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Resumen El objetivo de este articulo es ilustrar como poner en marcha y desarrollar un estudio multicentrico prospectivo, controlado y aleatorizado. Por ello, lo primero que se necesita es crear una idea que genere una hipotesis y un objetivo principal. La busqueda bibliografica nos permite ver su relevancia clinica y las evidencias publicadas. Ademas, hay que plantearse si el estudio es viable economicamente y si puede ser completado en un periodo menor a 4 anos. Una vez ideado el estudio multicentrico, para ejecutarlo se debe redactar un protocolo (segun la guia Standard Protocol items: Recommendations for Interventional Trials [SPIRIT 2013]). En el se recogeran el tipo de diseno, el tamano muestral y los centros que participaran. La aleatorizacion es clave en el diseno. Si puede ser aleatorizado, se recomienda utilizar la guia Consolidated Standards of Reporting Trials (CONSORT), si no, la Transparent Reporting of Evaluations with Non-Randomized Designs (TREND). Cuando el protocolo es aprobado por el Comite Etico de Investigacion Clinica del hospital, hay que darle visibilidad. Es por eso que se recomienda su registro en ClincalTrials.gov y su publicacion en revistas indexadas. Para el inicio del estudio, se requiere buscar fuentes de financiacion. Estas permiten tener una base de datos on line, que permiten aleatorizar al momento y mantener el registro al dia desde cualquier centro. Por ultimo, hay que destacar que es imprescindible la motivacion. La multicentricidad solo se entiende si todos los centros participan. Asi que informar de resultados y dar animos cada 1-3 meses (en forma de newsletter) es una manera de conseguir un buen funcionamiento del estudio.

Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial. The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years. In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended. When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines. Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately. And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study.

To establish which patients suffering ventral hernia benefit the most from laparoscopic approach.From January 2005 to October 2008, 126 patients underwent surgery due to incisional hernia at our University Hospital. Patients were assigned to laparoscopic surgery (n=60) or conventional surgery (n=66) at the surgeon's discretion. Patients were subdivided according to the greater diameter of the defect: (G1, defect5 cm; G2, defect 5 to 15 cm; and G3, defect15 cm). Data on patient demographic, clinical, and perioperative variables were collected prospectively.Groups were comparable in terms of sex, body mass index, American Society of Anesthesiologists score, size of defect, and proportion of primary repairs. Four patients were converted to open surgery. Mean hospital stay in the group with the smaller hernias (G1 was 3.16 d laparoscopic surgery vs. 2.87 d conventional surgery, P0.05). Hospital stay for patients who underwent laparoscopy was shorter in G3 (4.25 d Lap vs. 12.6 d Open; P=0.02).Patients with very large incisional hernias are those who benefit the most from laparoscopic treatment.

We present a case of gastroesophageal junction leak after gastric bypass with serious sepsis and hemodynamic instability. Minimally invasive treatment was performed in two stages: initial sepsis control by lavage and endoscopy-assisted laparoscopic placement of an intraluminal esophageal drainage tube through the leak orifice; this was followed by definitive leak treatment with a self-expandable covered metal stent after achieving hemodynamic stability. Patient evolution was satisfactory without the need for open surgery.

Resumen Introduccion La incorporacion de la cirugia laparoscopica del cancer de recto (CLCR) en la practica asistencial es uno de los retos que afrontan nuestras sociedades quirurgicas. El objetivo del presente estudio es analizar los resultados obtenidos durante la fase de implementacion de la tecnica. Pacientes y metodo Entre enero de 2003 y junio de 2005, en nuestro centro se intervino por laparoscopia a 40 pacientes con carcinoma rectal. Recogimos prospectivamente las variables clinicas y anatomopatologicas de los pacientes para su posterior analisis estadistico. Resultados En 27 varones y 13 mujeres se realizaron 11 resecciones anteriores altas (RAA), 20 bajas (RAB) y 9 resecciones abdominoperineales (RAP). El tiempo quirurgico fue de 240,4 ± 200 min, mayor para las RAB (259,7 min). La tasa de complicaciones intraoperatorias fue del 22,5% (n = 9). La estancia hospitalaria fue de 8,7 ± 4,8 dias. La tasa de complicaciones postoperatorias fue del 32,5% (n = 13). La tasa de conversion fue del 15% (n = 6), mayor en el grupo de RAB (n = 5). Los problemas con la seccion distal del recto, con 4 casos, fue la complicacion intraoperatoria mas frecuente y la causa mas frecuente de conversion. Se considero la cirugia como curativa en 34 casos (85%). Registramos 1 caso de margen de reseccion circunferencial (MRC) positivo (2,8%). Se obtuvo un margen longitudinal medio de 3,6 ± 2,7 cm y un MRC medio de 1,1 ± 0,9 cm. Conclusiones Durante la fase de implementacion de la CLCR obtuvimos unos resultados globales satisfactorios. La RAB se mostro como el procedimiento mas exigente, con una mayor tasa de conversion.

e a g w m m s l 8 Sleeve gastrectomy has spread rapidly as a single standalone surgical procedure for the treatment of morbid obesity. It is considered a rapid procedure with good short-term results and low morbidity, although it can be associated with serious complications such as leakage at the esophagogastric junction. Little is known about this complication and its treatment. It can usually be treated with coated self-expandable stents; however, when this fails, leakage at the angle of His can be challenging for the surgeon, requiring complex surgical procedures.

Obesity and gastroesophageal reflux disease (GERD) are both high-prevalence diseases in developed nations. Obesity has been identified as an important risk factor in the development of GERD. The objective of this study was to determine the frequency of abnormal esophageal acid exposure in patients candidate for bariatric surgery and its relationship with any clinical and endoscopic findings before surgery.Data collected from a group of 88 patients awaiting bariatric surgery included a series of demographic variables and symptoms typical of GERD. The tests patients underwent included manometry, pH monitoring, and upper gastrointestinal endoscopy. Univariate and multivariate analyses were conducted on the variables related to the onset of reflux.Esophageal pH monitoring tests were positive in 65% of the patients. Manometries showed lower esophageal sphincter hypotonia in 46%, while 20% returned abnormal upper endoscopy results. Out of the 45% of patients who were asymptomatic or returned normal endoscopies, half returned positive esophageal pH tests. In turn, among the 55% of patients who had symptoms or an abnormal upper endoscopy, three quarters had pH tests that diagnosed reflux. pH tests were also positive in 80% of symptomatic patients and 100% of patients with esophagitis (P.042). No statistically significant relationship was found between body mass index, sex, age, manometry, or hiatus hernia and the positive pH monitoring.Frequency of abnormal esophageal acid exposure among obese patients is high. There is a relationship between the presence of symptoms and reflux. But the absence of symptoms does not rule out the presence of abnormal esophageal function tests.

About the changes proposed by Dr. Santoro to improvethe safety of stapling, I agree that they could promotehemostasis and sealing of stapling in procedures such assleeve gastrectomy.As discussed in my article published in Obesity Surgery[1], my model of "asymmetrical stapler", proposes a cutlateral to apply more rows of staples in the gastric remnantand less in the resected stomach. Thus, not only could createmodels 4×2 rows of staples, but also of 5×1 or even 3×1models could be created; smaller intruments but equally safethan current. This is therefore a “functional design”, whichcan be applied to all fields of resective surgery and wouldbe perfectly compatible with the other improvements suchas the system of different sizes of staples, biomaterialsand so on. I am pleased to see that Dr. Santoro has alreadythought of this new concept before [2] and match the opinionof other experts consulted by me. I hope that the medicalindustry can incorporate this change in the coming years.

Laparoscopic treatment of simple acute appendicitis (AA) is a safe procedure; however, there are doubts about its safety in cases of complicated AA. The aim of this study was to determine the differences in results of laparoscopic treatment between cases of complicated versus simple AA.We prospectively included all patients treated for suspected AA by two surgeons of our service between May 2002 and May 2007. Of 221 patients, 20 were excluded from the study because the laparoscopic approach was not possible; 116 of 201 had uncomplicated AA, 57 complicated AA, 12 gynecologic ethiology, 11 negative appendectomy, and 5 other causes; patients without acute appendicitis were also excluded from the study. In all cases, laparoscopy was the first treatment option. The following variables were considered: mean surgical time, reconversions, emergency readmissions, emergency reinterventions or invasive procedures, mean postoperative hospital stay, and postoperative complications (i.e., infectious or noninfectious).Our results showed statistically significantly worse results, in terms of surgical time, postoperative stay, reconversions, and infectious complications, for patients with complicated versus uncomplicated AA; however, no differences were observed regarding noninfectious complications, emergency readmissions, and emergency reinterventions or invasive procedures.We consider that laparoscopic treatment of complicated AA may be safely used, despite worse results than in cases of simple AA, since the differences in numbers of severe postoperative complications requiring emergency readmission, reintervention, or invasive procedures were not statistically significant.

Esophageal liposarcoma is an extremely rare tumor. Different options of treatment have been advocated. We report the case of a 72-year-old-man with a large tumor resected through left cervicotomy with thoracoscopic assistance. Minimal invasive management of these infrequent tumors and the results of the literature are discussed.

Intrasplenic pseudoaneurysm is a potentially lethal complication of abdominal trauma. We present the case of a 33-year-old patient with this particular complication diagnosed by CT-scan. Selective embolization was not possible due to its extraordinarily large size and finally splenectomy was performed. We review the English literature and discuss the particular role of the interventional radiologist to treat this entity. The interventional radiologist is the specialist who better estimates the success of embolization or the risk and possibility of delayed splenic rupture. Embolization of the arterial tributary to the pseudoaneurysm should be considered as the treatment of choice only when the diagnosis is made before rupture of the spleen and only in selected cases. Splenectomy always remains as an alternative treatment for high-risk pseudoaneurysms.

Endoscopic India ink marking techniques are often used for the intraoperative location of colonic polyps and early stage neoplasms. The aim of this study was to compare how effective this technique is compared with conventional localization methods, as well as its influence on the results of colorectal laparoscopy (LSCRC) for endoscopically advanced tumors.From January 2003 to January 2005, 47 patients with colorectal carcinomas were included in the study. In one group, lesions were localized preoperatively by endoscopic India ink tattooing (n = 21; tattooed group, TG), while conventional methods were used in the others (n = 26; non-tattooed group, NTG). Patients' perioperative clinical and pathoanatomical data were prospectively collected.Both groups were comparable in age, sex distribution, American Society of Anesthesiologists (ASA) score, body mass index (BMI), technique performed, tumor size and proportion of patients who had previous abdominal surgery. Three patients presented ink spillage without clinical repercussions. Visualization of the correct resection site was higher in the TG (100% vs. 80.8%, P = 0.03). Operative time (147.3 +/- 46.2 vs. 187.0 +/- 52.7 minutes, P = 0.02) and blood loss (99.3 +/- 82.8 vs. 163.6 +/- 96.6 cc, P = 0.03) were lower in the TG. There were no differences between groups regarding peristalsis, introduction of oral intake, hospital stay or intra- and postoperative complication rates. No differences were observed amongst pathoanatomical data studied.Preoperative endoscopic tattooing is a safe and effective technique for intraoperative localization of advanced colorectal neoplasms, improving the operative results of LSCRC.

A noninvasive, quick, reliable, and relatively cheap procedure for the diagnosis of onychomycosis is put forward. It is known that a nail may show an abnormal appearance, although only 50% of all the nails having such an appearance may owe it to the presence of onychomycosis; hence, adequate diagnosis of nail disease is needed for appropriate prescription of medication and treatment of the nail. In order to contribute to the process of improvement in the diagnosis, a procedure based on the analysis of medium-range infrared images is presented in which it is possible to observe energy changes mostly due to the changes in emissivity of the nail. As a nail is more affected by onychomycosis, such changes become more intense. Also, it was found that a nail without onychomycosis has a lower temperature than toe skin, but has a higher emission of energy. Fifty percent of the ailments that may a cause a fingernail or toenail to have an abnormal appearance are not considered in the present work.

The human small and large intestine were studied for viruses, bacteria, and fungi in 29 adults with acute diarrheal disease. No etiologic agent was found in 83% of the cases. The most striking finding in these patients was a marked increase in the number of bacteria in the jejunal aspirates. No viruses were isolated in any of the jejunal, ileal, or fecal specimens.