915 resultados para Informed consent (Medical law)


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Scopo dello studio: Stabilire se cambiamenti della perfusione di una lesione target di epatocarcinoma (HCC), valutati quantitativamente mediante ecografia con contrasto (CE-US) alla settimana 2 e 4 di terapia con sorafenib, possono predire la progressione di malattia alla settimana 8, valutata con la tomografia computerizzata o la risonanza magnetica con mezzo di contrasto (TC-RM) usando i criteri RECIST/RECIST modificati (response evaluation criteria in solid tumors). Pazienti e metodi: Il comitato etico ha approvato lo studio ed i pazienti hanno fornito un consenso informato scritto prima dell’arruolamento. Lo studio è stato effettuato su un campione di soggetti con epatocarcinoma avanzato o non suscettibile di trattamento curativo, in monoterapia con sorafenib. La valutazione della risposta tumorale è stata effettuata con TC o RM a 2 mesi usando i criteri RECIST/RECIST modificati. La CE-US è stata effettuata entro 1 settimana prima dell’inizio del trattamento con sorafenib e durante la terapia alla settimana 2, 4, 8, 16 e 32. I parametri quantitativi funzionali sono stati ottenuti impiegando un software dedicato. I cambiamenti dei valori dei parametri suddetti tra il tempo zero ed i punti temporali successivi sono stati confrontati con la risposta tumorale basata sui criteri RECIST/RECIST modificati. Risultati: La riduzione dei valori dei parametri relativi alla perfusione tumorale, in particolare di WiAUC e PE (parametri correlati con il volume ematico), al T2/T4 (settimana 2, 4), predice la risposta tumorale a 2 mesi, valutata secondo i criteri RECIST e RECIST modificati, risultata indicativa di malattia stabile (responders). Conclusione: L’ecografia con contrasto può essere impiegata per quantificare i cambiamenti della vascolarizzazione tumorale già alla settimana 2, 4 dopo la somministrazione di sorafenib nei pazienti con HCC. Questi precoci cambiamenti della perfusione tumorale possono essere predittivi della risposta tumorale a 2 mesi e possono avere un potenziale nella valutazione precoce dell'efficacia della terapia antiangiogenica nell’epatocarcinoma.

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Il trattamento dell’osteoartrosi (OA) del cane è una sfida nella pratica clinica veterinaria. Molti trattamenti sono stati proposti, tuttavia la risposta clinica agli stessi non è sempre soddisfacente. Molti farmaci sono utilizzati per il trattamento dell’OA, tra cui farmaci anti-infiammatori non steroidei, corticosteroidi, ed inibitori della produzione dell’ossido nitrico. Lo stanozololo è un derivato sintetico del testosterone; oltre alle sue proprietà anaboliche/androgeniche , a basse dosi lo stanozololo ha un affinità per i recettori glucocorticoidi. Per questa attività antinfiammatoria e rigenerativa sui tessuti articolari danneggiati viene utilizzato nella degenerative joint desease del cavallo. Lo scopo di questo studio è stato di valutare l’efficacia clinica dello stanozololo intra-articolare a 15, 30, 45 e 60 giorni dal trattamento di gomiti con OA di cane. E’ stato eseguito uno studio cieco, multicentrico e randomizzato. Previo consenso informato, sono stati arruolati 48 cani, suddivisi in 3 gruppi e trattati con stanozololo, mavacoxib e con entrambi i farmaci. Sono state valutate zoppia, tollerabilità del trattamento, range of motion, e punteggio radiografico. Inoltre sono state stabilite e annoverate quantità e qualità del liquido sinoviale. Ai dati ottenuti sono stati applicati i test di Kruskal-Wallis, Chi-quadro e Fischer, i quali hanno dimostrato l’efficacia della terapia nei singoli gruppi e tra i diversi gruppi di studio. I risultati ottenuti hanno mostrato la riduzione di almeno un grado di zoppia e la riduzione della progressione dell’OA nei casi trattati con stanozololo. Si può quindi affermare che tale molecola per via intra-articolare può essere una valida alternativa per il trattamento dell’OA di gomito nel cane.

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PURPOSE: The aim of this two-center study was to evaluate screw-type titanium implants with a chemically modified, sandblasted and acid-etched surface when placed in the posterior maxilla or mandible, and loaded 21 days after placement. MATERIAL AND METHODS: All 56 patients met strict inclusion criteria and provided informed consent. Each patient displayed either a single-tooth gap, an extended edentulous space, or a distal extension situation in the posterior mandible or maxilla. Eighty-nine dental implants (SLActive, Institut Straumann AG, Basel, Switzerland) were inserted according to an established nonsubmerged protocol and underwent undisturbed healing for a period of 21 days. Where appropriate, the implants were loaded after 21 days of healing with provisional restorations in full occlusion. Definitive metal ceramic restorations were fabricated and positioned on each implant after 6 months of healing. Clinical measurements regarding soft tissue parameters and radiographs were obtained at different time points up to 24 months after implant placement. RESULTS: Of the 89 inserted implants, two (2.2%) implants failed to integrate and were removed during healing, and two (2.2%) additional implants required a prolonged healing time. A total of 85 (95.6%) implants were therefore loaded without incident after 21 days of healing. No additional implant was lost throughout the study period, whereas one implant was lost to follow-up and therefore left unaccounted for further analysis. The remaining 86 implants all exhibited favorable radiographic and clinical findings. Based on strict success criteria, these implants were considered successfully integrated 2 years after insertion, resulting in a 2-year success rate of 97.7%. CONCLUSION: The results of this prospective two-center study demonstrate that titanium implants with a modified SLA surface can predictably achieve successful tissue integration when loaded in full occlusion 21 days after placement. Integration could be maintained without incident for at least 2 years of follow-up.

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Purpose: To prospectively determine on T2 cartilage maps the effect of unloading during a clinical magnetic resonance (MR) examination in the postoperative follow-up of patients after matrix-associated autologous chondrocyte transplantation (MACT) of the knee joint. Materials and Methods: Ethical approval for this study was provided by the local ethics commission, and written informed consent was obtained. Thirty patients (mean age, 35.4 years +/- 10.5) with a mean postoperative follow-up period of 29.1 months +/- 24.4 were enrolled. A multiecho spin-echo T2-weighted sequence was performed at the beginning (early unloading) and end (late unloading) of the MR examination, with an interval of 45 minutes. Mean and zonal region of interest T2 measurements were obtained in control cartilage and cartilage repair tissue. Statistical analysis of variance was performed. Results: The change in T2 values of control cartilage (early unloading, 50.2 msec +/- 8.4; late unloading, 51.3 msec +/- 8.5) was less pronounced than the change in T2 values of cartilage repair tissue (early unloading, 51.8 msec +/- 11.7; late unloading, 56.1 msec +/- 14.4) (P = .024). The difference between control cartilage and cartilage repair tissue was not significant for early unloading (P = .314) but was significant for late unloading (P = .036). Zonal T2 measurements revealed a higher dependency on unloading for the superficial cartilage layer. Conclusion: Our results suggest that T2 relaxation can be used to assess early and late unloading values of articular cartilage in a clinical setting and that the time point of the quantitative T2 measurement affects the differentiation between native and abnormal articular cartilage. (c) RSNA, 2010.

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PURPOSE: To evaluate diffusion-weighted magnetic resonance (MR) imaging of the human placenta in fetuses with and fetuses without intrauterine growth restriction (IUGR) who were suspected of having placental insufficiency. MATERIALS AND METHODS: The study was approved by the local ethics committee, and written informed consent was obtained. The authors retrospectively evaluated 1.5-T fetal MR images from 102 singleton pregnancies (mean gestation ± standard deviation, 29 weeks ± 5; range, 21-41 weeks). Morphologic and diffusion-weighted MR imaging were performed. A region of interest analysis of the apparent diffusion coefficient (ADC) of the placenta was independently performed by two observers who were blinded to clinical data and outcome. Placental insufficiency was diagnosed if flattening of the growth curve was detected at obstetric ultrasonography (US), if the birth weight was in the 10th percentile or less, or if fetal weight estimated with US was below the 10th percentile. Abnormal findings at Doppler US of the umbilical artery and histopathologic examination of specimens from the placenta were recorded. The ADCs in fetuses with placental insufficiency were compared with those in fetuses of the same gestational age without placental insufficiency and tested for normal distribution. The t tests and Pearson correlation coefficients were used to compare these results at 5% levels of significance. RESULTS: Thirty-three of the 102 pregnancies were ultimately categorized as having an insufficient placenta. MR imaging depicted morphologic changes (eg, infarction or bleeding) in 27 fetuses. Placental dysfunction was suspected in 33 fetuses at diffusion-weighted imaging (mean ADC, 146.4 sec/mm(2) ± 10.63 for fetuses with placental insufficiency vs 177.1 sec/mm(2) ± 18.90 for fetuses without placental insufficiency; P < .01, with one false-positive case). The use of diffusion-weighted imaging in addition to US increased sensitivity for the detection of placental insufficiency from 73% to 100%, increased accuracy from 91% to 99%, and preserved specificity at 99%. CONCLUSION: Placental dysfunction associated with growth restriction is associated with restricted diffusion and reduced ADC. A decreased ADC used as an early marker of placental damage might be indicative of pregnancy complications such as IUGR.

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A 19-year old female patient was referred for removal of her wisdom teeth. The panoramic radiograph showed bilateral retromolar canals in the mandible. Since the retromolar canal is neglected in anatomical textbooks and is rarely documented in scientific publications, the case prompted us to perform further diagnostic examinations with informed consent by the patient. A limited cone beam computed tomography was made and, during the surgical removal of the patient's lower right wisdom tooth, a biopsy of the soft tissue bundle emerging from the retromolar foramen was taken. In accordance with the literature, the histology revealed myelinated nerve fibers, small arteries and venules. The limited data available in the literature about the retromolar canal report that this bony canal may convey an aberrant buccal nerve. In addition, sensory nerve fibers entering the retromolar canal from above and branching to the mandibular molars may evade a block anesthesia at the mandibular foramen. These rare anatomic features may explain why the elements of the retromolar canal account for failures of mandibular block anesthesia or postsurgical sensitivity changes in the supply area of the buccal nerve.

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We compared revision and mortality rates of 4668 patients undergoing primary total hip and knee replacement between 1989 and 2007 at a University Hospital in New Zealand. The mean age at the time of surgery was 69 years (16 to 100). A total of 1175 patients (25%) had died at follow-up at a mean of ten years post-operatively. The mean age of those who died within ten years of surgery was 74.4 years (29 to 97) at time of surgery. No change in comorbidity score or age of the patients receiving joint replacement was noted during the study period. No association of revision or death could be proven with higher comorbidity scoring, grade of surgeon, or patient gender. We found that patients younger than 50 years at the time of surgery have a greater chance of requiring a revision than of dying, those around 58 years of age have a 50:50 chance of needing a revision, and in those older than 62 years the prosthesis will normally outlast the patient. Patients over 77 years old have a greater than 90% chance of dying than requiring a revision whereas those around 47 years are on average twice as likely to require a revision than die. This information can be used to rationalise the need for long-term surveillance and during the informed consent process.

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Background Activation of the endothelium, complement activation and generation of cytokines are known events during ischemia-reperfusion (I/R) that mediate tissue injury. Our aim was to elucidate their respective participation at the onset of the reperfusion phase. Tourniquet application in hand surgery causes short-term ischemia, followed by reperfusion and was therefore used as the model in this study. Methods Ten patients were included in the study after obtaining informed consent. A tourniquet was placed on the upper arm and inflated to 250 mmHg for 116 ± 16 min, during which the surgery was performed. Venous blood and tissue samples from the surgical area were taken at baseline as well as 0, 2, and 10 min after reperfusion and analyzed for the following parameters: Endothelial integrity and/or activation were analyzed by measuring heparan sulfate and syndecan-1 in serum, and vWF, heparan sulfate proteoglycan as well as CD31on tissue. Complement activation was determined by C3a and C4d levels in plasma, levels of C1-inhibitor in serum, and IgG, IgM, C3b/c, and C4b/c deposition on tissue. Cytokines and growth factors IL-5, IL-6, IL-7, IL-8, IL-10, IL-17, G-CSF, GM-CSF, MCP-1, TNFα, VEGF, and PDGF bb were measured in the serum. Finally, CK-MM levels were determined in plasma as a measure for muscle necrosis. Results Markers for endothelial activation and/or integrity as well as complement activation showed no significant changes until 10 min reperfusion. Among the measured cytokines, IL-6, IL-7, IL-17, TNFα, GM-CSF, VEGF, and PDGF bb were significantly increased at 10 min reperfusion with respect to baseline. CK-MM showed a rise from baseline at the onset of reperfusion (p < 0.001) and dropped again at 2 min (p < 0.01) reperfusion, suggesting ischemic muscle damage. Conclusions In this clinical model of I/R injury no damage to the endothelium, antibody deposition or complement activation were observed during early reperfusion. However, an increase of pro-inflammatory cytokines and growth factors was shown, suggesting a contribution of these molecules in the early stages of I/R injury.

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Purpose: To assess possible association between intrinsic structural damage and clinical disability by correlating spinal cord diffusion-tensor (DT) imaging data with electrophysiological parameters in patients with a diagnosis of multiple sclerosis (MS). Materials and Methods: This study was approved by the local ethical committee according to the declaration of Helsinki and written informed consent was obtained. DT images and T1- and T2-weighted images of the spinal cord were acquired in 28 healthy volunteers and 41 MS patients. Fractional anisotropy (FA) and apparent diffusion coefficients were evaluated in normal-appearing white matter (NAWM) at the cervical level and were correlated with motor-evoked potentials (n = 34). Asymmetry index was calculated for FA values with corresponding left and right regions of interest as percentage of the absolute difference between these values relative to the sum of the respective FA values. Statistical analysis included Spearman rank correlations, Mann-Whitney test, and reliability analysis. Results: Healthy volunteers had low asymmetry index (1.5%-2.2%). In MS patients, structural abnormalities were reflected by asymmetric decrease of FA (asymmetry index: 3.6%; P = .15). Frequently asymmetrically affected among MS patients was left and right central motor conduction time (CMCT) to abductor digiti minimi muscle (ADMM) (asymmetry index, 15%-16%) and tibialis anterior muscle (TAM) (asymmetry index, 9.5%-14.1%). Statistically significant correlations of functional (ie, electrophysiological) and structural (ie, DT imaging) asymmetries were found (P = .005 for CMCT to ADMM; P = .007 for CMCT to TAM) for the cervical lateral funiculi, which comprise the crossed pyramidal tract. Interobserver reliability for DT imaging measurements was excellent (78%-87%). Conclusion: DT imaging revealed asymmetric anatomic changes in spinal cord NAWM, which corresponded to asymmetric electrophysiological deficits for both arms and legs, and reflected a specific structure-function relationship in the human spinal cord. © RSNA, 2013.

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Permission from the ethics committee and informed consent were obtained. The purpose of this study was to prospectively evaluate a method developed for the noninvasive assessment of muscle metabolites during exercise. Hydrogen 1 magnetic resonance (MR) spectroscopy peaks were measured during tetanic isometric muscle contraction imposed by supramaximal repetitive nerve stimulation. The kinetics of creatine-phosphocreatine and acetylcarnitine signal changes (P < .001) could be assessed continuously before, during, and after exercise. The control peak (trimethylammonium compounds), which served as an internal reference, did not change. This technique-that is, functional MR spectroscopy-opens the possibility for noninvasive diagnostic muscle metabolite testing in a clinical setting.

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PURPOSE: To prospectively evaluate feasibility and reproducibility of diffusion-weighted (DW) and blood oxygenation level-dependent (BOLD) magnetic resonance (MR) imaging in patients with renal allografts, as compared with these features in healthy volunteers with native kidneys. MATERIALS AND METHODS: The local ethics committee approved the study protocol; patients provided written informed consent. Fifteen patients with a renal allograft and in stable condition (nine men, six women; age range, 20-67 years) and 15 age- and sex-matched healthy volunteers underwent DW and BOLD MR imaging. Seven patients with renal allografts were examined twice to assess reproducibility of results. DW MR imaging yielded a total apparent diffusion coefficient including diffusion and microperfusion (ADC(tot)), as well as an ADC reflecting predominantly pure diffusion (ADC(D)) and the perfusion fraction. R2* of BOLD MR imaging enabled the estimation of renal oxygenation. Statistical analysis was performed, and analysis of variance was used for repeated measurements. Coefficients of variation between and within subjects were calculated to assess reproducibility. RESULTS: In patients, ADC(tot), ADC(D), and perfusion fraction were similar in the cortex and medulla. In volunteers, values in the medulla were similar to those in the cortex and medulla of patients; however, values in the cortex were higher than those in the medulla (P < .05). Medullary R2* was higher than cortical R2* in patients (12.9 sec(-1) +/- 2.1 [standard deviation] vs 11.0 sec(-1) +/- 0.6, P < .007) and volunteers (15.3 sec(-1) +/- 1.1 vs 11.5 sec(-1) +/- 0.5, P < .0001). However, medullary R2* was lower in patients than in volunteers (P < .004). Increased medullary R2* was paralleled by decreased diffusion in patients with allografts. A low coefficient of variation in the cortex and medulla within subjects was obtained for ADC(tot), ADC(D), and R2* (<5.2%), while coefficient of variation within subjects was higher for perfusion fraction (medulla, 15.1%; cortex, 8.6%). Diffusion and perfusion indexes correlated significantly with serum creatinine concentrations. CONCLUSION: DW and BOLD MR imaging are feasible and reproducible in patients with renal allografts.

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PURPOSE: To retrospectively determine the sensitivity of ovarian artery (OA) visualization at aortography performed after uterine fibroid embolization (UFE) and, using OA arteriography as the reference standard, compare the extent of arterial flow to the uterus at aortography with selective ovarian arteriography, to establish the utility of aortography and ovarian arteriography in the routine practice of UFE. MATERIALS AND METHODS: This study received institutional review board approval with waiver of informed consent and was HIPAA compliant. Retrospective review of 1129 consecutive UFE patients (1072 with aortograms, 57 excluded; mean age, 44 years; range, 21-60 years) was performed to identify all visible OAs. Visible OAs were independently graded by two interventional radiologists according to extent of pelvic arterial flow. If selective arteriography was performed, a second grade was assigned based on assessment of the selective study. Descriptive and summary statistics were used for assessment by the senior observer, and interobserver variability was determined. RESULTS: Of 1072 UFE patients, 184 (17.2%) had at least one visible OA. Ten (0.8%) patients were identified at aortography with collateral OA supply to more than 10% of the uterus. In total, 251 OAs were visualized, and 157 of these were further evaluated with selective study. Sixty-two (5.8%) patients were identified at selective arteriography as having collateral OA supply. The sensitivity of aortography was approximately 18%. Interobserver concordance was high (kappa values of 0.81 and 0.90 for aortography and selective study, respectively), but not perfect. CONCLUSION: Aortography rarely helps identify patients with substantial residual OA supply to the uterus and is a poor predictor of the extent of that supply, and thus may be of limited utility in routine UFE.

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BACKGROUND: Electrical stimulation of the P6 acupuncture point reduces the incidence of postoperative nausea and vomiting (PONV). Neuromuscular blockade during general anesthesia can be monitored with electrical peripheral nerve stimulation at the wrist. The authors tested the effect of neuromuscular monitoring over the P6 acupuncture point on the reduction of PONV. METHODS: In this prospective, double-blinded, randomized control trial, the authors investigated, with institutional review board approval and informed consent, 220 women undergoing elective laparoscopic surgery anesthetized with fentanyl, sevoflurane, and rocuronium. During anesthesia, neuromuscular blockade was monitored by a conventional nerve stimulator at a frequency of 1 Hz over the ulnar nerve (n = 110, control group) or over the median nerve (n = 110, P6 group) stimulating at the P6 acupuncture point at the same time. The authors evaluated the incidence of nausea and vomiting during the first 24 h. RESULTS: No differences in demographic and morphometric data were found between both groups. The 24-h incidence of PONV was 45% in the P6 acupuncture group versus 61% in the control group (P = 0.022). Nausea decreased from 56% in the control group to 40% in the P6 group (P = 0.022), but emesis decreased only from 28% to 23% (P = 0.439). Nausea decreased substantially during the first 6 h of the observation period (P = 0.009). Fewer subjects in the acupuncture group required ondansetron as rescue therapy (27% vs. 39%; P = 0.086). CONCLUSION: Intraoperative P6 acupuncture point stimulation with a conventional nerve stimulator during surgery significantly reduced the incidence of PONV over 24 h. The efficacy of P6 stimulation is similar to that of commonly used antiemetic drugs in the prevention of PONV.

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OBJECTIVES: Residual airspace following thoracic resections is a common clinical problem. Persistent air leak, prolonged drainage time, and reduced hemostasis extend hospital stay and morbidity. We report a trial of pharmacologic-induced diaphragmatic paralysis through continuous paraphrenic injection of lidocaine to reduced residual airspace. The objectives were confirmation of diaphragmatic paralysis and possible procedure related complications. METHODS: Six eligible patients undergoing resectional surgery (lobectomy or bilobectomy) were included. Inclusion criteria consisted of: postoperative predicted FEV1 greater than 1300 ml, right-sided resection, absence of parenchymal lung disease, no class III antiarrhythmic therapy, absence of hypersensitivity reactions to lidocaine, no signs of infection, and informed consent. Upon completion of resection an epidural catheter was attached in the periphrenic tissue on the proximal pericardial surface, externalized through a separate parasternal incision, and connected to a perfusing system injecting lidocaine 1% at a rate of 3 ml/h (30 mg/h). Postoperative ICU surveillance for 24h and daily measurement of vital signs, drainage output, and bedside spirometry were performed. Within 48 h fluoroscopic confirmation of diaphragmatic paralysis was obtained. The catheter removal coincided with the chest tube removal when no procedural related complications occurred. RESULTS: None of the patients reported respiratory impairment. Diaphragmatic paralysis was documented in all patients. Upon removal of catheter or discontinuation of lidocaine prompt return of diaphragmatic motility was noticed. Two patients showed postoperative hemodynamic irrelevant atrial fibrillation. CONCLUSION: Postoperative paraphrenic catheter administration of lidocaine to ensure reversible diaphragmatic paralysis is safe and reproducible. Further studies have to assess a benefit in terms of reduction in morbidity, drainage time, and hospital stay, and determine the patients who will profit.

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PURPOSE: To prospectively determine quantitatively and qualitatively the timing of maximal enhancement of the normal small-bowel wall by using contrast material-enhanced multi-detector row computed tomography (CT). MATERIALS AND METHODS: This HIPAA-compliant study was approved by the institutional review board. After information on radiation risk was given, written informed consent was obtained from 25 participants with no history of small-bowel disease (mean age, 58 years; 19 men) who had undergone single-level dynamic CT. Thirty seconds after the intravenous administration of contrast material, a serial dynamic acquisition, consisting of 10 images obtained 5 seconds apart, was performed. Enhancement measurements were obtained over time from the small-bowel wall and the aorta. Three independent readers qualitatively assessed small-bowel conspicuity. Quantitative and qualitative data were analyzed during the arterial phase, the enteric phase (which represented peak small-bowel mural enhancement), and the venous phase. Statistical analysis included paired Student t test and Wilcoxon signed rank test with Bonferroni correction. A P value less than .05 was used to indicate a significant difference. RESULTS: The mean time to peak enhancement of the small-bowel wall was 49.3 seconds +/- 7.7 (standard deviation) and 13.5 seconds +/- 7.6 after peak aortic enhancement. Enhancement values were highest during the enteric phase (P < .05). Regarding small-bowel conspicuity, images obtained during the enteric phase were most preferred qualitatively; there was a significant difference between the enteric and arterial phases (P < .001) but not between the enteric and venous phases (P = .18). CONCLUSION: At multi-detector row CT, peak mural enhancement of the normal small bowel occurs on average about 50 seconds after intravenous administration of contrast material or 14 seconds after peak aortic enhancement.