Respiratory adenovirus infections in immunocompetent and immunocompromised adult patients.

Adenovirus (AdV) can cause severe respiratory infections in children and immunocompromised patients, but less is known about severe AdV pneumonia in immunocompetent adults. In this retrospective study, we compared respiratory tract infections and pneumonia caused by AdV in immunocompromised and immunocompetent adult patients regarding clinical presentation and severity of infection. The results show that AdV can cause severe infections in both immunocompetent and immunocompromised patients, and the clinical presentation and need for hospitalisation, mechanical ventilation and antiviral treatment were equal in both groups. No underlying risk factors for severe AdV infection in healthy individuals were identified.

Risk of bacteremia in patients presenting with shaking chills and vomiting - a prospective cohort study.

Chills and vomiting have traditionally been associated with severe bacterial infections and bacteremia. However, few modern studies have in a prospective way evaluated the association of these signs with bacteremia, which is the aim of this prospective, multicenter study. Patients presenting to the emergency department with at least one affected vital sign (increased respiratory rate, increased heart rate, altered mental status, decreased blood pressure or decreased oxygen saturation) were included. A total of 479 patients were prospectively enrolled. Blood cultures were obtained from 197 patients. Of the 32 patients with a positive blood culture 11 patients (34%) had experienced shaking chills compared with 23 (14%) of the 165 patients with a negative blood culture, P = 0.009. A logistic regression was fitted to show the estimated odds ratio (OR) for a positive blood culture according to shaking chills. In a univariate model shaking chills had an OR of 3.23 (95% CI 1.35-7.52) and in a multivariate model the OR was 5.9 (95% CI 2.05-17.17) for those without prior antibiotics adjusted for age, sex, and prior antibiotics. The presence of vomiting was also addressed, but neither a univariate nor a multivariate logistic regression showed any association between vomiting and bacteremia. In conclusion, among patients at the emergency department with at least one affected vital sign, shaking chills but not vomiting were associated with bacteremia.

CT imaging for prediction of complications and recurrence in acute uncomplicated diverticulitis.

PURPOSE: The first randomized clinical trial of antibiotics in uncomplicated diverticulitis (the AVOD study) showed no benefit of antibiotics. The aim of this study was to re-evaluate the computed tomography (CT) scans of the patients in the AVOD study to find out whether there were CT findings that were missed and to study whether CT signs in uncomplicated diverticulitis could predict complications or recurrence. METHODS: The CT scan images from patients included in the AVOD study were re-evaluated and graded by two independent reviewers for different signs of diverticulitis, including complications, such as extraluminal gas or the presence of an abscess. RESULTS: Of the 623 patients included in the study, 602 CT scans were obtained and re-evaluated. Forty-four (7 %) patients were found to have complications on the admitting CT scan that had been overlooked. Twenty-seven had extraluminal gas and 17 had an abscess. Four of these patients deteriorated and required surgery, but the remaining patients improved without complications. Of the 18 patients in the no-antibiotic group, in whom signs of complications on CT were overlooked, 15 recovered without antibiotics. No CT findings in patients with uncomplicated diverticulitis could predict complications or recurrence. CONCLUSION: No CT findings that could predict complications or recurrence were found. A weakness in the initial assessment of the CT scans to detect extraluminal gas and abscess was found but, despite this, the majority of patients recovered without antibiotics. This further supports the non-antibiotic strategy in uncomplicated diverticulitis.

Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial.

AIM: Adhesions are the most common cause of small bowel obstruction (SBO). The costs of hospitalization and surgery for SBO are substantial for the health-care system. The adhesion-limiting potential of icodextrin has been shown in patients undergoing surgery for gynaecological diseases. A randomized, multicentre trial in colorectal cancer surgery started in 2009 with the aim of evaluating whether icodextrin could reduce the long-term risk of surgery for SBO. Because of some concerns about complications (especially anastomotic leakage) after icodextrin use, a preplanned interim analysis of morbidity and mortality was conducted. METHOD: Patients with colorectal cancer without metastasis were randomized 1:1 to receive standard surgery, with or without instillation of icodextrin in the abdominal cavity. For the first 300 patients, the 30-day follow-up data were collected from the Swedish ColoRectal Cancer Registry (SCRCR). Pre-, per- and postoperative data, morbidity and mortality were analysed. RESULTS: Of the 300 randomized patients, 288 had a data file in the SCRCR. Twelve patients did not have cancer and another five did not have a resection, leaving 283 for analysis. The authors were blinded to the randomization groups. Demographic data were similar in both groups. The overall complication rate was 24% in Group 1 and 23% in Group 2 (P = 0.89). Four cases of anastomotic leakage were reported in Group 1 and five were reported in Group 2 (P = 1.0). Mortality, intensive care unit (ICU) stay and re-operations did not differ between the groups. CONCLUSION: The pre-planned safety analysis of the first 300 patients enrolled in this randomized trial did not show any differences in adverse effects related to the use of icodextrin. All data were gathered from the SCRCR, giving us a strong message that we can continue to include patients in the trial.

Nomograms to predict survival and the risk for developing local or distant recurrence in patients with rectal cancer treated with optional short-term radiotherapy.

BACKGROUND: In many European countries, short-term 5 × 5 Gy radiotherapy has become the standard preoperative treatment of patients with resectable rectal cancer. Individualized risk assessment might allow a better selection of patients who will benefit from postoperative treatment and intensified follow-up. PATIENTS AND METHODS: From patient's data from three European rectal cancer trials (N = 2881), we developed multivariate cox nomograms reflecting the risk for local recurrence (LR), distant metastases (DM) and overall survival (OS). Evaluated variables were age, gender, tumour distance from the anal verge, the use of radiotherapy, surgical technique (total mesorectal excision/conventional surgery), surgery type (low anterior resection/abdominoperineal resection), time from randomization to surgery, residual disease (R0 versus R1 + 2), pT-stage, pN-stage and surgical complications. RESULTS: Pathological T- and N-status are of vital importance for an accurate prediction of LR, DM and OS. Short-course radiotherapy reduces the rate of LR. The developed nomograms are capable of predicting events with a validation c-index of 0.79 (LR), 0.76 (DM) and 0.75 (OS). The proposed stratification in risk groups allowed significant distinction between Kaplan-Meier curves for outcome. CONCLUSION: The developed nomograms can contribute to better individual risk prediction for LR, DM and OS for patients operated on rectal cancer. The practicality of the defined risk groups makes decision support in the consulting room feasible, assisting physicians to select patients for adjuvant therapy or intensified follow-up.

Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial.

BACKGROUND: The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME). PATIENTS AND METHODS: The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 × 5 Gy. Chemoradiotherapy consisted of 25 × 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival. RESULTS: Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39). CONCLUSION: The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete planned accrual. REGISTRATION NUMBER: Dutch Colorectal Cancer group, CKTO 2003-16, ISRCTN36266738.

Comparison between MRI and CT in prediction of peritoneal carcinomatosis index (PCI) in patients undergoing cytoreductive surgery in relation to the experience of the radiologist.

BACKGROUND: To compare CT and MRI for peritoneal carcinomatosis index (PCI) assessment and to compare assessments made by the radiologist based on their experiences. METHOD AND MATERIALS: MRI and CT of abdomen and pelvis were performed on 39 prospectively followed by surgery directly. Two blinded radiologists with different experience levels evaluated PCI separately on different occasions on 19 cases initially and later on the remaining 20. The agreement between the radiologists' assessment and surgical findings in total and per site were recorded. RESULTS: Total PCI: The experienced radiologist was able to assess total tumor burden correctly on both CT and MRI (kappa = 1.0). For the inexperienced radiologist the assessment was better on CT (kappa = 0.73) compared to MRI (kappa = 0.58). Different sites: The experienced radiologist showed high agreement with kappa = 0.77 for MRI and 0.80 for CT. Corresponding figures were 0.39 and 0.60 for the inexperienced radiologist. For the second phase the agreement levels increased for the inexperienced radiologist increased to 0.80 and 0.70, respectively. CONCLUSION: CT and MRI are equal when read by experienced radiologist. CT shows better results when read by an inexperienced radiologist compared to MRI, however the results of the latter can easily be improved.

Time trends, improvements and national auditing of rectal cancer management over an 18-year period.

AIM: The main aims were to explore time trends in the management and outcome of patients with rectal cancer in a national cohort and to evaluate the possible impact of national auditing on overall outcomes. A secondary aim was to provide population-based data for appraisal of external validity in selected patient series. METHOD: Data from the Swedish ColoRectal Cancer Registry with virtually complete national coverage were utilized in this cohort study on 29 925 patients with rectal cancer diagnosed between 1995 and 2012. Of eligible patients, nine were excluded. RESULTS: During the study period, overall, relative and disease-free survival increased. Postoperative mortality after 30 and 90 days decreased to 1.7% and 2.9%. The 5-year local recurrence rate dropped to 5.0%. Resection margins improved, as did peri-operative blood loss despite more multivisceral resections being performed. Fewer patients underwent palliative resection and the proportion of non-operated patients increased. The proportions of temporary and permanent stoma formation increased. Preoperative radiotherapy and chemoradiotherapy became more common as did multidisciplinary team conferences. Variability in rectal cancer management between healthcare regions diminished over time when new aspects of patient care were audited. CONCLUSION: There have been substantial changes over time in the management of patients with rectal cancer, reflected in improved outcome. Much indirect evidence indicates that auditing matters, but without a control group it is not possible to draw firm conclusions regarding the possible impact of a quality control registry on faster shifts in time trends, decreased variability and improvements. Registry data were made available for reference.

COMPRES: a prospective postmarketing evaluation of the compression anastomosis ring CAR 27(™) /ColonRing(™).

AIM: Preclinical studies have suggested that nitinol-based compression anastomosis might be a viable solution to anastomotic leak following low anterior resection. A prospective multicentre open label study was therefore designed to evaluate the performance of the ColonRing(™) in (low) colorectal anastomosis. METHOD: The primary outcome measure was anastomotic leakage. Patients were recruited at 13 different colorectal surgical units in Europe, the United States and Israel. Institutional review board approval was obtained. RESULTS: Between 21 March 2010 and 3 August 2011, 266 patients completed the study protocol. The overall anastomotic leakage rate was 5.3% for all anastomoses, including a rate of 3.1% for low anastomoses. Septic anastomotic complications occurred in 8.3% of all anastomoses and 8.2% of low anastomoses. CONCLUSION: Nitinol compression anastomosis is safe, effective and easy to use and may offer an advantage for low colorectal anastomosis. A prospective randomized trial comparing ColonRing(™) with conventional stapling is needed.

Impact of mechanical bowel preparation on survival after colonic cancer resection.

BACKGROUND: A randomized study in 1999-2005 of mechanical bowel preparation (MBP) preceding colonic resection found no decrease in postoperative complications. The aim of the present study was to evaluate the long-term effect of MBP regarding cancer recurrence and survival after colonic resections. METHODS: The cohort of patients with colonic cancer in the MBP study was followed up for 10 years. Data were collected from registers run by the National Board of Health and Welfare. Register data were validated against information in patient charts. Cox proportional hazards model was used for multivariable analysis of factors predictive of cancer-specific survival. RESULTS: Register analysis showed significantly fewer recurrences, and better cancer-specific and overall survival in the MBP group. After validation, 839 of 1343 patients remained for analysis (448 MBP, 391 no MBP). Eighty (17·9 per cent) of 448 patients in the MBP group and 88 (22·5 per cent) of 391 in the no-MBP group developed a cancer recurrence (P = 0·093). The 10-year cancer-specific survival rate was 84·1 per cent in the MBP group and 78·0 per cent in the no-MBP group (P = 0·019). Overall survival rates were 58·8 and 56·0 per cent respectively (P = 0·186). CONCLUSION: Patients receiving MBP before elective colonic cancer surgery had significantly better cancer-specific survival after 10 years.

Degree of blood loss during surgery for rectal cancer: a population-based epidemiologic study of surgical complications and survival.

AIM: The hypothesis tested in this study was that major blood loss during surgery for rectal cancer increases the risk for surgical complications and for small bowel obstruction (SBO) as a result of adhesions or tumour recurrence, and reduces overall survival. METHOD: Data were retrieved from the Uppsala/Örebro Regional Rectal Cancer Registry for all patients undergoing radical resection for rectal cancer during 1997-2003 (n = 1843) and were matched against the Swedish National Patient Registry regarding surgery and admission for SBO. These patient records were scrutinized to determine the etiology of surgery for SBO. The registry was scrutinized for blood loss and other surgical complications associated with surgery. Uni- and multivariate Cox analysis and logistic regression were used. RESULTS: Ninety-four (5.1%) patients underwent surgery for SBO > 30 days after the index operation: 82 for adhesions and 12 for tumour recurrence. The volume of blood lost did not influence the risk of surgery for SBO as a result of adhesions, but blood loss above the median (≥ 800 ml) increased the risk for surgery for SBO caused by tumour recurrence (hazard ratio = 10.52; 95% CI: 1.36-81.51). Increased blood loss increased the risk of surgical complications (OR = 1.78; 95% CI: 1.35-2.35 with blood loss of ≥ 450 ml) but did not reduce overall survival. Irradiation before surgery increased blood loss, complications and admission for SBO. CONCLUSION: Major blood loss during surgery for rectal cancer increases the risk of later surgery for SBO caused by tumour recurrence and surgical complications, but overall survival is not affected.

Patients with rectal cancer receiving adjuvant chemotherapy have an increased survival: a population-based longitudinal study.

BACKGROUND: The aim of this study was to investigate whether or not the use of adjuvant chemotherapy in stage III rectal cancer varies between regions and over time, and if this has had an effect on survival rates. PATIENTS AND METHODS: Patients from the Uppsala/Örebro region below 75 years-of-age, operated 1995-2002 and registered in the Swedish Rectal Cancer Register, were monitored between 1995 and September 2008. A multivariate Cox proportional hazard regression model was used for analysis. Overall survival was described using the Kaplan-Meier method. RESULTS: Four hundred and thirty-six patients with stage III rectal cancer were included. Adjuvant chemotherapy was given to 42% of the patients (proportions varying from 13% to 77% among counties), and there were substantial increases over time. The 5-year overall survival was 65.8% [95% confidence interval (CI) 50-84] for patients having adjuvant chemotherapy compared with 45.6% (95% CI 39-52) for patients not treated with chemotherapy. The multivariate hazard ratio for death was 0.65 (95% CI 0.5-0.8) for patients treated with adjuvant chemotherapy. CONCLUSIONS: The use of adjuvant chemotherapy for rectal cancer has increased, but varies considerably between hospitals/counties. In this cohort, those having adjuvant chemotherapy had a longer overall survival.

Population-based data from the Swedish Colon Cancer Registry.

BACKGROUND: Evaluating the external validity of clinical trials requires knowledge not only of the study population but also of a relevant reference population. The main aim of this study was to present data from a large, contemporary, population-based cohort of patients with colonic cancer. METHODS: Data on patients diagnosed between 2007 and 2011 were extracted from the Swedish Colon Cancer Registry. The data, registered prospectively in a national population of almost 10 million, included over 99 per cent of all diagnosed adenocarcinomas of the colon. RESULTS: This analysis included 18,889 patients with 19,526 tumours (3·0 per cent had synchronous tumours). The sex distribution was fairly equal, and the median age was 74·1 (interquartile range 65-81) years. The overall and relative (cancer-specific) survival rates after 3 years were 62·7 and 71·4 per cent respectively. Some 88·0 per cent of the patients were operated on, and 83·8 per cent had tumours resected. Median blood loss during bowel resection was 200 (mean 311) ml, and the median operating time was 160 min; 5·6 per cent of the procedures were laparoscopic. Preoperative chemotherapy was administered to 2·1 per cent of patients; postoperative chemotherapy was planned in 90·1 per cent of fit patients aged less than 75 years with stage III disease. In patients operated on in an emergency setting (21·5 per cent), the preoperative evaluation was less extensive, the proportion of R0 resections was lower, and the outcomes were poorer, in both the short and long term. CONCLUSION: These population-based data represent good-quality reference points.

The Easy-X magnetic stoma connector system. A future concept for stomal dressing?

AIM: A considerable proportion of stoma patients are disabled for various reasons and are elderly. To be able to dress their stoma themselves is of crucial importance for their integrity and social life. This study evaluates a novel stomal dressing system based on a magnetic connector--the Easy-X system. METHOD: Twenty patients (8 women, mean age of 40-89 years) with a well-functioning colostomy tested the Easy-X system for 6 weeks. The system was judged by the patients using a multiple choice scale, and by the stoma nurses using a 10-grade VAS. RESULTS: Eighteen of 20 patients completed the trial. Ten patients rated the Easy-X as better than their ordinary system, 3 as equal to and 4 deemed it inferior. Despite this, only three were prepared to change to the Easy-X system. Eleven of 18 patients experienced discomfort with the new adhesive plate. Three patients suffered leakage less often and five patients more often than with their ordinary system. Stoma nurse ratings were available for 14 patients. Their evaluation of the magnetic connector in the Easy-X system was positive in eight cases, neutral in one case and negative in three cases. Global impression ratings were 3 positive, 3 negative and 5 neutral. CONCLUSION: The Easy-X system showed potential advantages over conventional stomal dressing systems, but the system must be improved in terms of a varied assortment of dressing products enabling individual fitting before a larger trial can be carried out on disabled patients. Furthermore, the increased use of metal has to be handled with an ecologic recycling system. WHAT IS NEW IN THIS PAPER: A new stomal dressing system with a magnetic connector has potential advantages over conventional stomal dressings for disabled persons.

Altering the therapeutic paradigm towards a distal bowel margin of < 1 cm in patients with low-lying rectal cancer: a systematic review and commentary.

AIM: The 1-cm rule of distal bowel clearance in patients with low-lying rectal cancer undergoing anterior resection is based mainly on pathological data showing distal intramural spread. Because clinical data are contradictory, a review that includes only cancers located ≤ 5 or ≤ 6 cm from the anal verge was carried out. METHOD: A systematic review of the literature identified seven studies that presented results in relation to a margin of ≤ 1 cm (n = 293) vs > 1 cm (n = 315). In six studies, pre- or postoperative radiotherapy was implemented, and in one study patients were treated with surgery alone. Three studies, all implementing radiotherapy, reported results related to a margin of ≤ 5 mm (n = 51) vs > 5 mm (n = 125). RESULTS: In none of the studies were the differences in local recurrence rate between the small and large margin groups statistically significant. The pooled analysis of six studies, in which patients received perioperative radiotherapy, showed a 1.2% [95% confidence interval (Cl) -4.5-7.0%] higher local recurrence rate in the ≤ 1 cm margin group compared with the > 1 cm margin group (P = 0.6). The corresponding figures for the ≤ 5 mm cut-off point were 0.5% (95% CI -7.6-8.7%, P = 0.9). The 5-year local recurrence rate in the only study in which radiotherapy had not been used was 8.6% higher in the ≤ 1 cm margin group compared with the > 1 cm margin group (P = 0.09). CONCLUSION: Clinical evidence does not support the 1-cm rule in patients with low-lying rectal cancer undergoing pre- or postoperative radiotherapy.

Short-term outcome after neoadjuvant high-dose-rate endorectal brachytherapy or short-course external beam radiotherapy in resectable rectal cancer.

AIM: Total mesorectal excision with preoperative radiotherapy reduces local recurrence in rectal cancer, but radiotherapy increases the risk of complications. This study compared the immediate postoperative outcome after external beam radiotherapy with outome after high-dose-rate endorectal brachytherapy (HDREBT). METHOD: Patients (n = 318) treated with preoperative HDREBT (6.5 Gy, daily, over 4 days) followed by surgery 4-8 weeks later were matched with 318 patients from the Swedish Rectal Cancer Register treated with short-course radiotherapy (SCRT; 5 Gy, daily, over 5 days) and surgery in the subsequent week and with 318 patients who had surgery only (i.e. no preoperative radiotherapy; RT-) All 954 patients were followed for 30 days after surgery. Complications were divided into surgical, cardiovascular and infectious. RESULTS: The SCRT group had fewer cardiovascular complications (3.1%) than did HDREBT (9.4%, P = 0.002) and RT- (7.2%, P = 0.03) groups. There was less perioperative bleeding in HDREBT patients (379.3 ml) than in SCRT (947.2 ml; P < 0.0001) or RT- (918.9 ml) patients, and the re-intervention rate was lower in HDREBT (4.1%) patients than in SCRT (14.2%; P = 0.005) and RT- (12.3%; P < 0.005) patients. The HDREBT group had fewer R2 resections than did the SCRT and RT- groups, but had a higher proportion of R0 resections compared with the RT- group (P = 0.03). CONCLUSION: No major differences in postoperative complications were found. HDREBT patients had a higher rate of cardiovascular complications, but less perioperative bleeding and fewer re-interventions. A longer interval between radiotherapy and surgery may be beneficial for tumour regression and this could be reflected in the number of radical resections.

Effect of local gentamicin-collagen on perineal wound complications and cancer recurrence after abdominoperineal resection: a multicentre randomized controlled trial.

AIM: Perineal wound sepsis is a common problem after abdominoperineal resection of the rectum (APR), with a reported incidence of 10-15% in previously non-irradiated patients, 20-30% in patients given preoperative radiation and 50% among patients submitted to preoperative radiation combined with chemotherapy. The local application of gentamicin-collagen was evaluated to determine whether its use in the perineal wound reduced risk complications and had an effect on cancer recurrence. METHOD: In this prospective multicentre (seven hospitals) randomized controlled trial, 102 patients undergoing APR due to cancer or benign disease were randomized into two groups including surgery with gentamicin-collagen (GS+, n = 52) or surgery without gentamicin-collagen (GS-, n = 50). Patients were followed at 7, 30 and 90 days and at 1 and 5 years. RESULTS: There were no statistically significant differences between the two groups regarding perineal wound complications, infectious or non-infectious, or cancer recurrence. CONCLUSION: There was no statistically significant effect on perineal wound complications or cancer recurrence following the local administration of gentamicin-collagen during APR.

Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis.

BACKGROUND: The standard of care for acute uncomplicated diverticulitis today is antibiotic treatment, although there are no controlled studies supporting this management. The aim was to investigate the need for antibiotic treatment in acute uncomplicated diverticulitis, with the endpoint of recovery without complications after 12 months of follow-up. METHODS: This multicentre randomized trial involving ten surgical departments in Sweden and one in Iceland recruited 623 patients with computed tomography-verified acute uncomplicated left-sided diverticulitis. Patients were randomized to treatment with (314 patients) or without (309 patients) antibiotics. RESULTS: Age, sex, body mass index, co-morbidities, body temperature, white blood cell count and C-reactive protein level on admission were similar in the two groups. Complications such as perforation or abscess formation were found in six patients (1·9 per cent) who received no antibiotics and in three (1·0 per cent) who were treated with antibiotics (P = 0·302). The median hospital stay was 3 days in both groups. Recurrent diverticulitis necessitating readmission to hospital at the 1-year follow-up was similar in the two groups (16 per cent, P = 0·881). CONCLUSION: Antibiotic treatment for acute uncomplicated diverticulitis neither accelerates recovery nor prevents complications or recurrence. It should be reserved for the treatment of complicated diverticulitis.

The NordICC Study: rationale and design of a randomized trial on colonoscopy screening for colorectal cancer.

BACKGROUND AND STUDY AIM: While colonoscopy screening is widely used in several European countries and the United States, there are no randomized trials to quantify its benefits. The Nordic-European Initiative on Colorectal Cancer (NordICC) is a multinational, randomized controlled trial aiming at investigating the effect of colonoscopy screening on colorectal cancer (CRC) incidence and mortality. This paper describes the rationale and design of the NordICC trial. STUDY DESIGN: Men and women aged 55 to 64 years are drawn from the population registries in the participating countries and randomly assigned to either once-only colonoscopy screening with removal of all detected lesions, or no screening (standard of care in the trial regions). All individuals are followed for 15 years after inclusion using dedicated national registries. The primary end points of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow-up. POWER ANALYSIS: We hypothesize a 50 % CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50 % compliance, yielding a 25 % mortality reduction among those invited to screening. For 90 % power and a two-sided alpha level of 0.05, using a 2:1 randomization, 45 600 individuals will be randomized to control, and 22 800 individuals to the colonoscopy group. Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10-year follow-up. CONCLUSIONS: The aim of the NordICC trial is to quantify the effectiveness of population-based colonoscopy screening. This will allow development of evidence-based guidelines for CRC screening in the general population.

European quality assurance programme in rectal cancer--are we ready to launch?

AIM: There have been initiatives to create a European audit project. This paper addresses the issue of differences in data collected by different registries. METHOD: Patients with rectal cancer treated in 2008 and recorded in quality registries from Belgium, Germany/Poland, Spain and Sweden were analyzed. The comparison included number of patients, gender, age, American Society of Anesthesiology (ASA) classification, preoperative diagnostic and staging procedures, neoadjuvant therapy, surgical treatment and quality of surgery, postoperative complications and adjuvant treatment. RESULTS: The Belgian database consisted of 622 patients, the German/Polish database consisted of 3,393 patients, the Spanish database consisted of 1,641 patients and the Swedish database consisted of 1,826 patients. The percentage of patients in each ASA stage was highly variable. MRI use was highest in Spain and Sweden and very low in Germany/Poland. The percentage of cT4 stage tumours in Sweden was much higher than in all other countries. Sweden recorded the highest percentage of primary metastatic disease (20.3%) and Belgium recorded the lowest (10.2%). Neoadjuvant therapy in different protocols was administered to 41.2% patients in Germany/Poland, to 50.8% in Spain, to 55.2% in Belgium and to 62% in Sweden. Laparoscopic surgery (conversion rate) was performed for cure in 5% (28%) of patients in Sweden, in 20.8% (20.6%) in Spain, in 28.6% (15.2%) in Belgium and in 14.5% (8.9%) in Germany/Poland. The 30-day mortality for anterior resection, abdominoperineal excision and Hartmann's procedure in Sweden, Belgium and Spain was 2.0%, 2.3% and 3.1%, respectively. The German/Polish database reported an in-hospital mortality of 3.2%. CONCLUSION: A European quality assurance project in rectal cancer is possible only after data collection is standardized.