RS Group Research Articles

What is the best option for failed sphincter repair?

This study aimed to evaluate the outcome of various procedures for patients with fecal incontinence following failed sphincteroplasty. Patients who underwent surgery for failed sphincteroplasty from January 2000 to June 2011 [corrected] were identified. They were assessed using the Fecal Incontinence Quality of Life (FIQoL) scale and the Cleveland Clinic Florida-Wexner Fecal Incontinence Score (CCFFIS). Fifty-nine patients [97% females; median age 52 (25-81) years] were identified. They underwent either repeat sphincteroplasty (RS; n = 33), artificial bowel sphincter (ABS; n = 11) or sacral nerve stimulation (SNS; n = 15). The median follow-up was 31 (3-138) months. The RS group had a significantly wider external sphincter defect and had undergone fewer previous sphincteroplasties. The most common complication was infection. The incidence of complications was significantly higher after ABS (73%) compared with RS (24%) and SNS (33%) (P = 0.01). Seventeen (29%) patients required re-operation for complications or failure, with a lower rate in the RS group (P = 0.004). There was no difference in the rates of device removal after ABS or SNS. Ten (17%) patients underwent further surgery or re-implantation of the device with no difference between the groups. At follow-up, five (45%) ABS and 10 (67%) SNS patients retained a functioning device (P = 0.4). The mean postoperative CCFFIS decreased from 17.5 to 11.5 in the RS group, from 18.7 to 8.6 in the ABS group, and from 17.6 to 9.1 in the SNS group (P ≤ 0.02 for all). There were no differences in the improvement of CCFFIS or FIQoL scores among groups. RS, ABS and SNS are associated with similar improvements in continence after failed sphincteroplasty. Due to increased complications and re-operation with ABS and SNS, RS may be the first step in managing these patients.

Influence of male-to-female ratio and climatic conditions on the reproductive performance of Anglo Nubian goats

The objective of this study was to test the €œmale effect€ on the reproductive performance of Anglo Nubian does (n = 180), aged between 24 and 60 months, under different male-to-female ratios (1:20 €“ T20, 1:30 €“ T30, and 1:40 €“ T40) and climatic conditions (dry season €“ DS, and rainy season €“ RS). Does were randomly distributed into three groups (T20, T30, and T40) and were isolated from bucks at a distance of 300 m for 60 days before the start of the experiments. The first manifestation of estrous during the DS occurred 6.83 ± 4.54 (T20), 6.72 ± 4.56 (T30) and 7.05 ± 5.23 (T40) days following the onset of the breeding season (P>0.05). In the RS, onset of estrous was observed 6.60 ± 4.74 (T20), 6.70 ± 4.43 (T30) and 7.46 ± 4.54 (T40) days after the beginning of the breeding season (P>0.05). Estrous induction in females during the DS occurred in 95% (T20), 80% (T30), and 75.5% (T40) of all females. During the RS, estrous detection reached 100% (T20), 100% (T30), and 97.5% (T40) of all females, with no difference between all RS and DS groups. Estrous synchronization during the DS occurred in 35.00% (T20), 36.66% (T30), and 32.50% (T40) of all females, for an average occurrence of 34.72%. During the RS, synchronization occurred in 65% (T20), 70% (T30) and 62.25% (T40) of all females, for an average occurrence of 65.75%; no difference was detected between the RS and the DS. Pregnancy rates in the DS groups were 65.0% (T20), 70.0% (T30), and 62.5% (T40), while pregnancy rates in the RS were 90.0% (T20), 86.6% (T30), and 95.0% (T40). No difference was observed for conception rates between any of the RS and DS groups. Prolificacy during the DS was 1.30 (T20), 1.30 (T30) and 1.35 (T40), while in the RS prolificacy was 1.29 (T20), 1.25 (T30) and 1.30 (T40). Thus, the male effect can be used effectively for goats under 1:20€“1:40 male-to-female ratios in a 45-day mating season under varying climatic conditions.

A 10-second fluid challenge guided by transthoracic echocardiography can predict fluid responsiveness.

IntroductionThe accurate assessment of intravascular volume status for the therapy of severe hypovolemia and shock is difficult and critical to critically ill patients. Non-invasive evaluation of fluid responsiveness by the rapid infusion of a very limited amount of volume is an important clinical goal. This study aimed to test whether echocardiographic parameters could predict fluid responsiveness in critically ill patients following a low-volume (50-ml crystalloid solution) infusion over 10 seconds.MethodsWe prospectively studied 55 mechanically ventilated patients. Echocardiography was performed during a 50-ml infusion of crystalloid solution over 10 seconds and a further 450 ml over 15 minutes. Cardiac output (CO), stroke volume (SV), aortic velocity time index (VTI), and left ventricular ejection fraction (LVEF) were recorded. Patients were classified as responders (Rs) if CO increased by at least 15% following the 500-ml volume expansion or were classified as non-responders (NRs) if CO increased by less than 15%. Area under the receiver operating characteristic curves (AUC) compared CO variations after 50 ml over 10 seconds (∆CO50) and 500 ml over 15 minutes (∆CO500) and the variation of VTI after infusion of 50 ml of fluid over 10 seconds (∆VTI50).ResultsIn total, 50 patients were enrolled, and 27 (54%) of them were Rs. General characteristics, LVEF, heart rate, and central venous pressure were similar between Rs and NRs. In the Rs group, the AUC for ∆CO50 was 0.95 ± 0.03 (P <0.01; best cutoff value, 6%; sensitivity, 93%; specificity, 91%). Moreover, ∆CO50 and ∆CO500 were strongly correlated (r = 0.87; P <0.01). The AUC for ∆VTI50 was 0.91 ± 0.04 (P <0.01; best cutoff value, 9%; sensitivity, 74%; specificity, 95%). ∆VTI50 and ∆CO500 were positively correlated (r = 0.72; P <0.01).ConclusionIn critically ill patients, the variation of CO and VTI after the administration of 50-ml crystalloid solution over 10 seconds (∆CO50 and ∆VTI50) can accurately predict fluid responsiveness.Trial registrationCurrent Controlled Trials ISRCTN10524328. Registered 12 December 2013.

Abstract P6-06-46: Treatment decisions and five year outcomes of the oncotype Dx test: An independent assessment

Abstract INTRODUCTION: Oncotype DX (ODx) was validated to provide prognostic information in ER+ lymph node negative tumors. The work of Paik et al. (JCO 2006 23:3737) has provided evidence of predictive power of ODx for chemotherapy, but there is contrary literature in this regard (Ionnadis JP Oncologist 2007, 12: 301-11; NICE Guideline March 2013 http://guidance.nice.org.uk/DT4). The specific aims of our institutional study are to determine (1) how ODx influenced treatment decisions and (2) the outcomes of patients who had ODx. METHODS: Tumor registry follow-up information was supplied for 580 patients who had ODx and follow-up (mean/median 60/63 months). RESULTS: (Table 1) Distribution of RS was 40% intermediate (232/580), 15% high RS (87/580) and 45% (261/580) low RS. Hormonal therapy was recommended to 96% (558 of 580), but refused by 3% (16 of 580) and for 1% data was unavailable. In the high RS group, chemo was recommended to 90% (79 of 87), of which 6 (8%) refused. In the intermediate RS group, chemo was recommended to 49% of the patients of which 20 (18% of recommended) refused. In the low RS group, chemo was recommended to 12% of the patients of which 8 (26% of recommended) refused. Most chemotherapy treatment decisions made at our institution were based on oncotype DX. High RS group recurrence was 9% (7 of 87) of which 2 patients died. Of these 7 patients, 3 did not receive chemotherapy (2 were recommended but refused). The recurrence rate in the intermediate RS group was 6.5% (14 of 232) of which 3 patients died. Of these 14 patients, 8 did not receive chemotherapy based on clinician's judgment. The recurrence rate in the low RS group was 1% (3 of 261) and there were no deaths due to breast cancer. Of these 3 cases, one received chemotherapy. Oncotype DX Type of Recurrence vs Recurrence ScoresType RecurrenceHigh RSIntermediate RSLow RSTotalLocoregional49114(Scores)(35,38,47,63)(19,20,20,23,24,26,26,27,29)(16) Distant2529(Scores)(31,61)(19,19,22,29,30)(2,11) Local or Distant1 1Total714324 Conclusion: (1) The oncotype DX recurrence score is prognostic when low risk and high risk categories are considered. (2)The large number (40%) of intermediate RS appears to be a prognostic limitation of the test. (3) Of patients that recurred, (50%) received chemotherapy and were somewhat equally distributed between the high RS and the intermediate RS categories. Further follow-up of this cohort should address concerns of clinical utility of the Oncotype Dx test, especially for the intermediate RS category. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-06-46.

Sleep-dependent Neurophysiological Processes in Implicit Sequence Learning

Behavioral studies have cast doubts about the role that posttraining sleep may play in the consolidation of implicit sequence learning. Here, we used event-related fMRI to test the hypothesis that sleep-dependent functional reorganization would take place in the underlying neural circuits even in the possible absence of obvious behavioral changes. Twenty-four healthy human adults were scanned at Day 1 and then at Day 4 during an implicit probabilistic serial RT task. They either slept normally (RS) or were sleep-deprived (SD) on the first posttraining night. Unknown to them, the sequential structure of the material was based on a probabilistic finite-state grammar, with 15% chance on each trial of replacing the rules-based grammatical (G) stimulus with a nongrammatical (NG) one. Results indicated a gradual differentiation across sessions between RTs (faster RTs for G than NG), together with NG-related BOLD responses reflecting sequence learning. Similar behavioral patterns were observed in RS and SD participants at Day 4, indicating time- but not sleep-dependent consolidation of performance. Notwithstanding, we observed at Day 4 in the RS group a diminished differentiation between G- and NG-related neurophysiological responses in a set of cortical and subcortical areas previously identified as being part of the network involved in implicit sequence learning and its offline processing during sleep, indicating a sleep-dependent processing of both regular and deviant stimuli. Our results suggest the sleep-dependent development of distinct neurophysiological processes subtending consolidation of implicit motor sequence learning, even in the absence of overt behavioral differences.

Effect and mechanism of ketogenic diet on neurobehavioral demages induced by recurrent neonatal seizures

Objective To investigate the intervention effect of ketogenic diet (KD) on neurobehavioral demages after flurothyl-induced recurrent neonatal seizures in rats and on the expression of ApoE. Methods Postnatal day 8 (P8) SD rats (quantity: 48) were randomly divided into two groups: the non-seizure group (NS group, n=24) and the recurrent-seizure group (RS group, n=24). From P9, rats in RS group were subjected to recurrent seizures induced by volatile flurothyl 30 min each day for consecutive 8 days. While rats in NS group were placed into the container for an equal amount of time to their counterpart without exposuring to flurothyl. At P28, each group was divided into two groups again: non-seizure and normal diet group(NS+ ND group, n=12), non-seizure and ketogenic diet group(NS+ KD group, n=12), recurrent-seizure and normal diet group(RS+ ND group, n=12), recurrent-seizure and ketogenic diet group(RS+ KD group, n=12). At P42, neurodevelopmental indicators were monitored. ApoE protein levels in cerebral cortex were determined by western blot at P58. Results Neurodevelopmental indicators were analyzed at P42: in the plane righting experiment, the rats of group NS+ ND (1.0±0.14) about the time of plane righting was significant different comparing with group RS+ ND ((0.75±0.32)s)(P 0.05). In the negative geotaxis reaction experiment, the rats of groups NS+ KD and RS+ ND((3.17±0.58)s, (6.75±0.75)s) about the time of negative geotaxis reaction were significant different comparing with group NS+ ND ((1.58±0.52)s)(P<0.05). Compared with group RS+ ND, the group RS+ KD in the time of negative geotaxis reaction was obviously shortened(P<0.05). In the cliff avoidance test, there were significant differences between group NS+ ND、RS+ KD ((5.75±2.90)s, (9.50±4.36)s)and group RS+ ND((14.00±4.79)s) about the time of cliff avoidance(P<0.05). In western blot, the expression of ApoE in cerebral cortex in the RS+ ND group (1.26±0.30) was obviously increased compared with group NS+ ND (0.78±0.12) (P<0.05), and there had also significant difference between group RS+ KD (0.89±0.10) and group RS+ ND(P<0.05). Conclusion The neuroprotective effects of ketogenic diet on recurrent neonatal seizure-induced neurobehavioral demages may be associated with the reduction of ApoE in cerebral cortex. Key words: Neonatal seizure; Ketogenic diet; Neurobehavior; ApoE

Influence of mefenamic acid on the intestinal absorption and metabolism of three bioactive flavones in Radix Scutellariae and potential pharmacological impact

Context: Mefenamic acid (MEF) and the dried root of Scutellaria baicalensis Georgi (Radix Scutellariae, RS) share a high possibility of combined medication to treat inflammation.Objective: The present study investigates the impact of MEF on absorption/disposition of three major components in RS (baicalein, B; wogonin, W; oroxylin A, OA) and further pharmacological changes.Materials and methods: The apparent permeability (Papp) and percentage of metabolism of B, W and OA at 10 μΜ were measured at the absence/presence of MEF (100 μΜ) in the Caco-2 cell monolayer model. A modified whole blood assay was employed to quantify prostaglandin E2 (PGE2) 4, 6 and 8 h post-oral administration with water suspension of MEF at 40 mg/kg and RS at 200 mg/kg.Results: In the presence of MEF, Papp of B, W and OA were increased from 1.69 ± 0.89 × 10−6, 1.57 ± 0.10 × 10−6 and 3.09 ± 0.70 × 10−6 cm/sec to 5.24 ± 0.27 × 10−6, 6.08 ± 0.19 × 10−6 and 4.13 ± 0.38 × 10−6, whereas their percentage of metabolism was decreased from 72.75 ± 2.44%, 73.27 ± 3.25% and 89.84 ± 2.99% to 21.11 ± 0.69%, 17.90 ± 5.55% and 45.44 ± 3.38%. PGE2 level was much lower in the co-administration group (49.04 ± 2.03 pg/ml) than in the MEF group (73.13 ± 3.03 pg/ml) or RS group (494.37 ± 11.75 pg/ml) 4 h post MEF dosing, suggesting a synergic effect.Discussion and conclusion: Co-administration of MEF and RS could induce potential alterations in their pharmacokinetic profiles and anti-inflammatory effects.

Serum protein profile of Crohn's disease treated with infliximab

The infliximab (IFX) has dramatically improved the treatment of Crohn's disease (CD). However, the need for predictive factors, indicative of patients' response to IFX, has yet to be met. In the current study, proteomics technologies were employed in order to monitor for differences in protein expression in a cohort of patients following IFX administration, aiming at identifying a panel of candidate protein biomarkers of CD, symptomatic of response to treatment. We enrolled 18 patients, who either had achieved clinical and serological remission (Rm, n=6), or response (Rs, n=6) and/or were PNRs (n=6), to IFX. Serum samples were subjected to two-dimensional Gel Electrophoresis. Following evaluation of densitometrical data, protein spots exhibiting differential expression among the groups, were further characterized by MALDI-TOF-MS. Identified proteins where evaluated by immunoblot analysis while functional network association was carried out to asses significance. Proteins apolipoprotein A-I (APOA1), apolipoprotein E (APOE), complement C4-B (CO4B), plasminogen (PLMN), serotransferrin (TRFE), beta-2-glycoprotein 1 (APOH), and clusterin (CLUS) were found to be up-regulated in the PNR and Rs groups whereas their levels displayed no changes in the Rm group when compared to baseline samples. Additionally, leucine-rich alpha-2-glycoprotein (A2GL), vitamin D-binding protein (VTDB), alpha-1B-glycoprotein (A1BG) and complement C1r subcomponent (C1R) were significantly increased in the serum of the Rm group. Through the incorporation of proteomics technologies, novel serum marker-molecules demonstrating high sensitivity and specificity are introduced, hence offering an innovative approach regarding the evaluation of CD patients' response to IFX therapy.

Processing of ambiguous emotional messages in brain injured patients with and without subcortical lesions

Background: Emotional information in communicative messages is conveyed through a combination of linguistic and paralinguistic cues. Listeners must simultaneously process affective prosody, facial expressions, body gestures, and semantic information in order to determine the speaker's emotional intent. Findings from recent research support the involvement of subcortical structures in unimodal emotion recognition; however, given the propensity for emotional information to be conveyed across multiple modalities simultaneously, clinical advances require an understanding of how subcortical and cortical structures are involved in the recognition of multi-modal stimuli. Aims: To determine if individuals with and without a history of brain damage demonstrate affective processing biases on ambiguous and congruous multi-modal emotive stimuli.1 Methods & Procedures: Twenty individuals with brain damage and five individuals without a history of brain injury (NC) were included in the study. Participants with brain damage were grouped by depth and location of lesion site (left cortical [LC], right cortical [RC], left subcortical-cortical [LS], and right subcortical-cortical [RS]) to determine the effects of damage location on emotion processing. Participants identified emotions from stimuli containing incongruent affective information across two tasks using combinations of verbal, prosodic, and visual (i.e. facial expression) information. In Task 1, affectively charged sentences were presented with conflicting paralinguistic information (speech prosody, facial expression, and a combined modality condition). Task 2 involved the presentation of conflicting facial expression and prosodic information in linguistically neutral sentences. Response preferences for specific modalities were examined to understand potential processing biases. Outcomes & Results: The NC and LC groups demonstrated a bias for selecting emotions displayed by paralinguistic information in all Task 1 conditions. The RC group exhibited a similar preference when facial expression was included in the stimulus, but a decreased bias for selecting paralinguistic information when speech prosody was presented alone. In contrast to the NC and cortical damage groups, the RS group consistently selected emotions based on linguistic cues. The LS group exhibited the greatest inter-subject variability. Group patterns suggested no clear preference for either linguistic or paralinguistic information when speech prosody was included in the stimulus. In the task involving conflicting facial expression and linguistic information, the LS group exhibited a bias for facial expression information. All groups demonstrated a preference for facial expression information over speech prosody; however, the RS group's preference was significantly weaker. Conclusions: The data suggest that combined cortical and subcortical damage disrupts typical processing strategies for emotion recognition.

The effect of timing electrical stimulation to robotic-assisted stepping on neuromuscular activity and associated kinematics

Results of previous studies raise the question of how timing neuromuscular functional electrical stimulation (FES) to limb movements during stepping might alter neuromuscular control differently than patterned stimulation alone. We have developed a prototype FES system for a rodent model of spinal cord injury (SCI) that times FES to robotic treadmill training (RTT). In this study, one group of rats (n = 6) was trained with our FES+RTT system and received stimulation of the ankle flexor (tibialis anterior [TA]) muscle timed according to robot-controlled hind-limb position (FES+RTT group); a second group (n = 5) received a similarly patterned stimulation, randomly timed with respect to the rats' hind-limb movements, while they were in their cages (randomly timed stimulation [RS] group). After 4 wk of training, we tested treadmill stepping ability and compared kinematic measures of hind-limb movement and electromyography (EMG) activity in the TA. The FES+RTT group stepped faster and exhibited TA EMG profiles that better matched the applied stimulation profile during training than the RS group. The shape of the EMG profile was assessed by "gamma," a measure that quantified the concentration of EMG activity during the early swing phase of the gait cycle. This gamma measure was 112% higher for the FES+RTT group than for the RS group. The FES+RTT group exhibited burst-to-step latencies that were 41% shorter and correspondingly exhibited a greater tendency to perform ankle flexion movements during stepping than the RS group, as measured by the percentage of time the hind limb was either dragging or in withdrawal. The results from this study support the hypothesis that locomotor training consisting of FES timed to hind-limb movement improves the activation of hind-limb muscle more so than RS alone. Our rodent FES+RTT system can serve as a tool to help further develop this combined therapy to target appropriate neurophysiological changes for locomotor control.

Comparison of Dietary Habit and Food Consumption among Elementary School Students with or without Rhinitis and Sinusitis

Rhinitis and sinusitis are among the most common medical conditions in Korea, as well as Western societies. Environmental factors may influence both rhinitis and sinusitis; however, the role of dietary factors in rhinitis and sinusitis is not clear. The present study aims tocompare the dietary habit, food consumption frequency, and food preference of elementary school students with or without rhinitis and sinusitis. The demand of their parents for an education program for the dietary prevention against rhinitis and sinusitis was also examined. The survey was conducted with a total of 200 subjects recruited from two elementary schools located in Gyeonggi area of Korea. The subjects consisted of 101 students with rhinitis and/or sinusitis (RS group) and 99 without rhinitis and sinusitis (control group). The students of the RS group were more likely to have habits of eating-out and street food use, to consume bean, peanut, walnut, almond, yogurt, egg, snack, and French fries frequently, and to prefer the types of foods prepared by stir-frying and deep-frying than the control group. The parents who recognized ‘school nutrition teachers or food/nutrition-majored specialists’ as the most appropriate educator for the dietary education program in the RS group (48.5% of their parents) were less than those in the control group (67.7% of their parents). The present study suggest that students with rhinitis and/or sinusitis may be different from those without the disease(s) in their dietary habit, frequently consumed foods, and preferred type of foods. More epidemiological, intervention, and laboratory studies are needed in order to elucidate the role of dietary factors in the development and prevention of rhinitis and sinusitis, which will have a significant implication to public health.

Influence of Titanium Surface Topography on Peri-Implant Soft Tissue Integration

At the neck area of dental implant surface, machined surface (Ms) has been employed to avoid surface contamination. Recently, implants which have roughened surface texture (Rs) at their neck are also available. However, from the viewpoint of soft tissue integration, it remains to be elucidated whether or not surface topography affects the soft tissue attachment around implants. The aim of the present study was to clarify the influence of surface topography on peri-implant soft tissue integration. First, surface roughness of both surfaces was measured. Second, protein adsorption capability on both surfaces was examined. Then, as the rat implant model, titanium implants with each surface were inserted into the maxillae. Horseradish peroxidase (HRP) tracer was applied 4 weeks post implantation to the gingival sulci of implants or natural teeth (NT) to investigate the sealing capability of periodontal/peri-implant soft tissue. Collagen density was also observed by fluorescent staining. As a result, surface roughness (Sa) of Ms and Rs was 0.16 µm and 0.25 µm, respectively. Protein adsorption capability on both surface showed no significant differences. In the NT group of the rat implant model, presence of HRP was restricted only in the coronal portion of epithelium. In both implant groups, in contrast, more invasion of HRP was observed in the soft tissue around implants. Especially in the Ms group, more HRP was observed in the deeper area compared with Rs group. Stronger expression of collagen was observed around Rs compared to Ms at the connective tissue-implant interface. It could be speculated that, with dense collagen, Rs implants showed stronger soft tissue integration compared with Ms implants, but the integration is not as strong as NT’s.

Patterns of femoropopliteal recurrence after routine and selective stenting endoluminal therapy

This study determined the incidence and characteristics of recurrent disease after femoropopliteal angioplasty, following either selective or routine stenting of diseased site(s). Retrospective analysis of a prospectively maintained database for femoropopliteal interventions from June 2003 to July 2010 was performed. Interventions during this period were from a single institution, followed up at 1, 3, and 6 months after initial intervention and on a semiannual basis thereafter with clinical examinations and duplex ultrasound imaging. Two groups were identified: those with routine stenting (RS; routine stenting for all diseased areas) and those with selective stenting (SS; selective stenting for only segments which exhibited compromised flow from residual stenosis or significant dissection). Patients who developed recurrent symptoms (claudication, rest pain), a decrease in ankle-brachial index (ABI) (>0.2), or duplex documentation of a significant (>80%) recurrent stenosis underwent reintervention. Patient demographics, comorbidities, Trans-Atlantic Inter-Society Consensus (TASC) II classification, runoff, and degree of calcification (none, mild, moderate, severe) at initial intervention were recorded. The time to reintervention and recurrence pattern were recorded for both groups. During the study period, 746 endovascular interventions in 477 patients were performed. Total reintervention rate, including bypass, amputation, and asymptomatic occlusion after initial intervention, was 36.48% (group SS, 42.9%; group RS, 33.1%; P=.04). Of all initial interventions, 182 endovascular reinterventions in 165 patients for recurrent femoropopliteal disease were identified (group SS, 70; group RS, 95). No differences were noted among the groups in gender, comorbidities, initial TASC II classification, run off, calcification scores, or statin or clopidogrel use, or both. Time to recurrence was similar in the RS and SS groups. TASC II classification, runoff score, and degree of calcification were similar between the two groups. Although not statistically significant, analysis of recurrence pattern demonstrated de novo stenosis was more common in the SS group (50.0% vs 34.7%; P=.06). This single-center retrospective study found a significant difference in the incidence of recurrence requiring reintervention between patients treated with selective and routine stenting for femoropopliteal disease. Analysis of endovascular reinterventions, however, reveals no significant difference in recurrence time or recurrence pattern between the two groups. No significant differences were identified in time to recurrence, TASC II classification, runoff, and calcification of endovascular reinterventions between the two groups' end points. Additional prospective studies to evaluate the roles of routine and selective stenting in symptomatic femoropopliteal peripheral arterial disease and to investigate recurrence lesion characteristics and the patency of multiple endovascular interventions between these two groups are needed.

Genetics, inheritance and strategies for prevention in populations at high risk of colorectal cancer (CRC).

Hereditary forms of colorectal cancer account for less than 5 % of colorectal cancer but attract disproportionate attention because they offer an opportunity for effective surgical prophylaxis, influence the health of the wider family and give insight into the critical pathways of carcinogenesis. Familial Adenomatous Polyposis (FAP) due to loss of the APC gene and Lynch syndrome or Hereditary Non-Polyposis Colon Cancer (HNPCC) due to breakdown in MisMatch Repair are the principal syndromes of broader interest and both have been the subject of chemoprevention trials. There has been a longstanding interest in non-steroidal anti inflammatories in FAP where trials have shown regression of polyps with the "pro drug"sulindac and the selective COX2 inhibitors though impact on long-term cancer risk is not confirmed. The CAPP1 trial focused on two interventions in a factorial design, aspirin and resistant starch or fermentable fibre. Resistant starch is not absorbed in the small intestine and undergoes colonic fermentation to short-chain fatty acids including butyrate which have anti-cancer effects. Polyposis registry clinicians across Europe recruited adolescents with FAP to receive aspirin (600 mg as 2 tablets/d) and/or 30 g as 2 sachets/d in a 1:1 blend of potato starch and high amylose maize starch [Hylon VII]) with placebo control for at least a year or until surgery before age 21. Fifty-nine percent (133/227) of recruits had a baseline and at least one other endoscopy. After a median of 17 months , the primary endpoint of a risk of an increased polyp number in the rectum and sigmoid colon was not significantly reduced in either treatment group with relative risks of 0.77 (aspirin; 95 % CI, 0.54-1.10;) and 1.05 (RS; 95 % CI, 0.73-1.49. The diameter of the largest polyp detected tended to be smaller in the aspirin arm. The planned subgroup analyses of patients who elected to continue on study for more than one year found a significant reduction in the size of the largest polyp in the aspirin versus non-aspirin group (p = 0.02), Mean crypt length decreased significantly over time on study in the two combined RS groups, compared with the two combined non-RS groups (p < 0.0001 for interaction), in a model of the interaction between intervention and time. In CAPP2, 1009 Lynch syndrome gene carriers were recruited from 43 international centres. 937 commenced intervention: 600 mg enteric coated aspirin and/or 30grams of the resistant starch Novelose in a 2 by 2 factorial placebo controlled design. After a mean of 29 months, intervention, there was no evidence that either agent influenced development of colonic neoplasia. However, the design included double blind follow-up for at least 10 years. After a mean of 55.7 months, and despite regular colonoscopy and polyp removal, 48 recruits developed CRC. Of these, 18 received aspirin and 30 received AP; the HR for CRC for aspirin was 0.63 (CI 0.35-1.13, p = 0.12). Five of the 48 people who developed CRC each had two primary colon cancers. Poisson regression analysis to allow for multiple primary events indicated a protective effect: IRR 0.56 (CI 0.32-0.99, p = 0.05). For those who took aspirin (or AP) for a minimum of 2 years (per protocol) the HR was 0.41 (CI 0.19-0.86 p = 0.02) and the IRR, 0.37 (CI 0.18-0.78 p = 0.008). Combined analysis of all LS cancers including CRC revealed a similar effect. On intention to treat analysis, the HR was 0.65 (CI 0.42-1.00, p = 0.05 and IRR was 0.59 (CI 0.39-0.90 p = 0.01), while the Per Protocol analysis HR was 0.45 (CI 0.26-0.79 p = 0.005,) and IRR was 0.42 (CI 0.25-0.72, p = 0.001). Adverse events in the aspirin and placebo groups were similar with 11 significant gastrointestinal bleeds or ulcers in the aspirin group and 9 in the placebo group. The evidence is now sufficient to recommend aspirin to all Lynch syndrome gene carriers. CAPP3 will recruit 3000 gene carriers into a dose inferiority study to test the relative benefits of 100mg, 300 or 600mg daily doses.

11O Prospective Comparison of Risk Assessment Tools in Early Breast Cancer: Correlation Analysis from the Phase III Wsg-Plan B Trial

ABSTRACT Background St. Gallen Consensus recommends use of Ki-67 and/or grade for definition of luminal A/B for indication of adj. chemotherapy (cht) in HR-pos. disease. Multi-gene based assays e.g. Recurrence Score® (RS) are used for decision support regarding adjuvant cht. Final WSG-PlanB trial correlation analysis of risk assessment tools focussing on correlation between central and local pathology assessment and RS is presented. Methods PlanB trial: 6xTC vs. 4xEC-4xDOC, locally HER2-negative BC; n = 2,448 for cht. RS was used as selection criterion for cht vs. endocrine therapy alone in HR + BC (if RS Results 3196 patients recruited, 2448 randomized. RS available in 2551 patients with HR+ tumors. RS distributed: 0-11 (18%), 12-25 (60%), >25 (22%). In 354 patients, cht was omitted based on low RS. Central grade was available for 3038 samples, IHC results are currently available in 1476 cases. Moderate significant correlations were found between RS and both central grade (Spearman’s coefficient rs = .313; p Discussion First prospective data show that high-risk status according to RS is predictive of high risk by uPA/PAI-1, high grade by central pathology, and luminal B subtype by Ki-67. There is substantial heterogeneity in risk assessment in the low and intermediate risk RS groups, where there are still patients considered high-risk according to uPA/PAI-1, Ki-67 or central grade. Follow-up of the WSG-Plan B trial will clarify the significance of these findings regarding patient outcomes. Disclosure S. Shak and C. Svedman: Employee of Genomic Health, Inc. All other authors have declared no conflicts of interest.

1324 A RANDOMIZED STUDY OF VESICO-URETHRAL ANASTOMOSIS COMPARING RUNNING SUTURE WITH CONVENTIONAL INTERRUPTED SUTURE IN PATIENTS WITH RETROPUBIC RADICAL PROSTATECTOMY

You have accessJournal of UrologyProstate Cancer: Localized VI1 Apr 20121324 A RANDOMIZED STUDY OF VESICO-URETHRAL ANASTOMOSIS COMPARING RUNNING SUTURE WITH CONVENTIONAL INTERRUPTED SUTURE IN PATIENTS WITH RETROPUBIC RADICAL PROSTATECTOMY Hideyasu Matsuyama, Shigeru Sakano, Takahiko Hara, Hiroaki Matsumoto, and Yoshihisa Kawai Hideyasu MatsuyamaHideyasu Matsuyama Ube, Japan More articles by this author , Shigeru SakanoShigeru Sakano Ube, Japan More articles by this author , Takahiko HaraTakahiko Hara Ube, Japan More articles by this author , Hiroaki MatsumotoHiroaki Matsumoto Ube, Japan More articles by this author , and Yoshihisa KawaiYoshihisa Kawai Ube, Japan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1706AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Although interrupted suture is a standard technique of vesico-urethral anastomosis in open retropubic radical prostatectomy (RRP), urine leakage from anastomosis could delay the catheter removal, and may influence postoperative unfavorable events including urethral stricture, or recovery of continence. Objectives of the study is to study if different suture techniques of the vesico-urethral anastomosis may influence the postoperative condition. METHODS Totally, 108 patients who had undergone retropubic radical prostatectomy at our hospital from 2008 to 2011 were included in this study. Patients were randomly assigned to running suture group (RS, 54 pts.), or interrupted suture group (IS, 54 pts.). IS was performed by conventional 6 (1, 3, 5, 7, 9, 11 o'clock) interrupted suture using 2-0 polyglactin. RS was performed by 12 bite running sutures starting from 6 to 12 o'clock direction using 3-0 poliglecaprone. Urethro-cystography was routinely performed on POD 5-7. Removal of the catheter was postponed until disappearance of extravasation. Primary endpoint of the study was frequency of extravasation at first urethra-cystography, and secondary endpoints were frequency of postoperative stricture, % incontinent volume at discharge, Social continence rate (0-1 pad/day) at 1, 3, 6, and 12 months after surgery. RESULTS The mean age of the patient was 66.6 year. There was no statistical difference of patient background (clinical stage, biopsy Gleason score, D'Amico risk classification) between two groups. There was no statistical difference of suturing time between two groups (RS: 23.3min. vs. IS: 19.9min., p=0.1282). Frequency of extravasation and % incontinent volume at discharge was significantly higher in IS group as compared with that in RS group (38.5% vs. 9.8%, p=0.001, 38.4 % vs. 24.6%, p=0.0228, respectively). Postoperative hospital stay of IS was significantly longer than that of RS (p=0.037). Social continence rate of RS group at 3month were significantly higher than that of IS group (73.8% vs.45.8%, p=0.0336), although not significant at 6 (82.1% vs.68.0%), 12 months (93.8% vs. 88.6%). As for complication, urethral stricture for which postoperative intervention was needed was noted in 4 (7.7%) in IS, 2 (3.9%) in RS, respectively. CONCLUSIONS Running suture of vesico-urethral anastomosis may be feasible technique even in non-laparoscopic RRP, and is likely to have an advantage of early recovery of continence. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e537 Peer Review Report Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hideyasu Matsuyama Ube, Japan More articles by this author Shigeru Sakano Ube, Japan More articles by this author Takahiko Hara Ube, Japan More articles by this author Hiroaki Matsumoto Ube, Japan More articles by this author Yoshihisa Kawai Ube, Japan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Effect of Number and Geometry of Resorbable Screws on Biomechanical Stability of In Vitro Model With Sagittal Split Ramus Osteotomy

The purpose of this study was to investigate the effect of the number and the geometry of resorbable screws (RSs; Inion CPS System; Inion Ltd, Tampere, Finland) on the biomechanical stability of the in vitro model with sagittal split ramus osteotomy. The sagittal split ramus osteotomy polyurethane hemimandible (Synbone, Malans, Switzerland) was fixed by 7 osteosynthesis methods after 5 mm advancement of the distal segment (n = 5 for each method): 1TP (1 titanium miniplate and 4 screws), 3RL (3 RSs with linear configuration at the retromolar area [RMA]), 2R1B (2 RSs at RMA and 1 RS at the mandibular body [MB]), 2R1A (2 RSs at the RMA and 1 RS at the mandibular angle [MA]), 3R1B (3 RSs at RMA and 1 RS at the MB), 3R1A (3 RSs at RMA and 1 RS at the MA), and 3R1A1B (3 RSs at the RMA, 1 RS at the MA, and 1 RS at the MB). Values of linear compressive load were measured at 1- to 5-mm displacement of the lower first molar with a 1-mm interval and were statistically analyzed. From 1- to 5-mm displacement, there were significant differences in load values among groups (P < 0.05, P < 0.01, P < 0.01, P < 0.001, and P < 0.001, respectively). When the amount of displacement was increased, the difference in load values between 1TP, 3RL, and 2R1B became significantly prominent. There was a significant difference in total load values according to number and geometry of RSs (P < 0.001). All kinds of geometry with more than 3 RSs were more rigid than 1TP. The 3R1A1B method showed better biomechanical stability than 1TP, 3RL, and 2R1B. In 3 RS and 4 RS groups, fixation in MA (2R1A, 3R1A) exhibited a tendency of better stability than fixation in MB (2R1B, 3R1B). Fixation with 2R1A could provide better biomechanical stability than 1TP and similar rigidity with 3R1A1B.

S4-3: Prospective Comparison of Risk Assessment Tools in Early Breast Cancer (Recurrence Score, uPA/PAI-1, Central Grade, and Luminal Subtypes): Final Correlation Analysis from the Phase III WSG-Plan B Trial.

Abstract Background: Both the Recurrence Score® (RS) multi-gene assay and invasion factors uPA/PAI-1 are recommended by guidelines (ASCO, AGO) for decision support regarding adjuvant chemotherapy (cht) in patients with early breast cancer (BC). In the EC-DOC trial, we previously suggested central grade 3 and high Ki-67 levels as independent predictive markers for enhanced benefit of taxane-based cht in intermediate risk BC. Here, we present the final WSG-Plan B trial correlation analysis of these risk assessment tools. Methods: Plan B trial (evaluating anthracyline-free adjuvant cht, 6xTC, vs. 4xEC-4xDOC in HER2−negative BC; n=2,448 to be randomized for chemotherapy). RS has been used as the selection criterion for cht vs. endocrine therapy alone in HR+ BC (if RS≤11 in pN0 or pN1) since an amendment in August 2009. uPA/PAI-1 (by ELISA) is obtained as an optional risk factor. Evaluation of central grade and luminal B subtype (using 14% or 20% Ki-67 cut-offs) are performed by the independent trial pathologist in all HR+ tumors. Results: From April 2009 to June 2011, 3037 patients have been recruited and 2290 randomized. The study will be completed by August 2011. Data on RS are available in 2361 patients with HR+ tumors: RS is distributed as follows: 0–11 (18%), 12–25 (61%), &amp;gt;25 (21%). In 257 patients with 0–3 involved LN, cht was omitted based on RS results (12.3% of patients after amendment). By the last interim analysis in February 2011, data on central grade are available in 1509 patients and Ki-67 in 592 patients. An only moderate positive correlation was observed between Ki-67 and RS (Spearman's coefficient rs=0.336; p&amp;lt;0.001) as continuous variables and between RS and central grade (rs=0.498, p&amp;lt;0.001). High RS is predictive of high grade G3 (66% of RS25 high risk and 74% of RS30 high risk are G3), but 30–33% of tumors were assessed as G3 within the low-risk RS11-18 group and 14%-40% of G3 tumors were classified as low-risk RS11-18. When considered as risk categories, there was only a weak concordance between RS and uPA/PAI-1, using either standard RS (18; 30) or PlanB cut-offs (low risk ≤11 RS), with 67% of patients having high uPA/PAI-1 within the low/intermediate-RS subgroups. High-risk RS is predictive of high-risk by uPA/PAI-1, poor grade and luminal B subtype. However, the converse is not true, since clinically relevant proportions (between 33–66%) of patients identified by uPA/PAI-1 or Ki-67 as being at high-risk had low or intermediate RS. Final correlation analyses in all Plan B patients with HR+ tumors (n&amp;gt;2.500) will be presented at the meeting. Discussion: For the first time, risk groups according to RS, Ki-67 and uPA/PAI-1 have been prospectively compared within a phase III trial setting both in N0 and N+ early BC. These data show high-risk status according to RS is predictive of high risk by uPA/PAI-1, high grade by central pathology and luminal B subtype, but not converse. In the low and intermediate risk RS groups, there are still patients considered high-risk according to uPA/PAI-1, Ki-67 or central grade. Further follow-up of the WSG-Plan B trial will clarify the clinical significance of these findings regarding patient outcomes. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr S4-3.

Protective effects of bubble bath hydrotherapy on brain damage of neonatal rats with recurrent seizures

Objective To explore the potentiality of protection by bubble bath hydrotherapy to brain damage of neonatal rats with recurrent seizures.Methods Sixty Sprague-Dawley neonatal rats were randomly divided into control group ( CON),control hydrotherapy group ( HCON ),recurrent-seizure group (RS) and recurrent-seizure hydrotherapy group (HRS).Each group had 15 rats.The volatile agent flurothyl was used to induce 30 min seizure attack.At postnatal day 6 (P6),recurrent seizures were induced once per day for consecutive 6 days in the RS group and HRS group.Rats in the CON and HCON group were placed into the container for same time as their counterpart without exposure to flurothyl.In HCON and HRS groups,Bubble bath hydrotherapy intervention was used after the end of the last seizure for 28 consecutive days.Inspections were made for maturation of physical characteristics,neural behavior.PRG-1 and Bcl-2 protein level in cerebral cortex were detected by western blot method at P50.Results 1.Maturation of physical characteristics:body weights of the rats in the RS group were decreased significantly (P＜0.05).Body weights of HRS rats were significantly increased than that of RS rats(P＜0.05 ).There were no significant difference of physiological development phenomenon among the five groups (P ＞0.05 ).2.There was high nerve excitation in hydrotherapy group ( At P26,the scores of OFT respectively were 45.78 ± 18.31 for CON,59.78 ± 25.61 for HCON,27.78 ± 16.83 for RS and 53.15 ± 22.43 for HRS,P ＜ 0.01 ).3.The expression of PRG-1 in cerebral cortex of RS group were significantly higher than that of CON group (1.149 ±0.191 for RS,0.910 ±0.162 for CON,P＜ 0.05 ).The level of Bcl-2 in cerebral cortex of RS group ( 1.149 ±0.191 ) were significantly lower than that of CON group( 1.259 ±0.157) (P＜0.05 ),the level of Bcl-2in cerebral cortex of HRS group( 1.572 ± 0.333 ) were significantly higher than that of RS group(P＜ 0.05 ).Conclusion Maturation of physical characteristics and neurobehavioral were damages following recurrent neonatal seizures,which may be associated with significantly increased level of PRG-1 protein and decreased level of Bcl-2protein in cerebral cortex.The early intervention by Bubble bath hydrotherapy can play a positive role on developmental rehabilitation. Key words: Neonatal; Seizure; Bubble bath hydrotherapy; Neurobehavioral; PRG-1; Bcl-2

The Value of Palliative Gastrectomy in Gastric Cancer with Distant Metastasis

The purpose of this study was to examine the value of surgical resection and to find prognostic factors for metastatic gastric cancer. Clinicopathological data of 257 cM1 gastric cancer patients who underwent an operation at Seoul National University Hospital from January 1999 to December 2004 were reviewed. Patients were grouped into the resection (RS, n=165) and nonresection groups (NR, n=92). To evaluate whether there was any selection bias, patients were stratified according to chemotherapy and preoperative CT findings were compared. There were no significant differences in clinicopathologic features and preoperative CT findings between the RS and NR groups. For chemotherapy, the RS group had a survival benefit (median survival; 12.7 vs. 11.2 months, p=0.0107). In the subanalysis, there was a survival benefit to the RS group when metastasis was confined to one site (14 vs. 9.7 months, p=0.04). In patients with no chemotherapy, the RS group had no benefit (p=0.151). In univariate and multivariate analyses, resection (p=0.001), chemotherapy (p<0.001), the number of organs with metastatic lesions (p=0.003), and elective operation (p<0.001) were significant prognostic factors. This retrospective study suggests that surgical resection in metastatic gastric cancer may improve survival when combined with chemotherapy, especially when metastasis is confined to one site.