/m2): Restorelle® Direct Fix™. METHODS: A case series of 218 consecutive patients, operated on between January 2013 and December 2016 in ten tertiary and secondary care centres, was retrospectively analyzed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle® Direct Fix™ mesh (with or without posterior mesh). Surgical complications were graded using the Clavien-Dindo classification. RESULTS: Intraoperative complications were bladder wound (0.5%), rectal wound (0.5%), ureteral injuries (0.9%). 98.2% of the patient did not have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and haematoma (2.7%). One haematoma required surgical treatment and another, embolization. 80.7% of the patient did not have complications during hospitalization and 80.3% did not have complication at the follow up visit. None of the analyzed factors (age, body mass index, surgical history, grade of prolapse or concomitant procedure) was significantly associated with the risk of perioperative complications. A total of 2.8% patients had grade III complications according Clavien Dindo. None had grade IV or V. CONCLUSIONS: This multicentre case-series on the early experience of the use of anterior Restorelle® Direct Fix™ mesh showed a satisfactory technical feasibility and a low rate of grade III complications according Clavien Dindo. Long term studies are necessary to assess anterior Restorelle® Direct Fix™ mesh performances and to appraise patient satisfaction feedback.