Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: A prospective, randomized, multicenter trial.

BACKGROUND: This study sought to determine whether a protective diverting ileostomy improves short-term outcomes in patients with rectal resection and colonic J-pouch reconstruction for low anastomoses. Criteria for the use of a proximal stoma in rectal resections with colonic J-pouch reconstruction have not been defined sufficiently. METHODS: In a multicenter prospective study, rectal cancer patients with anastomoses below 8 cm treated with low anterior resection and colonic J-pouch were randomized to a defunctioning loop ileostomy or no ileostomy. The primary study endpoint was the rate of anastomotic leakage, and the secondary endpoints were surgical complications related to primary surgery, stoma, or stoma closure. RESULTS: From 2004 to 2014, a total of 166 patients were randomized to 1 of the 2 study groups. In the intention-to-treat analysis, the overall leakage rate was 5.8% in the stoma group and 16.3% in the no stoma group (P = .0441). However, some patients were not treated according to randomization and only 70% of our patients with low anastomoses received a pouch. Therefore, we performed a second analysis as to actual treatment. In this analysis, as well, leakage rates (P = .044) and reoperation rates for leakage (P = .021) were significantly higher in patients without a stoma. In multivariate analysis, male gender (P = .0267) and the absence of a stoma (P = .0092) were significantly associated with anastomotic leakage. CONCLUSION: Defunctioning loop ileostomy should be fashioned in rectal cancer patients with anastomoses below 6 cm, particularly in male patients, even if reconstruction was done with a J-pouch.

Efficacy of argatroban in critically ill patients with heparin resistance: a retrospective analysis.

The patients who do not respond even to very high dosages of heparin are assumed to suffer from heparin resistance. The aim of this study was to investigate whether critically ill patients suffering from heparin resistance generally have low antithrombin III (AT) levels, and if the direct thrombin inhibitor argatroban in that case can be an effective option to achieve prophylactic anticoagulation. The study was conducted at the Department for General and Surgical Intensive Care Medicine at the University Hospital Innsbruck. We retrospectively included all patients between 2008 and 2012, who received argatroban because of poor response to high-dosage heparin prophylaxis. The period under observation lasted in total for 9 days, 2 days of anticoagulation with unfractionated heparin (UFH) and 7 days with argatroban. The primary objective was to investigate if after 7 (± 1) hours of switching to argatroban the activated partial thromboplastin time (aPTT) levels were in a prophylactic range of 45 to 55 seconds. Further objectives were to assess the AT level, side effects such as bleeding or thromboembolism, platelet count, correlation between organ function and argatroban dose as well as any need for allogeneic blood products. The study population, consisting of 5 women and 15 men with a mean (± standard deviation, SD) age of 54.6 ± 16.3 years, differed in many clinical aspects. A median (interquartile range) heparin dose of 1,000, 819 to 1,125 IU/h was administered for 2 days and failed in providing a prophylactic anticoagulation measured by the aPTT. The mean aPTT level with heparin treatment was 38.5 seconds (± 4.7) its change within that period was not significant. After switching to argatroban, the mean increase of the aPTT levels in all study patients amounted from 38.5 to 48.3 seconds (p < 0.001). The rise in aPTT clearly reaches sufficient prophylactic anticoagulant levels. The maintenance of prophylactic aPTT levels was achieved over the period of 1 week. There was neither a correlation found between low-AT levels and occurrence of heparin resistance, nor between the simplified acute physiology score II and the administered argatroban dose (r = -0.224, p = 0.342). The results of the present study indicate that argatroban is an effective alternative therapy, especially in critically ill patients, to achieve prophylactic anticoagulation when heparin resistance occurs.

Morphological differences in adolescent idiopathic scoliosis: a histological and ultrastructural investigation.

STUDY DESIGN: Histological and ultrastructural evaluation of cell morphologies at the concave and convex side of apical intervertebral discs (IVD) of adolescent idiopathic scoliosis (AIS). OBJECTIVE: To determine changes in cell morphology, viability, and cell death after asymmetric disc loading in AIS and to compare the findings with the tilt angles. SUMMARY OF BACKGROUND DATA: The reaction of cells to loading stimuli in the IVD seems to be specific. Although dynamic loads are more beneficial to the disc cells and maintain the matrix biosynthesis, static compressive loads suppress gene expression. METHODS: Apical IVDs (Th8-Th9 to L1-L2) from 10 patients with AIS were studied histologically (including TUNEL [TdT-mediated dUTP-biotin nick end labeling] staining to identify disc cell death by apoptosis) and ultrastructurally for matrix evaluations and to quantify healthy, balloon, chondroptotic, apoptotic, and necrotic cells on the concave and convex sides. Patients' spines were classified according to the Lenke classification. Degeneration was assessed according to the Pfirrmann grading system. Two groups were established; group 1 (G1) with a tilt of 5° to 9° and group 2 (G2) with a tilt of 10° to 19°. RESULTS: Balloon cells were found in significantly higher numbers at the concave side (G1-annulus fibrosus [AF]: mean 16%), with almost none found at the convex side. Mean numbers of healthy cells did not show differences comparing both sides. Significantly higher numbers of healthy cells were found with increasing tilt angle at the concave side. Necrosis (mean, 47%) increased toward the center of the disc but did not differ between the sides of the IVDs. The fibrils found in the outer AF on the convex side were 30% thinner. CONCLUSION: This study was able to show significant differences in cell morphologies in the AF on both sides and in correlation to the different tilt angles. The type and magnitude of load seem to influence disc cells. Further studies are required to provide more information on disc and cell changes in scoliosis.

Mortality patterns and site heterogeneity of severe malaria in African children.

BACKGROUND: In this study we aimed to assess site heterogeneity of early, intermediate, and late mortality prediction in children with severe Plasmodium falciparum malaria in sub-Saharan Africa. METHODS: Medical records of 26,036 children admitted with severe Plasmodium falciparum malaria in six hospital research centers between December 2000 to May 2005 were analyzed. Demographic, clinical and laboratory data of children who died within 24 hours (early), between 24 and 47 hours (intermediate) and thereafter (48 hours or later, late mortality) were compared between groups and survivors. RESULTS: Overall mortality was 4·3% (N = 1,129). Median time to death varied across sites (P<0·001), ranging from 8 h (3 h-52 h) in Lambaréné to 40 h (10 h-100 h) in Kilifi. Fifty-eight percent of deaths occurred within 24 hours and intermediate and late mortality rate were 19% and 23%, respectively. Combining all sites, deep breathing, prostration and hypoglycemia were independent predictors for early, intermediate and late mortality (P<0·01). Site specific independent predictors for early death included prostration, coma and deep breathing at all sites (P<0·001). Site specific independent predictors for intermediate and late death largely varied between sites (P<0·001) and included between 1 and 7 different clinical and laboratory variables. CONCLUSION: Site heterogeneity for mortality prediction is evident in African children with severe malaria. Prediction for early mortality has the highest consistency between sites.

LUCAS compared to manual cardiopulmonary resuscitation is more effective during helicopter rescue-a prospective, randomized, cross-over manikin study.

OBJECTIVE: High-quality chest-compressions are of paramount importance for survival and good neurological outcome after cardiac arrest. However, even healthcare professionals have difficulty performing effective chest-compressions, and quality may be further reduced during transport. We compared a mechanical chest-compression device (Lund University Cardiac Assist System [LUCAS]; Jolife, Lund, Sweden) and manual chest-compressions in a simulated cardiopulmonary resuscitation scenario during helicopter rescue. METHODS: Twenty-five advanced life support-certified paramedics were enrolled for this prospective, randomized, crossover study. A modified Resusci Anne manikin was employed. Thirty minutes of training was allotted to both LUCAS and manual cardiopulmonary resuscitation (CPR). Thereafter, every candidate performed the same scenario twice, once with LUCAS and once with manual CPR. The primary outcome measure was the percentage of correct chest-compressions relative to total chest-compressions. RESULTS: LUCAS compared to manual chest-compressions were more frequently correct (99% vs 59%, P < .001) and were more often performed correctly regarding depth (99% vs 79%, P < .001), pressure point (100% vs 79%, P < .001) and pressure release (100% vs 97%, P = .001). Hands-off time was shorter in the LUCAS than in the manual group (46 vs 130 seconds, P < .001). Time until first defibrillation was longer in the LUCAS group (112 vs 49 seconds, P < .001). CONCLUSIONS: During this simulated cardiac arrest scenario in helicopter rescue LUCAS compared to manual chest-compressions increased CPR quality and reduced hands-off time, but prolonged the time interval to the first defibrillation. Further clinical trials are warranted to confirm potential benefits of LUCAS CPR in helicopter rescue.

Morphological changes in disc herniation in the lower cervical spine: an ultrastructural study.

INTRODUCTION: The basis of disc degeneration is still unknown, but is believed to be a cell-mediated process. Apoptosis might play a major role in degenerative disc disease (DDD). The aim of this study was to correlate the viability of disc cells with the radiological degeneration grades (rDG) in disc herniation. MATERIALS AND METHODS: Forty anterior IVD's (C4-C7) from 39 patients with DDD were studied histologically and ultrastructurally to quantify healthy, "balloon", chondroptotic, apoptotic and necrotic cells. Patients were classified to their rDG, as having either prolapse (P: DGII + III) and/or osteochondrosis (O: DGIV + V). Similar studies were undertaken on eight control discs. RESULTS: Cell death by necrosis (mean 35%) was common but differed not significantly in both groups. All patients with a disc prolapse DGII + III revealed balloon cells (iAF: mean 32%). All appeared alive and sometimes were hypertrophic. However, significantly less balloon cells were found in the O-Group. Control samples revealed no evidence of "balloon" cells in DGII and only a minor rate in DGIII. CONCLUSION: According to the different rDG, quantitative changes were obvious in healthy and "balloon" cells, but not for cell death. At the moment it can only be hypothesized if "balloon" cells are part of a repair strategy and/or cause of disc herniation.

Craniomaxillofacial trauma: synopsis of 14,654 cases with 35,129 injuries in 15 years.

Craniomaxillofacial (CMF) trauma occurs in isolation or in combination with other serious injuries, including intracranial, spinal, and upper- and lower-body injuries. It is a major cause of expensive treatment and rehabilitation requirements, temporary or lifelong morbidity, and loss of human productivity. The aim of this study was to evaluate patterns of CMF trauma in a large patient sample within a 15-year time frame. Between 1991 and 2005, CMF trauma data were collected from 14,654 patients with 35,129 injuries at the Department of Cranio-Maxillofacial and Oral Surgery in Innsbruck, assessing a plethora of parameters such as injury type and mechanism as well as age and gender distribution over time. Three main groups of CMF trauma were evaluated: facial bone fractures, dentoalveolar trauma, and soft tissue injuries. Statistical comparisons were carried out using a chi-square test. This was followed by a logistic regression analysis to determine the impact of the five main causes for CMF injury. Older people were more prone to soft tissue lesions with a rising risk of 2.1% per year older, showing no significant difference between male and female patients. Younger patients were at higher risk of suffering from dentoalveolar trauma with an increase of 4.4% per year younger. This number was even higher (by 19.6%) for female patients. The risk of sustaining facial bone fractures increased each year by 4.6%. Male patients had a 66.4% times higher risk of suffering from this type of injury. In addition, 2550 patients (17.4%) suffered from 3834 concomitant injuries of other body parts. In summary, we observed changing patterns of CMF trauma over the last 15 years, paralleled by advances in refined treatment and management options for rehabilitation and reconstruction of patients suffering from CMF trauma.

Intracardiac echocardiography: a new guiding tool for transcatheter aortic valve replacement.

BACKGROUND: Echocardiography has been debated as an adjunct for transcatheter aortic valve replacement (TAVR). The aim of this prospective study was to comparatively evaluate intraprocedural guidance using intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE). METHODS: Fifty high-risk patients with severe aortic stenosis scheduled for TAVR were randomized to either guidance using ICE (group 1; n = 25) or monitoring using TEE (group 2; n = 25). RESULTS: In contrast to TEE, ICE allowed continuous monitoring. The need for probe repositioning during the procedure was much lower in group 1 (0.1 ± 0.3 vs 5.7 ± 0.7 maneuvers, P < .001). Compared with TEE, the transcaval intracardiac echocardiographic view provided higher coaxiality with the ascending aorta expressed as the length of ascending aorta depicted (4.9 ± 1.2 vs 6.1 ± 1.2 cm, P = .003). Both coronary ostia were more frequently visualized in group 1 (18 vs 2 cases, P < .001). ICE-derived annular measurements were correlated closely with preinterventional readings on TEE (n = 25, r(2) = 0.90, P < .001). TEE underestimated intraprocedural pressure gradients in comparison with preinterventional measurements (mean difference, -10.2 ± 11.1 mm Hg; n = 11, P = .012), but ICE did not (mean difference, -0.3 ± 14.1 mm Hg; n = 25, P = .913). ICE and TEE detected newly grown thrombi (2 vs 1 case). Severe complications (e.g., annular dissection, pericardial effusion) were not observed. CONCLUSIONS: ICE, which is compatible with sedation and local anesthesia, can be considered an alternative to TEE for intraprocedural guidance during TAVR. It also seems to match the required work flow during TAVR better than TEE.

Comparison of real-time sonoelastography with T2-weighted endorectal magnetic resonance imaging for prostate cancer detection.

OBJECTIVES: The purpose of this study was to compare the value of real-time sonoelastography with T2-weighted endorectal magnetic resonance imaging (MRI) for prostate cancer detection. METHODS: Thirty-three patients with an elevated prostate-specific antigen level were investigated with real-time sonoelastography and T2-weighted endorectal MRI for prostate cancer diagnosis before systematic prostate biopsy. Real-time sonoelastography was performed to assess prostate tissue elasticity, and hard areas were considered suspicious for prostate cancer. Low-signal intensity nodules on T2-weighted endorectal MRI were considered suspicious for prostate cancer. Imaging findings were assigned to 6 areas of the peripheral zone (sextants), and their cancer detection rates were compared. RESULTS: Overall, prostate cancer was detected in 13 of 33 patients (39.4%). Both real-time sonoelastography and T2-weighted endorectal MRI detected 11 cancer-positive patients (84.6%). Real-time sonoelastography showed 27 suspicious lesions in 198 sextants, and 15 (55.6%) were cancer positive. T2-weighted endorectal MRI showed 31 suspicious lesions in 198 sextants, and 13 (40.6%) were cancer positive. These findings resulted in sensitivity rates and negative predictive values per patient of 84.6% and 86.7%, respectively, for sonoelastography and 84.6% and 83.3% for MRI. The per-sextant analysis showed sensitivity rates and negative predictive values of 57.7% and 93.6% for sonoelastography and 50.0% and 92.2% for MRI. CONCLUSIONS: Real-time sonoelastography showed comparable results as T2-weighted endorectal MRI for prostate cancer detection.

Value of real-time elastography targeted biopsy for prostate cancer detection in men with prostate specific antigen 1.25 ng/ml or greater and 4.00 ng/ml or less.

PURPOSE: We assessed the prostate cancer detection rate of real-time elastography targeted biopsy in men with total prostate specific antigen 1.25 ng/ml or greater and 4.00 ng/ml or less. MATERIALS AND METHODS: Real-time elastography using an EUB 8500 Hitachi ultrasound system (Hitachi Medical, Tokyo, Japan) was done in 94 men with a mean age of 57.4 years (range 35 to 77) with increased prostate specific antigen between 1.25 ng/ml or greater and 4.00 ng/ml or less (mean 3.20, range 1.30 to 4.00) and a free-to-total prostate specific antigen ratio of less than 18%. Real-time elastography was done to evaluate peripheral zone tissue elasticity and hard areas were defined as suspicious. Targeted biopsies with a maximum of 5 cores were done in suspicious areas, followed by 10-core systematic biopsy. We analyzed the cancer detection rate of real-time elastography and systematic biopsy. RESULTS: Cancer was found in 27 of 94 patients (28.7%). Real-time elastography detected cancer in 20 patients (21.3%) and systematic biopsy detected it in 18 (19.1%). Positive cancer cores were found in real-time elastography targeted cores in 38 of 158 cases (24%) and in systematic cores in 38 of 752 (5.1%) (chi-square test p <0.0001). The cancer detection rate per core was 4.7-fold greater for targeted than for systematic biopsy. CONCLUSIONS: Real-time elastography targeted biopsy allows prostate cancer detection in men with prostate specific antigen 1.25 ng/ml or greater and 4 ng/ml or less with a decreased number of cores compared with that of systematic biopsy.