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Objective. Only a minority of patients with low-risk prostate cancer needs treatment, but the methods for optimal selection of patients for treatment are not established. This article describes the Study of Active Monitoring in Sweden (SAMS), which aims to improve those methods. Material and methods. SAMS is a prospective, multicentre study of active surveillance for low-risk prostate cancer. It consists of a randomized part comparing standard rebiopsy and follow-up with an extensive initial rebiopsy coupled with less intensive follow-up and no further scheduled biopsies (SAMS-FU), as well as an observational part (SAMS-ObsQoL). Quality of life is assessed with questionnaires and compared with patients receiving primary curative treatment. SAMS-FU is planned to randomize 500 patients and SAMS-ObsQoL to include at least 500 patients during 5 years. The primary endpoint is conversion to active treatment. The secondary endpoints include symptoms, distant metastases and mortality. All patients will be followed for 10-15 years. Results. Inclusion started in October 2011. In March 2013, 148 patients were included at 13 Swedish urological centres. Conclusions. It is hoped that the results of SAMS will contribute to fewer patients with indolent, low-risk prostate cancer receiving unnecessary treatment and more patients on active surveillance who need treatment receiving it when the disease is still curable. The less intensive investigational follow-up in the SAMS-FU trial would reduce the healthcare resources allocated to this large group of patients if it replaced the present standard schedule.

Objective. Only a minority of patients with low-risk prostate cancer needs treatment, but the methods for optimal selection of patients for treatment are not established. This article describes the Study of Active Monitoring in Sweden (SAMS), which aims to improve those methods. Material and methods. SAMS is a prospective, multicentre study of active surveillance for low-risk prostate cancer. It consists of a randomized part comparing standard rebiopsy and follow-up with an extensive initial rebiopsy coupled with less intensive follow-up and no further scheduled biopsies (SAMS-FU), as well as an observational part (SAMS-ObsQoL). Quality of life is assessed with questionnaires and compared with patients receiving primary curative treatment. SAMS-FU is planned to randomize 500 patients and SAMS-ObsQoL to include at least 500 patients during 5 years. The primary endpoint is conversion to active treatment. The secondary endpoints include symptoms, distant metastases and mortality. All patients will be followed for 10-15 years. Results. Inclusion started in October 2011. In March 2013, 148 patients were included at 13 Swedish urological centres. Conclusions. It is hoped that the results of SAMS will contribute to fewer patients with indolent, low-risk prostate cancer receiving unnecessary treatment and more patients on active surveillance who need treatment receiving it when the disease is still curable. The less intensive investigational follow-up in the SAMS-FU trial would reduce the healthcare resources allocated to this large group of patients if it replaced the present standard schedule.

Background.Postoperative pain after radical retropubic prostatectomy is moderate to severe. The primary aim of this study was to assess whether intra-abdominal local anaesthetics provide similar analgesia compared with thoracic epidural analgesia (TEA). Methods.Fifty patients, ASA I–II, participated in this prospective, doubleblinded study. All patients had TEA. After operation, they were randomized into two groups of 25 patients: Group PCLA (patient- ontrolled local analgesia): self-administration of 10 ml of ropivacaine 2 mg ml21 via the intra-abdominal catheter for 48 h. Group TEA: infusion of 10 ml h–1 of ropivacaine 1 mg ml–1, fentanyl 2mg ml21, and epinephrine 2mg ml21 epidurally for 48 h. The primary endpoint was pain on coughing at 4 h after operation. Rescue medication was morphine i.v. as required. Results.Pain on coughing at 4, 24, and 48 h was significantly lower in Group TEA [0 (0–10)] compared with Group PCLA [4 (0–10)] (P,0.05). Significantly lower pain intensity was also found in Group TEA compared with Group PCLA at the incision site, deep pain, and pain on coughing at 4 and 24 h (P,0.05). Morphine consumption was significantly greater in Group PCLA [12 (0–46)] compared with Group TEA [0 (0–20)] at 0–48 h after operation [median (range)] (P¼0.015). Maximum expiratory pressure was higher in Group TEA compared with Group PCLA at 24 h (P,0.01).Conclusions.TEA provides superior postoperative pain relief with better preservation of expiratory muscle strength compared with PCLA.

Purpose: Polidocanol sclerotherapy for hydrocele or spermatocele combines high efficiency with low morbidity, but the optimal dose is not known. We compared the efficacy and morbidity of 2 or 4 ml polidocanol sclerotherapy for hydrocele or spermatocele. less thanbrgreater than less thanbrgreater thanMaterials and Methods: From 1993 to 2005 a double-blind randomized clinical trial was conducted using 2 or 4 ml polidocanol (30 mg/ml) for sclerotherapy of hydrocele/spermatocele in 224 evaluable patients at 3 university hospitals. Fluid was evacuated and 2 or 4 ml polidocanol was administered by a nurse, with the amount injected concealed from others present. At 3-month followup morbidity was ascertained using a questionnaire completed by the patients. Fluid recurrence was determined clinically and generally re-treated. less thanbrgreater than less thanbrgreater thanResults: After the first treatment, cure was observed in 59% and 47% in the 4 and the 2 ml group, respectively (p = 0.04). More patients in the 4 ml group had complications (31% vs 18%, p = 0.04). Complications were mostly of low or moderate intensity and seldom required medication. After 1 to 4 treatments 200 of 224 patients (89%) were cured and another 10 (5%) had small amounts of residual fluid, with no difference between the groups. Of the patients with hydroceles/spermatoceles larger than 175 ml, 58% and 34% were cured after the first treatment in the 4 and 2 ml groups, respectively (p = 0.012), with no differences in complications between the groups. less thanbrgreater than less thanbrgreater thanConclusions: Polidocanol sclerotherapy was effective for the treatment of hydrocele or spermatocele in our patients, with 94% satisfactory results after 1 to 4 treatments. A dose of 4 ml was superior to 2 ml, particularly for larger hydroceles/spermatoceles.

BACKGROUND: Postoperative pain after radical retropubic prostatectomy can be severe unless adequately treated. Low thoracic epidural analgesia and patient-controlled intravenous analgesia were compared in this double-blind, randomized study. METHODS: Sixty patients were randomly assigned to receive either low thoracic epidural analgesia (group E) or patient-controlled intravenous analgesia (group P) for postoperative pain relief. All patients had general anesthesia combined with thoracic epidural analgesia during the operation. Postoperatively, patients in group E received an infusion of 1 mg/ml ropivacaine, 2 microg/ml fentanyl, and 2 microg/ml adrenaline, 10 ml/h during 48 h epidurally, and a placebo patient-controlled intravenous analgesia pump intravenously. Patients in group P received a patient-controlled intravenous analgesia pump with morphine intravenously and 10 ml/h placebo epidurally. Pain, the primary outcome variable, was measured using the numeric rating scale at rest (incision pain and "deep" visceral pain) and on coughing. Secondary outcome variables included gastrointestinal function, respiratory function, mobilization, and full recovery. Health-related quality of life was measured using the Short Form-36 questionnaire, and plasma concentration of fentanyl was measured in five patients to exclude a systemic effect of fentanyl. RESULTS: Incisional pain and pain on coughing were lower in group E compared with group P at 2-24 h, as was deep pain between 3 and 24 h postoperatively (P < 0.05). Maximum expiratory pressure was greater in group E at 4 and 24 h (P < 0.05) compared with group P. No difference in time to home discharge was found between the groups. The mean plasma fentanyl concentration varied from 0.2 to 0.3 ng/ml during 0-48 h postoperatively. At 1 month, the scores on emotional role, physical functioning, and general health of the Short Form-36 were higher in group E compared with group P. However, no group x time interaction was fou

Background:Clinical studies in humans as well as experimental evidence from animal studiessuggests that the immune system plays an important role in perioperative metastases following cancer surgery. However, the precise role of the different components of the immune system in this process appears conflicting. Our primary aim was to assess T cell activity and natural killer (NK) cell toxicity in patients undergoing prostate cancer surgery and randomized to epidural or intravenous analgesia. Methods:26 patients were randomized to receive general anaesthesia and patient controlled analgesia (PCA) with morphine postoperatively (Group P) or combined, general and epidural anaestesia with patient-controlled thoracic epidural analgesia postoperatively (Group E). Blood sample were obtained perioperatively at different time points for analyses of: subpopulations of leukocytes, cell- ediated immune response after mitogen stimulation, NK cell cytotoxicity, vascular endothelial growth factor (VEGF), IFN-g/IL-10 ratio, C-reactive protein (CRP) and white blood cell (WBC) count. In addition, pain and morphine consumtion were also determined. Results: T lymphocytes decreased more in Group P compared to Group E at 24 hours postoperatively while T-helper lymphocytes decreased more in Group E compared to Group P at the same time point without reaching statistically significant difference.No differences were seen in NK cells or cytotoxic T lymphocytes between the groups. The CD4+/CD8+ ratio remained constant between the groups over time. Natural Killer Cell cytotoxicity did not show statistically significant differences between the groups at the different postoperative time points. No other differences ere found between the groups except in pain intensity which was lower in Group E, and morphine consumption which was greater in Group P. Conclusions:Our findings suggest that regional anaesthesia and analgesia appears to play a minor role in immunomodulation following surgery for prostat

Background: Epidural anesthesia and analgesia has been shown to suppress the neurohormonalstress response in certain types of surgery, but its role in the inflammatory responseto surgery is unclear. The primary aim of this study was to assess whether the choice ofanalgesic technique influences these processes in patients undergoing radical retropubicprostatectomy (RRP). Method: 26 patients undergoing RRP were randomized to Group P (systemic opioid-basedanalgesia) or Group E (thoracic epidural-based analgesia) perioperatively. Induction andmaintenance of anesthesia in both groups followed a standardized protocol. The followingmeasurements were made perioperatively : plasma cortisol, glucose, insulin, plasma cytokines(IL-6, TNF-a) and pokeweed mitogen-stimulated cytokines (IFN-g, IL-2, IL-12p70, IL-10,IL-4, and IL-17), C-reactive proteins and leucocyte count. Other parameters recordedincluded pain, morphine consumption and perioperative complications during 72 hours. Results: Plasma concentration of cortisol and glucose were significantly higher in Group Pcompared to Group E at the end of surgery with a mean difference between groups of 232nmol/L (95% CI 84-381) (P=0.004) and 1.6 mmol/L (95% CI 0.6-2.5) (P=0.003) respectively.No significant differences were seen in any plasma cytokine except IL-17, which was higherin Group P compared with Group E, both at 24 h (P< 0.001) and 72 h (P=0.018)postoperatively. Significantly higher pain intensity was seen up to 24 hours postoperatively inGroup P compared to Group E (p < 0.05). Conclusion: Thoracic epidural analgesia reduces the early postoperative stress response butnot the acute inflammatory response to radical retrobupic prostatectomy suggesting that otherpathways are involved during the acute phase reaction.