A Randomized Study on the Prophylactic Use of Acetaminophen to Prevent Fever after the Removal of Drainage Tubes for Lumbar Surgery.

BACKGROUND: Many inpatients encounter a fever in the first 24 h after drainage removal. It is costly to exclude the possibility of deep infection and cultures usually fail to identify the etiology. We hypothesize that the fever is caused by a normal inflammatory response and tested whether the prophylactic use of acetaminophen could reduce the fever rate. METHODS: This was a prospectively randomized clinical trial performed from July 2019 to January 2020. A total of 183 consecutive patients undergoing lumbar spine surgery were prospectively randomized into two groups. Ninety-one patients were randomized into the study group; they received oral acetaminophen before removal of the drainage tubes and a second dose at 8 p.m. on the same day. The remaining 92 patients were placed in the control group, and they were given routine treatment without acetaminophen. The two groups were compared for differences in age, sex, height, weight, BMI, surgical segments, surgical time, blood loss, blood transfusion, ASA score, duration of drainage, total volume of the drainage, variation of WBC and CRP, hospital stay after the removal of the drainage tube and the rate of fever. Student's t-test and the Mann-Whitney U test were used to analyze the continuous data, while the chi-square test was used for the analysis of the ranked data. RESULTS: Regarding the comparisons of basic information, there were no significant differences between the two groups for age, height, weight, BMI, surgical segments, surgical time, blood loss, blood transfusion, total drainage volume, duration of drainage, hospital stay, WBC, and CRP variation or the duration of hospital stay after removal of the drainage tube (all p > 0.05). However, the fever rate was significantly different (p = 0.006), and the fever rate of the study group (14/91, 15.38%) was significantly lower than that of the control group (30/92, 32.61%). In the study group, there were no complications related to the use of acetaminophen during the hospital stay or during the outpatient follow-up period. CONCLUSION: Fever after removal of tube drainage is caused by a normal inflammatory response, and a small dose of acetaminophen could significantly reduce the possibility of fever.

Correlación fisiopatológica, diagnóstica y terapéutica en el derrame pleural paraneumónico / Pathophysiological, diagnostic and therapeutic correlation in parapneumonic pleural effusion

Introducción: La inflamación de la pleura desencadenada por bacterias y mediada por citocinas, aumenta la permeabilidad vascular y produce vasodilatación, lo cual genera desequilibrio entre la producción de líquido pleural y su capacidad de reabsorción por eficientes mecanismos fisiológicos. La condición anterior conduce al desarrollo de derrame pleural paraneumónico. Objetivo: Exponer la importancia de la correlación fisiopatológica y diagnóstica con los pilares fundamentales de actuación terapéutica en el derrame pleural paraneumónico. Métodos: Revisión en PubMed y Google Scholar de artículos publicados hasta abril de 2021 que abordaran el derrame pleural paraneumónico, su fisiopatología, elementos diagnósticos, tanto clínicos como resultados del estudio del líquido pleural, pruebas de imágenes, y estrategias terapéuticas. Análisis y síntesis de la información: El progreso de una infección pulmonar y la producción de una invasión de gérmenes al espacio pleural favorece la activación de mecanismos que conllevan al acúmulo de fluido, depósito de fibrina y formación de septos. Este proceso patológico se traduce en manifestaciones clínicas, cambios en los valores citoquímicos y resultados microbiológicos en el líquido pleural, que acompañados de signos radiológicos y ecográficos en el tórax, guían la aplicación oportuna de los pilares de tratamiento del derrame pleural paraneumónico. Conclusiones: Ante un derrame pleural paraneumónico, con tabiques o partículas en suspensión en la ecografía de tórax, hallazgo de fibrina, líquido turbio o pus en el proceder de colocación del drenaje de tórax, resulta necesario iniciar fibrinólisis intrapleural. Cuando el tratamiento con fibrinolíticos intrapleurales falla, la cirugía video-toracoscópica es el procedimiento quirúrgico de elección(AU)

Introduction: The inflammation of the pleura triggered by bacteria and mediated by cytokines, increases vascular permeability and produces vasodilation, which generates imbalance between the production of pleural fluid and its resorption capacity by efficient physiological mechanisms. The above condition leads to the development of parapneumonic pleural effusion. Objective: To expose the importance of the pathophysiological and diagnostic correlation with the fundamental pillars of therapeutic action in parapneumonic pleural effusion. Methods: Review in PubMed and Google Scholar of articles published until April 2021 that addressed parapneumonic pleural effusion, its pathophysiology, diagnostic elements, both clinical and results of the pleural fluid study, imaging tests, and therapeutic strategies. Analysis and synthesis of information: The progress of a lung infection and the production of an invasion of germs into the pleural space favors the activation of mechanisms that lead to the accumulation of fluid, fibrin deposition and formation of septa. This pathological process results in clinical manifestations, changes in cytochemical values and microbiological results in the pleural fluid, which accompanied by radiological and ultrasound signs in the chest, guide the timely application of the pillars of treatment of parapneumonic pleural effusion. Conclusions: In the event of a parapneumonic pleural effusion, with septums or particles in suspension on chest ultrasound, finding fibrin, turbid fluid or pus in the procedure of placement of the chest drain, it is necessary to initiate intrapleural fibrinolytic. When treatment with intrapleural fibrinolytics fails, video-thoracoscopic surgery is the surgical procedure of choice(AU)

Bula gigante secundaria a neumonía adquirida en la comunidad en niños / Giant Bulla Secondary to Community-Acquired Pneumonia in Children

Introducción: Los neumatoceles y las bulas pulmonares son lesiones que se observan en los niños casi siempre asociadas a neumonías infecciosas, aunque sus causas pueden ser diversas. La importancia clínica de estos procesos radica en el peligro de crecimiento progresivo, que puede comprometer las funciones respiratoria y cardiovascular. Objetivo: Describir las experiencias derivadas del proceso de diagnóstico por imágenes y del tratamiento invasivo de casos atendidos. Presentación de los casos: Desde finales de 2021 y durante un período de un año, se atendieron, en la unidad de cuidados intensivos pediátricos del Hospital Pediátrico Universitario de Cienfuegos, cinco niños con neumonías extensas, que desarrollaron bulas de gran tamaño varios días después del tratamiento antimicrobiano adecuado. Estas necesitaron drenaje y aspiración percutáneos debido a su magnitud y a la presencia de síntomas cardiovasculares. Conclusiones: Las bulas que aparecieron como complicación de la neumonía en el niño pueden presentarse con una frecuencia no despreciable, y hay que mantenerse atentos a su evolución, porque, a diferencia de los neumatoceles, pueden crecer progresivamente y comprometer las funciones respiratoria y cardiovascular. El drenaje percutáneo y aspiración continua por cinco días resultó un método seguro y eficaz para tratar estos procesos(AU)

Introduction: Pneumoatoceles and pulmonary bullae are lesions that are observed in children almost always associated with infectious pneumonia, although their causes may be diverse. The clinical importance of these processes lies in the danger of progressive growth, which can compromise respiratory and cardiovascular functions. Objective: To describe the experiences derived from the imaging process and the invasive treatment of treated cases. Presentation of the cases: Since the end of 2021 and for a period of one year, five children with extensive pneumonia were treated in the pediatric intensive care unit of the University Pediatric Hospital of Cienfuegos, who developed large bullae several days after appropriate antimicrobial treatment. The bullae required percutaneous drainage and aspiration due to their magnitude and the presence of cardiovascular symptoms. Conclusions: The bulla that appeared as a complication of pneumonia in the child can occur with a not negligible frequency, and it is necessary to be attentive to their evolution, because, unlike pneumoatoceles, can grow progressively and compromise respiratory and cardiovascular functions. Percutaneous drainage and continuous aspiration for five days was a safe and effective method to treat these processes(AU)

Analysis of long-term effect of ureteral balloon dilatation combined with internal and external drainage tube in the treatment of benign ureteral stricture.

PURPOSE: There are few reports about balloon dilatation combined with internal and external drainage tube in the treatment of ureteral stricture under interventional therapy. The aim of the study is to explore the safety, effectiveness and long-term efficacy of this treatment strategy. MATERIALS AND METHODS: It is a retrospective and observational study. From October 2013 to October 2016, 42 patients with benign lower ureteral stricture received interventional treatment. Balloon dilatation combined with internal and external drainage tube implantation were used. There were 25 male patients and 17 female patients. There were 7 cases (16.7%) with congenital ureteral stricture, 12 cases (28.6%) with inflammation, 15 cases (35.7%) with ureteral stricture after lithotomy or lithotripsy, and 8 cases (19.0%) with ureteral stricture after pelvic or abdominal surgery. After the drainage tube was removed, B ultrasound, enhanced CTU or IVP of urinary system were reexamined every six months. The follow-up time was 12-60 months. RESULTS: The age was 52.9 ± 11.6 years. The length of ureteral stricture was 1.1 ± 0.5 cm. 42 patients completed interventional treatment, the technical success rate was 100%, no ureteral perforation, rupture or other complications were identified. Preoperative urea nitrogen 9.2 ± 2.3 mmol/L and creatinine 175.8 ± 82.8umol/L. Urea nitrogen and creatinine were 3.8-9.1 mmol/L and 45.2-189.6 umol/L when removing the drainage tube. There were significant differences in the levels of urea nitrogen and creatinine before and after tube removal (P < 0.05). The ureteral patency rate was 100% at 6 months, 93% at 12 months, 83% at 18 months, 79% at 24 months, 76% at 30 months and 73% at 36-60 months. The overall success rate was 73%. Multivariate Cox regression analysis showed that stenosis length was a risk factor for postoperative patency (P < 0.05). CONCLUSION: Balloon dilatation combined with internal and external drainage tube implantation in the treatment of benign lower ureteral stricture is safe and effective.

Experimental study of a physician-controlled electrocautery-enhanced delivery system incorporating a newly developed lumen-apposing metal stent for interventional endoscopic ultrasound (with videos).

BACKGROUND/PURPOSE: Although the lumen-apposing metal stent (LAMS) is useful for interventional endoscopic ultrasound (EUS) procedures, there has been some concern about the potential for stent-induced adverse events because of the high lumen-apposing force. A newly designed LAMS with less lumen-apposing force has been developed for use with a physician-controlled electrocautery-enhanced delivery system. The aim of this animal study was to evaluate the feasibility of performing interventional EUS using this newly designed LAMS system. METHODS: Endoscopic ultrasound-guided cystogastrostomy was performed using the novel LAMS three times in a wet simulation model. EUS-guided gastroenterostomy and EUS-guided gallbladder drainage were then performed using the system in four pigs. RESULTS: The LAMS was successfully placed in all three EUS-guided cystogastrostomy procedures using the wet simulation model and in all four EUS-guided gastroenterostomy and gallbladder drainage procedures in the animal model. In the 3 weeks following the procedure, eating behavior was normal in all animals and there were no adverse events. The stents remained patent during this time and were removed without difficulty. The fistula was mature in all cases and a standard upper gastrointestinal endoscope was easily advanced via the fistula to observe the afferent and efferent loops or the lumen of the gallbladder. Necropsy confirmed complete adhesion between the stomach and the wall of the jejunum or gallbladder. CONCLUSIONS: Our study findings demonstrate the feasibility of this new LAMS system and its potential clinical value for interventional EUS.

Application of magnetically actuated self-clearing catheter for rapid in situ blood clot clearance in hemorrhagic stroke treatment.

Maintaining the patency of indwelling drainage devices is critical in preventing further complications following an intraventricular hemorrhage (IVH) and other chronic disease management. Surgeons often use drainage devices to remove blood and cerebrospinal fluid but these catheters frequently become occluded with hematoma. Using an implantable magnetic microactuator, we created a self-clearing catheter that can generate large enough forces to break down obstructive blood clots by applying time-varying magnetic fields. In a blood-circulating model, our self-clearing catheters demonstrated a > 7x longer functionality than traditional catheters (211 vs. 27 min) and maintained a low pressure for longer periods (239 vs. 79 min). Using a porcine IVH model, the self-clearing catheters showed a greater survival rate than control catheters (86% vs. 0%) over the course of 6 weeks. The treated animals also had significantly smaller ventricle sizes 1 week after implantation compared to the control animals with traditional catheters. Our results suggest that these magnetic microactuator-embedded smart catheters can expedite the removal of blood from the ventricles and potentially improve the outcomes of critical patients suffering from often deadly IVH.

New Stent Technologies.

Ureteral stents are an indispensable part of any (endo-) urologic practice. Despite the widely demonstrated advantages of stents, they also carry a considerable risk of side effects and complications, such as urinary symptoms, pain, hematuria, decreased quality of life, stent-related infection, and encrustation. Multiple pathways in preventing or mitigating these side effects and complications and improving stent efficacy have been and are being investigated, including stent architecture and design, biomaterials, and coatings. This article provides an update on currently researched and available stents as well as future perspectives.

Surgical Resection of Gastro-Pleural-Bronchial Fistula after Prolonged Endoscopic Treatments.

Sleeve gastrectomy is the most commonly performed bariatric surgery in the United States. While complication rates are typically low, some studies have reported leaks in up to 2.4-5.3% of cases. Here, we examine such a case with subsequent failure of numerous endoscopic interventions ultimately necessitating formal resection of a gastro-Pleural-bronchial fistula.

Early Drain Removal is Safe in Patients With Low or Intermediate Risk of Pancreatic Fistula After Pancreaticoduodenectomy: A Multicenter, Randomized Controlled Trial.

OBJECTIVE: This multicenter randomized controlled trial was designed to test the hypothesis that early drain removal (EDR) could decrease the incidence of grade 2 to 4 complications for patients undoing pancreaticoduodenectomy (PD) with low or intermediate risk of postoperative pancreatic fistula (POPF). BACKGROUND: The safety and effects of EDR on postoperative complications after PD are still controversial. METHODS: A multicenter randomized controlled trial at 6 tertiary referral hospitals was carried out (NCT03055676). Patients who met the inclusion criteria, including drain amylase level less than 5000 U/L on postoperative day (POD) 1 and POD 3, and drain output less than 300 mL per day within 3 days after surgery, were enrolled. Patients were then randomized to the EDR group or the routine drain removal (RDR) group. In the EDR group, all drainage tubes were removed on POD3. In the RDR group, drainage tubes were removed on POD 5 or beyond. Primary outcome was the incidence of Clavien-Dindo grade 2 to 4 complications. Secondary outcomes were comprehensive complication index, grade B/C POPF, total medical expenses and postoperative in-hospital stay etc, within 90 days after surgery. RESULTS: A total of 692 patients were screened, and 312 patients were eligible for randomization. Baseline characteristics were well balanced between the 2 groups and 96.8% of these 312 patients had low or intermediate risk of POPF, according to the 10-point fistula risk score. A total of 20.5% of the patients in the EDR group suffered at least 1 grade 2 to 4 complication, versus 26.3% in the RDR group (P = 0.229). Multi-variate analysis showed older age (>65 years old) and blood transfusion were independent risk factors for grade 2 to 4 complications. The rate of grade B/C POPF was low in either group (3.8% vs 6.4%, P = 0.305). The comprehensive complication index of the 2 groups was also comparable (20.9 vs 20.9, P = 0.253). Total medical expenses were not significantly different. Postoperative in-hospital stay was clinically similar (15 days vs 16 days, P = 0.010). CONCLUSIONS: Nearly half of the patients undergoing PD met the inclusion criteria, predicting low incidence of grade B/C POPF and major complications. EDR was safe in these patients but did not significantly decrease major complications.

Evaluation and management of traumatic pneumothorax: A Western Trauma Association critical decisions algorithm.

ABSTRACT: This is a recommended algorithm of the Western Trauma Association for the management of a traumatic pneumothorax. The current algorithm and recommendations are based on available published prospective cohort, observational, and retrospective studies and the expert opinion of the Western Trauma Association members. The algorithm and accompanying text represents a safe and reasonable approach to this common problem. We recognize that there may be variability in decision making, local resources, institutional consensus, and patient-specific factors that may require deviation from the algorithm presented. This annotated algorithm is meant to serve as a basis from which protocols at individual institutions can be developed or serve as a quick bedside reference for clinicians. LEVEL OF EVIDENCE: Consensus algorithm from the Western Trauma Association, Level V.

Highlights of the development in ultrasound during the last 70 years: A historical review.

This review looks at highlights of the development in ultrasound, ranging from interventional ultrasound and Doppler to the newest techniques like contrast-enhanced ultrasound and elastography, and gives reference to some of the valuable articles in Acta Radiologica. Ultrasound equipment is now available in any size and for any purpose, ranging from handheld devices to high-end devices, and the scientific societies include ultrasound professionals of all disciplines publishing guidelines and recommendations. Interventional ultrasound is expanding the field of use of ultrasound-guided interventions into nearly all specialties of medicine, from ultrasound guidance in minimally invasive robotic procedures to simple ultrasound-guided punctures performed by general practitioners. Each medical specialty is urged to define minimum requirements for equipment, education, training, and maintenance of skills, also for medical students. The clinical application of contrast-enhanced ultrasound and elastography is a topic often seen in current research settings.

Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial.

Importance: Preventing anastomotic leakage (AL) is crucial for colorectal surgery. Some studies have suggested a positive role of transanal drainage tubes (TDTs) in AL prevention after low anterior resection, but this finding is controversial. Objective: To assess the effect of TDTs in AL prevention after laparoscopic low anterior resection for rectal cancer. Design, Setting, and Participants: This multicenter randomized clinical trial with parallel groups (TDT vs non-TDT) was performed from February 26, 2016, to September 30, 2020. Participants included patients from 7 different hospitals in China who were undergoing laparoscopic low anterior resection with the double-stapling technique for mid-low rectal cancer; 576 patients were initially enrolled in this study, and 16 were later excluded. Ultimately, 560 patients were randomly divided between the TDT and non-TDT groups. Interventions: A silicone tube was inserted through the anus, and the tip of the tube was placed approximately 5 cm above the anastomosis under laparoscopy at the conclusion of surgery. The tube was fixed with a skin suture and connected to a drainage bag. The TDT was scheduled for removal 3 to 7 days after surgery. Main Outcomes and Measures: The primary end point was the postoperative AL rate within 30 days. Results: In total, 576 patients were initially enrolled in this study; 16 of these patients were excluded. Ultimately, 560 patients were randomly divided between the TDT group (n = 280; median age, 61.5 years [IQR, 54.0-68.8 years]; 177 men [63.2%]) and the non-TDT group (n = 280; median age, 62.0 years [IQR, 52.0-69.0 years]; 169 men [60.4%]). Intention-to-treat analysis showed no significant difference between the TDT and non-TDT groups in AL rates (18 [6.4%] vs 19 [6.8%]; relative risk, 0.947; 95% CI, 0.508-1.766; P = .87) or AL grades (grade B, 14 [5.0%] and grade C, 4 [1.4%] vs grade B, 11 [3.9%] and grade C, 8 [2.9%]; P = .43). In the stratified analysis based on diverting stomas, there was no significant difference in the AL rate between the groups, regardless of whether a diverting stoma was present (without stoma, 12 [5.8%] vs 15 [7.9%], P = .41; and with stoma, 6 [8.3%] vs 4 [4.5%], P = .50). Anal pain was the most common complaint from patients in the TDT group (130 of 280, 46.4%). Accidental early TDT removal occurred in 20 patients (7.1%), and no bleeding or iatrogenic colonic perforations were detected. Conclusions and Relevance: The results from this randomized clinical trial indicated that TDTs may not confer any benefit for AL prevention in patients who undergo laparoscopic low anterior resection for mid-low rectal cancer without preoperative radiotherapy. Trial Registration: ClinicalTrials.gov Identifier: NCT02686567.

A portable multi-sensor module for monitoring external ventricular drains.

External ventricular drains (EVDs) are used clinically to relieve excess fluid pressure in the brain. However, EVD outflow rate is highly variable and typical clinical flow tracking methods are manual and low resolution. To address this problem, we present an integrated multi-sensor module (IMSM) containing flow, temperature, and electrode/substrate integrity sensors to monitor the flow dynamics of cerebrospinal fluid (CSF) drainage through an EVD. The impedimetric sensors were microfabricated out of biocompatible polymer thin films, enabling seamless integration with the fluid drainage path due to their low profile. A custom measurement circuit enabled automated and portable sensor operation and data collection in the clinic. System performance was verified using real human CSF in a benchtop EVD model. Impedimetric flow sensors tracked flow rate through ambient temperature variation and biomimetic pulsatile flow, reducing error compared with previous work by a factor of 6.6. Detection of sensor breakdown using novel substrate and electrode integrity sensors was verified through soak testing and immersion in bovine serum albumin (BSA). Finally, the IMSM and measurement circuit were tested for 53 days with an RMS error of 61.4 µL/min.

Drainage of pancreatic fluid collections using a lumen-apposing metal stent with an electrocautery-enhanced delivery system.

BACKGROUND AND AIM: Our aim was to evaluate the efficacy and safety of a lumen-apposing metal stent with an electrocautery-enhanced delivery system (EDS-LAMS) for endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) in regular clinical practice. METHODS: A retrospective and subsequent prospective analysis was undertaken of all patients who underwent EUS-guided drainage of their PFCs using the EDS-LAMS at 17 tertiary therapeutic endoscopy centers. RESULTS: Two hundred eight cases of EDS-LAMS deployment were attempted in 202 patients (mean age 52.9 years) at time of evaluation. Ninety-seven patients had pancreatic pseudocysts (PPs), 75 walled-off pancreatic necrosis (WOPN), 10 acute peripancreatic fluid collections (APFCs), 6 acute necrotic collections (ANCs), and 14 postoperative collections (POCs). Procedural technical success was achieved in 202/208 cases (97.1%). Maldeployment occurred in 7/208 cases (3.4%). Clinical success was achieved in 142/160 (88.8%) patients (PP 90%, WOPN 85.2%, APFC 100%, ANC 75%, POC 100%). Delayed adverse events included stent migration in 15/202 (7.4%), stent occlusion and infection in 16/202 (7.9%), major bleeding in 4/202 (2%), and buried EDS-LAMS in 2/202 (1%). PFC recurrence occurred in 13/142 (9.2%) patients; 9/202 (4.5%) required surgical or radiological intervention for PFC management after EDS-LAMS insertion. CONCLUSIONS: This large international multicenter study evaluating the EDS-LAMS for drainage of PFCs in routine clinical practice suggests that the EDS-LAMS are safe and effective for drainage of all types of PFCs; however, further endoscopic therapy is often required for WOPN. Major bleeding was a rare complication in our cohort.

Comparative study of renal drainage with different ureteral stents subject to extrinsic ureteral obstruction using an in vitro ureter-stent model.

BACKGROUND: To compare the efficacy of different ureteral stents subject to extrinsic ureteral obstruction (EUO), in a controlled in vitro stented ureter experiment. METHODS: We employ an in vitro ureter-stent experimental set-up, with latex tubing simulating flexible ureters attached to vessels simulating renal units and bladders. The flow behavior of five ureteral stents-polymeric 8F, tandem 6F, tandem 7F, endopyelotomy and metal-was tested under a ureteral deformation configuration of 40°, with 2000 g external force over a 3.5 cm length of the ureter. A constant fluid flow was applied through the ureter-stent configurations, and pressure fluctuations in the renal unit were monitored. We considered a renal unit pressure of 10 cmH2O or flow discontinuation in the bladder as stent failure. Urine containing debris was mimicked by use of a colloidal solution. RESULTS: Of all assessed ureteral stents, under EUO conditions, only the single 8F stents remained patent throughout the length of the experiment. All other stents-tandem 6F and 7F, single 7F, metal and endopyelotomy-displayed limitations. CONCLUSIONS: Tandem and metal stents show no superiority over large luminal polymeric stents for EUO treatment in this in vitro model. Larger luminal stents offer excellent resistance to external pressure and allow adequate colloidal flow. The need for frequent exchange and bladder irritation should also be considered in the choice of stent configuration for treatment of kidney drainage under EUO.

Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis.

BACKGROUND: The usefulness of digital chest drain is still debated. We are carrying out a study to determine if the use of a digital system compared with a traditional system reduces the duration of chest drainage. To evaluate safety, benefit, or futility of this trial we planned the current interim analysis. METHODS: An interim analysis on preliminary data from ongoing investigator-initiated, multicenter, interventional, prospective randomized trial. Original protocol number: (NCT03536130). The interim main endpoint was overall complications; secondary endpoints were the concordance between the two primary endpoints of the RCT (chest tube duration and length of hospital stay). We planned the interim analysis when half of the patients have been randomised and completed the study. Data were described using mean and standard deviation or absolute frequencies and percentage. T-test for unpaired samples, Chi-square test, Poisson regression and absolute standardized mean difference (ASMD) were used. P-value < 0.05 was considered significant. RESULTS: From April 2017 to November 2018, out of 317 patients enrolled by 3 centers, 231 fulfilled inclusion criteria and were randomized. Twenty-two of them dropped out after randomization. Finally, 209 patients were analyzed: among them 94 used the digital device and 115 the traditional one. The overall postoperative complications were 35 (16.8%) including prolonged air leak (1.9%). Mean chest tube duration was 3.6 days (SD = 1.8), with no differences between two groups (p = 0.203). The overall difference between hospital stay and chest tube duration was 1.4 days (SD = 1.4). Air leak at first postoperative day detected by digital and traditional devices predicted increasing in tube duration of 1.6 day (CI 95% 0.8-2.5, p < 0.001) and 2.0 days (CI 95% 1.0-3.1, p < 0.001), respectively. CONCLUSIONS: This interim analysis supported the authors' will to continue with the enrollment and to analyze data once the estimated sample size will be reached. TRIAL REGISTRATION: Trial registration number NCT03536130 , Registered 24 May 2018 - Retrospectively registered.

Endoscopic transmural drainage tailored to quantity of necrotic debris versus laparoscopic transmural internal drainage for walled-off necrosis in acute pancreatitis: A randomized controlled trial.

BACKGROUND AND AIMS: Both endoscopic and laparoscopic transmural internal drainage are practiced for drainage of walled-off necrosis (WON) following acute pancreatitis (AP) but the superiority of either is not established. Our aim was to compare transperitoneal laparoscopic drainage with endoscopic drainage using either lumen apposing metal stents (LAMS) or plastic stents tailored to the amount of necrotic debris in WON. METHODS: In a randomized controlled trial, adequately powered to exclude the null hypothesis, patients with symptomatic WON were randomized to either endoscopic or laparoscopic drainage. In the endoscopy group, two plastic stents were placed if the WON contained <1/3rd necrotic debris and a LAMS was placed if it was >1/3rd. Primary outcome was resolution of WON within 4 weeks without re-intervention for secondary infection. Secondary outcome was overall success (resolution of WON at 6 months) and adverse events. RESULTS: Forty patients were randomized: 20 to each group. Baseline characteristics were comparable between the groups. Primary outcome was similar between the groups [16 (80%) in laparoscopy and 15 (75%) in endoscopy group; p = 0.89]. The overall success was similar [18 (90%) in laparoscopy vs. 17 (85%) in endoscopy; p = 0.9]. Median duration of hospital stay was shorter in endoscopy group [4 (4-8) vs. 6 days (5-9); p = 0.03]. Adverse events were comparable between the groups. CONCLUSION: Laparoscopic drainage was not superior to endoscopic transmural drainage with placement of multiple plastic stent or LAMS depending on the amount of necrotic debris for symptomatic WON in AP. The hospital stay was shorter with the endoscopic approach.

A novel technique for large lateral enterocutaneous fistula management after intestinal transplantation.

BACKGROUND: Enterocutaneous fistula (ECF) is a serious and complex problem when affecting children, being responsible for a high morbidity burden, with an estimated mortality rate of 10 to 20%. There are many therapeutic options, including surgery and a wide variety of nonoperative strategies. Prognosis of ECF closure depends on the output and also on the patency of distal bowel. Spontaneous closure without operative intervention occurs in approximately 50% of patients with lateral ECF and distal bowel transit, but this drastically decreases in high output fistulas. High-volume fistula output and consequent skin damage are a great challenge for the health-care team. METHODS: We describe a postoperative complication that required a new nonoperative technique for the transient management of a lateral high-output ECF, involving the insertion of an occlusive device in order to redirect intestinal content to the distal bowel, reducing the fistula output. RESULTS AND CONCLUSIONS: The main benefit of this nonoperative technique is the ability to occlude a high-output fistula, allowing the distal flow to be restored and reducing abdominal wall damage, as a bridge to definitive surgical closure.

Selective Versus Routine Spinal Drain Use for Fenestrated/Branched Endovascular Aortic Repair (F-BEVAR).

BACKGROUND: Spinal drains are used to ameliorate spinal cord ischemia (SCI), but their use may result in inherent morbidity and mortality. Although prophylactic spinal drain has proven of benefit in open repairs, that is not the case for endovascular repairs. The aim of this study was to assess the outcomes of spinal cord protection with and without the routine use of spinal drains during fenestrated-branched endovascular repair (F-BEVAR). METHODS: A retrospective single center study was performed using a prospectively maintained dataset of all patients undergoing F-BEVAR over a 4-year period. The primary endpoint of the study was the frequency of SCI. Prophylactic spinal drain was placed pre-operatively in 33 patients (23%) with a median time for removal of 3 days (IQR, 2-3 days). Routine intraoperative neuromonitoring was used. Spinal cord protection relied primarily on maintaining a perioperative systolic blood pressure between 140 and 160 mm Hg or a mean arterial pressure >90 mm Hg, avoiding hypotension, preservation of as many collateral beds as possible, staged repairs and early lower extremity reperfusion based on neuromonitoring. RESULTS: A total of 145 patients, 104 men (71%) and 41 women (28%) with a median age of 70 years (interquartile range [IQR], 53-62) underwent F-BEVAR. Branched custom-made devices (CMDs) (11%), fenestrated CMDs (70%) and off-the-shelf T-Branch device (17%) were used with a median number of branches/fenestrations of 4 (IQR, 3-4). SVS classification of implantation zones were determined as follows: 9 (6%) zone 2, 21 (20%) zone 3, 26 (18%) zone 4 and 89 (61%) zone 5. SCI was present in 8 patients (5.5%) and classified according to the SVS SCI grading system as follows: 1 grade 1, 5 grade 2 and 2 grade 3a. When evaluating implantation zone independently of coverage length and patency of collateral beds, a high implantation zone (1-4) was not associated with SCI (P = 0.9). Similarly, prophylactic spinal drain did not demonstrate association with the occurrence of SCI (3[9%] vs. 5[4%], with and without spinal drain, respectively) (P = 0.3). For patients with high implantation zones, staged repair was performed in 38 patients (26%) at a median time of 2 months (IQR, 2-6 months). Among these patients, the frequency of SCI was 13%. Staged repair was associated with an 80% reduction in the frequency of SCI (OR, 0.19 [95% CI, 0.04-0.084]) (P = 0.02). CONCLUSION: F-BEVAR can be performed with a minimal risk of SCI without the need for routine prophylactic spinal drains. High implantation zones did not predict SCI after F-BEVAR; however, staged repair significantly decreased the risk of SCI after F-BEVAR.