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.

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.

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.

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.

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.

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.

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: The presence of bowel contents during colorectal surgery has been related to anastomotic leakage, but the belief that mechanical bowel preparation (MBP) is an efficient agent against leakage and infectious complications is based on observational data and expert opinions only.An enema before the rectal surgery to clean the rectum and facilitate the manipulation for the mechanical anastomosis is used for many surgeons. This is analysed separately OBJECTIVES: To determine the security and effectiveness of MBP on morbidity and mortality in colorectal surgery. SEARCH STRATEGY: Publications describing trials of MBP before elective colorectal surgery were sought through searches of MEDLINE, EMBASE, LILACS, IBECS and The Cochrane Library; by handsearching relevant medical journals and conference proceedings, and through personal communication with colleagues.Searches were performed December 1, 2010. SELECTION CRITERIA: Randomised controlled trials (RCTs) including participants submitted for elective colorectal surgery. Eligible interventions included any type of MBP compared with no MBP. Primary outcomes included anastomosis leakage - both rectal and colonic - and combined figures. Secondary outcomes included mortality, peritonitis, reoperation, wound infection, extra-abdominal complications, and overall surgical site infections. DATA COLLECTION AND ANALYSIS: Data were independently extracted and checked. The methodological quality of each trial was assessed. Details of randomisation, blinding, type of analysis, and number lost to follow up were recorded. For analysis, the Peto-Odds Ratio (OR) was used as the default (no statistical heterogeneity was observed). MAIN RESULTS: At this update six trials and a new comparison (Mechanical bowel preparation versus enema) were added. Altogether eighteen trials were analysed, with 5805 participants; 2906 allocated to MBP (Group A), and 2899 to no preparation (Group B), before elective colorectal surgery.For the comparison Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation results were:1. Anastomotic leakage for low anterior resection: 8.8% (38/431) of Group A, compared with 10.3% (43/415) of Group B; Peto OR 0.88 [0.55, 1.40].2. Anastomotic leakage for colonic surgery: 3.0% (47/1559) of Group A, compared with 3.5% (56/1588) of Group B; Peto OR 0.85 [0.58, 1.26].3. Overall anastomotic leakage: 4.4% (101/2275) of Group A, compared with 4.5% (103/2258) of Group B; Peto OR 0.99 [0.74, 1.31].4. Wound infection: 9.6% (223/2305) of Group A, compared with 8.5% (196/2290) of Group B; Peto OR 1.16 [0.95, 1.42].Sensitivity analyses did not produce any differences in overall results.For the comparison Mechanical Bowel Preparation (A) Versus Rectal Enema (B) results were:1. Anastomotic leakage after rectal surgery: 7.4% (8/107) of Group A, compared with 7.9% (7/88) of Group B; Peto OR 0.93 [0.34, 2.52].2. Anastomotic leakage after colonic surgery: 4.0% (11/269) of Group A, compared with 2.0% (6/299) of Group B; Peto OR 2.15 [0.79, 5.84].3. Overall anastomotic leakage: 4.4% (27/601) of Group A, compared with 3.4% (21/609) of Group B; Peto OR 1.32 [0.74, 2.36].4. Wound infection: 9.9% (60/601) of Group A, compared with 8.0% (49/609) of Group B; Peto OR 1.26 [0.85, 1.88]. AUTHORS' CONCLUSIONS: Despite the inclusion of more studies with a total of 5805 participants, there is no statistically significant evidence that patients benefit from mechanical bowel preparation, nor the use of rectal enemas. In colonic surgery the bowel cleansing can be safely omitted and induces no lower complication rate. The few studies focused in rectal surgery suggested that mechanical bowel preparation could be used selectively, even though no significant effect was found. Further research on patients submitted for elective rectal surgery, below the peritoneal verge, in whom bowel continuity is restored, and studies with patients submitted to laparoscopic surgeries are still warranted.

Data completeness can be optimized in clinical databases.

INTRODUCTION: The aim of the present paper was to analyse the incidence of and reasons for data incompleteness in reporting of colorectal cancer from a single department to a national database. MATERIAL AND METHODS: A list of errors comparing the database with the National Patient Registry is drawn up monthly and has been used for data completeness analysis for several years as part of the department's daily routine. In May 2009, this system was revised and we identified a number of new errors which we previously thought had been corrected. The nature of these errors has been analysed in detail. RESULTS: According to the National Patients Registry, a total of 1,530 patients were treated for a first-time colorectal cancer. In 60 cases (3.9%) patients were missing in the database. Erroneous registration of the diagnosis in the National Patient Registry on the part of the department was the primary reason why data were missing. This was followed by clerical errors at the department. All mistakes were explainable, but changes in the registry structure prevented some of the mistakes discovered from being corrected retrospectively. CONCLUSION: The number of missing patients in the database could be minimized by a meticulous effort at controlling data and comparing them with data in national registries.

Acceptable results using plug for the treatment of complex anal fistulas.

INTRODUCTION: The management of complex fistula-in-ano remains a surgical challenge. Previously published studies on the treatment of fistula-in-ano with the anal fistula plug (AFP) have reported a success rate reaching 35-87%. The aim of this study was to assess the results of the AFP procedure in a group of Danish patients with complex fistulas, and to analyse if the results were compatible with previous international findings. MATERIAL AND METHODS: A retrospective analysis of prospectively collected data was performed for 37 consecutive patients treated with the Surgisis AFP plug for complex fistula-in-ano at the Surgical Department of Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, between June 2006 and April 2010. Surgery and evaluation were performed by one of two specially trained proctologists. RESULTS: The success rate per patient was 45.9% (17/37) and the success rate per procedure was 44.7% (17/38). A total of 40 fistulas were treated with the AFP and the success rate per fistula was 47.5% (19/40). Plug dislodgement occurred after 28.9% of the procedures, thereby accounting for 52.4% of the failed AFP procedures (11/38). No patients experienced any change in continence after the procedure. CONCLUSION: We found a patient cure rate of 45.9% which is in accordance with previously reported patient cure rates of 35-87%. Current knowledge suggests that the AFP is a good choice for first-line management of complex fistula-in-ano, but further evaluation is needed.

Use of preoperative bowel preparation in elective colorectal surgery in Denmark remains high.

INTRODUCTION: Previous studies have shown that preoperative bowel preparation does not influence the frequency of postoperative complications after elective open colonic resections. The Danish Colorectal Cancer Group (DCCG) recommends that mechanical bowel preparation (MBP) should be omitted prior to elective colonic resections. Several surveys show that most surgeons use MBP before colorectal surgery. The aim of this survey was to investigate the use of preoperative bowel preparation in elective colonic and rectal resections in Denmark. MATERIAL AND METHODS: The survey was conducted in 2009. A questionnaire on the use of preoperative bowel preparation in elective colonic and rectal resections performed in 2008 was sent to all the departments of surgery that perform colorectal surgery in Denmark. RESULTS: 34% of the patients received bowel preparation before open colonic resection compared with 81% before open rectal resection. Overall, the frequency of bowel preparation was significantly higher in laparoscopic (63%) than in open surgery (50%). CONCLUSION: MBP before elective open colonic resections remains widely used despite the national DCCG guideline. MBP before laparoscopic colorectal resections was more frequently used than before open colorectal resections as MBP before rectal resections was more frequently used than before colonic resections. The need for preoperative bowel preparation in these procedures has yet to be determined. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

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.

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.

Reconstruction of the pelvic floor with a biological mesh after abdominoperineal excision for rectal cancer.

AIM: The aim of the study is to describe the results of reconstruction of the pelvic floor by using an absorbable biological mesh after having performed an abdomino-perineal resection with excision of whole of the pelvic floor for rectal cancer MATERIAL AND METHODS: Eleven consecutive patients had reconstruction of the pelvic floor after abdominoperineal excision (APR) with a biological mesh. The peri- and postoperative courses were registered in a prospective database. Six patients received preoperative radiochemotherapy. RESULTS: One patient had the mesh removed due to infection and later developed local recurrence. The rest had an uneventful postoperative course despite more pain than is usually experienced in the perineal wound after traditional APR. CONCLUSION: The use of a biological mesh for pelvic floor reconstruction is feasible with satisfactory results. A randomised trial is warranted in order to evaluate this technique properly.

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: The presence of bowel contents during surgery has been related to anastomotic leakage, but the belief that mechanical bowel preparation (MBP) is an efficient agent against leakage and infectious complications is based on observational data and expert opinions only. OBJECTIVES: To determine the security and effectiveness of MBP on morbidity and mortality in colorectal surgery. SEARCH STRATEGY: Publications describing trials of MBP before elective colorectal surgery were sought through searches of MEDLINE, EMBASE, LILACS, and The Cochrane Library; by handsearching relevant medical journals and conference proceedings, and through personal communication with colleagues.Searches were performed March 13, 2008. SELECTION CRITERIA: Randomised controlled trials (RCTs) including participants submitted for elective colorectal surgery. Eligible interventions included any type of MBP compared with no MBP. Primary outcomes included anastomosis leakage - both rectal and colonic - and combined figures. Secondary outcomes included mortality, peritonitis, reoperation, wound infection, extra-abdominal complications, and overall surgical site infections. DATA COLLECTION AND ANALYSIS: Data were independently extracted and checked. The methodological quality of each trial was assessed. Details of randomisation, blinding, type of analysis, and number lost to follow up were recorded. For analysis, the Peto-Odds Ratio (OR) was used as the default (no statistical heterogeneity was observed). MAIN RESULTS: Four new trials were included at this update (total 13 RCTs with 4777 participants; 2390 allocated to MBP (Group A), and 2387 to no preparation (Group B), before elective colorectal surgery) .Anastomotic leakage occurred:(i) in 10.0% (14/139) of Group A, compared with 6.6% (9/136) of Group B for low anterior resection; Peto OR 1.73 (95% confidence interval (CI): 0.73 to 4.10).(ii) in 2.9% (32/1226) of Group A, compared with 2.5% (31/1228) of Group B for colonic surgery; Peto OR 1.13 (95% CI: 0.69 to 1.85). Overall anastomotic leakage occurred in 4.2% (102/2398) of Group A, compared with 3.4% (82/2378) of Group B; Peto OR 1.26 (95% CI: 0.941 to 1.69). Wound infection occurred in 9.6% (232/2417) of Group A, compared with 8.3% (200/2404) of Group B; Peto OR 1.19 (95% CI: 0.98 to 1.45). Sensitivity analyses did not produce any differences in overall results. AUTHORS' CONCLUSIONS: There is no statistically significant evidence that patients benefit from MBP. The belief that MBP is necessary before elective colorectal surgery should be reconsidered. Further research on patients submitted for elective colorectal surgery in whom bowel continuity is restored, with stratification for colonic and rectal surgery, is still warranted.

Prolonged thromboprophylaxis with low molecular weight heparin for abdominal or pelvic surgery.

BACKGROUND: Major abdominal and pelvic surgery carries a high risk of venous thromboembolism (VTE). The efficacy of thromboprophylaxis with low-molecular weight heparin (LMWH) administered during the in-hospital period is well documented, but the optimal duration of thromboprophylaxis after surgery remains controversial. Some studies suggest that patients undergoing major abdominal surgery benefit from prolongation of the thromboprophylaxis to 1 month after surgery. No systematic review on prolonged thromboprophylaxis after major abdominal or pelvic surgery has been published. OBJECTIVES: To evaluate the efficacy and safety of prolonged thromboprophylaxis with LMWH for at least 1 month after abdominal or pelvic surgery with thromboprophylaxis administered during the in-hospital period only in preventing late VTE. SEARCH STRATEGY: Electronic searches were performed January 2008 in the Medline, Embase, Lilacs, and the Cochrane Central Register of Controlled Trials. Abstract books from major congresses addressing thromboembolism were hand searched, as were reference lists from studies of relevance. SELECTION CRITERIA: We assessed both randomised and non-randomised controlled clinical trials comparing prolonged thromboprophylaxis with any anti-thrombotic agent with placebo and/or thromboprophylaxis during the admission period only. The patient population in the trials were patients undergoing abdominal or pelvic surgery. The outcome measures included VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE)) as assessed by objective means (ascending bilateral venography, ultrasonography, pulmonary ventilation/perfusion scintigraphy, spiral CT scan or autopsy). Studies exclusively reporting on clinical diagnosis of VTE, without objective confirmation were excluded. DATA COLLECTION AND ANALYSIS: The identification of studies and data extraction were performed by the authors. Outcomes were VTE (DVT or PE) assessed by objective means. Safety outcome were defined as bleeding complications and mortality within 3 months after surgery. MAIN RESULTS: The search exclusively detected trials evaluating prolonged thromboprophylaxis with LMWH as compared to control or placebo. 133 studies were found in the searches, of which only 4 were found eligible for inclusion, and 129 were excluded. The incidence of overall VTE after major abdominal or pelvic surgery was 14.3% (95% confidence interval 11.2% - 17.8%) in the control group as compared to 6.1% (95% CI 4.0% - 8.7%) in the patients receiving out-of-hospital LMWH. This difference was statistically significant, Peto Odds Ratio 0.41 (95% CI 0.26 -0.63), P < 0.0005. Prolonged thromboprophylaxis with LMWH was also associated with a statistically significant reduction of even the incidence of symptomatic VTE from 1.7% (95% CI 0.8% - 3.4%) in the control group to 0.2 % (95% CI 0.0% - 1.2%) in patients receiving prolonged thromboprophylaxis, Peto Odds ratio 0.22 (95% CI 0.06 -0.80), P = 0.02. The respective incidence of bleeding in the control and LMWH group were 3.7% (95% CI 2.4% -5.5%) and 4.1% (95% CI 2.7% - 6.0%), Peto Odds ratio 1.11 (95% CI 0.62 - 1.97), P = 0.73. There was no significant heterogeneity detected as regards to outcome parameters reported in the included trials. AUTHORS' CONCLUSIONS: Prolonged thromboprophylaxis with LMWH significantly reduces the risk of VTE compared to thromboprophylaxis during hospital admittance only, without increasing bleeding complications after major abdominal or pelvic surgery.

Risk factors for mortality and postoperative complications after gastrointestinal surgery.

BACKGROUND: Predictors of a poor surgical outcome are numerous, of which some are well-defined. We aimed to assess risk factors predictive of poor surgical outcome across different gastrointestinal operations related to the patient, the disease, the treatment, and the organization of care. METHODS: Data from 5,255 unselected patients undergoing open gastrointestinal surgery from 1995 through 1998 was prospectively recorded in a clinical database and validated. The database embraced variables related to patient history, preoperative clinical condition, operative findings and complexity, and the surgeon's training. Variables predictive of mortality and complications occurring within 30 days after surgery were assessed by multiple logistic regression analysis. RESULTS: After elective operation, the 30-day mortality was 2.8% and major complications occurred in 11.5% of the patients. The corresponding figures in emergency surgery were 13.8% and 30.1%. Independent of elective or emergency surgery, dependent functional status, and type of operation were associated with postoperative mortality. Comorbidity, type of operation, blood loss, and reoperation were predictors of complications regardless of elective or emergency operation. In elective surgery, predictors of poor surgical outcome were high age, comorbidity, malignancy, and the surgeons training, whereas abnormal vital signs values and peritonitis were predictors of poor outcome after emergency surgery. CONCLUSION: Premorbid factors, characteristics of the disease, the patients' preoperative condition, operative factors, and the surgeon's training are all associated with surgical outcome across different gastrointestinal operations and should be assessed when auditing surgical outcome.