Cranial stent position is independently associated with the development of TIPS dysfunction.

Complications of portal hypertension can be treated with transjugular intrahepatic portosystemic shunt (TIPS) in selected patients. TIPS dysfunction is a relevant clinical problem. This study investigated the prognostic value of two-dimensional (2D) TIPS geometry for the development of TIPS dysfunction. Three hundred and seven patients undergoing TIPS procedure between 2014 and 2019 were analyzed in this monocentric retrospective study. 2D angiograms from the patients with and without TIPS dysfunction were reviewed to determine geometric characteristics including insertion and curve angles and the location of the stent. Primary outcome was the development of TIPS dysfunction. A total of 70 patients developed TIPS dysfunction and were compared to the dysfunction-free (n = 237) patients. The position of the cranial stent end in the hepatic vein and the persistence of spontaneous portosystemic shunts were significantly associated with the development of TIPS dysfunction. Among significant parameters in univariable regression analysis (portal vein-pressure after TIPS, Child-Pugh Score before TIPS, MELD before TIPS and white blood cell count before TIPS), multivariable models showed cranial stent position (p = 0.027, HR 2.300, 95% CI 1.101-4.806) and SPSS embolization (p = 0.006, HR 0.319, 95% CI 0.140-0.725) as the only predictors of TIPS dysfunction. This monocentric study demonstrates that the position of the cranial stent end is independently associated with the development of TIPS dysfunction. The distance of the cranial stent end to the IVC at the time of TIPS placement should be less than 1 cm in 2D angiography.

Glue Embolization of Gastroesophageal Varices during Transjugular Intrahepatic Portosystemic Shunt (TIPS) Improves Survival Compared to Coil-only Embolization-A Single-Center Retrospective Study.

PURPOSE: To compare the safety and effectiveness of coil versus glue embolization of gastroesophageal varices during transjugular intrahepatic portosystemic shunt (TIPS) creation. MATERIALS AND METHODS: In this monocentric retrospective study 104 (males: 67 (64%)) patients receiving TIPS with concomitant embolization of GEV and a minimum follow-up of one year (2008-2017) were included. Primary outcome parameter was overall survival (6 week; 1 year). Six-week overall survival was assessed as a surrogate for treatment failure as proposed by the international Baveno working group. Secondary outcome parameters were development of acute-on-chronic liver failure (ACLF), variceal rebleeding and hepatic encephalopathy (HE). Survival analysis was performed using Kaplan-Meier with log-rank test and adjusted Cox regression analysis. RESULTS: Indications for TIPS were refractory ascites (n = 33) or variceal bleeding (n = 71). Embolization was performed using glue with or without coils (n = 40) (Group G) or coil-only (n = 64) (Group NG). Overall survival was significantly better in group G (p = 0.022; HR = -3.333). Six-week survival was significantly lower in group NG (p = 0.014; HR = 6.945). Rates of development of ACLF were significantly higher in group NG after 6 months (NG = 14; G = 6; p = 0.039; HR = 3.243). Rebleeding rates (NG = 6; G = 3; p = 0.74) and development of HE (NG = 22; G = 15; p = 0.75) did not differ significantly between groups. CONCLUSION: Usage of glue in embolization of GEV may improve overall survival, reduce treatment failure and may be preferable over coil embolization alone.

Catheter-Directed Thrombectomy for Highly Symptomatic Patients with Iliofemoral Deep Venous Thrombosis not Responsive to Conservative Treatment.

PURPOSE: The use of pharmacomechanical thrombectomy in patients with symptomatic iliofemoral deep venous thrombosis (DVT) not responsive to conservative treatment is under-investigated until now. This prompted us to review and analyze our results (technical/clinical outcome, complications) and compare them to the current literature. MATERIALS AND METHODS: Between 2013 and 2019, 19 patients (14 women and 5 men; mean age: 41.2 years, SD: 18.2) with iliofemoral DVT and excessive pain not responsive to conservative treatment were treated with pharmacomechanical thrombectomy. Patients were followed up for 12 months. Demographics, technical success and clinical outcome data (pain score/Villalta score) were collected. RESULTS: Thrombectomy ± thrombolysis was successful in all cases (n = 19). No major complications were observed. Eight out of nineteen cases developed hematoma at the sheath insertion site not requiring further treatment. Seven out of nineteen cases required additional continuous lysis for complete iliofemoral clot solution. All patients received balloon angioplasty to treat post-thrombotic strictures. In 16/19 cases, stents were placed to preserve iliofemoral caliber and maintain unrestricted iliac venous outflow. Three patients (16%) required re-intervention due to re-thrombosis or in-stent stenosis after 4, 14 days and 4 months, respectively. Symptoms could be improved temporarily or indefinitely in 19 out of 19 patients. 1 year following thrombectomy mean pain score was reduced by 87%, mean Villalta score was 2.6 (SD: 4), and iliofemoral veins were patent in 15/17 patients. CONCLUSION: In symptomatic patients with iliofemoral DVT, refractory to conservative treatment, catheter-directed thrombectomy enables rapid and long-lasting pain relief. High patency rates can be achieved in patients receiving PTA and venous stenting post-thrombectomy.

Total area of spontaneous portosystemic shunts independently predicts hepatic encephalopathy and mortality in liver cirrhosis.

BACKGROUND & AIMS: Spontaneous portosystemic shunts (SPSS) frequently develop in liver cirrhosis. Recent data suggested that the presence of a single large SPSS is associated with complications, especially overt hepatic encephalopathy (oHE). However, the presence of >1 SPSS is common. This study evaluates the impact of total cross-sectional SPSS area (TSA) on outcomes in patients with liver cirrhosis. METHODS: In this retrospective international multicentric study, CT scans of 908 cirrhotic patients with SPSS were evaluated for TSA. Clinical and laboratory data were recorded. Each detected SPSS radius was measured and TSA calculated. One-year survival was the primary endpoint and acute decompensation (oHE, variceal bleeding, ascites) was the secondary endpoint. RESULTS: A total of 301 patients (169 male) were included in the training cohort. Thirty percent of all patients presented with >1 SPSS. A TSA cut-off of 83 mm2 was used to classify patients with small or large TSA (S-/L-TSA). Patients with L-TSA presented with higher model for end-stage liver disease score (11 vs. 14) and more commonly had a history of oHE (12% vs. 21%, p <0.05). During follow-up, patients with L-TSA experienced more oHE episodes (33% vs. 47%, p <0.05) and had lower 1-year survival than those with S-TSA (84% vs. 69%, p <0.001). Multivariate analysis identified L-TSA (hazard ratio 1.66; 95% CI 1.02-2.70, p <0.05) as an independent predictor of mortality. An independent multicentric validation cohort of 607 patients confirmed that patients with L-TSA had lower 1-year survival (77% vs. 64%, p <0.001) and more oHE development (35% vs. 49%, p <0.001) than those with S-TSA. CONCLUSION: This study suggests that TSA >83 mm2 increases the risk for oHE and mortality in patients with cirrhosis. Our results support the clinical use of TSA/SPSS for risk stratification and decision-making in the management of patients with cirrhosis. LAY SUMMARY: The prevalence of spontaneous portosystemic shunts (SPSS) is higher in patients with more advanced chronic liver disease. The presence of more than 1 SPSS is common in advanced chronic liver disease and is associated with the development of hepatic encephalopathy. This study shows that total cross-sectional SPSS area (rather than diameter of the single largest SPSS) predicts survival in patients with advanced chronic liver disease. Our results support the clinical use of total cross-sectional SPSS area for risk stratification and decision-making in the management of SPSS.

The impact of rheolytic percutaneous mechanical thrombectomy on glomerular filtration rate levels.

OBJECTIVE: Rheolytic percutaneous mechanical thrombectomy (PMT) has been established as an endovascular technique for thrombus removal. Initial studies reporting on postinterventional kidney dysfunction have surfaced. The aim of this study was to investigate glomerular filtration rate (GFR) changes after PMT. METHODS: A total of 45 interventions were included; 21 were performed in the venous system and 24 in the arterial system. Renal function was evaluated through assessment of GFR value changes from baseline to a minimum of two postinterventional values, and RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, End-stage kidney disease) were applied. RESULTS: The univariate analysis of variance revealed a significant association of GFR increase between time points and the type of intervention (arterious or venous; P = .002), whereas there was no significant association of intervention duration (P = .382), quantity of administered contrast medium (P = .544), or use of urokinase (P = .377). Repeated measures analysis of variance revealed a significant difference in GFR values between the four time points for venous interventions (P = .008) but not for arterial interventions (P = .908). In venous interventions, postinterventional GFR values were significantly lower compared with preinterventional values (P = .008) and the two measurements after intervention (P = .017 and P = .014, respectively). According to the RIFLE criteria, 1 of the 21 patients in the venous group had a complete loss of kidney function and 2 patients progressed to the risk group (GFR decreases >25%). CONCLUSIONS: PMT in the venous system has a significant impact on GFR levels, although there is only a low risk for clinically important renal dysfunction. The occurrence of renal impairment should be taken into account in evaluating PMT treatment, especially because of the associated morbidity.

Interventional Treatment of Acute Portal Vein Thrombosis.

BACKGROUND: Acute portal vein thrombosis is a potentially fatal condition. In symptomatic patients not responding to systemic anticoagulation, interventional procedures have emerged as an alternative to surgery. This study sought to retrospectively evaluate initial results of interventional treatment of acute portal vein thrombosis (aPVT) using a transjugular interventional approach. MATERIALS AND METHODS: Between 2014 and 2016, 11 patients were treated because of aPVT (male: 7; female: 4; mean age: 41.06 years). All patients presented a rapid onset of symptoms without collateralization of portal flow as assessed by a CT scan at the time of admittance. The patients showed thrombotic occlusion of the main portal vein (11/11), the lienal vein (10/11) and the superior mesenteric vein (10/11). Different techniques for recanalization were employed: catheter thromboaspiration (1/9), AngioJet device (7/9), local-lysis-only (1/9) and TIPSS (7/9). Local lysis was administered using a dual (4/9) or single (5/9) catheter technique. The mean follow-up was 24.32 months. RESULTS: In 9 patients transhepatic access was successful. Initially reduction of thrombus load and recanalization were achieved in all 9 cases with residual thrombi in PV (n = 3), SMV (n = 7), and IL (n = 5). In the collective undergoing interventional procedures (n = 9) rethrombosis and continuous abdominal pain were seen in one patient, and thrombus progression after successful recanalization was seen in another. Freedom from symptoms could be achieved in 6 patients. One patient developed peritoneal and pleural effusion, respiratory insufficiency and portosystemic collaterals. Both patients who could not undergo an interventional procedure developed a cavernous transformation of the portal vein. One of them also had continuous intermittent abdominal pain. CONCLUSION: Interventional percutaneous approaches are able to improve patient outcome in patients with aPVT. It appears to be of utmost importance to not only remove/reduce the thrombotic material but to establish sufficient inflow and outflow by TIPS and simultaneous multi-catheter thrombolysis. KEY POINTS: · Pharmacomechanic thrombectomy in combination with local thrombolysis is a feasible approach. · The transjugular transhepatic approach seems to be a safe procedure. · TIPSS and dual catheter lysis may support flow management. CITATION FORMAT: · Wolter K, Decker G, Kuetting D et al. Interventional Treatment of Acute Portal Vein Thrombosis. Fortschr Röntgenstr 2018; 190: 740 - 746.

Influence of Chitosan Treatment on Surrogate Serum Markers of Cholesterol Metabolism in Obese Subjects.

Chitosan treatment results in significantly lower serum low density lipoprotein (LDL) cholesterol concentrations. To assess the working mechanisms of chitosan, we measured serum surrogate markers of cholesterol absorption (campesterol, sitosterol, cholestanol), synthesis (lathosterol, lanosterol, desmosterol), and degradation to bile acids (7α-hydroxy-cholesterol, 27-hydroxy-cholesterol), corrected for cholesterol concentration (R_sterols). Over 12 weeks, 116 obese subjects (Body Mass Index, BMI 31.7, range 28.1-38.9 kg/m²) were studied under chitosan (n = 61) and placebo treatments (n = 55). The participants were briefly educated regarding improvement of nutrition quality and energy expenditure. Daily chitosan intake was 3200 mg. Serum LDL cholesterol concentration decreased significantly more (p = 0.0252) under chitosan (-8.67 ± 18.18 mg/dL, 5.6%) than under placebo treatment (-1.00 ± 24.22 mg/dL, 0.9%). This reduction was not associated with the expected greater decreases in markers of cholesterol absorption under chitosan treatment. Also, increases in markers of cholesterol synthesis and bile acid synthesis under chitosan treatment were not any greater than under placebo treatment. In conclusion, a significant selective reduction of serum LDL cholesterol under chitosan treatment is neither associated with a reduction of serum surrogate markers of cholesterol absorption, nor with increases of markers for cholesterol and bile acid synthesis.

Revised PROPELLER for T2-weighted imaging of the prostate at 3 Tesla: impact on lesion detection and PI-RADS classification.

PURPOSE: To evaluate revised PROPELLER (RevPROP) for T2-weighted imaging (T2WI) of the prostate as a substitute for turbo spin echo (TSE). MATERIALS AND METHODS: Three-Tesla MR images of 50 patients with 55 cancer-suspicious lesions were prospectively evaluated. Findings were correlated with histopathology after MRI-guided biopsy. T2 RevPROP, T2 TSE, diffusion-weighted imaging, dynamic contrast enhancement, and MR-spectroscopy were acquired. RevPROP was compared to TSE concerning PI-RADS scores, lesion size, lesion signal-intensity, lesion contrast, artefacts, and image quality. RESULTS: There were 41 carcinomas in 55 cancer-suspicious lesions. RevPROP detected 41 of 41 carcinomas (100%) and 54 of 55 lesions (98.2%). TSE detected 39 of 41 carcinomas (95.1%) and 51 of 55 lesions (92.7%). RevPROP showed fewer artefacts and higher image quality (each p < 0.001). No differences were observed between single and overall PI-RADS scores based on RevPROP or TSE (p = 0.106 and p = 0.107). Lesion size was not different (p = 0.105). T2-signal intensity of lesions was higher and T2-contrast of lesions was lower on RevPROP (each p < 0.001). CONCLUSION: For prostate cancer detection RevPROP is superior to TSE with respect to motion robustness, image quality and detection rates of lesions. Therefore, RevPROP might be used as a substitute for T2WI. KEY POINTS: • Revised PROPELLER can be used as a substitute for T2-weighted prostate imaging. • Revised PROPELLER detected more carcinomas and more suspicious lesions than TSE. • Revised PROPELLER showed fewer artefacts and better image quality compared to TSE. • There were no significant differences in PI-RADS scores between revised PROPELLER and TSE. • The lower T2-contrast of revised PROPELLER did not impair its diagnostic quality.

AngioJet-assisted transvenous-transhepatic mechanical thrombectomy in the portal vein.

PURPOSE: To evaluate AngioJet-assisted transvenous portal vein (PV) thrombectomy for non-cirrhotic patients with total portal vein and mesenteric vein thrombosis (PVMVT). MATERIAL AND METHODS: From 2015 to 2016 four patients (3 male, mean 43.9 years, range 33-52 years) with acute (3 cases) and acute-on-chronic (1 case) PVMVT underwent transvenous thrombolysis. All patients received initial AngioJet (Boston Scientific, Natick, MA, USA) thrombectomy followed by continuous catheter directed thrombolysis with Urokinase (Medac, Wedel, Germany) for 22-52 hours. Transjugular intrahepatic portosystemic shunts (TIPS), using Viatorr stent grafts (W.L. Gore and Associates, AZ, USA; mean diameter: 10 mm, length: 60-80 mm), were implanted in all patients. Patients were followed clinically and with imaging (mean 646 days, range 392 to 936 days). RESULTS: Technical success was 100%. Therapeutic success was achieved in 75% of cases. AngioJet-assisted thrombectomy substantially reduced thrombus load in the acute cases, while only slight improvement was achieved in the acute-on-chronic case. Continuous thrombolysis subtotally re-established PV flow in the acute cases, while only minimal improvement was seen in the acute-on-chronic case. Following TIPS implantation complete PV recanalisation could be achieved in all acute cases. In the acute-on-chronic case initial stagnant PV flow was seen; however, PV and TIPS re-occluded 10 days after implantation. During follow-up PV remained patent in acute cases. CONCLUSIONS: AngioJet-assisted thrombectomy was technically feasible and uncomplicated in all of our patients. The initial results suggest that AngioJet-assisted thrombectomy facilitates recanalisation in acute and severe cases of PVMVT.

In-bore transrectal MRI-guided prostate biopsies: Are there risk factors for complications?

PURPOSE: To systematically analyze risk factors for complications of in-bore transrectal MRI-guided prostate biopsies (MRGB). MATERIALS AND METHODS: 90 patients, who were scheduled for MRGB were included for this study. Exclusion criteria were coagulation disorders, therapy with anticoagulant drugs, and acute infections of the urinary and the lower gastrointestinal tract. Directly after, one week and one year after the biopsy, we assessed biopsy related complications (e.g. hemorrhages or signs of prostatitis). Differences between patients with and without complications were analyzed regarding possible risk factors: age, prostate volume, number of taken samples, biopsy duration, biopsy of more than one lesion, diabetes, arterial hypertension, hemorrhoids, benign prostate hyperplasia, carcinoma or prostatitis (according to histopathological analysis), and lesion localization. Complications were classified according to the Clavien-Dindo classification. RESULTS: We observed 15 grade I complications in 90 biopsies (16.7%) with slight hematuria in 9 cases (10%), minor vasovagal reactions in 4 cases (4.4%), and urinary retention and positioning-related facial dysesthesia in 1 case each (1.1%). One patient showed acute prostatitis requiring antibiotics as the only grade II complication (1.1%). There were no adverse events that occurred later than one week. Complications grade III or higher such as pelvic abscesses, urosepsis or severe hemorrhages were not seen. There were no significant associations between the assessed risk factors and biopsy-related complications. CONCLUSION: In-bore transrectal MRI-guided prostate biopsies can be considered safe procedures in the diagnosis of prostate cancer with very low complication rates. There seem to be no risk factors for complications.

Differentiation of prostatitis and prostate cancer using the Prostate Imaging-Reporting and Data System (PI-RADS).

PURPOSE: To determine if prostate cancer (PCa) and prostatitis can be differentiated by using PI-RADS. MATERIALS AND METHODS: 3T MR images of 68 patients with 85 cancer suspicious lesions were analyzed. The findings were correlated with histopathology. T2w imaging (T2WI), diffusion weighted imaging (DWI), dynamic contrast enhancement (DCE), and MR-Spectroscopy (MRS) were acquired. Every lesion was given a single PI-RADS score for each parameter, as well as a sum score and a PI-RADS v2 score. Furthermore, T2-morphology, ADC-value, perfusion type, citrate/choline-level, and localization were evaluated. RESULTS: 44 of 85 lesions showed PCa (51.8%), 21 chronic prostatitis (24.7%), and 20 other benign tissue such as hyperplasia or fibromuscular tissue (23.5%). The single PI-RADS score for T2WI, DWI, DCE, as well as the aggregated score including and not including MRS, and the PI-RADS v2-score were all significantly higher for PCa than for prostatitis or other tissue (p<0.001). The single PI-RADS score for MRS and the PI-RADS sum score including MRS were significantly higher for prostatitis than for other tissue (p=0.029 and p=0.020), whereas the other parameters were not different. Prostatitis usually presented borderline pathological PI-RADS scores, showed restricted diffusion with ADC≥900mm(2)/s in 100% of cases, was more often indistinctly hypointense on T2WI (66.7%), and localized in the transitional zone (57.1%). An ADC≥900mm(2)/s achieved the highest predictive value for prostatitis (AUC=0.859). CONCLUSION: Prostatitis can be differentiated from PCa using PI-RADS, since all available parameters are more distinct in cases of cancer. However, there is significant overlap between prostatitis and other benign findings, thus PI-RADS is only suitable to a limited extent for the primary assessment of prostatitis. Restricted diffusion with ADC≥900mm(2)/s is believed to be a good indicator for prostatitis. MRS can help to distinguish between prostatitis and other tissue.

Colonoscopy detects significantly more flat adenomas than 3-tesla magnetic resonance colonography: a pilot trial.

BACKGROUND AND STUDY AIMS: Colorectal cancer (CRC) is one of the most common cancers worldwide, and several efforts have been made to reduce its occurrence or severity. Although colonoscopy is considered the gold standard in CRC prevention, it has its disadvantages: missed lesions, bleeding, and perforation. Furthermore, a high number of patients undergo this procedure even though no polyps are detected. Therefore, an initial screening examination may be warranted. Our aim was to compare the adenoma detection rate of magnetic resonance colonography (MRC) with that of optical colonoscopy. PATIENTS AND METHODS: A total of 25 patients with an intermediate risk for CRC (17 men, 8 women; mean age 57.6, standard deviation 11) underwent MRC with a 3.0-tesla magnet, followed by colonoscopy. The endoscopist was initially blinded to the results of MRC and unblinded immediately after examining the distal rectum. Following endoscopic excision, the size, anatomical localization, and appearance of all polyps were described according to the Paris classification. RESULTS: A total of 93 lesions were detected during colonoscopy. These included a malignant infiltration of the transverse colon due to gastric cancer in 1 patient, 28 adenomas in 10 patients, 19 hyperplastic polyps in 9 patients, and 45 non-neoplastic lesions. In 5 patients, no lesion was detected. MRC detected significantly fewer lesions: 1 adenoma (P = 0.001) and 1 hyperplastic polyp (P = 0.004). The malignant infiltration was seen with both modalities. Of the 28 adenomas, 23 (82 %) were 5 mm or smaller; only 4 adenomas 10 mm or larger (14 %) were detected. CONCLUSION: MRC does not detect adenomas sufficiently independently of the location of the lesion. Even advanced lesions were missed. Therefore, colonoscopy should still be considered the current gold standard, even for diagnostic purposes.

Use of routine thoracic and abdominal computed tomography scans for assessing bone mineral density and detecting osteoporosis.

OBJECTIVE: Evaluation of computed tomography (CT) attenuation measurements for assessing bone mineral density (BMD) and predicting osteoporosis in thoracic and abdominal CT scans for various clinical indications using dual-energy X-ray absorptiometry (DXA) as reference standard. RESEARCH DESIGN AND METHODS: A total of 234 patients (147 women, 87 men) undergoing DXA and CT were examined retrospectively. Mean time between both studies was 0.5 years. CT-attenuation values in Hounsfield units (HU) were measured at the thoracic and lumbar spine (T1, T6, T12, L1-L5), at the femoral neck, and then assigned to their corresponding DXA scores. RESULTS: Patients with DXA-defined osteoporosis or osteopenia showed significantly lower HU values of trabecular bone at all measured levels compared to healthy subjects (p < 0.001). HU values were highest at T1 and T6, lowest at L1-L3 and the femoral neck. There were no significant intraindividual differences between HU values in the sagittal, coronal or transversal plane. Significant differences between normal and abnormal BMD categories were verified for three CT scanners. More than half of all fractures were detected in patients with non-osteoporotic DXA T-scores. CONCLUSIONS: Abdominal and particularly thoracic CT scans obtained for other clinical indications can sensibly be applied toward determining low BMD, detecting osteoporosis and identifying persons at increased fracture risk. Osteoporotic morbidity and mortality might be minimized. Superiorly to DXA, fragility fractures can be found without additional imaging or radiation exposure which can initiate early adequate treatment. LIMITATIONS: Key limitations of the study were as following: a retrospective, single-center study; small patient cohort - larger cohorts are needed to evaluate the sensitivity and specificity of diagnostic performance measurements; more complex CT evaluation of the hip for BMD assessment; DXA measurements were used as a reference standard, however, patients with unsuspected compression fractures but showing osteopenic or even normal BMD outline the limitations of DXA.

Clinical equivalence of controlled-release oxycodone 20 mg and controlled-release tramadol 200 mg after surgery for breast cancer.

AIMS: To assess clinical equivalence of 20 mg controlled-release oxycodone (Oxygesic; Mundipharma, Limburg, Germany) and 200 mg controlled-release tramadol (Tramal long; Grunenthal, Aachen, Germany) on a 12-hour dosing schedule in a randomized, double-blinded study of 54 ASA I-III physical status (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer. METHODS: General anesthesia using remifentanil and propofol was performed for surgery. Patients were randomly allocated to 2 groups, receiving either 20 mg controlled-release oxycodone (Oxy group) or 200 mg controlled-release tramadol (Trama group) with the premedication (7.5 mg midazolam) and again 12 hours later. All patients had access to rescue medication (i.v. paracetamol). The primary variables for clinical equivalence were the differences between the mean values for pain scores at rest and pain scores on coughing over 24 hours after operation. The equivalence margin was determined as +/-10 on the visual analogue scale. RESULTS: Fifty-four patients were enrolled. Regarding pain scores at rest, the 90% CI of the mean differences between the treatment groups over 24 hours after operation was found to be within the predefined equivalence margin [-4.5 to +1.7], and the CI values for pain scores on coughing [-6.2 to +1.7] were similar. Cumulative paracetamol given over the 24-hour observation period did not differ significantly between the Oxy group (1.32 +/-1.9 g) and the Trama group (1.61 +/- 1.1 g; p = 0.32). There were no significant differences between the treatment groups regarding adverse events such as nausea (p = 0.13), vomiting (p = 0.24) and itching (p = 0.77). Also, no differences were found concerning patient satisfaction scores (p = 0.8) or patients' general perception of postoperative pain management (p = 0.71). CONCLUSION: 20 mg controlled-release oxycodone is clinically equivalent to 200 mg controlled-release tramadol for postoperative analgesia after surgery for breast cancer.

Haloperidol versus haloperidol plus ondansetron for the prophylaxis of postoperative nausea and vomiting after ophthalmologic surgery.

INTRODUCTION: In this prospective, randomized, and double-blinded study we investigated the efficacy of haloperidol (10 microg/kg) and the combination of haloperidol (10 microg/kg) with ondansetron (0.1 mg/kg) for the prophylaxis of postoperative nausea and vomiting (PONV) after ophthalmologic surgery. METHODS: 60 patients (ASA status 1-3) with risk factors for PONV (female, non-smoker, motion sickness or PONV in history, opioids for postoperative analgesia) undergoing retinal or strabismus surgery were included into the study and randomised to the haloperidol group (H-Group) or the haloperidol-ondansetron group (H/O-Group). 20 min before the end of anaesthesia the study medication was given. Nausea, vomiting, pain scores, and adverse events were assessed postoperatively over 24 h. RESULTS: The incidence of PONV was lower for the H/O-Group (23 vs. 57% for the H-Group). Especially the incidence of vomiting was reduced for the H/O-Group (7 vs. 27% in the H-Group). No significant differences could be detected regarding adverse events. CONCLUSION: The single use of haloperidol for the prophylaxis of PONV is doubtful. Better results were obtained with the combination therapy of haloperidol with ondansetron, especially for vomiting.