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BACKGROUND: The routine use of MRI in rectal cancer treatment allows the use of a strict definition for low rectal cancer. This study aimed to compare minimally invasive total mesorectal excision in MRI-defined low rectal cancer in expert laparoscopic, transanal and robotic high-volume centres. METHODS: All MRI-defined low rectal cancer operated on between 2015 and 2017 in 11 Dutch centres were included. Primary outcomes were: R1 rate, total mesorectal excision quality and 3-year local recurrence and survivals (overall and disease free). Secondary outcomes included conversion rate, complications and whether there was a perioperative change in the preoperative treatment plan. RESULTS: Of 1071 eligible rectal cancers, 633 patients with low rectal cancer were identified. Quality of the total mesorectal excision specimen (P = 0.337), R1 rate (P = 0.107), conversion (P = 0.344), anastomotic leakage rate (P = 0.942), local recurrence (P = 0.809), overall survival (P = 0.436) and disease-free survival (P = 0.347) were comparable among the centres. The laparoscopic centre group had the highest rate of perioperative change in the preoperative treatment plan (10.4%), compared with robotic expert centres (5.2%) and transanal centres (2.1%), P = 0.004. The main reason for this change was stapling difficulty (43%), followed by low tumour location (29%). Multivariable analysis showed that laparoscopic surgery was the only independent risk factor for a change in the preoperative planned procedure, P = 0.024. CONCLUSION: Centres with expertise in all three minimally invasive total mesorectal excision techniques can achieve good oncological resection in the treatment of MRI-defined low rectal cancer. However, compared with robotic expert centres and transanal centres, patients treated in laparoscopic centres have an increased risk of a change in the preoperative intended procedure due to technical limitations.
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Laparoscopía , Imagen por Resonancia Magnética , Neoplasias del Recto , Procedimientos Quirúrgicos Robotizados , Humanos , Neoplasias del Recto/cirugía , Neoplasias del Recto/patología , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/mortalidad , Masculino , Femenino , Persona de Mediana Edad , Anciano , Recurrencia Local de Neoplasia , Hospitales de Alto Volumen/estadística & datos numéricos , Países Bajos , Resultado del Tratamiento , Supervivencia sin Enfermedad , Proctectomía/métodos , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Cirugía Endoscópica Transanal/métodos , Fuga Anastomótica/epidemiología , Fuga Anastomótica/etiologíaRESUMEN
Prehabilitation is an upcoming strategy to optimize patient's functional capacity, nutritional status, and psychosocial well-being in order to reduce surgical complications and enhance recovery. This study aims to assess the feasibility of implementing a multimodal prehabilitation program into the standard care of gynecological oncology patients at an academic hospital in terms of recruitment, adherence, and safety, which were assessed by the number of patients eligible, recruitment rate, participation rate, and adherence to individual modalities. Data were derived from the F4S PREHAB trial, a single-center stepped-wedge trial implementing a multimodal prehabilitation program among various surgical specialties. All patients undergoing elective surgery as part of treatment for ovarian, uterine, and vulvar cancer at the Radboudumc, an academic hospital in The Netherlands, between May 2022 and September 2023 were considered eligible for the F4S PREHAB trial and, consequently, were included in this cohort study. The multimodal prehabilitation program comprised a physical exercise intervention, nutritional intervention, psychological intervention, and an intoxication cessation program. A total of 152 patients were eligible and approached for participation of which 111 consented to participate, resulting in a recruitment rate of 73%. Participants attended an average of six exercise sessions and adhered to 85% of possible training sessions. Respectively, 93% and 98% of participants adhered to the prescribed daily protein and vitamin suppletion. Ten participants were referred to a psychologist and completed consultations. Out of nine active smokers, two managed to quit smoking. A total of 59% adhered to alcohol cessation advice. No adverse events were reported. This study demonstrates that introducing a multimodal prehabilitation program into the standard care of gynecological oncology patients is feasible in terms of recruitment and adherence, with no serious adverse events.
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AIM: The Kono-S anastomosis was introduced as a possible solution to the high surgical recurrence rates in Crohn's disease. However, this technique is known to be challenging, which is why it was originally performed in an extracorporeal setting. The aim of this case series was to assess safety, in terms of intra-/postoperative complications, and feasibility, in terms of successful performance of anastomosis, of a robot-assisted intracorporeal Kono-S anastomosis. METHOD: This is a prospective single-centre consecutive case series. Patients were considered eligible if they were diagnosed with refractory Crohn's disease with significant bowel stenosis of the terminal ileum. All patients underwent robot-assisted intracorporeal Kono-S anastomosis. Perioperative care was provided according to the Enhanced Recovery After Surgery® protocol. Follow-up for postoperative complications was 30 days. RESULTS: Twenty patients were included, of whom 11 (55%) were men. The median age was 30 years [interquartile range (IQR) 22-51 years] and the median BMI was 25 kg/m2 (IQR 19-28 kg/m2). Intracorporeal Kono-S anastomosis was successfully performed in all cases. The median operating time was 155 min (IQR 144-176 min) and the median length of stay was 3 days (IQR 1-5 days). No conversions or 30-day mortality were observed. One patient experienced anastomotic leakage, which was treated with radiologically guided drainage. A total of three patients experienced postoperative complications in the first 30 days. CONCLUSION: Performance of intracorporeal robot-assisted Kono-S anastomosis seems safe and feasible in this case series for Crohn's disease. Since this is a first case series, further research is required to confirm results in a larger population-based cohort.
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Anastomosis Quirúrgica , Enfermedad de Crohn , Estudios de Factibilidad , Íleon , Tempo Operativo , Complicaciones Posoperatorias , Procedimientos Quirúrgicos Robotizados , Humanos , Enfermedad de Crohn/cirugía , Masculino , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Anastomosis Quirúrgica/métodos , Anastomosis Quirúrgica/efectos adversos , Femenino , Adulto , Persona de Mediana Edad , Estudios Prospectivos , Íleon/cirugía , Adulto Joven , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Constricción Patológica/cirugía , Constricción Patológica/etiologíaRESUMEN
BACKGROUND: In endometrial cancer (EC), preoperative anaemia, thrombocytosis and leucocytosis appear to be associated with worse prognosis. It remains unclear whether these parameters solely reflect tumour aggressiveness, or also impact response to adjuvant treatment. Therefore, our primary aim is to evaluate the prognostic relevance of anaemia, thrombocytosis and leucocytosis on survival in EC. Secondary, to explore their predictive relevance in response to radiotherapy in EC. METHODS: A retrospective multicentre cohort study was performed within 10 hospitals. Preoperative haematological parameters were defined as: Anaemia - haemoglobin <7.45 mmol/L (<12 g/Dl), thrombocytosis - platelets >400 × 109 platelets/L, leucocytosis - leukocytes >10 × 109/L. The relationship of haematological parameters with clinicopathological characteristics, ESGO/ESTRO/ESP risk groups and survival were evaluated. Furthermore, the predictive value of haematological parameters was determined on the overall response to adjuvant radiotherapy and for the ESGO/ESTRO/ESP intermediate-risk group solely receiving radiotherapy. RESULTS: A total of 894 patients were included with a median follow-up of 4.5 years. Anaemia was present in 103 (11.5%), thrombocytosis in 79 (8.8%) and leucocytosis in 114 (12.7%) patients. The presence of anaemia or thrombocytosis was significantly associated with ESGO/ESTRO/ESP high-risk (respectively, P = 0.002 and P = 0.041). In the entire cohort, anaemia remained independently associated with decreased disease-specific survival (HR 2.31, 95% CI (1.19-4.50), P = 0.013) after adjusting for age, the abnormal haematological parameters and ESGO/ESTRO/ESP risk groups. In patients that were treated with adjuvant radiotherapy (n = 239), anaemia was associated with significant reduced 5-year disease-specific and recurrence-free survival (P = 0.005 and P = 0.025, respectively). In ESGO/ESTRO/ESP intermediate risk patients that received solely vaginal brachytherapy (n = 74), anaemia was associated with reduced disease-specific survival (P = 0.041). CONCLUSIONS: Current data demonstrate the importance of preoperative anaemia as independent prognostic factor in patients with EC. Moreover, anaemia seems to be associated with reduced response to radiotherapy. Prospective validation in a larger study cohort is needed to verify anaemia as predictive biomarker for radiotherapy.What is already known on this subject? In endometrial cancer, preoperative abnormal haematological parameters like, anaemia, thrombocytosis and leucocytosis appears to be associated with FIGO advanced-stage and unfavourable outcome.What do the results of this study add? It remains unclear whether anaemia, thrombocytosis or leucocytosis solely reflecting worse prognosis by advanced tumour stage, or also impact response to adjuvant treatment. Current data demonstrate that anaemia is independent associated with decreased disease-specific survival and anaemia seems related with reduced response to radiotherapy and in specific to vaginal brachytherapy in ESGO/ESTRO/ESP intermediate risk patients.What are the implications of these findings for clinical practice and/or further research? Specific applied adjuvant treatment is needed if patients with anaemia have a reduced response to radiotherapy in EC. Prospective validation in a larger study cohort is required to verify anaemia as predictive biomarker for radiotherapy and to further evaluate the prognostic/predictive impact of anaemia in addition to the molecular subgroups.
In this study we focused on three specific blood values before surgery to predict survival outcomes in endometrial cancer patients: low haemoglobin (anaemia), high platelet count (thrombocytosis) and high white blood cell count (leucocytosis). We studied 894 patients with endometrial cancer over about 4.5 years, in which 11.5% had anaemia, 8.8% thrombocytosis and 12.7% leucocytosis. Anaemia was linked to a lower chance of surviving endometrial cancer, even after we considering patients' age, thrombocytosis, leucocytosis and the endometrial cancer risk classification groups. In patients who received radiotherapy after surgery (293 patients), anaemia was linked to a lower change of surviving and cancer coming back within 5 years. In patients within the intermediate endometrial cancer risk classification group who only received specific radiotherapy (74 patients), anaemia was even linked with lower chance of survival. In conclusion, anaemia is an important factor in predicting endometrial cancer outcomes, and it might also make radiotherapy less effective for some patients.
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Anemia , Neoplasias Endometriales , Trombocitosis , Femenino , Humanos , Anemia/etiología , Biomarcadores , Estudios de Cohortes , Neoplasias Endometriales/complicaciones , Neoplasias Endometriales/radioterapia , Neoplasias Endometriales/cirugía , Leucocitosis , Trombocitosis/etiología , Estudios RetrospectivosRESUMEN
BACKGROUND: Receiving a stoma significantly impacts patients' quality of life. Coping with this new situation can be difficult, which may result in a variety of physical and psychosocial problems. It is essential to provide adequate guidance to help patients cope with their stoma, as this positively influences self-efficacy in return. Higher self-efficacy reduces psychosocial problems increasing patient's quality of life. This study investigates whether a new mobile application, the Stoma App, improves quality of life. And if personalized guidance, timed support, and peer contact offered as an in-app surplus makes a difference. METHODS: A double-blind, randomized controlled trial was conducted between March 2021 and April 2023. Patients aged > 18 years undergoing ileostomy or colostomy surgery, in possession of a compatible smartphone were included. The intervention group received the full version of the app containing personalized and time guidance, peer support, and generic (non-personalized) stoma-related information. The control group received a restricted version with only generic information. Primary outcome was stoma quality of life. Secondary outcomes included psychological adaption, complications, re-admittance, reoperations, and length of hospital stay. RESULTS: The intervention version of the app was used by 96 patients and the control version by 112 patients. After correction for confounding, the intervention group reported a significant 3.1-point improvement in stoma-related quality of life one month postoperatively (p = 0.038). On secondary outcomes, no significant improvements could be retrieved of the intervention group. CONCLUSION: The Stoma App improves the quality of life of stoma patients. Peer support and personalized guidance are of significant importance in building self-efficacy. It is to be recommended to implement Stoma app-freely available software qualifying as a medical device-in standard stoma care pathways for the benefits of both patients and healthcare providers.
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Aplicaciones Móviles , Estomas Quirúrgicos , Humanos , Colostomía , Ileostomía , Calidad de Vida , AdultoRESUMEN
BACKGROUND: Substantial variation exists when performing a minimally invasive right hemicolectomy (MIRH) due to disparities in training, expertise and differences in implementation of innovations. This study aimed to achieve national consensus on an optimal and standardized MIRH technique for colon cancer and to develop and validate a video-based competency assessment tool (CAT) for MIRH. METHOD: Statements covering all elements of MIRH were formulated. Subsequently, the Delphi technique was used to reach consensus on a standardized MIRH among 76 colorectal surgeons from 43 different centres. A CAT was developed based on the Delphi results. Nine surgeons assessed the same 12 unedited full-length videos using the CAT, allowing evaluation of the intraclass correlation coefficient (ICC). RESULTS: After three Delphi rounds, consensus (≥80% agreement) was achieved on 23 of the 24 statements. Consensus statements included the use of low intra-abdominal pressure, detailed anatomical outline how to perform complete mesocolic excision with central vascular ligation, the creation of an intracorporeal anastomosis, and specimen extraction through a Pfannenstiel incision using a wound protector. The CAT included seven consecutive steps to measure competency of the MIRH and showed high consistency among surgeons with an overall ICC of 0.923. CONCLUSION: Nationwide consensus on a standardized and optimized technique of MIRH was reached. The CAT developed showed excellent interrater reliability. These achievements are crucial steps to an ongoing nationwide quality improvement project (the Right study).
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Neoplasias del Colon , Laparoscopía , Cirujanos , Humanos , Reproducibilidad de los Resultados , Neoplasias del Colon/cirugía , Colectomía/métodos , Estándares de Referencia , Laparoscopía/métodos , Técnica DelphiRESUMEN
Introduction: Patients with colonic obstruction are at risk for emergency resection, which is a risk factor for increased mortality and morbidity. In left-sided obstructive colon cancer, the principle of bridge-to-surgery is already recommended to reduce complications. From this treatment strategy, the obstruction treatment is derived. In this treatment strategy, bowel wall distention is reduced by minimizing stool production through laxatives and dietary measures. Short-term outcomes have already shown promising results. This study aims to evaluate long-term outcomes in patients treated with this obstruction treatment. Methods: This is a multicenter prospective study that included patients who presented with symptomatic colonic obstruction and radiologic confirmation of obstruction between May 2019 and August 2020 in the contributing hospitals. Patients with malignant and benign colonic obstruction were included. Follow-up in this study consisted of at least 36 months. Endpoints of the study included 1- and 3-year stoma and mortality rates. Results: Ninety-eight patients were included in this study. For the overall cohort complication, reoperation, and readmission rates after one year were 37%, 14%, and 10% respectively. Overall, 3-year mortality was 21%. The presence of a stoma after 1 year was 18%, and after 3 years 17% in this cohort. Conclusion: Long-term results of this study indicate that obstruction treatment has acceptable long-term outcomes in terms of mortality and stoma rates, compared to literature on emergency surgery and bridge-to-surgery alternatives. Permanent stoma rates are lower, compared to the literature on other treatment strategies in bowel obstruction. (AU)
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Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Obstrucción Intestinal/mortalidad , Obstrucción Intestinal/terapia , Estudios de Seguimiento , Resultado del Tratamiento , Estomas QuirúrgicosRESUMEN
Preoperative cardiopulmonary exercise testing (CPET) provides an objective assessment of functional capability. In other intra-abdominal surgical specialties, CPET outcomes are predictive of operative morbidity. However, in ovarian cancer surgery, its predictive value remains unknown. In this study, we evaluated the association between CPET performance and surgical morbidity in ovarian cancer patients. Secondly, we assessed the association between CPET performance and other surgical outcomes (i.e., hospital stay, readmission and residual disease). This was a retrospective cohort study of patients undergoing primary surgery for ovarian cancer between 2020 and 2023. CPET performance included peak oxygen uptake (VO2 max), ventilatory efficiency (VE/VO2) and anaerobic threshold. Outcomes were operative morbidity and included intra- and postoperative complications (Clavien-Dindo), hospital stay, readmission within 30 days and residual disease. A total of 142 patients were included. A lower VO2 peak and a higher VE/VCO2 were both associated with the occurrence of postoperative complications, and a poorer anaerobic threshold was associated with more transfusions. VE/VCO2 remained significantly associated after multivariate analysis (p = 0.035). None of the CPET outcomes were associated with length of stay, readmission or residual disease. In conclusion, VE/VCO2 was significantly associated with an increased risk of all-cause postoperative complications in ovarian cancer patients undergoing primary surgery.
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The prevalence of an unhealthy lifestyle among patients with gynecological cancer is high and associated with increased risk of all-cause mortality. Although lifestyle changes have the potential to improve outcomes, lifestyle counseling is not routinely integrated into standard care. This review explores research on the barriers to and facilitators of both the promotion of healthy lifestyles by healthcare providers (HCPs) and healthy lifestyle changes by patients with gynecological cancer. The Theoretical Domains Framework (TDF) was used to deductively code the identified factors for a comprehensive understanding of the barriers and facilitators. A search across five databases yielded a total of 12,687 unique studies, of which 43 were included in the review. Of these 43, 39 included gynecological cancer patients and only 6 included HCPs. Among the barriers identified for HCPs, most studies evaluated barriers regarding weight loss counseling. Limited knowledge, reluctance to address weight loss, skepticism about the benefits, and workload concerns were commonly reported barriers for HCPs. HCPs will benefit from education and training in lifestyle counseling, including effective communication skills like motivational interviewing. Gynecological cancer patients lacked tools, support, knowledge, and faced mental health issues, environmental constraints, and physical limitations. The review emphasizes the importance of addressing these barriers and utilizing identified facilitators, such as social support, to promote and support healthy lifestyle behaviors on the part of patients and their promotion by HCPs. Future research should focus not only on patients but also on supporting HCPs and implementing necessary changes in current practices.
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Personal de Salud , Neoplasias , Humanos , Estilo de Vida Saludable , Estilo de Vida , Pérdida de Peso , Investigación CualitativaRESUMEN
Background: Total mesorectal excision has been the gold standard for the operative management of rectal cancer. The most frequently used minimally invasive techniques for surgical resection of rectal cancer are laparoscopic, robot-assisted, and transanal total mesorectal excision. As studies comparing the costs of the techniques are lacking, this study aims to provide a cost overview. Method: This retrospective cohort study included patients who underwent total mesorectal resection between 2015 and 2017 at 11 dedicated centers, which completed the learning curve of the specific technique. The primary outcome was total in-hospital costs of each technique up to 30 days after surgery including all major surgical cost drivers, while taking into account different team approaches in the transanal approach. Secondary outcomes were hospitalization and complication rates. Statistical analysis was performed using multivariable linear regression analysis. Results: In total, 949 patients were included, consisting of 446 laparoscopic (47%), 306 (32%) robot-assisted, and 197 (21%) transanal total mesorectal excisions. Total costs were significantly higher for transanal and robot-assisted techniques compared to the laparoscopic technique, with median (interquartile range) for laparoscopic, robot-assisted, and transanal at 10,556 (8,642;13,829), 12,918 (11,196;16,223), and 13,052 (11,330;16,358), respectively (P < 0.001). Also, the one-team transanal approach showed significant higher operation time and higher costs compared to the two-team approach. Length of stay and postoperative complications did not differ between groups. Conclusion: Transanal and robot-assisted approaches show higher costs during 30-day follow-up compared to laparoscopy with comparable short-term clinical outcomes. Two-team transanal approach is associated with lower total costs compared to the transanal one-team approach.
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Introduction: The introduction of Enhanced Recovery After Surgery led to increasing twenty-four hours discharge pathways, for example in laparoscopic cholecystectomy and bariatric surgery. However, implementation in colorectal surgery still must set off. This systematic review assesses safety and feasibility of twenty-four hours discharge in colorectal surgery in terms of readmission and complications in current literature. Secondary outcome was identification of factors associated with success of twenty-four hours discharge. Methods: Pubmed and EMBASE databases were searched to identify studies investigating twenty-four hours discharge in colorectal surgery, without restriction of study type. Search strategy included keywords relating to ambulatory management and colorectal surgery. Studies were scored according to MINORS score. Results: Thirteen studies were included in this systematic review, consisting of six prospective and seven retrospective studies. Number of participants of the included prospective studies ranged from 5 to 157. Median success of discharge was 96% in the twenty-four hours discharge group. All prospective studies showed similar readmission and complication rates between twenty-four hours discharge and conventional postoperative management. Factors associated with success of twenty-four hours discharge were low ASA classification, younger age, minimally invasive approach, and relatively shorter operation time. Conclusions: Twenty-four hours discharge in colorectal surgery seems feasible and safe, based on retro- and prospective studies. Careful selection of patients and establishment of a clear and adequate protocol are key items to assure safety and feasibility. Results should be interpreted with caution, due to heterogeneity. To confirm results, an adequately powered prospective randomized study is needed. (AU)
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Alta del Paciente , Neoplasias Colorrectales/cirugía , Tiempo de Internación , Complicaciones Posoperatorias , Periodo PosoperatorioRESUMEN
The epicardium plays an essential role in cardiogenesis by providing cardiac cell types and paracrine cues to the developing myocardium. The human adult epicardium is quiescent, but recapitulation of developmental features may contribute to adult cardiac repair. The cell fate of epicardial cells is proposed to be determined by the developmental persistence of specific subpopulations. Reports on this epicardial heterogeneity have been inconsistent, and data regarding the human developing epicardium are scarce. Here we specifically isolated human fetal epicardium and used single-cell RNA sequencing to define its composition and to identify regulators of developmental processes. Few specific subpopulations were observed, but a clear distinction between epithelial and mesenchymal cells was present, resulting in novel population-specific markers. Additionally, we identified CRIP1 as a previously unknown regulator involved in epicardial epithelial-to-mesenchymal transition. Overall, our human fetal epicardial cell-enriched dataset provides an excellent platform to study the developing epicardium in great detail.
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Miocardio , Pericardio , Adulto , Humanos , Pericardio/metabolismo , Miocardio/metabolismo , Transición Epitelial-Mesenquimal , Feto/metabolismo , Análisis de la Célula Individual , Proteínas Portadoras/metabolismo , Proteínas con Dominio LIM/metabolismoRESUMEN
BACKGROUND: Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of surgical treatment for suspicious LLNs is lacking. This study evaluated the surgical treatment of LLNs in an untrained setting at a national level. METHODS: Patients who underwent additional LLN surgery were selected from a national cross-sectional cohort study regarding patients undergoing rectal cancer surgery in 69 Dutch hospitals in 2016. LLN surgery consisted of either 'node-picking' (the removal of an individual LLN) or 'partial regional node dissection' (PRND; an incomplete resection of the LLN area). For all patients with primarily enlarged (≥7 mm) LLNs, those undergoing rectal surgery with an additional LLN procedure were compared to those undergoing only rectal resection. RESULTS: Out of 3057 patients, 64 underwent additional LLN surgery, with 4-year LR and LLR rates of 26% and 15%, respectively. Forty-eight patients (75%) had enlarged LLNs, with corresponding recurrence rates of 26% and 19%, respectively. Node-picking (n = 40) resulted in a 20% 4-year LLR, and a 14% LLR after PRND (n = 8; p = 0.677). Multivariable analysis of 158 patients with enlarged LLNs undergoing additional LLN surgery (n = 48) or rectal resection alone (n = 110) showed no significant association of LLN surgery with 4-year LR or LLR, but suggested higher recurrence risks after LLN surgery (LR: hazard ratio [HR] 1.5, 95% confidence interval [CI] 0.7-3.2, p = 0.264; LLR: HR 1.9, 95% CI 0.2-2.5, p = 0.874). CONCLUSION: Evaluation of Dutch practice in 2016 revealed that approximately one-third of patients with primarily enlarged LLNs underwent surgical treatment, mostly consisting of node-picking. Recurrence rates were not significantly affected by LLN surgery, but did suggest worse outcomes. Outcomes of LLN surgery after adequate training requires further research.
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Escisión del Ganglio Linfático , Neoplasias del Recto , Humanos , Escisión del Ganglio Linfático/métodos , Estudios Transversales , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patología , Neoplasias del Recto/patología , Recto/patología , Estudios Retrospectivos , Recurrencia Local de Neoplasia/cirugía , Recurrencia Local de Neoplasia/patología , Estadificación de NeoplasiasRESUMEN
INTRODUCTION: Organ preservation is associated with superior functional outcome and quality of life (QoL) compared with total mesorectal excision (TME) for rectal cancer. Only 10% of patients are eligible for organ preservation following short-course radiotherapy (SCRT, 25 Gy in five fractions) and a prolonged interval (4-8 weeks) to response evaluation. The organ preservation rate could potentially be increased by dose-escalated radiotherapy. Online adaptive magnetic resonance-guided radiotherapy (MRgRT) is anticipated to reduce radiation-induced toxicity and enable radiotherapy dose escalation. This trial aims to establish the maximum tolerated dose (MTD) of dose-escalated SCRT using online adaptive MRgRT. METHODS AND ANALYSIS: The preRADAR is a multicentre phase I trial with a 6+3 dose-escalation design. Patients with intermediate-risk rectal cancer (cT3c-d(MRF-)N1M0 or cT1-3(MRF-)N1M0) interested in organ preservation are eligible. Patients are treated with a radiotherapy boost of 2×5 Gy (level 0), 3×5 Gy (level 1), 4×5 Gy (level 2) or 5×5 Gy (level 3) on the gross tumour volume in the week following standard SCRT using online adaptive MRgRT. The trial starts on dose level 1. The primary endpoint is the MTD based on the incidence of dose-limiting toxicity (DLT) per dose level. DLT is a composite of maximum one in nine severe radiation-induced toxicities and maximum one in three severe postoperative complications, in patients treated with TME or local excision within 26 weeks following start of treatment. Secondary endpoints include the organ preservation rate, non-DLT, oncological outcomes, patient-reported QoL and functional outcomes up to 2 years following start of treatment. Imaging and laboratory biomarkers are explored for early response prediction. ETHICS AND DISSEMINATION: The trial protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht. The primary and secondary trial results will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: WHO International Clinical Trials Registry (NL8997; https://trialsearch.who.int).
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Traumatismos por Radiación , Neoplasias del Recto , Humanos , Calidad de Vida , Preservación de Órganos , Neoplasias del Recto/radioterapia , Neoplasias del Recto/cirugía , Neoplasias del Recto/patología , Traumatismos por Radiación/etiología , Traumatismos por Radiación/prevención & control , Ensayos Clínicos Fase I como AsuntoRESUMEN
BACKGROUND: Colorectal cancer causes the majority of large bowel obstructions and surgical resection remains the gold standard for curative treatment. There is evidence that a deviating stoma as a bridge to surgery can reduce postoperative mortality rate; however, the optimal stoma type is unclear. The aim of this study was to compare outcomes between ileostomy and colostomy as a bridge to surgery in left-sided obstructive colon cancer. METHODS: This was a national, retrospective population-based cohort study with 75 contributing hospitals. Patients with radiological left-sided obstructive colon cancer between 2009 and 2016, where a deviating stoma was used as a bridge to surgery, were included. Exclusion criteria were palliative treatment intent, perforation at presentation, emergency resection, and multivisceral resection. RESULTS: A total of 321 patients underwent a deviating stoma; 41 (12.7 per cent) ileostomies and 280 (87.2 per cent) colostomies. The ileostomy group had longer length of stay (median 13 (interquartile range (i.q.r.) 10-16) versus 9 (i.q.r. 6-14) days, P = 0.003) and more nutritional support during the bridging interval. Both groups showed similar complication rates in the bridging interval and after primary resection, including anastomotic leakage. Stoma reversal during resection was more common in the colostomy group (9 (22.0 per cent) versus 129 (46.1 per cent) for ileostomy and colostomy respectively, P = 0.006). CONCLUSION: This study demonstrated that patients having a colostomy as a bridge to surgery in left-sided obstructive colon cancer had a shorter length of stay and lower need for nutritional support. No difference in postoperative complications were found.
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Neoplasias del Colon , Colostomía , Ileostomía , Humanos , Neoplasias del Colon/cirugía , Estudios Retrospectivos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más AñosRESUMEN
BACKGROUND: The concept of value-based healthcare is being used worldwide to improve healthcare. The Intervention Selection Toolbox was developed to bridge the gap of value-based healthcare, between insights in outcomes and actual quality improvement initiatives. In this study we aimed to evaluate the use of the Intervention Selection Toolbox in daily practice of a quality improvement team in a hospital setting. METHODS: A methodological triangulation design was used. The Intervention Selection Toolbox was used by a multidisciplinary quality improvement team for colorectal cancer care in a large teaching hospital. In-depth semi-structured interviews, focusing on the key elements of process evaluation, were conducted after implementation with representatives of the quality improvement team to evaluate the use of the Intervention Selection Toolbox. Quantitative data regarding improvement initiatives and degree of implementation was also collected. RESULTS: The use of the Intervention Selection Toolbox initially resulted in 80 potential quality improvement initiatives. Eventually, two high potential improvement initiatives were selected. Some components of the toolbox were successfully implemented in daily practice, although 'standard monitoring' and 'causal chain analysis' proved more difficult to implement. Qualitative analysis was performed with ten members of the multidisciplinary team before thematic saturation occurred. Interviewed members had a wide range in characteristics: age 28-61 years, clinical experience 6-38 years and educational attainment from vocational program to academic doctorate. The Interviews showed added value in the use of the toolbox, but identified time and organizational management as restricting factors. CONCLUSIONS: The Intervention Selection Toolbox is useful to systematically identify improvement initiatives with impact on health outcomes that matter to patients. However, before implementation organizational structure should be optimized to maximize success and efficiency on integration of the Intervention Selection Toolbox.
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Neoplasias Colorrectales , Hospitales , Humanos , Adulto , Persona de Mediana Edad , Atención a la Salud , Neoplasias Colorrectales/cirugía , Mejoramiento de la CalidadRESUMEN
OBJECTIVE: To report our institutional experience with sentinel lymph node (SLN) detection using indocyanine green for cervical cancer, in terms of detection rates, detection of SLN at unusual locations, and factors associated with unusual SLN locations. In addition, we performed a systematic review of the literature to identify factors associated with unusual SLN localizations. METHODS: This is a retrospective cohort study of women with early-stage cervical cancer undergoing sentinel lymph node mapping between 2015 and 2019. Outcome measures were SLN detection rates, detection rates of unusual locations for SLN and risk factors for aberrant lymphatic drainage pathways. In addition, studies evaluating factors associated with unusual SLN locations in cervical cancer were assessed in a systematic review. RESULTS: A total of 100 patients were included. The unilateral SLN detection rate was 88%, whereas the bilateral detection rate was 75%. In 37% of all patients, SLN were found in unusual locations, and in 10% of patients SLN were solely found in unusual locations. Body mass index (BMI) was associated with finding SLN in unusual locations, with unusual nodes detected in 52% of patients with BMI <25 kg/m2 and in 28% of patients with BMI ≥25 kg/m2. The systematic review identified three studies, identifying lower BMI, nulliparity and tumor size of >20 mm as factors associated with finding SLN at unusual locations. CONCLUSION: Aberrant drainage sites represent a significant proportion of SLN detected in cervical cancer. Factors associated with increased rates of unusual nodal locations are a lower BMI, with a possible association with nulliparity and tumor size of >20 mm.