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INTRODUCTION: To assess the efficacy and morbidity of percutaneous nephrolithotomy (PNLT) in the treatment of renal stones in patients with neurogenic lower urinary tract dysfunction (NLUTD). METHODS: Retrospective, monocentric study including all patients with NLUTD who had undergone PNLT between 2005 and 2017. Pre-operative clinical data (neurological condition, voiding mode, preoperative urine culture ), peri-operative and post-operative data (success and morbidity) were collected from the patients' charts. Success was defined by the absence of residual fragment (RF), on imaging or intraoperative endoscopy. Partial efficacy was defined by the presence of RF lower than 4mm. Early complications were reported according to the Clavien-Dindo classification. RESULTS: In all, 53 PNLTs were performed, in 35 patients, mostly with spinal cord injury. The success and partial efficacy rates were 66.0% and 71.7% respectively. The failure rate was correlated with increased stone burden (P=0.03), increased size of the largest stone (P=0.02), and the presence of complex stones (P<0.02). The rate of early complications was 41.5%, with 27.3% major, mostly septic, and bleeding. The retreatment rate within 3 years was 41.5%. CONCLUSION: In patients with NLUTD, PNLT allows a high success rate, but with a significant rate of retreatment and infectious complications. However, NLPC remains the gold standard in this population, especially for renal stones larger 20mm, allowing a higher success rate than ureteroscopy and a lower retreatment rate.
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Cálculos Renales , Nefrolitotomía Percutánea , Nefrostomía Percutánea , Vejiga Urinaria Neurogénica , Humanos , Cálculos Renales/complicaciones , Cálculos Renales/cirugía , Nefrolitotomía Percutánea/efectos adversos , Nefrostomía Percutánea/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Vejiga Urinaria Neurogénica/complicaciones , Vejiga Urinaria Neurogénica/cirugíaRESUMEN
INTRODUCTION: In front of a very calcified aortoiliac axis, renal transplantation with implantation of the artery on vascular prosthesis can be proposed. This rare intervention is considered difficult and morbid. The main objective of this work was to evaluate the overall and specific survival of the transplant in this situation. The secondary objective was the study of the complications and the evolution of the transplant's renal function. MATERIAL AND METHODS: From a multicenter retrospective data collection of the DIVAT cohort (6 centers) added with data from 4 other transplant centers, we studied transplants with prosthetic arterial anastomosis. RESULTS: Thirty four patients was included. The median duration of follow-up was 2.5 years. 4 patients died in the month following transplantation, 16 were hemodialysis and 9 were transfused. The median survival of the transplant was 212 days. Functional arrests of the transplant were mostly associated with nephrological degradation and return to dialysis (about 80%) while 10% were related to a death of the recipient directly attributable to renal transplantation. The surgical complications of the transplantation were marked by one arterial stenosis, one fistula and 4 urinary stenoses. CONCLUSION: Thus, renal transplantation with arterial anastomosis on vascular prosthesis, on selected patients, offers an alternative to dialysis. A national compendium of transplanted patients on vascular prosthesis would allow a long-term follow-up of transplant's survival and define selection criteria prior to this kind of surgery. LEVEL OF EVIDENCE: 3.
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Prótesis Vascular , Trasplante de Riñón/métodos , Adulto , Anciano , Anastomosis Quirúrgica , Femenino , Supervivencia de Injerto , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Procedimientos Quirúrgicos VascularesRESUMEN
PURPOSE: To determine the impact of transplant nephrectomy on morbidity and mortality and HLA immunization. METHODS: All patients who underwent transplant nephrectomy in our centre between 2000 and 2016 were included in this study. A total of 2822 renal transplantations and 180 transplant nephrectomies were performed during this period. RESULTS: The indications for transplant nephrectomy were graft intolerance syndrome: 47.2%, sepsis: 22.2%, vascular thrombosis: 15.5%, tumour: 8.3% and other 6.8%. Transplant nephrectomies were performed via an intracapsular approach in 61.7% of cases. The blood transfusion rate was 50%, the morbidity rate was 38% and the mortality rate was 3%. Transplant nephrectomies more than 12 months after renal transplant failure were associated with more complications (p = 0.006). Transfusions in the context of transplant nephrectomy had no significant impact on alloimmunization. CONCLUSION: The risk of bleeding, and therefore of transfusion, constitutes the major challenge of this surgery in patients eligible for retransplantation. Even if transfusions in this context of transplant nephrectomy had no significant impact on alloimmunization, this high-risk surgery, whenever possible, must be performed electively in a well-prepared patient.
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Pérdida de Sangre Quirúrgica , Rechazo de Injerto/cirugía , Antígenos HLA/inmunología , Neoplasias Renales/cirugía , Nefrectomía/efectos adversos , Complicaciones Posoperatorias/etiología , Adolescente , Adulto , Anciano , Transfusión Sanguínea , Niño , Femenino , Humanos , Trasplante de Riñón , Tiempo de Internación , Masculino , Persona de Mediana Edad , Nefrectomía/mortalidad , Factores de Riesgo , Sepsis/cirugía , Trombosis/cirugía , Adulto JovenRESUMEN
OBJECTIVE: The study's objective was to evaluate the effectiveness and morbidity of flexible ureterorenoscopy and laser lithotripsy for upper urinary tract stones in patients with a nervous system pathology including severe motor disability. METHODS: Between 2006 and 2013, we retrospectively analyzed 83 flexible ureterorenoscopy to treat 63 kidneys in 42 patients. Stone free (SF) kidneys defined as an absence of stones on computerized tomography, renal ultrasound, X-ray or direct ureterorenoscopy, were considered a surgical success. Complications were classified according to the Clavien-Dindo system. RESULTS: Success rates were 49.2 %, 57.1 % and 58.7 %, respectively after first, second and third flexible ureterorenoscopy procedure. Clearance after one procedure was achieved in 64.3 % of cases involving less than 20mm stones. No major complication (Clavien-Dindo>2) was described (0 %). Complication rates were 44.7 %, with 31.6 % Clavien-Dindo 2. The main complication was urosepsis, which occurred in 27.6 % of cases. CONCLUSION: Flexible ureteroscopy and laser lithotripsies for upper urinary tract stones in neurologic patients with severe motor disability are associated with a lower success rate and some frequent low grade complications compared to overall population. In clinical practice, the indications of flexible ureterorenoscopy for these patients seem restricted. LEVEL OF EVIDENCE: 5.
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Cálculos Renales/etiología , Cálculos Renales/terapia , Litotripsia por Láser , Enfermedades del Sistema Nervioso/complicaciones , Cálculos Ureterales/etiología , Cálculos Ureterales/terapia , Ureteroscopios , Ureteroscopía/instrumentación , Adulto , Terapia Combinada , Femenino , Humanos , Masculino , Estudios Retrospectivos , Índice de Severidad de la EnfermedadRESUMEN
PURPOSE: To evaluate the management of renal colic in pregnant woman in our hospital. MATERIAL AND METHODS: A retrospective study of 103 pregnant patients, hospitalized for back pain of renal colic type, associated or not with a urinary tract infection, between January 2005 and October 2010. Three groups of patients were identified from the initial clinical and paraclinical (ultrasound). Group I involved patients with dilatation of the renal cavities associated with septic syndrome, they received analgesic treatment and empiric antibiotic therapy. Group II involved patients with dilatation of the renal cavities isolated, without fever, they received only analgesic treatment. Group III involved patients without dilatation of the renal cavities, they received analgesic treatment and antibiotics in case of fever, and then another cause of pain was sought. RESULTS: The renal colic was due to a stone in 19.4 % of cases. A urinary infection was associated in 28 % of patients. Ultrasond was sufficient to confirm the diagnosis in 96 % of cases. In 4 % of cases, MRI or low-dose CT were necessary. Therapeutic management based on analgesic treatment, associated with probabilistic antibiotherapy or adapted in case of documented infection, allowed sedation of pain in two-third of cases. In case of failure or signs of severity, the urinary diversion by a double J stent was efficient, without consequences on pregnancy issue. One stone was treated by ureteroscopy during pregnancy without complication. CONCLUSION: The management of renal colic in pregnant woman based on ultrasound diagnosis, symptomatic treatment and urinary diversion by double J stent in case of failure therefore seemed quite sure on mother and fetus.
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Complicaciones del Embarazo/etiología , Complicaciones del Embarazo/terapia , Cólico Renal/etiología , Cólico Renal/terapia , Adolescente , Adulto , Analgésicos/uso terapéutico , Antibacterianos/uso terapéutico , Femenino , Humanos , Cálculos Renales/complicaciones , Cálculos Renales/diagnóstico , Embarazo , Estudios Retrospectivos , Infecciones Urinarias/complicaciones , Infecciones Urinarias/diagnóstico , Adulto JovenRESUMEN
OBJECTIVE: Portal veinous thrombosis (VT) in the pancreatic transplant (6 to 20% of the cases) is the first cause of early loss of the transplant. Our objective was to identify the risk factors of VT in our experiment. METHOD: The sample group includes 106 patients who underwent pancreas transplantation (portal venous drainage, enteric-drained pancreas) within our institute of transplantation from 2004 until 2010. We completed a portal vein extension graft in 25% of the cases. First of all, risk factors were selected from preoperative and operative data with an univariate analysis. We then carried out a multivariate analysis of these factors (binary logistic regression). The threshold P was 0.05. RESULTS: Sixteen patients (15%) showed a VT. Eight of them developed a total thrombosis and required a transplantectomy. Three risk factors of VT were isolated by the multivariate analysis: a BMI of the receiver>25kg/m(2) (Odds Ratio [OR]=6.977), a portal vein extension graft (OR=4.1) and an age of the donor>45 years (OR=4.432). CONCLUSIONS: The knowledge of these risk factors of thrombosis allows the implementation of preventive measures (selection of the donor, nutritional support of the receiver in the registration if BMI>25kg/m(2)). The portal lengthening should be avoided by an attentive retrieval of the transplant (without shorter section of the portal vein). Nevertheless, the presence of one of these risk factors in a transplant patient should lead to start an antithrombotic treatment.
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Trasplante de Páncreas/efectos adversos , Trombosis de la Vena/etiología , Adulto , Femenino , Humanos , Masculino , Análisis Multivariante , Estudios Retrospectivos , Factores de Riesgo , Trombosis de la Vena/epidemiologíaRESUMEN
OBJECTIVES: A retrospective evaluation of artificial urinary sphincter (AUS) implantation in women with previous pelvic radiotherapy (PR). POPULATION AND METHODS: From May 1987 to December 2009, on the 215 women implanted with AUS, nine (4.2%) had previous PR. We compared two groups of women, the first one without PR (group 1; n=206) and the other group with PR (group 2; n=9). Previous preop. urodynamics were realized. Patients using more than one pad per day at the end of follow-up were considered in failure. RESULTS: Mean follow-up for these two groups was 6 years (SD: 5.6 years), with a mean age of 62.8 years. Mean delay between PR and surgery was 14 years. PR was indicated for cervix cancer in 78% (7/9), endometrial cancer and ovarian cancer in 9% (1/9) each. PR was responsible of an increased rate of AUS erosion and explantation (P<0.001). In group 2, more than half of women had AUS failure and 60% for AUS erosion, versus 22% and 26% respectively in group 1. In group 2, all the AUS eroded were explanted, one third of women, with a mean delay of 59.8 months (4-140) with AUS implantation. CONCLUSION: AUS implantation in a female population with previous PR is not necessary inconsistent, but the failure rate is high. This difficult surgery should be reserved for specialized centres.
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Incontinencia Urinaria de Esfuerzo/cirugía , Esfínter Urinario Artificial , Neoplasias del Cuello Uterino/radioterapia , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios RetrospectivosRESUMEN
OBJECTIVES: To study oncological results and functional results after partial nephrectomy in imperative indication for the treatment of renal cell carcinoma. PATIENTS AND METHODS: From January 1990 to December 2009, 65 partial nephrectomies in 61 patients were performed in imperative indication for renal cell carcinoma. RESULTS: The mean age of patients was 59.3 years. The mean follow-up was 47.4 months. The tumours were asymptomatic in 87.5%. The average tumour diameter was 4.3 cm. Twenty-nine percent of patients relapsed after a mean time of 27.4 months. The morbidity was 38.5%. Preoperative and endpoint serum creatinine and renal clearance were respectively 119 µmol/L and 63.1 mL/min versus 137 µmol/L and 50.9 mL/min (P=0.0003; 0.0002). Overall survival at one, three, five and ten years was 98.4%, 91.2%, 91.2% and 51.9%. CONCLUSION: Partial nephrectomy in imperative indication for renal cell carcinoma has helped preserve renal function but has a significant morbidity and recurrence rate.
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Carcinoma de Células Renales/cirugía , Neoplasias Renales/cirugía , Nefrectomía/métodos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
Kidney transplantation has become the treatment of choice for patients with end stage renal disease since it offers an excellent quality of life. Moreover, the economic impact is considerable, particularly beyond the first year. Indeed, the annual cost of a successful renal transplantation is ten fold lower than haemodialysis. But surgical complications remain one of our main concerns. Surgical complications are various. They may be non-specific as haematomas, incision-induced hernias and wound infections. They may also be directly related to the procedure as vascular thrombosis and urinary fistula in the early postoperative period or arterial stenosis and ureteral obstruction in the late post-operative period. The accurate diagnosis and the appropriate management of these complications are the most important tasks for the surgical team. This review is based upon our experience in kidney transplantation and upon the medical published data.
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Complicaciones Intraoperatorias/etiología , Trasplante de Riñón , Complicaciones Posoperatorias/etiología , Pérdida de Sangre Quirúrgica/prevención & control , Hemorragia/etiología , Hemorragia/prevención & control , Humanos , Complicaciones Intraoperatorias/epidemiología , Complicaciones Intraoperatorias/prevención & control , Riñón/irrigación sanguínea , Trasplante de Riñón/efectos adversos , Trasplante de Riñón/métodos , Linfocele/etiología , Linfocele/prevención & control , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Dehiscencia de la Herida Operatoria/prevención & control , Infección de la Herida Quirúrgica/prevención & control , Trombosis/etiología , Trombosis/prevención & control , Obstrucción Ureteral/etiología , Obstrucción Ureteral/prevención & control , Cálculos Urinarios/etiología , Cálculos Urinarios/prevención & control , Fístula Urinaria/diagnóstico , Fístula Urinaria/etiología , Fístula Urinaria/prevención & control , Enfermedades Vasculares/etiología , Enfermedades Vasculares/prevención & control , Reflujo Vesicoureteral/etiología , Reflujo Vesicoureteral/prevención & controlRESUMEN
OBJECTIVE: The number of acute hospital beds is determined by health authorities using methods based on ratios and/or target bed occupancy rates. These methods fail to consider the variability in hospitalization demands over time. On the other hand, the implementation of sophisticated models requires the decision concerning the number of beds to be made by an expert. Our aim is to develop a new method that is as simple to use as the ratio method while minimizing the roundabout approaches of these methods. METHOD: A score was constructed with three parameters: number of transfers due to lack of space, number of days with no possibility for S unscheduled admissions and number of days with at least a threshold of U unoccupied beds. The optimal number of beds is the number for which both the mean and the standard deviation of the score reach their minimum. We applied this method to two internal medicine departments and one urological surgery department and we compared the solutions proposed by this method with those put forward by the ratio method. RESULTS: The solutions proposed by this method were intermediate to those calculated by the local and national length of Stays ratio methods. Simulating an unusual increase in admission requests had no consequence on the bed number selected, indicating that the method was robust. CONCLUSION: Our tool represents a real alternative to the ratio methods. A software has been developed and is now available for use.
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Capacidad de Camas en Hospitales/estadística & datos numéricos , Planificación Hospitalaria/métodos , Algoritmos , Técnicas de Apoyo para la Decisión , Humanos , Tiempo de Internación/estadística & datos numéricos , Admisión del Paciente/estadística & datos numéricos , Transferencia de Pacientes/estadística & datos numéricos , Programas InformáticosRESUMEN
Methodological analysis, in particular of an article on a clinical trial, first comprises a check of the quality of the study design: description of the primary objective and assumptions leading to the conduct of the study; description of patients; description and justification of the treatments compared and primary end-point; justification for the number of included patients; description of randomization; suitable statistical tests selected a priori; respect of legal and ethical framework. Then, in the results, the comparability of the randomly assigned groups must be checked. The primary end-point must be assessed by intention to treat analysis, then per protocol where necessary. Lastly, it is necessary to seek bias liable to reduce the quality of the demonstration.
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Ensayos Clínicos como Asunto/normas , EdiciónRESUMEN
OBJECTIVES: Analysis of changes in voiding patterns after sub-urethral TVT procedure: urodynamic variations and clinical repercussions. METHODS: 112 women included in an ethics committee protocol (CCPPRB ) with a mean follow-up of 22 months underwent complete urodynamic testing before and after TVT procedure and filled in pre- and post-operative questionnaires. RESULTS: Analysis of the questionnaires showed that two clinical symptoms were predominant post-operatively: dysuria and micturitional urge. The urodynamic profiles showed that TVT banding led to infravesical obstruction but not to significant detrusor overactivity. CONCLUSION: Our results show that clinical changes induced by the TVT procedure were due to infravesical obstruction, and that there was no progression of detrusor overactivity. We suggest two ways to avoid, or diminish, this post-operative obstruction, or to detect patients at risk from obstruction: training for women who use their abdominal muscles for voiding rather than their detrusor, or pre-operative screening of hypotonic bladders.
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Satisfacción del Paciente , Prótesis e Implantes/efectos adversos , Implantación de Prótesis/métodos , Incontinencia Urinaria de Esfuerzo/cirugía , Procedimientos Quirúrgicos Urológicos/métodos , Vagina/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Hematoma/etiología , Hematoma/terapia , Humanos , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Estudios Prospectivos , Implantación de Prótesis/efectos adversos , Resultado del Tratamiento , Vejiga Urinaria/lesiones , Incontinencia Urinaria de Esfuerzo/fisiopatología , Retención Urinaria/etiología , Micción , Urodinámica , Procedimientos Quirúrgicos Urológicos/efectos adversosRESUMEN
The fact that a difference is not statistically significant does not mean that it does not exist. Some differences are not demonstrated by studies conducted on small sample sizes due to random sampling fluctuations. To demonstrate a difference which really exists or to conclude on the absence of a difference, the study must have a sufficient power, essentially determined by the number of subjects included. In the case of comparisons of survival curves, the number of events or total deaths at the time of analysis determines the power of the study. Examples derived from the urological or theoretical literature will illustrate the value of calculating the number of subjects required before starting the study and the value of retrospectively evaluating the power of a study in order to interpret its results.
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Ensayos Clínicos como Asunto/normas , Tamaño de la Muestra , HumanosRESUMEN
Subgroup analyses, "retrospective" statistics, and multiple tests, motivated by the search for explanatory covariables, are frequently used in the medical literature. However, these data manipulations induce modifications of the groups defined by initial randomization, an unverifiable increase of the alpha risk, a reduction of the power of the study and a risk of circular reasoning. Taking the example of an article concerning the hormonal treatment of prostate cancer, several situations are discussed, according to whether or not the study is prospective, whether or not the covariables are defined from the outset, and whether or not the results for the primary endpoint are significant.
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Proyectos de Investigación/estadística & datos numéricos , Humanos , Masculino , Neoplasias de la Próstata/tratamiento farmacológicoRESUMEN
UNLABELLED: The accuracy of measurements performed by a balloon catheter used to record abdominal pressure during urodynamic investigations was verified on a test bench. OBJECTIVE: To study the accuracy and precision of the pressure measurements obtained with a new rectal balloon catheter (ref. 95018 Laboratoires Vermed), designed to record abdominal pressure during urodynamic assessments. The clinical value of this catheter, using air for pressure transmission, is its simplicity, as there is no contamination of the perfusion circuit or transducer, no purging of the circuit, and artefacts related to movements of the tubing are eliminated. METHOD: The catheter was placed in a pressure chamber fitted with a precise, calibrated regulation system allowing programmed pressure variations from 10 to 150 cmH2O. Pressures recorded by the test catheter were compared to reference pressures applied to the chamber. The frequency of acquisition of pressure measurements was 100 Hertz and the resolution was 10 Hertz. This model was used to study the accuracy of pressure measurements and the response times of the catheter. Measurements were performed with a volume of 2 ml of air introduced into the catheter (volume recommended by the manufacturer), and the optimal volume was investigated by inflating the catheter until the best result was obtained. The evaluation was based on calculation of the mean difference observed between the two measurements and the scatter of the differences observed. RESULTS: When the catheter was filled with 2 ml of air, pressures measured by the catheter were overestimated an average of 1.1 cmH2O (standard deviation = 1), and 95% of the differences between the two measurements were within +/- 2.15 cmH2O. The optimal air volume was found to be 1.5 ml. With this air volume, no significant difference was observed between the two measurements. The mean observed difference was 0.2 cmH2O (SD = 1.2), which means that 95% of the differences were situated within the range of +/- 2.35 cmH2O. CONCLUSION: The pressure recording method with this new catheter is validated in terms of physical parameters.
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Urodinámica , Urología/instrumentación , Diseño de Equipo , Presión , Recto , Reproducibilidad de los ResultadosRESUMEN
Only the controlled trial method, clinical equivalent to the experimental method, with its successive phases and randomization, is able to confirm a real causal relationship and quantify the risk of error (alpha). However, the study must have sufficient power and randomization must not have resulted in an unbalanced distribution of various parameters likely to influence the result. Other methods, particularly surveys and case studies, only provide presumptions of causality. This review article, illustrated by three examples from the urological literature, is designed to demonstrate the difficulties of establishing a causal relationship when possible biases and confounding factors are taken into account.
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Causalidad , Ensayos Clínicos como Asunto/métodos , HumanosRESUMEN
BACKGROUND/AIMS: To report the clinical presentation, diagnosis and results of aggressive surgical management in patients with metastatic ampullary and pancreatic tumors. METHODOLOGY: Twelve patients underwent pancreaticoduodenectomy for ampullary or pancreatic metastases from January 1, 1987, to June 30, 1998, in 2 institutions. The primary cancer was renal cell carcinoma (n = 5), melanoma (n = 2), venous leiomyosarcoma (n = 1), carcinoid tumor (n = 1), colon carcinoma (n = 1), breast carcinoma (n = 1) and small-cell lung carcinoma (n = 1). The mean interval between primary treatment and metachronous pancreatic metastasis was 88 months. In 3 cases, pancreatic metastases were synchronous with the primary tumor. The main symptoms were jaundice (n = 8) and upper gastrointestinal tract bleeding (n = 2). The principal investigations were computed tomography scan (n = 9), arteriography (n = 7), duodenoscopy (n = 6) and fine-needle aspiration (n = 4). A correct preoperative diagnosis was made for 8 patients. RESULTS: In all cases, the pancreatic tumor was resected with intention to cure or provide useful palliation, using pancreaticoduodenectomy for isolated tumors (n = 11) or total pancreatectomy for multiple lesions (n = 1). Three out of 12 patents had positive lymph nodes, and the resection margin was free of disease in all cases. There was no postoperative mortality. Survival after pancreaticoduodenectomy averaged 26 months. Overall survival of patients undergoing pancreaticoduodenectomy was 35% at 2 years and 17% at 5 years. One patient is still alive more than 10 years after pancreaticoduodenectomy. CONCLUSIONS: Pancreaticoduodenectomy can be performed safely, representing a suitable option for resection in patients with symptomatic or late isolated pancreatic metastases in the absence of widely metastatic disease. The best indications are solitary metastases from renal cell carcinoma, sarcoma and neuroendocrine tumors. However, there is no evidence of survival benefit after pancreaticoduodenectomy for synchronous tumors or metachronous tumors from melanoma or colon carcinoma.
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Ampolla Hepatopancreática/cirugía , Neoplasias del Conducto Colédoco/secundario , Neoplasias Pancreáticas/secundario , Pancreaticoduodenectomía/métodos , Adulto , Anciano , Neoplasias del Conducto Colédoco/mortalidad , Neoplasias del Conducto Colédoco/cirugía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Neoplasias Pancreáticas/mortalidad , Neoplasias Pancreáticas/cirugía , Tasa de SupervivenciaRESUMEN
Intent to treat methodology consists of keeping all patients included, in their initial group in the case of randomization, to perform final analysis of a study. This attitude is justified methodologically, as it preserves the validity of the statistical rationale, and clinically, as it more closely reproduces real prescribing conditions. In the light of a classical example, this review illustrates several clinical situations raising the problem of intent to treat.
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Ensayos Clínicos como Asunto/métodos , Selección de Paciente , HumanosRESUMEN
Implantation of an artificial sphincter is an alternative treatment for patients with severe faecal incontinence. This prospective study from one institution has evaluated the results from 13. Preoperative and postoperative incontinence scores, anal manometry, and quality of life were evaluated in 13 patients who had undergone implantation of an artificial sphincter over a 7-year period. Two patients were definitive failures. One developed acute total colitis after 5 years of satisfactory function, and a second had discomfort and demanded removal of an otherwise functioning device. After a median follow-up of 30 (range 5-76) months, 11 patients had an activated and functional device. These included 6 with a urinary AMS 800 and 5 with the newly designed anal ABS. The mean incontinence score decreased from 17 to 4, and quality of life improved markedly. Two of the 11 patients had undergone successful reimplantation, one following rupture of the cuff and the second following ulceration of the control pump through the labia. In no case was infection or erosion of the anal canal a cause of failure. While the cause of incontinence and age did not affect outcome, psychological reaction had a significant impact. The artificial anal sphincter may have a role to play in severe faecal incontinence.