Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study.

Introduction: Intraoperative adverse events (iAEs) occur and have the potential to impact the postoperative course. However, iAEs are underreported and are not routinely collected in the contemporary surgical literature. There is no widely utilized system for the collection of essential aspects of iAEs, and there is no established database for the standardization and dissemination of this data that likely have implications for outcomes and patient safety. The Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration initiated a global effort to address these shortcomings, and the establishment of an adverse event data collection system is an essential step. In this study, we present the core-set variables for collecting iAEs that were based on the globally validated ICARUS criteria for surgical/interventional and anesthesiologic intraoperative adverse event collection and reporting. Material and Methods: This article includes three tools to capture the essential aspects of iAEs. The core-set variables were developed from the globally validated ICARUS criteria for reporting iAEs (item 1). Next, the summary table was developed to guide researchers in summarizing the accumulated iAE data in item 1 (item 2). Finally, this article includes examples of the method and results sections to include in a manuscript reporting iAE data (item 3). Then, 5 scenarios demonstrating best practices for completing items 1-3 were presented both in prose and in a video produced by the ICARUS collaboration. Dissemination: This article provides the surgical community with the tools for collecting essential iAE data. The ICARUS collaboration has already published the 13 criteria for reporting surgical adverse events, but this article is unique and essential as it actually provides the tools for iAE collection. The study team plans to collect feedback for future directions of adverse event collection and reporting. Highlights: This article represents a novel, fully-encompassing system for the data collection of intraoperative adverse events.The presented core-set variables for reporting intraoperative adverse events are not based solely on our opinion, but rather are synthesized from the globally validated ICARUS criteria for reporting intraoperative adverse events.Together, the included text, figures, and ICARUS collaboration-produced video should equip any surgeon, anesthesiologist, or nurse with the tools to properly collect intraoperative adverse event data.Future directions include translation of this article to allow for the widest possible adoption of this important collection system.

Transvesical Laparoendoscopic Single-Site Management of Distal Ureter During Laparoscopic Radical Nephroureterectomy.

Objective: To describe the management of the distal ureter during radical nephroureterectomy with the transvesical laparoendoscopic single-site surgery (T-LESS) approach. Methods: Between January 2010 and October 2013, five patients underwent laparoscopic radical nephroureterectomy for upper urinary tract carcinoma (UTUC) with the T-LESS approach. Patients were placed in the supine position. A 2.5-cm skin incision was made in the line between the pubis and the umbilicus. The bladder was identified and a multiport was inserted into the bladder. The patients were repositioned to a lateral decubitus position; pneumovesicum was established and the ureteral openings were identified. We marked the bladder cuff with electrocautery all the way through to the extravesical fat. The bladder defect was sealed with sutures. After checking for any leak or bleeding, the multiport was removed and the bladder was closed. At this point, we continued with nephrectomy by standard laparoscopy or LESS. A 18F Foley catheter was placed into the bladder. Results: The mean age was 70 years (range 58-81 years), the mean operative time was 198 minutes (range 115-390 minutes), the mean time for the management of the distal ureter was 35 minutes (range 27-45 minutes), the mean estimated blood loss was 234 mL (range 60-850 mL), and the mean hospital stay was 3.8 days (range 2-8 days). In all patients the bladder cuff was free of disease. Conclusion: The transvesical laparoendoscopic single-site approach to the distal ureter for UTUC appears safe and reproducible, with faster closure of the bladder defect and improved cosmesis.

Robotic simple prostatectomy plus panniculectomy and Giant umbilical hernia repair.

INTRODUCTION: Simple prostatectomy is the gold standard for prostates >80 grams, robotic system has proven to help into speed the recovery of the patient and in morbid obesity the advantages of the robotic system can help to perform a successful surgery. CASE: 80 years old male with morbid obesity (BMI 45) and several other comorbidities, with history of an umbilical hernia and obstructive lower urinary tract symptoms in acute urinary retention. PSA was 7 ng/dl, DRE demonstrates a >100gr prostate gland. A robotic simple prostatectomy, urethropexy, umbilical hernia repair and panniculectomy in Fleur-de-Lis was performed. RESULTS: Operative time (OT) and estimated blood loss (EBL) were 438 min and 160 ml respectively. A JP drain was placed in the pelvis and 2 additional were left in the abdominal cavity with several Penrose drains. No immediate or intraoperative complications were observed. The length of stay (LOS) was 6 days without complications. Pathology report showed prostate of 304gr and benign prostatic tissue. DISCUSSION: In patients with multiple comorbidities robot-assisted surgery provides advantages of shorter LOS, EBL, less transfusion and lower rate of complications. In patients with morbid obesity where the increased girth makes difficult the open approach, robotic surgery is an ideal way to provide definitive treatment; concomitant, Fleur-de-Lis panniculectomy can correct the abdominal contour in both vertical and horizontal orientation at the same time that provides a better plane for trocar insertion, an accurate location of the needle tip and a proper position of the remote center decreasing the possible complication of port placement.

Complications of robotic surgery in urological diseases: are we using standardized methodology to report complications?

PURPOSE OF REVIEW: The current data on complications reporting related to robot-assisted procedures (RAPs) in the urology literature are not comparable and do not use a validated classification. In this review, findings from various studies reporting positive and negative outcomes will be outlined. RECENT FINDINGS: Robotic procedures have outcomes similar to open and laparoscopic techniques but generally cause fewer adverse events. However, the lack of standards for presenting surgical morbidity related to RAP leads to underreporting of surgical complications, makes comparisons of surgical outcomes difficult and prevents adequate knowledge about the outcomes of procedures. SUMMARY: Although a reasonable number of positive outcomes of RAP have been reported in the literature, the extent of underreporting with this process is unknown. Further research and the development of a validated classification for reporting surgical complications will facilitate a better understanding of the actual outcomes.

Safer Surgery by Learning from Complications: A Focus on Robotic Prostate Surgery.

BACKGROUND: The uptake of robotic surgery has led to changes in potential operative complications, as many surgeons learn minimally invasive surgery, and has allowed the documentation of such complications through the routine collection of intraoperative video. OBJECTIVE: We documented intraoperative complications from robot-assisted radical prostatectomy (RARP) with the aim of reporting the mechanisms, etiology, and necessary steps to avoid them. Our goal was to facilitate learning from these complications to improve patient care. DESIGN, SETTING, AND PARTICIPANTS: Contributors delivered videos of complications that occurred during laparoscopic and robotic prostatectomy between 2010 and 2015. SURGICAL PROCEDURE: Surgical footage was available for a variety of complications during RARP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Based on these videos, a literature search was performed using relevant terms (prostatectomy, robotic, complications), and the intraoperative steps of the procedures and methods of preventing complications were outlined. RESULTS AND LIMITATIONS: As a major surgical procedure, RARP has much potential for intra- and postoperative complications related to patient positioning, access, and the procedure itself. However, with a dedicated approach, increasing experience, a low index of suspicion, and strict adherence to safety measures, we suggest that the majority of such complications are preventable. CONCLUSIONS: Considering the complexity of the procedure, RARP is safe and reproducible for the surgical management of prostate cancer. Insight from experienced surgeons may allow surgeons to avoid complications during the learning curve. PATIENT SUMMARY: Robot-assisted radical prostatectomy has potential for intra- and postoperative complications, but with a dedicated approach, increasing experience, a low index of suspicion, and strict adherence to safety measures, most complications are preventable.

Perioperative Outcomes of Robotic and Laparoscopic Simple Prostatectomy: A European-American Multi-institutional Analysis.

BACKGROUND: Laparoscopic and robotic simple prostatectomy (SP) have been introduced with the aim of reducing the morbidity of the standard open technique. OBJECTIVE: To report a large multi-institutional series of minimally invasive SP (MISP). DESIGN, SETTING, AND PARTICIPANTS: Consecutive cases of MISP done for the treatment of bladder outlet obstruction (BOO) due to benign prostatic enlargement (BPE) between 2000 and 2014 at 23 participating institutions in the Americas and Europe were included in this retrospective analysis. INTERVENTION: Laparoscopic or robotic SP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Demographic data and main perioperative outcomes were gathered and analyzed. A multivariable analysis was conducted to identify factors associated with a favorable trifecta outcome, arbitrarily defined as a combination of the following postoperative events: International Prostate Symptom Score <8, maximum flow rate >15ml/s, and no perioperative complications. RESULTS AND LIMITATIONS: Overall, 1330 consecutive cases were analyzed, including 487 robotic (36.6%) and 843 laparoscopic (63.4%) SP cases. Median overall prostate volume was 100ml (range: 89-128). Median estimated blood loss was 200ml (range: 150-300). An intraoperative transfusion was required in 3.5% of cases, an intraoperative complication was recorded in 2.2% of cases, and the conversion rate was 3%. Median length of stay was 4 d (range: 3-5). On pathology, prostate cancer was found in 4% of cases. Overall postoperative complication rate was 10.6%, mostly of low grade. At a median follow-up of 12 mo, a significant improvement was observed for subjective and objective indicators of BOO. Trifecta outcome was not significantly influenced by the type of procedure (robotic vs laparoscopic; p=0.136; odds ratio [OR]: 1.6; 95% confidence interval [CI], 0.8-2.9), whereas operative time (p=0.01; OR: 0.9; 95% CI, 0.9-1.0) and estimated blood loss (p=0.03; OR: 0.9; 95% CI, 0.9-1.0) were the only two significant factors. Retrospective study design, lack of a control arm, and limited follow-up represent major limitations of the present analysis. CONCLUSIONS: This study provides the largest outcome analysis reported for MISP for BOO/BPE. These findings confirm that SP can be safely and effectively performed in a minimally invasive fashion in a variety of healthcare settings in which specific surgical expertise and technology is available. MISP can be considered a viable surgical treatment in cases of large prostatic adenomas. The use of robotic technology for this indication can be considered in centers that have a robotic program in place for other urologic indications. PATIENT SUMMARY: Analysis of a large data set from multiple institutions shows that surgical removal of symptomatic large prostatic adenomas can be carried out with good outcomes by using robot-assisted laparoscopy.

Robotic intracorporeal urinary diversion: technical details to improve time efficiency.

OBJECTIVES: To present time-efficiency data during our initial experience with intracorporeal urinary diversion and technical tips that may shorten operative time early in the learning curve. PATIENTS AND METHODS: Data were analyzed in the initial 37 consecutive patients undergoing robotic radical cystectomy and intracorporeal urinary diversion in whom detailed stepwise operative time data were available. Median age was 65 years and median body mass index was 27. Neoadjuvant chemotherapy was administered in 6 patients and 11 patients had clinical evidence of T3 or lymph node-positive disease. Each component of the operation was subdivided into specific steps and operative time for each step was prospectively recorded. Peri-operative and follow-up data up to 90 days and final pathological data were recorded. RESULTS: All procedures were completed intracorporeally and robotically without need for conversion to open surgery or extracorporeal diversion. Median total operative time was 387 vs 386 minutes (p=0.2) and median total console time was 361 vs 295 minutes (p<0.007) for orthotopic neobladder and ileal conduit, respectively. Median time for radical cystectomy was 77 minutes, extended pelvic lymph node dissection was 63 minutes, and diversion was 111 minutes (ileal conduit 92 minutes and orthotopic neobladder 124 minutes). Median estimated blood loss was 250 mL, and median hospital stay was 9 days. High grade (Clavien grade 3-5) complications at 30 and 90 days follow-up were recorded in 6 (16%) and 9 (24%) patients, respectively. Over a median follow-up of 16 months, 12 (32%) patients experienced disease recurrence and 9 (24%) died from bladder cancer. These correspond to 1-year recurrence-free and overall survival of 64% and 70%, respectively. CONCLUSIONS: Intracorporeal urinary diversion following robotic radical cystectomy can be safely performed and reproducible in a time-efficient manner even during the early learning curve.

Laparoscopic anatrophic nephrolithotomy: developments of the technique in the era of minimally invasive surgery.

BACKGROUND AND PURPOSE: The complete removal of the stone is the ultimate goal in management, a result that might not be attained even after several sessions of percutaneous nephrolithotomy (PCNL) and/or extracorporeal shockwave lithotripsy (SWL) and/or retrograde intrarenal surgery (ureteroscopy). The objective of this study is to assess our technique of anatrophic nephrolithotomy, with decreased renal ischemia and reduced patient morbidity. PATIENTS AND METHODS: From 2007 to 2010, we performed eight anatrophic laparoscopic nephrolithotomies in adult patients with staghorn renal calculus. The mean patient age was 49 years (range 35-62 y). The mean stone size was 53 mm (range 35-70 mm). All patients had complex renal calculi, with stones occupying more than 80% of the caliceal system. In all cases, a Double-J stent was placed before surgery. After clamping the hilum, the incision was made laterally and longitudinally through full thickness of cortex using a laparoscopic scalpel. A running cortical suture was performed with Hem-o-lok reinforcement. Renal function was assessed in three patients, using renography with technetium-99m-diethylenetriaminepentacetic acid (99mTc-DTPA), before and 3 months after the surgery. RESULTS: Procedures for all patients were completed laparoscopically. The mean operative time was 142.5 minutes, and the mean warm ischemia time was 20.8 minutes. The estimated blood loss was 315 mL. The hospital stay average was 3.5 days. Only one patient had a complication--a vascular fistula with permanent postoperative hematuria. This patient subsequently underwent successful endovascular embolization. Residual stones were identified in 37% of cases (three patients) during follow-up imaging at 15 days. There were minimal changes on serum creatinine values. CONCLUSIONS: Laparoscopic surgery is feasible when anatrophic nephrolithotomy is indicated. This technique minimizes the barriers of an open flank incision, while achieving excellent stone-free rates. This minimally invasive technique should be considered for complex stones that would necessitate multiple renal access tracks and secondary procedures.

Molleja de pollo: un nuevo modelo para entrenamiento laparoscópico de la anastomosis uretrovesical / Chicken gizzard: a new training model for laparoscopic urethrovesical anastomosis

Objetivo: Crear un modelo animal simple, económico y reproducible que presente una nueva opción de entrenamiento para la realización de la anastomosis vesicouretral durante la prostatectomía radical laparoscópica. Material y métodos: La creación y la experimentación se llevaron a cabo durante 2008. Se utilizaron diferentes materiales: caja de entrenamiento laparoscópico, cámara de vídeo, monitor, porta agujas, suturas y pollos no eviscerados de más de 2 kg de peso. El modelo fue elaborado con una nueva percepción de una estructura similar a la pelvis humana. Para la anastomosis se utilizó la molleja (cuello vesical) y el recto (uretra). Con el modelo en la caja, en condiciones anatómicas muy similares a los procedimientos reales, se realizó la experimentación con la anastomosis. La calidad de la anastomosis se evaluó mediante una prueba de impermeabilidad y endoscopia transanal. Resultados: El área de trabajo fue muy similar a la de la pelvis humana. Tejidos de calidad, textura y diámetro similares a los de la uretra (recto) y el cuello vesical (molleja) ofrecen la posibilidad de practicar la anastomosis y la “raqueta anterior”. Conclusiones: El modelo es simple, fácil, asequible, económico y reproducible. La anatomía del pollo, así como las características de sus tejidos, permite el entrenamiento en condiciones muy similares a las realizadas en casos humanos (AU)

Objective: To create a simple, inexpensive, and reproducible model that would provide a new training option for performing urethrovesical anastomosis during laparoscopic radical prostatectomy. Material and methods: Design and experimentation were carried out in 2008. Materials employed included a laparoscopic training box, video camera, monitor, needle holder, sutures, and non-eviscerated chickens weighing more than 2 kilograms. The model was prepared with a new vision of a structure similar to the human pelvis. To create the anastomosis, we used the gizzard (bladder neck) and the rectum (urethra). Once the model was placed in the box, the anastomosis was performed in very similar anatomical conditions to those in real procedures. The anastomosis quality was assessed by means ofan impermeability test and transanal endoscopy. Results: The operating field is very similar to the human pelvis. Tissues with a quality, texture, and diameter resembling those of the urethra (rectum) and the bladder neck (gizzard) offer the possibility of practicing anastomosis and anterior racket. Conclusions: The model for urethrovesical anastomosis using the chicken gizzard and rectum is simple, easy, available, inexpensive and reproducible. The anatomy of the chicken and the characteristics of its tissues allow for training under conditions very similar to those present in human cases (AU)

Laparoendoscopic single-site surgery simple prostatectomy: initial report.

OBJECTIVES: To report the first case and detailed technique of laparoendoscopic single-site (LESS) surgery simple prostatectomy for benign hypertrophy. METHODS: A 67-year-old man presented with acute urinary retention requiring catheterization. Serum prostate-specific antigen level was 5 ng/mL, and a biopsy revealed benign hypertrophy with a transrectal ultrasound volume estimation of 110 mL. LESS simple prostatectomy was performed using a single multilumen port inserted through a solitary 2.5-cm intraumbilical incision. Standard laparoscopic ultrasonic shears and needle drivers, articulating scissors, and specifically designed bent grasping instruments facilitated dissection and suturing. RESULTS: An R-port was placed intraperitoneally through a 2.5-cm intraumbilical incision. No extraumbilical skin incisions were made. Total operative time was 120 minutes and estimated blood loss was 200 mL. A closed suction drain was externalized through the umbilical incision. No intraoperative or postoperative complications occurred. Hospital stay was 2 days, the retropubic drain was removed at 3 days, and the catheter removed at 1 week. Specimen weight was 95 g and final pathology revealed benign prostatic hyperplasia. At 3 months follow-up, the patient was completely continent and voiding spontaneously with a Q(max.) of 85 mL/s. CONCLUSIONS: We demonstrate technical feasibility and describe the detailed surgical technique of LESS simple prostatectomy. Our initial experience suggests that this technique may be an alternative for large-volume benign prostatic hyperplasia in lieu of open surgery. Comparative studies with other surgical techniques will determine its place in the surgical armamentarium of benign prostatic hyperplasia.

Chicken gizzard: a new training model for laparoscopic urethrovesical anastomosis.

OBJECTIVE: To create a simple, inexpensive, and reproducible animal model to provide a new training option for performing urethrovesical anastomosis during laparoscopic radical prostatectomy. MATERIAL AND METHODS: Development and testing were carried out in 2008. The materials used included a laparoscopic training box, video camera, monitor, needle holder, sutures, and non-eviscerated chickens weighing more than 2 kilograms. The model was prepared with a new perception of a structure similar to the human pelvis. To create the anastomosis, we used the gizzard (bladder neck) and the rectum (urethra). Once the model was placed in the box, the anastomosis was performed under very similar anatomical conditions to real procedures. Anastomosis quality was assessed by means of a permeability test and transanal endoscopy. RESULTS: The operating field is very similar to the human pelvis. The tissues have a quality, texture, and diameter resembling those of the urethra (rectum) and the bladder neck (gizzard), and offer the opportunity to practise anastomosis and anterior racket. CONCLUSIONS: The model for urethrovesical anastomosis using the chicken gizzard and rectum is simple, easily available, inexpensive and reproducible. The anatomy of the chicken and the characteristics of its tissues allow for training under conditions very similar to those present in human cases.

Assay standardization bias: different prostate cancer detection rates and clinical outcomes resulting from different assays for free and total prostate-specific antigen.

OBJECTIVES: Numerous commercial assays are available for measuring total and free prostate-specific antigen (PSA) levels in serum. These assays can be referenced to different laboratory standards, and interassay variability occurs. Patients and physicians might be affected by the variability between PSA assays that results from the use of different PSA standards. METHODS: We prospectively compared the free and total PSA measurements obtained using two commercially available PSA assays in 103 participants from a prostate cancer screening program in Caracas, Venezuela. We recommended biopsy to men with a total PSA level of 3 to 10 ng/mL and a free/total PSA ratio of 20% or less with either assay. We compared the sensitivity, specificity, and concordance index between the two assays to assess the effects of interassay variability on the cancer detection rate and clinical outcomes. RESULTS: Although the total PSA results were similar between the assays, the free PSA level was significantly greater with one assay. Therefore, the free/total PSA ratio was discordant between the two assays, resulting in different biopsy recommendations and cancer detection rates. CONCLUSIONS: Using a free/total PSA ratio of 20% or less as the threshold for biopsy, the differences in assay sensitivity and specificity for detecting prostate cancer are significant. Commercially available assays for PSA and its derivatives are not necessarily interchangeable, and these differences might lead to different clinical outcomes. When using free and total PSA measurements to make clinical decisions, patients and physicians should be aware of the potential standardization bias and which assay is being used.

Estudios sobre las condiciones de vida de los aborígenes

Antecedentes de la colonia Aborigen "Chaco". Marco geográfico. Demografía. Marco Social. Salud. Relación con la administración. Declaración de principios

Estudios sobre las condiciones de vida de los aborígenes

Antecedentes de la colonia Aborigen "Chaco". Marco geográfico. Demografía. Marco Social. Salud. Relación con la administración. Declaración de principios