No benefit of more intense follow-up after surgery for colorectal cancer in the risk group with elevated CEA levels - An analysis within the COLOFOL randomized clinical trial.

BACKGROUND: Patients with colorectal cancer were examined to determine (1) whether elevated carcinoembryonic antigen (CEA) levels, either before treatment or after surgery, was associated with an increased risk of overall or colorectal cancer-specific mortality or recurrence, and (2) whether high intensity follow-up would benefit those patients. MATERIALS AND METHODS: Post-hoc analysis based on 2509 patients that underwent surgery for colorectal cancer, stage II or III, in the COLOFOL randomized trial with 5-year follow-up. Serum CEA levels were ascertained before treatment and one month after surgery. Follow-up examinations included computed tomography of the thorax and abdomen and serum CEA sampling. Patients were randomized to examinations at either 6, 12, 18, 24, and 36 months (high-intensity group) or at 12 and 36 months after surgery (low-intensity group). Levels of CEA >5 µg/l were defined as elevated. RESULTS: Elevated CEA levels before treatment were associated with increased risk of recurrence (hazard ratio [HR], 1.49; 95% confidence interval [CI]: 1.22-1.83), colorectal cancer-specific mortality (HR, 1.44; 95% CI: 1.08-1.91), and overall mortality (HR, 1.38; 95% CI: 1.07-1.78). Elevated CEA levels after surgery were associated with increased colorectal cancer-specific mortality (HR, 1.68; 95% CI: 1.08-2.61) and overall mortality (HR, 1.79; 95% CI: 1.22-2.63). The intensity of the follow-up regimen had no effect on 5-year outcomes in patients with elevated CEA levels. CONCLUSION: Both pre-treatment and post-surgery elevated serum CEA levels were associated with increased overall and cancer-specific mortality. Intensified follow-up showed no benefit over low-intensity follow-up in this high-risk group of patients with elevated CEA levels.

Tomografía computarizada para el diagnóstico de la apendicitis aguda en adultos / Computed tomography for diagnosis of acute appendicitis in adults

¿Por qué es importante mejorar el diagnóstico de la apendicitis? El propósito de utilizar la tomografía computarizada (TC) en personas con sospecha de apendicitis es ayudar al médico a diferenciar entre los pacientes que necesitan una cirugía con resección del apéndice (apendicectomía) y los que no necesitan este procedimiento. ¿Cuál es el objetivo de esta revisión? El objetivo de esta revisión Cochrane fue averiguar cómo de precisa es la TC de abdomen y pelvis para el diagnóstico de apendicitis en adultos. Los investigadores de Cochrane incluyeron 64 estudios en la revisión para responder a esta pregunta. ¿Qué se estudió en la revisión? Una TC puede realizarse de varias maneras. La calidad de la imagen puede mejorarse mediante el uso de material de contraste intravenoso, y la visualización del apéndice puede ser mejor cuando se utiliza contraste oral o rectal. La TC también puede realizarse con una dosis baja de radiación. La exposición a la radiación relacionada con la TC puede aumentar el riesgo de cáncer de por vida. Esta revisión estudió la precisión de los siguientes tipos de TC: cualquier tipo de TC, TC según el tipo de contraste, y TC de baja dosis. ¿Cuáles son los principales resultados? Esta revisión incluyó 64 estudios relevantes que informaron de los resultados de 71 poblaciones de estudio diferentes con un total de 10.280 participantes. Los resultados generales indican que, en teoría, si se utilizara una TC de cualquier tipo urgencias en un grupo de 1.000 personas, de las cuales el 43% tuviese apendicitis, entonces se estima que: a) 443 personas tendrían una TC que indicaría apendicitis y, de estas, el 8% no tendría apendicitis aguda; y b) 557 personas tendrían una TC que indicaría que no hay apendicitis, y el 4% tendría en realidad apendicitis aguda. La TC de baja dosis sería tan precisa como la TC de dosis estándar para diagnosticar la apendicitis. La TC con material de contraste intravenoso, rectal u oral e intravenoso sería igual de precisa, y más precisa que la TC sin contraste. ¿Cómo de fiables son los resultados de los estudios en esta revisión? Entre los estudios incluidos, el diagnóstico final de apendicitis se basó en los hallazgos quirúrgicos o en el examen microscópico del apéndice resecado. Entre los participantes sin cirugía, la apendicitis se descartó mediante un seguimiento para ver si sus síntomas se resolvían sin apendicectomía. Es probable que este haya sido un método fiable para decidir si los pacientes realmente tenían apendicitis si el seguimiento fue cuidadoso y completo. Lamentablemente, no fue así en una proporción sustancial de los estudios incluidos. En general, se observaron algunos problemas en la forma de realizar los estudios. Esto puede haber dado lugar a que la TC parezca más precisa de lo que realmente es, aumentando así el número de resultados correctos de la TC. ¿A quién son aplicables los resultados? Los estudios incluidos en la revisión se realizaron principalmente en los servicios de urgencias. Se sospechó que todos los participantes tenían apendicitis después del examen clínico y los análisis de sangre. Los estudios incluidos evaluaron una amplia gama de tipos de TC. La edad promedio de los participantes varió entre 25 y 46años, porcentaje de mujeres varió entre el 26% y el 100%, y el porcentaje de participantes con un diagnóstico final de apendicitis varió entre el 13% y el 92% (promedio: 43%). ¿Cuáles son las implicaciones? La TC es una prueba precisa que probablemente ayude a los médicos a tratar a las personas con posible apendicitis. Los resultados de esta revisión indican que la probabilidad de que un clínico diagnostique erróneamente una apendicitis aguda parece ser baja (8% cuando la TC sugiere que tienen apendicitis). La probabilidad de no obtener un diagnóstico de apendicitis también es baja (4% cuando la TC sugiere que no tienen apendicitis). ¿Cómo de actualizada es esta revisión? Se incluyeron estudios publicados hasta el 16 de junio de 2017

No disponible

Computed tomography for diagnosis of acute appendicitis in adults.

BACKGROUND: Diagnosing acute appendicitis (appendicitis) based on clinical evaluation, blood testing, and urinalysis can be difficult. Therefore, in persons with suspected appendicitis, abdominopelvic computed tomography (CT) is often used as an add-on test following the initial evaluation to reduce remaining diagnostic uncertainty. The aim of using CT is to assist the clinician in discriminating between persons who need surgery with appendicectomy and persons who do not. OBJECTIVES: Primary objective Our primary objective was to evaluate the accuracy of CT for diagnosing appendicitis in adults with suspected appendicitis. Secondary objectives Our secondary objectives were to compare the accuracy of contrast-enhanced versus non-contrast-enhanced CT, to compare the accuracy of low-dose versus standard-dose CT, and to explore the influence of CT-scanner generation, radiologist experience, degree of clinical suspicion of appendicitis, and aspects of methodological quality on diagnostic accuracy. SEARCH METHODS: We searched MEDLINE, Embase, and Science Citation Index until 16 June 2017. We also searched references lists. We did not exclude studies on the basis of language or publication status. SELECTION CRITERIA: We included prospective studies that compared results of CT versus outcomes of a reference standard in adults (> 14 years of age) with suspected appendicitis. We excluded studies recruiting only pregnant women; studies in persons with abdominal pain at any location and with no particular suspicion of appendicitis; studies in which all participants had undergone ultrasonography (US) before CT and the decision to perform CT depended on the US outcome; studies using a case-control design; studies with fewer than 10 participants; and studies that did not report the numbers of true-positives, false-positives, false-negatives, and true-negatives. Two review authors independently screened and selected studies for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently collected the data from each study and evaluated methodological quality according to the Quality Assessment of Studies of Diagnostic Accuracy - Revised (QUADAS-2) tool. We used the bivariate random-effects model to obtain summary estimates of sensitivity and specificity. MAIN RESULTS: We identified 64 studies including 71 separate study populations with a total of 10,280 participants (4583 with and 5697 without acute appendicitis). Estimates of sensitivity ranged from 0.72 to 1.0 and estimates of specificity ranged from 0.5 to 1.0 across the 71 study populations. Summary sensitivity was 0.95 (95% confidence interval (CI) 0.93 to 0.96), and summary specificity was 0.94 (95% CI 0.92 to 0.95). At the median prevalence of appendicitis (0.43), the probability of having appendicitis following a positive CT result was 0.92 (95% CI 0.90 to 0.94), and the probability of having appendicitis following a negative CT result was 0.04 (95% CI 0.03 to 0.05). In subgroup analyses according to contrast enhancement, summary sensitivity was higher for CT with intravenous contrast (0.96, 95% CI 0.92 to 0.98), CT with rectal contrast (0.97, 95% CI 0.93 to 0.99), and CT with intravenous and oral contrast enhancement (0.96, 95% CI 0.93 to 0.98) than for unenhanced CT (0.91, 95% CI 0.87 to 0.93). Summary sensitivity of CT with oral contrast enhancement (0.89, 95% CI 0.81 to 0.94) and unenhanced CT was similar. Results show practically no differences in summary specificity, which varied from 0.93 (95% CI 0.90 to 0.95) to 0.95 (95% CI 0.90 to 0.98) between subgroups. Summary sensitivity for low-dose CT (0.94, 95% 0.90 to 0.97) was similar to summary sensitivity for standard-dose or unspecified-dose CT (0.95, 95% 0.93 to 0.96); summary specificity did not differ between low-dose and standard-dose or unspecified-dose CT. No studies had high methodological quality as evaluated by the QUADAS-2 tool. Major methodological problems were poor reference standards and partial verification primarily due to inadequate and incomplete follow-up in persons who did not have surgery. AUTHORS' CONCLUSIONS: The sensitivity and specificity of CT for diagnosing appendicitis in adults are high. Unenhanced standard-dose CT appears to have lower sensitivity than standard-dose CT with intravenous, rectal, or oral and intravenous contrast enhancement. Use of different types of contrast enhancement or no enhancement does not appear to affect specificity. Differences in sensitivity and specificity between low-dose and standard-dose CT appear to be negligible. The results of this review should be interpreted with caution for two reasons. First, these results are based on studies of low methodological quality. Second, the comparisons between types of contrast enhancement and radiation dose may be unreliable because they are based on indirect comparisons that may be confounded by other factors.

Effect of More vs Less Frequent Follow-up Testing on Overall and Colorectal Cancer-Specific Mortality in Patients With Stage II or III Colorectal Cancer: The COLOFOL Randomized Clinical Trial.

Importance: Intensive follow-up of patients after curative surgery for colorectal cancer is common in clinical practice, but evidence of a survival benefit is limited. Objective: To examine overall mortality, colorectal cancer-specific mortality, and colorectal cancer-specific recurrence rates among patients with stage II or III colorectal cancer who were randomized after curative surgery to 2 alternative schedules for follow-up testing with computed tomography and carcinoembryonic antigen. Design, Setting, and Participants: Unblinded randomized trial including 2509 patients with stage II or III colorectal cancer treated at 24 centers in Sweden, Denmark, and Uruguay from January 2006 through December 2010 and followed up for 5 years; follow-up ended on December 31, 2015. Interventions: Patients were randomized either to follow-up testing with computed tomography of the thorax and abdomen and serum carcinoembryonic antigen at 6, 12, 18, 24, and 36 months after surgery (high-frequency group; n = 1253 patients) or at 12 and 36 months after surgery (low-frequency group; n = 1256 patients). Main Outcomes and Measures: The primary outcomes were 5-year overall mortality and colorectal cancer-specific mortality rates. The secondary outcome was the colorectal cancer-specific recurrence rate. Both intention-to-treat and per-protocol analyses were performed. Results: Among 2555 patients who were randomized, 2509 were included in the intention-to-treat analysis (mean age, 63.5 years; 1128 women [45%]) and 2365 (94.3%) completed the trial. The 5-year overall patient mortality rate in the high-frequency group was 13.0% (161/1253) compared with 14.1% (174/1256) in the low-frequency group (risk difference, 1.1% [95% CI, -1.6% to 3.8%]; P = .43). The 5-year colorectal cancer-specific mortality rate in the high-frequency group was 10.6% (128/1248) compared with 11.4% (137/1250) in the low-frequency group (risk difference, 0.8% [95% CI, -1.7% to 3.3%]; P = .52). The colorectal cancer-specific recurrence rate was 21.6% (265/1248) in the high-frequency group compared with 19.4% (238/1250) in the low-frequency group (risk difference, 2.2% [95% CI, -1.0% to 5.4%]; P = .15). Conclusions and Relevance: Among patients with stage II or III colorectal cancer, follow-up testing with computed tomography and carcinoembryonic antigen more frequently compared with less frequently did not result in a significant rate reduction in 5-year overall mortality or colorectal cancer-specific mortality. Trial Registration: clinicaltrials.gov Identifier: NCT00225641.

The COLOFOL trial: study design and comparison of the study population with the source cancer population.

INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. RESULTS: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate). A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56%) were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized eligible patients. However, a difference was noted in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage and localization. The analyses will be stratified by these variables. Taken together, we conclude that our trial results will be robust and possible to extrapolate to the target population.

Indeterminate pulmonary nodules in colorectal-cancer: do radiologists agree?

BACKGROUND: The clinical significance of indeterminate pulmonary nodules (IPN) at staging computed tomography (CT) for colorectal cancer (CRC), and the optimal diagnostic approach, are debated. This study aimed to analyse variability in radiologists' detection of IPN at staging CT for CRC. METHODS: All patients with CRC referred to our center between 2006 and 2011 were included. Primary staging CT scans were re-evaluated by an experienced thoracic radiologist whose findings were entered into a dedicated database and merged with data from the Danish Colorectal Cancer Group database, the National Patient Registry, the Danish Pathology Registry, and the primary CT evaluation. Inter-reader agreement was calculated by Kappa statistics, and associations between variables and malignancy of pulmonary nodules were analyzed with χ (2) and Mann-Whitney-Wilcoxon tests. Multivariable logistic regression analyses were used to adjust for potential confounding variables. RESULTS: In total, 841 patients were included. The primary CT assessment reported IPN in 9.8 % of patients and pulmonary metastases in 5.1 % of patients compared with 5.6 and 7.0 %, respectively, reported by the experienced thoracic radiologist. Kappa for agreement between the primary assessor and the thoracic radiologist on IPN was 0.31 and 0.65 for pulmonary metastases. Synchronous liver metastases were predictive of malignancy of IPN (adjusted odds ratio 20.1; 95 % confidence interval 2.64-437.66; p = 0.012), whereas no other investigated radiological characteristics or clinicopathological factors were significantly associated with malignancy of IPN. CONCLUSION: The characterization of pulmonary findings on staging CT for CRC varied greatly between the radiologists, and double-reading of scans with IPN is recommended prior to further diagnostic work-up.

Occurrence and survival of synchronous pulmonary metastases in colorectal cancer: a nationwide cohort study.

OBJECTIVE: To investigate the occurrence of synchronous colorectal cancer metastases (SCCM) confined to the lungs, risk factors for these metastases and their impact on survival. METHODS: In a nationwide cohort study of 26,200 patients data were prospectively entered into the Danish Colorectal Cancer Group's (DCCG's) database between May 2001 and December 2011. The recorded data were merged with data from the Danish Pathology Registry and the National Patient Registry. Multivariable logistic- and extended Cox regression analyses were used to adjust for confounding variables. RESULTS: In total, 1970 patients (7.5%) had pulmonary SCCM of whom 736 (37%) had metastases exclusively in the lungs. Advanced age, recent years of diagnosis and a rectal index cancer were significantly associated with pulmonary SCCM. Adjustment for excess use of thoracic CT scans in rectal cancer patients did not alter this association (adjusted OR=1.81 (95% CI: 1.46-2.25, P<0.001)). Patients subjected to pulmonary metastasectomy, resection of primary tumour and chemotherapy had a superior overall survival compared with non-treated patients, especially when these therapeutic modalities were combined. CONCLUSIONS: The occurrence of pulmonary SCCM was higher than previously reported and had a severe impact on survival. Our analyses suggest that pulmonary metastasectomy, resection of the primary tumour and chemotherapy may be a sound strategy in patients with confined pulmonary SCCM, but the risk of selection bias and consequent exaggeration of the treatment effect should be kept in mind. This study may serve as a reliable un-biased reference for future evaluation on detection strategies and potential therapeutic interventions.

Indeterminate pulmonary nodules at colorectal cancer staging: a systematic review of predictive parameters for malignancy.

BACKGROUND: This study aimed to estimate the prevalence of indeterminate pulmonary nodules and specific radiological and clinical characteristics that predict malignancy of these at initial staging chest computed tomography (CT) in patients with colorectal cancer. A considerable number of indeterminate pulmonary nodules, which cannot readily be classified as either benign or malignant, are detected at initial staging chest CT in colorectal cancer patients. METHODS: A systematic review based on a search in EMBASE, Medline, the Cochrane library and science citation index, PubMed databases, Google scholar, and relevant conference proceedings was performed in cooperation with the Cochrane Colorectal Cancer Group. RESULTS: A total of 2,799 studies were identified, of which 12 studies met the inclusion criteria. The studies primarily consisted of case series and included a total of 5,873 patients. Of these patients, 9% (95% confidence interval [95% CI] 8.9-9.2%) had indeterminate pulmonary nodules at chest CT, of which 10.8% (95% CI 10.3-11.2%) turned out to be colorectal cancer metastases at follow-up. Generally, regional lymph node metastasis, and multiple numbers of indeterminate pulmonary nodules were reported to predict malignancy, whereas calcification of the nodules indicated benign lesions. CONCLUSION: It was found that 1 in 100 colorectal cancer patients subjected to preoperative staging chest CT will have an indeterminate pulmonary nodule that proves to be metastatic disease. Such a low risk suggests that indeterminate pulmonary nodules should not cause further preoperative diagnostic workup or follow-up besides routine regimens.

Case-mix study of single incision laparoscopic surgery (SILS) vs. conventional laparoscopic surgery in colonic cancer resections.

UNLABELLED: Single incision laparoscopic surgery (SILS) may be even less invasive to a patient than conventional laparoscopic surgery (CLS). AIM OF THE STUDY: of the applicability of the procedure, the first 1½ year of experiences and comparison with CLS for colonic cancer resections. MATERIAL AND METHODS: Since November 2010 SILS procedures was trained by two surgeons. Data was prospectively registered. Each of all colonic cancer resections was blindly matched with two patients operated with CLS within the period from 2009-2011 with respect of procedure, gender, T stadium, age, ASA score and BMI. In the routine accelerated "fast track" program the use of additional opioids was registered. RESULTS: SILS was performed in 18 patients with cancer resections. Comparisons between the SILS procedures and the matched 36 CLS operations showed no significant difference in operation time, blood loss, lymph node harvest and hospital stay, but length of vascular pedicle was significantly larger in SILS procedures. Although only 50% of SILS patients received opioids postoperatively, this was not significantly different from the 71% receiving opioids in the CLS group, and similarly no significant difference in number of administrations or amount of opioids were seen. CONCLUSION: With reservation of a small study group we find SILS is like worthy to CLS in colorectal cancer surgery and a benefit in postoperative recovery and pain is possible, but has to be investigated in larger randomised studies.

Quality of life after rectal resection for cancer, with or without permanent colostomy.

BACKGROUND: For almost one hundred years abdominoperineal excision has been the standard treatment of choice for rectal cancer. With advances in the techniques for rectal resection and anastomosis, anterior resection with preservation of the sphincter function has become the preferred treatment for rectal cancers, except for those cancers very close to the anal sphincter. The main reason for this has been the conviction that the quality of life for patients with a colostomy after abdominoperineal excision was poorer than for patients undergoing an operation with a sphincter-preserving technique. However, patients having sphincter-preserving operations may experience symptoms affecting their quality of life that are different from stoma-patients. OBJECTIVES: To compare the quality of life in rectal cancer patients with or without permanent colostomy. SEARCH METHODS: We searched PUBMED, EMBASE, LILACS, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Colorectal Cancer Group's specialised register. Abstract books from major gastroenterological and colorectal congresses were searched. Reference lists of the selected articles were scrutinized. SELECTION CRITERIA: All controlled clinical trials and observational studies in which quality of life was measured in patients with rectal cancer having either abdominoperineal excision/Hartmann's operation or low anterior resection, using a validated quality of life instrument, were considered. DATA COLLECTION AND ANALYSIS: One reviewer (JP) checked the titles and abstracts identified from the databases and hand search. Full text copies of all studies of possible relevance were obtained. The reviewer decided which studies met the inclusion criteria. Both reviewers independently extracted data. If information was insufficient the original author was contacted to obtain missing data. Extracted data were cross-checked and discrepancies resolved by consensus. MAIN RESULTS: Sixty-nine potential studies were identified. Thirty-five of these, all non-randomised and representing 5127 participants met the inclusion criteria. Fourteen trials found that people undergoing abdominoperineal excision/Hartmann's operation did not have poorer quality of life measures than patients undergoing anterior resection. The rest of the studies found some difference, but not always in favour of non-stoma patients. Due to clinical heterogeneity and the fact that all studies were observational trials, meta-analysis of the included studies was not possible. AUTHORS' CONCLUSIONS: The studies included in this review do not allow firm conclusions as to the question of whether the quality of life of people after anterior resection is superior to that of people after abdominoperineal excision/Hartmann's operation. The included studies challenges the assumption that anterior resection patients fare better. Larger, better designed and executed prospective studies are needed to answer this question.

Antibiotics for uncomplicated diverticulitis.

BACKGROUND: Diverticulitis is an inflammatory complication to the very common condition diverticulosis. Uncomplicated diverticulitis has traditionally been treated with antibiotics with reference to the microbiology, extrapolation from trials on complicated intra-abdominal infections and clinical experience. OBJECTIVES: To assess the effects of antibiotic interventions for uncomplicated diverticulitis on relevant outcome. SEARCH METHODS: Studies were identified by computerised searches of the The Cochrane Library (CENTRAL), MEDLINE and EMBASE. Ongoing trials were identified and reference lists of identified trials and relevant review articles were screened for additional studies. SELECTION CRITERIA: RCTs including all types of patients with a radiological confirmed diagnosis of left-sided uncomplicated diverticulitis. Interventions of antibiotics compared to any other antibiotic treatment (different regime, route of administration, dosage or duration of treatment), placebo or no antibiotics. Outcome measures were complications, emergency surgery, recurrence, late complications and duration of hospital stay and recovery of signs of infection. DATA COLLECTION AND ANALYSIS: Two authors performed the searches, identification of RCTs, trial assessment and data extraction. Disagreements were resolved by discussion or involvement of a third part. Authors of trials were contacted to obtain additional data if needed or were contacted for preliminary results of ongoing trials. Effect estimates were extracted as relative risks (RR). MAIN RESULTS: Three RCTs were identified. A qualitative approach with no meta analysis was performed because of variety in interventions between included studies. Interventions compared were antibiotics to no antibiotics, single to double compound antibiotic therapy and short to long IV administration. None of the studies found significant difference between the tested interventions. Risk of bias varied from low to high. The newest RCT overall had the best quality and statistical power. AUTHORS' CONCLUSIONS: The newest evidence from one RCT says there is no significant difference between antibiotics versus no antibiotics in the treatment of uncomplicated diverticulitis. Previous RCTs have only suggested a non-inferiority between different antibiotic regimes and treatment lengths. This new evidence needs confirmation from more RCTs before it can be implicated safely in clinical guidelines. Ongoing RCTs will be published in the years to come and more are needed. The role of antibiotics in the treatment of complicated diverticulitis has not been investigated yet.

Postoperative adjuvant chemotherapy in rectal cancer operated for cure.

BACKGROUND: Colorectal cancer is one of the most common types of cancer in the Western world. Apart from surgery - which remains the mainstay of treatment for resectable primary tumours - postoperative (i.e., adjuvant) chemotherapy with 5-fluorouracil (5-FU) based regimens is now the standard treatment in Dukes' C (TNM stage III) colon tumours i.e. tumours with metastases in the regional lymph nodes but no distant metastases. In contrast, the evidence for recommendations of adjuvant therapy in rectal cancer is sparse. In Europe it is generally acknowledged that locally advanced rectal tumours receive preoperative (i.e., neoadjuvant) downstaging by radiotherapy (or chemoradiotion), whereas in the US postoperative chemoradiotion is considered the treatment of choice in all Dukes' C rectal cancers. Overall, no universal consensus exists on the adjuvant treatment of surgically resectable rectal carcinoma; moreover, no formal systematic review and meta-analysis has been so far performed on this subject. OBJECTIVES: We undertook a systematic review of the scientific literature from 1975 until March 2011 in order to quantitatively summarize the available evidence regarding the impact of postoperative adjuvant chemotherapy on the survival of patients with surgically resectable rectal cancer. The outcomes of interest were overall survival (OS) and disease-free survival (DFS). SEARCH METHODS: CCCG standard search strategy in defined databases with the following supplementary search. 1. Rect* or colorect* - 2. Cancer or carcinom* or adenocarc* or neoplasm* or tumour - 3. Adjuv* - 4. Chemother* - 5. Postoper* SELECTION CRITERIA: Randomised controlled trials (RCT) comparing patients undergoing surgery for rectal cancer who received no adjuvant chemotherapy with those receiving any postoperative chemotherapy regimen. DATA COLLECTION AND ANALYSIS: Two authors extracted data and a third author performed an independent search for verification. The main outcome measure was the hazard ratio (HR) between the risk of event between the treatment arm (adjuvant chemotherapy) and the control arm (no adjuvant chemotherapy). The survival data were either entered directly in RevMan or extrapolated from Kaplan-Meier plots and then entered in RevMan. Due to expected clinical heterogeneity a random effects model was used for creating the pooled estimates of treatment efficacy. MAIN RESULTS: A total of 21 eligible RCTs were identified and used for meta-analysis purposes. Overall, 16,215 patients with colorectal cancer were enrolled, 9,785 being affected with rectal carcinoma. Considering patients with rectal cancer only, 4,854 cases were randomized to receive potentially curative surgery of the primary tumour plus adjuvant chemotherapy and 4,367 to receive surgery plus observation. The mean number of patients enrolled was 466 (range: 54-1,243 cases). 11 RCTs had been performed in Western countries and 10 in Japan. All trials used fluoropyrimidine-based chemotherapy (no modern drugs - such as oxaliplatin, irinotecan or biological agents - were tested).Overall survival (OS) data were available in 21 RCTs and the data available for meta-analysis regarded 9,221 patients: of these, 4854 patients were randomized to adjuvant chemotherapy (treatment arm) and 4,367 patients did not receive adjuvant chemotherapy (control arm). The meta-analysis of these RCTs showed a significant reduction in the risk of death (17%) among patients undergoing postoperative chemotherapy as compared to those undergoing observation (HR=0.83, CI: 0.76-0.91). Between-study heterogeneity was moderate (I-squared=30%) but significant (P=0.09) at the 10% alpha level.Disease-free survival (DFS) data were reported in 20 RCTs, and the data suitable for meta-analysis included 8,530 patients. Of these, 4,515 patients were randomized to postoperative chemotherapy (treatment arm) and 4,015 patients received no postoperative chemotherapy (control arm). The meta-analysis of these RCTs showed a reduction in the risk of disease recurrence (25%) among patients undergoing adjuvant chemotherapy as compared to those undergoing observation (HR=0.75, CI: 0.68-0.83). Between-study heterogeneity was moderate (I-squared=41%) but significant (P=0.03).While analyzing both OS and DFS data, sensitivity analyses did not find any difference in treatment effect based on trial sample size or geographical region (Western vs Japanese). Available data were insufficient to investigate on the effect of adjuvant chemotherapy separately in different TNM stages in terms of both OS and DFS. No plausible source of heterogeneity was formally identified, although variability in treatment regimens and TNM stages of enrolled patients might have played a significant role in the difference of reported results. AUTHORS' CONCLUSIONS: The results of this meta-analysis support the use of 5-FU based postoperative adjuvant chemotherapy for patients undergoing apparently radical surgery for non-metastatic rectal carcinoma. Available data do not allow us to define whether the efficacy of this treatment is highest in one specific TNM stage. The implementation of modern anti-cancer agents in the adjuvant setting is warranted to improve the results shown by this meta-analysis. Randomized trials of adjuvant chemotherapy for patients receiving preoperative neoadjuvant therapy are also needed in order to define the role of postoperative chemotherapy in the multimodal treatment of resectable rectal cancer.

Workload and surgeon's specialty for outcome after colorectal cancer surgery.

BACKGROUND: A large body of research has focused on investigating the effects of healthcare provider volume and specialization on patient outcomes including outcomes of colorectal cancer surgery. However there is conflicting evidence about the role of such healthcare provider characteristics in the management of colorectal cancer. OBJECTIVES: To examine the available literature for the effects of hospital volume, surgeon caseload and specialization on the outcomes of colorectal, colon and rectal cancer surgery. SEARCH METHODS: We searched Cochrane Central Register of Controlled Trials (CENTRAL), and LILACS using free text search words (as well as MESH-terms). We also searched Medline (January 1990-September 2011), Embase (January 1990-September 2011) and registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. SELECTION CRITERIA: Non-randomised and observational studies that compared outcomes for colorectal cancer, colon cancer and rectal cancer surgery (overall 5-year survival, five year disease specific survival, operative mortality, 5-year local recurrence rate, anastomotic leak rate, permanent stoma rate and abdominoperineal excision of the rectum rate) between high volume/specialist hospitals and surgeons and low volume/specialist hospitals and surgeons. DATA COLLECTION AND ANALYSIS: Two review authors independently abstracted data and assessed risk of bias in included studies. Results were pooled using the random effects model in unadjusted and case-mix adjusted meta-analyses. MAIN RESULTS: Overall five year survival was significantly improved for patients with colorectal cancer treated in high-volume hospitals (HR=0.90, 95% CI 0.85 to 0.96), by high-volume surgeons (HR=0.88, 95% CI 0.83 to 0.93) and colorectal specialists (HR=0.81, 95% CI 0.71 to 0.94). Operative mortality was significantly better for high-volume surgeons (OR=0.77, 95% CI 0.66 to 0.91) and specialists (OR=0.74, 95% CI 0.60 to 0.91), but there was no significant association with higher hospital caseload (OR=0.93, 95% CI 0.84 to 1.04) when only case-mix adjusted studies were included. There were differences in the effects of caseload depending on the level of case-mix adjustment and also whether the studies originated in the US or in other countries. For rectal cancer, there was a significant association between high-volume hospitals and improved 5-year survival (HR=0.85, 95% CI 0.77 to 0.93), but not with operative mortality (OR=0.97, 95% CI 0.70 to 1.33); surgeon caseload had no significant association with either 5-year survival (HR=0.99, 95% CI 0.86 to 1.14) or operative mortality (OR=0.86, 95% CI 0.62 to 1.19) when case-mix adjusted studies were reviewed. Higher hospital volume was associated with significantly lower rates of permanent stomas (OR=0.64, 95% CI 0.45 to 0.90) and APER (OR=0.55, 95% CI 0.42 to 0.72). High-volume surgeons and specialists also achieved lower rates of permanent stoma formation (0.75, 95% CI 0.64 to 0.88) and (0.70, 95% CI 0.53 to 0.94, respectively). AUTHORS' CONCLUSIONS: The results confirm clearly the presence of a volume-outcome relationship in colorectal cancer surgery, based on hospital and surgeon caseload, and specialisation. The volume-outcome relationship appears somewhat stronger for the individual surgeon than for the hospital; particularly for overall 5-year survival and operative mortality, there were differences between US and non-US data, suggesting provider variability at hospital level between different countries, making it imperative that every country or healthcare system must establish audit systems to guide changes in the service provision based on local data, and facilitate centralisation of services as required. Overall quality of the evidence was low as all included studies were observational by design. In addition there were discrepancies in the definitions of caseload and colorectal specialist. However ethical challenges associated with the conception of randomised controlled trials addressing the volume outcome relationship makes this the best available evidence.

Preoperative mechanical bowel preparation in elective colorectal surgery: an update of systematic review of the literature and meta-analysis

The belief that mechanical bowel preparation is related to the reduction of complications in elective colorectal surgery is based on observational studies and expert opinion. This question led the authors to a systematic literature review, with the completion of meta-analysis, followed by three updates. METHOD: The sources of information were EMBASE, LILACS, MEDLINE, IBECS, the Cochrane Controlled Trials Register and letters to the authors. The studies were included according to the randomization criteria. The studied variables were: anastomotic dehiscence, mortality and operatory wound infection. The analysis was divided into two comparisons: one group with mechanical preparation (Group A) compared with a group without preparation (Group B) (Comparison I) and a group submitted to rectal enema (Comparison II). RESULTS: We analyzed 5,805 patients in 20 clinical trials. In comparison I, anastomotic leak occurred in 4.4% (101/2,275 patients) in Group A and 4.5% (103/2,258 patients) in Group B. In comparison II, anastomotic leak occurred in 4.4% (27/601 patients) in Group A and 3.4% (21/609 patients) in Group B. CONCLUSION: Despite the inclusion of more studies, evidences found in studies did not show any benefit obtained from the use of preoperative mechanical bowel preparation or rectal cleansing enemas in elective colorectal surgery. (AU)

A crença de que o preparo mecânico do cólon está relacionado à diminuição de complicações na cirurgia colorretal eletiva é baseada em estudos observacionais e opinião de especialistas. Seu questionamento motivou os autores na busca sistemática da literatura, com a realização de meta-análise, seguida de três atualizações. MÉTODO: Fontes de informação foram EMBASE, LILACS, MEDLINE, IBECS, Registros de Ensaios Clínicos Casualizados da Colaboração Cochrane e cartas para os autores. Os estudos foram incluídos de acordo com os critérios de casualização. Os desfechos clínicos estudados foram: deiscência anastomótica, mortalidade e infecção da ferida operatória. A análise dos grupos foi dividida em duas comparações: comparação I, grupo submetido a preparo mecânico do cólon (Grupo A) comparado ao grupo sem preparo (Grupo B); comparação II, Grupo A, submetido a preparo do cólon e Grupo B, realizado apenas enema retal. RESULTADOS: Foram analisados 5.805 doentes em 20 ensaios clínicos. Na comparação I, deiscência anastomótica ocorreu em 4,4% (101/2.275 doentes) no Grupo A e 4,5% (103/2.258 doentes) no Grupo B. Na comparação II, deiscência anastomótica ocorreu em 4,4% (27/601 doentes) no Grupo A e 3,4% (21/609 doentes) no Grupo B. CONCLUSÃO: Apesar da inclusão de mais estudos, as evidências encontradas não demonstraram benefício no uso do preparo mecânico pré-operatório do cólon, assim como de enemas de limpeza do reto em cirurgia colorretal eletiva. (AU)

Preliminary results after single-port laparoscopic colonic surgery.

INTRODUCTION: Single incision laparoscopic surgery (SILS) may be even less invasive to patients than conventional laparoscopic surgery (CLS). The present study investigates the applicability of the procedure and we report the first year of experiences and operative quality. MATERIAL AND METHODS: Patients were selected clinically and after computed tomography. Easy resections (or stoma creations) with small tumours, a body mass index < 30 kg/square meter and American Society of Anesthesiologists group I-II were included. The data were prospectively registered until 1 January 2012. In the standard accelerated "fast track" programme, the use of additional opioids was registered. RESULTS: SILS was performed in 24 patients including 15 patients with cancer resections. In eight stoma creations, no scars were left other than the stoma hole. The overall conversion rate was 17% and the complication rate was 13% with no wound infections. In the 15 SILS colon resections, median operation time (171 min.), blood loss (0 ml), lymph node harvest (median n = 14), dissection quality (73% mesocolic), specimen length (23 cm), height of vascular pedicle (8 cm) and hospital stay (three days) were comparable to international reports. One serious complication of small bowel injury was seen, but this was the only complication (7%) in this group. CONCLUSION: With the proviso that our study population was limited in size, SILS seems equal to CLS in colorectal cancer surgery - although with a high conversion rate in the learning period, and it is a suitable procedure for minimal invasion in creation of a stoma.

Inadequate use of prophylaxis against venous thromboembolism in Danish medical departments.

INTRODUCTION: Venous thromboembolism (VTE) constitutes a major risk factor in hospitalized acutely ill medical patients. It has been demonstrated in numerous papers that by using different forms of prophylaxis, a significant reduction of the incidence of VTE can be achieved. In this article we assessed the tendencies in the use of venous thromboprophylaxis (TP) at internal medicine departments in Denmark. The results were compared with results from a similar study conducted in 2005. MATERIAL AND METHODS: All medical departments in Denmark received a two-page questionnaire on TP. The recipients were asked to evaluate the frequency, use of local instructions, form of administration, side-effects and duration of TP at their departments. One reminder was sent out. RESULTS: A total of 188 responses were received (90% response rate), 16 were excluded. Virtually all departments indicated that they used TP (92%). At intensive care units, the TP was used according to local guidelines at 77% of the wards and at the other subspecialties of internal medicine, TP was used in less than 50%. By far the most frequently used prophylaxis method was low molecular weight heparin, which was used by more than 80% of the departments. Side-effects, most often superficial bleeding and haematomas, were reported in 25% of the cases. The following serious side-effects were reported: heparininduced thrombocytopenia (n = 2), stroke (n = 1) and gastrointestinal bleeding (n = 3). No difference was observed between the hospitals of larger cities and those of smaller cities. CONCLUSION: In Denmark, no significant increase in the use of TP at internal medicine departments has been observed since 2005. The guideline's strong recommendation of TP is still not reflected in daily practice. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.