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Angel Silmi Moyano

Publications and source records attributed to Angel Silmi Moyano.

17 recordsLinked to original sources

[Spanish registry of the TRT Reemex system in women with stress urinary incontinence (SUI)].

OBJECTIVES: Due to the absence of randomized studies, the Spanish Reemex Working Group started a registry to analyze and review the results of a large group of patients with mid-term and long-term follow-up to obtain conclusions based on clinical experience. METHODS: A registry of 715 patients who underwent surgical intervention for insertion of the SUI readjustable prosthesis Reemex TRT (tension free readjustable tape) in 15 Spanish hospitals (40% urology departments, 60% gynecology departments). The registry was established to evaluate the safety and efficacy of the sling adjustability concept in the surgical treatment of female SUI. The Spanish Working Group was able to evaluate results of the Reemex system in 683 patients of a total of 715. Mean age was 59.9 yr (range 21-87) with a mean follow-up of 23 months (6-93). The group includes: 30.2% patients with mixed incontinence, 73.1% patients with urodynamic intrinsic sphincteric deficit, 35.7% patients with previous history of failed surgical interventions for urinary incontinence, and 54.3% previous pelvic floor associated operations. All patients were evaluated preoperatively with history, physical examination and urinary incontinence questionnaire. Each follow-up visit included incontinence questionnaire, physical examination and stress test. RESULTS: Cure rate was 92.2%, with 6.9% improvement and 0.9% failures. Readjustment was performed in 416 patients (60.9%) as a second phase of surgery over the following 24-48 hours, before hospital discharge. 80 patients (11.7%) were readjusted in the mid- or long-term (between 6 and 8 months after surgery). The level of support of the sling was successfully reduced in three patients between 6 and 14 months after surgery. No other patient suffered voiding difficulties in the long-term. 1.7% of the patients needed extraction of the tensor due to persistent abdominal wall seroma. 0.8% presented vaginal extrusion of the sling. CONCLUSIONS: The Reemex system is a minimally invasive technique with consistent results and even improved in heterogeneous groups of patients including intrinsic sphincter defficiency, reoperations, mixed incontinence and associated pathologies.

Adult↗

[Suburethral readjustable sling (Remeex) for the treatment of female urinary incontinence: personal surgical technique].

OBJECTIVES: Currently there is not agreement about the adequate tension for each patient with female stress urinary incontinence treated with urethral slings. The adjustable tension sling Remeex (external mechanic regulation) allows adjustment to ideal tension trying to avoid or minimize possible reoperations. The objective of these paper is to describe the components of the Remeex system, its indications, and the surgical technique to implant and adjust it. METHODS INDICATIONS: The Remeex system is indicated for female urinary incontinence in cases of urethral hypermobility, fixed urethra, primary sphincteric dysfunction, failure of other incontinence repaired techniques, and urinary incontinence in bladder hyperreflexia. STUDY PROTOCOL: The diagnosis is made with appropriate history and physical examination and completed with voiding cystourethrogram and urodynamic study, urinary tract ultrasound and, optionally, urethrocystoscopy. Remeex prosthesis characteristics: The system has three elements: polypropylene mesh, pressure tensor, and disconnection tool. TECHNIQUE: 1. Anesthesia: It maybe performed under general or spinal anesthesia. 2. Preparation and patient position. 3. Surgical technique step-by-step:--Abdominal access: 4-6 cm suprapubic incision and development of a supra- aponeurotic space to place the pressure tensor.--Vaginal access: longitudinal incision 1 cm from the urethra meatus, dissection of the vesicovaginal plane, and development of the space to place the polypropylene mesh.--Combined abdominal-vaginal access: bilateral punction with a 20 cm suture-passing needle from the abdomen to the vagina and passage of the mesh from the paraurethral espace threading its sutures in the pressure tensor system, and closure of the incisions.--Cystoscopy.--Tension adjustment and postoperative control. CONCLUSIONS: 1. It is an easy to implant system and a reproducible operation. 2. This technique avoids the morbidity of abdominal operations. 3. It allows the readjustment after surgery through a small suprapubic incision under local anesthesia. 4. Good results have been described in the short and mid-term.

Female↗

[Filling phase abnomalities and cystocele].

OBJECTIVES: To evaluate the clinical and urodynamic characteristics of a series of women with lower urinary tract symptoms (bladder filling phase) presenting various rates of cystocele. METHODS: 119 female patients were included in this study; mean age was 55.8 yr. (range 15-87). All patients underwent urogynecologic physical examination (cystocele was graded 0-3) and complete urodynamic study. Urodynamic terminology and measurements comply with the ICS (InternationaL Continence Society) standards. Statistical significance was established below 0.05. Quantitative variables were compared by the Student's t and non parametric variables by Pearson's chi-square. RESULTS: The most frequently reported symptom was urinary incontinence when coughing (77/118, 65.3%), followed by urge incontinence (71 patients, 60.2%). The grade of cystocele was 0 in 31.1%, 1 in 25.2%, and 2 in 26.1%, and 3 in 17.6%. There was a statistically significant association between grade of cystocele and the symptom "vaginal bulge" (p=0.00002). The presence of cystocele did not show any statistical association with lower urinary tract symptoms of the filling phase. Mean cystomanometric bladder capacity was 224.8 ml. Involuntary contractions of the detrusor muscle appeared in 38 cases (21.9%), stress urinary incontinence in 19 (16%), mixed incontinence in 8 (6.7%) and absence of evidence of urinary incontinence in 58 (48.7%). Patients with urgency had a lower bladder capacity than patients without it (p = 0.02), as did patients with urge incontinence (p = 0.02). Nocturia (p = 0.05), urgency (p = 0.02) and urge incontinence (p = 0.01) were significantly associated to bladder capacity. The existence of involuntary contractions was statistically associated with urge incontinence (p = 0.01). Patients with involuntary contractions during the filling phase showed increased diurnal voiding frequency (p = 0.02), as well as patients without a stress urinary incontinence (p = 0.04) and cases without a stress urinary incontinence (p = 0.04). The symptom incontinence with coughing had a significant statistical association with the urodynamic diagnosis of stress urinary incontinence (p= 0.01). Bladder capacity was augmented in grade 3 cystocele (p = 0.003). The existence of cystocele was not associated with bladder hyperactivity (p = 0.65), neither was the diagnosis of a stress urinary incontinence (p = 0.37). CONCLUSIONS: No relationship has been demonstrated between existence and degree of cystocele and functional lower urinary tract symptoms of the filling phase, on the one hand, and urodynamic evidence of bladder hyperactivity and incontinence on the other hand. This could have important therapeutic implications.

Adolescent↗

[Factors for voiding dysfunction and cystocele].

OBJECTIVES: To evaluate the clinical and urodynamic features of a series of women with post void residual urine (disbalanced voiding) and various degrees of associated cystocele. METHODS: 119 female patients were studied by clinical evaluation, urodynamics, and imaging tests (VCUG). All patients underwent history and genitourological examination (evaluating cystoceles from grade o to 3), neuro-urological examination, and complete urodynamic study. Fifty patients (42%) underwent radiological studies of the upper urinary tract. Disbalanced voiding was defined as existence of post void residual greater than 20% of the voided volume. Urethral resistance was measured by URA. Structural obstruction was characterized by PURR (CHESS classification). Functional obstruction was studied by DURR and perineal EMG (associated with flowmetry). Detrusor contractile power was evaluated by W max, W 80-20, and duration of contraction. Urodynamic terminology and measurements complied with the International Continence Society (ICS) standards. Statistical significance was established at 0.05. Statistical analysis was done by Student's t for quantitative variables, and Pearson's chi-square for non parametric variables. RESULTS: 119 patients were enrolled. Mean age was 55.84 yr. (range 15-87). Regarding post void residual (114 valid uroflowmetry studies), 25 patients were classified as voiding disbalance (21.9%) and 89 as balanced (74.8%). Regarding clinical data, there were only significant differences between groups in voiding difficulty. For uroflowmetry, only the percentile of the Maximal flow (Qmax) showed significant differences (35 vs. 22 for balanced/disbalanced voiding respectively, p = 0.02). Pressure/volume studies demonstrated bladder hyperactivity in 16 cases (64%) in the group of disbalanced voiding and 31 cases (34.8%) in the normal voiding group (p = 0.008), which presented associated with increased urethral resistance (URA)(p = 0.01) . In the pressure/flow study, there were significant differences in the URA (14.7 vs. 25.3, p = 0.001). There were statistically significant differences in the degree of constrictive (0.5 vs. 1.1, p = 0.009) and compressive (0.5 vs. 1.1; p = 0.04) obstruction (Chess classification). There were not significant differences in the analysis of isometric contractility (Wmax), but there were in the isotonic contractility (W80-20) and detrusor contraction duration. These latter differences presented significant association with the degree of cystocele. DURR and perineal EMG data did not show differences between groups. Radiological abnormalities of urethral morphology were statistically different between groups, presenting in 10% of the patients with normal voiding and 50% of the disbalanced voiding group, although there was not statistical association with obstruction (p = 0.64). The existence of cystocele did not show a statistical association with these variables either. CONCLUSIONS: Disbalanced voiding appeared with organic obstruction of the lower urinary tract (constrictive most significantly), as well as detrusor abnormal contractility, but whereas the first was not significantly associated with presence and grade of cystocele, the second showed such association.

Adolescent↗

[Urodynamics of the bladder diverticulum in the adult male].

OBJECTIVES: To evaluate the clinical and urodynamic characteristics of a series of adult males with BPH and bladder diverticula, and to analyze the changes in urodynamics in patients undergoing lower urinary tract surgery to relieve obstruction, with or without associated diverticulectomy. METHODS: We studied 91 patients in two groups: Group 1- BPH: 67 cases (73.6%) and Group 2-BPH + diverticulum: 24 cases (25%). Mean age was 65.04 years. All patients underwent urological physical examination and complete urodynamic study including cystogram. In addition, we studied 19 patients with BPH and bladder diverticula (mean age 64.58 years) who underwent either endoscopic surgery (1 I cases; 57.9%) or endoscopic surgery plus diverticulectomy (8 cases, 42. 1%). Complete clinical study and urodynamics (including cystogram) were performed preoperative and three months after surgery. Statistical significance was established at 0.05. RESULTS: Comparative study between group 1 (BPH) and group 2 (BPH with diverticulum): there were significant differences in clinical data: acute urinary retention (6.1% vs. 25%;p<0.01), and urinary tract infection (3.1% vs. 21.7%;p=0,004). All evaluated cases had single diverticula (8 cases). Urodynamic studies showed: 1) Post-void residual after free flowmetry: 45.9 ml vs. 221.4 ml, p = 0.008. 2) Bladder capacity on cystometrogram: 211.2 ml vs. 350.8 ml, p = 0.024. 3) Voiding pressure/flow study: a) Voiding with abdominal press 23.9% vs. 50%, p = 0.02. b) URA 36.5 cm H2O vs. 48.5 cm H2O, p= 0.04, c) post void residual 70.7ml vs. 210.3 ml, p= 0.004. d) Bladder contractility measurements (Wmax- isometric contractility- and W80, W20- isotonic contractility) did not show significant differences between groups. Bladder contractility duration was significantly decreased in group 2. In the analysis of patients undergoing surgery to relieve obstruction (Group A- Surgery without diverticulectomy; Group B Surgery with diverticulectomy) there were not differences between groups in clinical data. Urethral resistance parameters (URA) decreased in both groups. Group A: from 43 cm H20 to 26.3 cm H2O. Group B: from 60.6 cm H2O to 48 cm H2O. This decrease was similar after either TURP or myocapsulotomy. Post void residual diminished in both groups. There were no statistical differences between groups in Wmax, W 80-20, or volume, number and site of the diverticula. On the contrary, bladder contractility duration diminished after diverticulectomy. CONCLUSIONS: Bladder diverticula appear in the cases with highest ureteral resistance values (lower urinary tract obstruction). Standard bladder contractility parameters were not diminished. Duration of detrusor contraction was the only contractility parameter significantly affected in cases of bladder diverticula and presented a significant association with the use of abdominal press while voiding. Diverticulectomy showed an improvement of bladder contractility with longer detrusor contraction duration, which supports its use in cases of BPH-associated diverticula. Both TURP and transurethral incision of the prostate diminished urethral resistance in a similar way, so that they may be considered alternative options. Our data should be confirmed with a bigger sample size.

Aged↗

[Abdominal compartment syndrome in an urological patient].

OBJECTIVES: Abdominal compartment syndrome is an infrequent clinical entity, the course of which has a rapid progression with multiorgan compromise leading to a fatal outcome if appropriate and urgent action is not undertaken. METHODS AND RESULTS: We report the clinical case of a patient who developed the clinical picture after renal trauma. Diagnosis was obtained by CT scan and arteriography, afterwards the patient required ICU admission with intra-abdominal pressure monitoring, and several decompression laparotomies before definitive closure with a reabsorbable mesh. CONCLUSIONS: Urologists should know the existence of this syndrome its appropriate treatment, because we manage patients who are candidates to suffer it. Due to the high mortality rate associated, it is essential to know how to recognize it in order to act fast.

Abdomen↗

[Renal transplant in a patient with aortobifemoral bypass].

OBJECTIVES: Over the last few years we see an increase in the number of patients with vascular disease who need a renal transplant. We discuss their management and different therapeutic options available. METHODS/RESULTS: We report the case of a female patient with history of systemic vascular disease having undergone multiple surgical procedures for it, including aortobifemoral bypass, presenting with end stage renal disease. A kidney transplant into the right iliac fossa was carried out with end to side vascular anastomosis to the iliac vein and arterial vascular prosthesis, respectively. The main difficulty came from the existence of an important fibrosis around the prosthesis, which forced a much more careful dissection of the iliac vein. Immediate postoperative course was uneventful, and the graft shows a normal function two years after surgery. CONCLUSIONS: The coexistence of vascular and renal disease is not a contraindication for kidney transplantation. Larger experience is required, but published data to date do not show significant differences on graft or patient survival.

Aorta, Abdominal↗

[Systematic review about the usefulness and prognostic value of the p53 oncoprotein and proliferation marker Ki-67 for upper urinary tract transitional cell carcinoma].

OBJECTIVES: To perform a systematic review on the expression and prognostic value of the p 53 oncoprotein and Ki 67 proliferation marker in transitional cell carcinoma of the upper urinary tract. METHODS: A systematic review of cohort, prospective and retrospective studies from 1/1/1990 to 11/24/2003 has been undertaken, performing a bibliographic search both manual and electronic in the main databases. 632 works were found using the keywords "ureter, renal and pelvis tumor", and 14 with "ureter, renal and pelvis tumor, and immunohistochemical". RESULTS: 509 patients were studied; they were selected from 7 retrospective studies about the usefulness of p53 and Ki 67 in transitional cell carcinoma of the upper urinary tract published between 1995 and 2002 (three Spanish studies, three Japanese and one North American). Each one analyzes between 37 and 121 cases, with a mean age of 66.8 years (range 63.0-74.7) and a predominance of male sex in 100% of the studies. The pyelocalyceal site was the most frequent in these series. Treatment is another issue taken into consideration in this papers, being nephroureterectomy the most frequently found. The p53 and Ki 67 percentage expression in various studies has been related to clinical and histological factors. Only 5 studies performed a multivariate analysis using Cox regression models. Three of them deal with Ki 67 and two with p53, although one of the p53 studies associates cyclin E determinations. Only two out of three studies about Ki 67 were considered evaluable, because multivariate analysis was not performed in the other one. CONCLUSIONS: 1) There are a few studies and they are very heterogeneous in terms of design, selection criteria, follow-up, and use of prognostic variables. 2) The analyzed studies establish that oncoprotein p53 and proliferation marker Ki 67 are prognostic factors for transitional cell carcinoma of the upper urinary tract, and 3) To perform a meta-analysis was deemed not indicated because of the heterogeneicity of the studies found in our search.

Biomarkers, Tumor↗

[The management of azoospermic patient].

OBJECTIVES: Since first pregnancy after ICSI was achieved in 1992, the treatment and prognosis of severe male factor, i.e azoospermia, has radically changed. The objective of this article is to review the issue from the urologist-andrologist point of view. METHODS: We perform a short revision of the two types of azoospermia and diagnostic tests, and show the algorithm used in our centre for the management of patients with azoospermia. We review the techniques for spermatozoid recovery and surgical treatment of obstructive azoospermia because the role of the urologist is maximum in these aspects. Genetic anomalies in azoospermic patients is one of the issues analyzed in more detail for being one of the most important and of maximum interest currently. RESULTS: Nearly 1% of pregnancies in developed countries are achieved by assisted reproduction techniques, and genetic anomalies among newborns from ICSI cycles have increased to 1.6%, three times normal population. Genetic anomalies are tenfold in azoospermic patients in comparison to general population. We analyze the importance of these studies in patients with secretory azoospermia. We review the most frequent genetic anomalies associated with azoospermia and diagnostic tests employed. Its importance is based on this diagnosis allowing genetic counselling and pre-implant or prenatal diagnosis with the aim of trying to minimize genetic anomalies and disease transmission to next generations. CONCLUSIONS: The diagnosis and treatment of azoospermia continues to be one of the most thrilling challenges in the field of infertility, with promising research lines such as in vitro spermatogenesis from stem cells and autotransplantation of criopreserved cells in patients undergoing radiotherapy and chemotherapy.

Equipment Design↗

[Renal transplantation in donors over 60 years of age].

OBJECTIVES: To evaluate the impact of receptor's advanced age on kidney transplant outcomes. METHODS: We reviewed all transplants performed between January 1990 and December 1999. Among 570 patients receiving grafts, 115 patients were 60 years or older at the time of transplantation. We compared this group with receptors younger than 60 years. We studied possible prognostic variables and compared patient and graft outcomes. RESULTS: Mean age 63.81 (typical deviation (TD): 2.96). Mean follow-up time for elderly receptors was 41.6 months (TD: 26.58). 55.7% patients were males (p: 0.4). The most frequent cause for end stage renal disease was unknown etiology in group 1 and glomerular in the younger group (p: 0.01). 42% patients older than 60 years presented initial graft dysfunction, in comparison to 28.1% among younger than 60 (p: 0.006). Three-year graft survival was 90.42% for receptors 60 years old or older compared to 88.72% for group 2, without significant differences (p: 0.5). The most frequent graft loss etiology was patient death. (67.7%). (p = 0.005). Patient survival was 81.01% in group 1 and 95.25% in group 2, being differences significant (p < 0.001). CONCLUSIONS: Renal grafts in receptors over the age of 60 years show a greater incidence of delayed graft function, although it doesn't seem to influence final graft survival. The most frequent cause for graft loss is receptor's death. Receptor's age does not represent a contraindication for transplant.

Age Factors↗

[Effect of recipient age on transplants performed using organs from donors in asystole].

OBJECTIVES: To evaluate the influence of receptor's age on the outcomes of kidney transplants with organs from non heart beating donors. METHODS: Observational study of the historic cohort of 570 kidney transplants performed at the Hospital Clínico San Carlos between 1991 and 1999. Receptor's were divided into two age groups, group 1 younger than 50 years, and group 2 older than 50 years. All organs where harvested from non heart beating donors. RESULTS: We studied 110 kidney transplants coming from non heart beating donors; 52 belonged to group 1, and 57 to group 2. Three-year patient survival for receptor's younger than 50 years was 100%. The probability of three-year survival for receptor's older than 50 years was 79.39% (p 0.07). Graft survival was 88.46%, 86.54%, and 86.54% at 12, 24, and 36 months respectively for receptor's younger than 50 years. When receptors were older than 50 years the probability of functioning graft in the same periods of time was 89.20%, 89.20%, and 86.32% respectively. CONCLUSIONS: Receptor's age doesn't seem to influence graft survival when kidneys from non heart beating donors are used.

Adolescent↗

[Ipsilateral metanephric adenoma and clear-cell carcinoma. Personal experience and review of the literature].

OBJECTIVES: To perform an update in such an infrequent pathology and to report our own experience. METHODS: We report two new cases and review the national and international literature. RESULTS: We report two cases of ipsilateral metanephric adenoma and clear cell carcinoma. The first case, metachronous, was detected after 15 months of follow-up in a patient who underwent partial nephrectomy due to clear cell carcinoma. The second one, synchronic, was incidentally discovered in the surgical specimen. CONCLUSIONS: Metanephric adenoma is as infrequent neoplasia; its diagnosis is histological, being difficult to suspect by complementary diagnostic tests, so that most cases undergo surgical treatment in spite of its benign character.

Adenocarcinoma, Clear Cell↗

[Influence of recipient age on renal transplantation performed with organs coming from child donors].

OBJECTIVES: To evaluate the influence of receptor's age on the outcomes of kidney transplants with organs from donors below the age of three years and/or weighting less than 15 Kg. METHODS: We retrospectively studied the renal transplants with organs from donors below the age of three years and/or weighting less than 15 Kg performed at the Hospital Clínico San Carlos between 1991 and 1999. Receptors were divided into two groups depending on the age at the time of transplantation; group I included patients younger than 50 years and group II patients older than 50. RESULTS: We study 49 kidney transplants with pediatric donors (8.6%); 22 of them were included in group I and 27 in group II. There were no deaths among receptors younger than 50 years. Five-year survival for group II was 75.99%. Five-year graft survival what's 81.82% for group I, and 88.89% for group II (p 0.45). CONCLUSIONS: Receptor's age does not seem to influence graft survival when this kind of organs are used; we consider that the lower incidence of acute rejection in patients older than 50 years may explain the excellent response.

Acute Kidney Injury↗

[Collecting duct carcinoma. Personal experience and review of the literature].

OBJECTIVE: To present our experience with renal collecting duct carcinoma and review the literature. METHODS: We reviewed our experience with collecting duct carcinoma of the kidney. We found 6 cases out of 176 nephrectomies (3.4%), which accounts for one of the largest series reported in the literature. The radiological, histological and immunohistochemical findings are analyzed. RESULTS: The histological and immunohistochemical findings showed a specificity for high molecular weight cytokeratins and Ulex europeaeus but the imaging findings were not distinct from those of other renal tumors. According to the anatomopathological findings, we have classified the patients into three groups with three distinct courses. All patients underwent radical nephrectomy and one patient received adjuvant therapy. CONCLUSIONS: We have identified a subgroup of low grade collecting duct carcinoma of the kidney with a particularly favorable behavior in two patients of our series. At 56 and 41 months' follow-up, both patients remain disease-free. As reported in the literature, patients with high grade and stage collecting duct carcinoma of the kidney have a poor outcome. They develop severe complications and die less than one year after the diagnosis, despite adjuvant immunotherapy.

Aged↗

[New male sling "Argus" for the treatment of stress urinary incontinence].

OBJECTIVES: Male stress urinary incontinence is usually a consequence or sequel of a prostatic surgical procedure (radical prostatectomy, surgery for BPH or bladder neck sclerosis: adenomectomy, conventional and/or bipolar transurethral resection, laser...). This kind of surgery may have undesirable effects on the quality of life and patients' expectations, although we should bear in mind that the primary objective in patients with prostate adenocarcinoma is to cure cancer and for patients with obstructive lower urinary tract symptoms to improve their voiding quality Over the last decade, surgical procedures to compress the bulbar urethra with slings have been employed successfully in the treatment of male stress urinary incontinence, being considered highly effective in the treatment of post-prostatectomy incontinence in the long-term by groups with large experience. To describe the elements of the Argus system, its indications, and the surgical technique for its implant and adjustment, modified from Schäeffer and carried out by Victor Romano. METHODS: Argus system: The sling has three components: radiopaque cushioned system with silicone foam, 42 mm x 26 mm x 9 mm, which is waterproof to body fluids; two silicone columns formed by multiple conical elements, which allow system readjustment; and two radiopaque silicone washers (15 mm diameter and 2.9 mm width) which enable proper fixation and readjustment (Figure 1). Once the system is open, it is recommended to place the sling within antibiotic solution until implantation. CONCLUSIONS: 1. It is a safe, easy to implant, reproducible system, with few complications and a good cost-benefit relation. 2. Results are comparable to the gold standard, but it has the following advantages: immediate voiding control recovery and no need for patient training. 3. This article does not intend to show our short experience with only five cases, but we want to mention that all of them are continent with a good quality of life. 4. Our objective will be to publish our results when we can show a minimal follow-up.

Humans↗

[Clinical research in urology and scientific methodology].

Clinical epidemiology is the science and method of studying the optimal decisions in clinical medicine, taking into consideration the epidemiological characteristics of the patient and his/her external clinical environment, the disease involved, and factors and procedures to which the patient is exposed in his/her clinical environment, specially clinical actions. Research should be a systematic process, organized and objective, aimed to answer the question posed. Systematic means that the scientific method is applied, for that a hypothesis or work objective is formulated from observations or established knowledge about a topic, data are collected following a pre-established design, and, once analyzed and interpreted, conclusions are obtained which will modify or add new knowledge to the previous, and a new cycle starts again. Organization means that all members in the research team know perfectly what to do during the whole study, apply the same definitions and criteria to all participants, and act in identical way in front of any doubt. To achieve this, it is mandatory to write a protocol specifying all details related to the study. The meaning of the word objective is that conclusions obtained are not based on subjective impressions but on facts that have been observed, measured, and analyzed, and that any prejudice the study responsibles could have is avoided during its interpretation.

Biomedical Research↗