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Objective: To assess the impact of surgical technique in regard to morbidity and mortality after neoadjuvant treatment for esophageal cancer., Background: The SAKK trial 75/08 was a multicenter phase III trial (NCT01107639) comparing induction chemotherapy followed by chemoradiation and surgery in patients with locally advanced esophageal cancer., Methods: Patients in the control arm received induction chemotherapy with cisplatin and docetaxel, followed by concomitant chemoradiation therapy with cisplatin, docetaxel, and 45Gy. In the experimental arm, the same regimen was used with addition of cetuximab. After completion of neoadjuvant treatment, patients underwent esophagectomy. The experimental arm received adjuvant cetuximab. Surgical outcomes and complications were prospectively recorded and analyzed., Results: Total of 259 patients underwent esophagectomy. Overall complication rate was 56% and reoperation rate was 15% with no difference in complication rates for transthoracic versus transhiatal resections (56% vs 54%, P = 0.77), nor for video assisted thoracic surgeries (VATS) versus open transthoracic resections (67% vs 55%, P = 0.32). There was a trend to higher overall complication rates in squamous cell carcinoma versus adenocarcinoma (65% vs 51%, P = 0.035), and a significant difference in ARDS in squamous cell carcinoma with 14% versus 2% in adenocarcinoma (P = 0.0002). For patients with involved lymph nodes, a lymph node ratio of ≥0.1 was an independent predictor of PFS (HR 2.5, P = 0.01) and OS (HR 2.2, P = 0.03)., Conclusions: This trial showed no difference in surgical complication rates between transthoracic and transhiatal resections. For patients with involved lymph nodes, lymph node ratio was an independent predictor of progression free survival and overall survival., Competing Interests: The authors report no conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Patients with diabetes mellitus type 2 (DM2) inhere impaired peripheral insulin action leading to higher perioperative morbidity and mortality rates, with hospital-acquired infections being one important complication. This post hoc, observational study aimed to analyze the impact of surgical and metabolic stress as defined by the surrogate marker hemoglobin A1c (HbA1c), in relation to self-reported DM2, on perioperative infection rates in a subcohort of the Surgical Site Infection (SSI) Trial population., Methods: All patients of the SSI study were screened for HbA1c levels measured perioperatively for elective or emergency surgery and classified according to the American Diabetes Association HbA1c cutoff values. SSI and nosocomial infections, self-reported state of DM2 and type of surgery (minor, major) were assessed., Results: HbA1c levels were measured in 139 of 5175 patients (2.7%) of the complete SSI study group. Seventy patients (50.4%) self-reported DM2, while 69 (49.6%) self-reported to be non-diabetic. HbA1c levels indicating pre-diabetes were found in 48 patients (34.5%) and diabetic state in 64 patients (46%). Forty-five patients of the group self-reporting no diabetes (65.2%) were previously unaware of their metabolic derangement (35 pre-diabetic and 10 diabetic). Eighteen infections were detected. Most infections (17 of 18 events) were found in patients with HbA1c levels indicating pre-/diabetic state. The odds for an infection was 3.9-fold (95% CI 1.4 to 11.3) higher for patients undergoing major compared to minor interventions. The highest percentage of infections (38.5%) was found in the group of patients with an undiagnosed pre-/diabetic state undergoing major surgery., Conclusions: These results encourage investment in further studies evaluating a more generous and specific use of HbA1c screening in patients without self-reported diabetes undergoing major surgery. Trial registration Clinicaltrials.gov identifier: NCT01790529., (© 2021. The Author(s).)

Background: Antimicrobial prophylaxis (AMP) adjustment according to bodyweight to prevent surgical-site infections (SSI) is controversial. The impact of weight-adjusted AMP dosing on SSI rates was investigated here., Methods: Results from a first study of patients undergoing visceral, vascular or trauma operations, and receiving standard AMP, enabled retrospective evaluation of the impact of bodyweight and BMI on SSI rates, and identification of patients eligible for weight-adjusted AMP. In a subsequent observational prospective study, patients weighing at least 80 kg were assigned to receive double-dose AMP. Risk factors for SSI, including ASA classification, duration and type of surgery, wound class, diabetes, weight in kilograms, BMI, age, and AMP dose, were evaluated in multivariable analysis., Results: In the first study (3508 patients), bodyweight and BMI significantly correlated with higher rates of all SSI subclasses (both P < 0.001). An 80-kg cut-off identified patients receiving single-dose AMP who were at higher risk of SSI. In the prospective study (2161 patients), 546 patients weighing 80 kg or more who received only single-dose AMP had higher rates of all SSI types than a group of 1615 who received double-dose AMP (odds ratio (OR) 4.40, 95 per cent c.i. 3.18 to 6.23; P < 0.001). In multivariable analysis including 5021 patients from both cohorts, bodyweight (OR 1.01, 1.00 to 1.02; P = 0.008), BMI (OR 1.01, 1.00 to 1.02; P = 0.007) and double-dose AMP (OR 0.33, 0.23 to 0.46; P < 0.001) among other variables were independently associated with SSI rates., Conclusion: Double-dose AMP decreases SSI rates in patients weighing 80 kg or more., (© The Author(s) 2020. Published by Oxford University Press on behalf of BJS Society Ltd.)

Background/aim: To investigate whether teaching procedures and surgical experience are associated with surgical site infection (SSI) rates., Methods: This prospective cohort study of patients undergoing general, orthopedic trauma and vascular surgery procedures was done between 2012 and 2015 at two tertiary care hospitals in Switzerland/Europe., Results: Out of a total of 4560 patients/surgeries, 1403 (30.8%) were classified as teaching operations. The overall SSI rate was 5.1% (n = 233). Teaching operations (OR 0.78, 95% CI 0.57-1.07, p = 0.120), junior surgeons (OR 0.80, 95% CI 0.55-1.15, p = 0.229) and surgical experience (OR 0.997, 95% CI 0.982-1.012, p = 0.676) were overall not independently associated with the odds of SSI. However, for surgeons' seniority and experience, these associations depended on the duration of surgery., Conclusions: In procedures of shorter and medium duration, teaching procedures and junior as well as less experienced surgeons are not independently associated with increased odds of SSI., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Surgical site infections (SSIs) are common surgical complications that lead to increased costs. Depending on payer type, however, they do not necessarily translate into deficits for every hospital., Objective: We investigated how surgical site infections (SSIs) influence the contribution margin in 2 reimbursement systems based on diagnosis-related groups (DRGs)., Methods: This preplanned observational health cost analysis was nested within a Swiss multicenter randomized controlled trial on the timing of preoperative antibiotic prophylaxis in general surgery between February 2013 and August 2015. A simulation of cost and income in the National Health Service (NHS) England reimbursement system was conducted., Results: Of 5,175 patients initially enrolled, 4,556 had complete cost and income data as well as SSI status available for analysis. SSI occurred in 228 of 4,556 of patients (5%). Patients with SSIs were older, more often male, had higher BMIs, compulsory insurance, longer operations, and more frequent ICU admissions. SSIs led to higher hospital cost and income. The median contribution margin was negative in cases of SSI. In SSI cases, median contribution margin was Swiss francs (CHF) -2045 (IQR, -12,800 to 4,848) versus CHF 895 (IQR, -2,190 to 4,158) in non-SSI cases. Higher ASA class and private insurance were associated with higher contribution margins in SSI cases, and ICU admission led to greater deficits. Private insurance had a strong increasing effect on contribution margin at the 10th, 50th (median), and 90th percentiles of its distribution, leading to overall positive contribution margins for SSIs in Switzerland. The NHS England simulation with 3,893 patients revealed similar but less pronounced effects of SSI on contribution margin., Conclusions: Depending on payer type, reimbursement systems with DRGs offer only minor financial incentives to the prevention of SSI.

Background: Long-duration surgery requires repeated administration of antimicrobial prophylaxis (amp). Amp "redosing" reduces incidence of surgical site infections (SSI) but is frequently omitted. Clinical relevance of redosing timing needs to be investigated. Here, we evaluated the effects of compliance with amp redosing and its timing on SSI incidence in prolonged duration surgery., Methods: Data from >9000 patients undergoing visceral, trauma, or vascular surgery with elective or emergency treatment in two tertiary referral Swiss hospitals were analyzed. All patients had to receive amp preoperatively and redosing, if indicated. Antibiotics used were cefuroxime (1.5 or 3 g, if weight >80 kg), or cefuroxime and metronidazole (1.5 and 0.5 g, or 3 and 1 g doses, if weight >80 kg). Alternatively, in cases of known or suspected allergies, vancomycin (1 g), gentamicin (4 mg/Kg), and metronidazole or clindamycin (300 mg) with or without ciprofloxacin (400 mg) were used. Association of defined parameters, including wound class, ASA scores, and duration of operation, with SSI incidence was explored., Results: In the whole cohort, SSI incidence significantly correlated with duration of surgery (ρ = 0.73, p = 0.031). In 593 patients undergoing >240 min long interventions, duration of surgery was the only parameter significantly (p < 0.001) associated with increased SSI risk, whereas wound class, ASA scores, treatment areas, and emergency versus elective hospital entry were not. Redosing significantly reduced SSI incidence as shown by multivariate analysis (OR 0.60, 95% CI 0.37-0.96, p = 0.034), but exact timing had no significant impact., Conclusions: Long-duration surgery associates with higher SSI incidence. Irrespective of its exact timing, amp redosing significantly decreases SSI risk.

Background: Functional outcomes of different reconstruction techniques have an impact on patients' quality of life (QoL), but information on long-term QoL is lacking. We compared QoL among three reconstruction techniques after total mesorectal excision (TME)., Methods: Quality of life was assessed within a randomized, multicenter trial comparing rectal surgery using side-to-end anastomosis (SEA), colon J-pouch (CJP), and straight colorectal anastomosis (SCA) by the Functional Assessment of Cancer Therapy-Colorectal scale (FACT-C) before randomization and every 6 months up to 2 years post-TME. The primary QoL endpoint was the change in the Trial Outcome Index (TOI), including the FACT-C subscales of physical and functional well-being and colorectal cancer symptoms (CSS), from baseline to month 12. Pair-wise comparisons of changes from baseline (presurgery) to each timepoint between the three arms were analyzed by Mann-Whitney tests., Results: For the QoL analysis, 257 of 336 randomized patients were in the per protocol evaluation (SEA = 95; CJP = 63; SCA = 99). Significant differences between the reconstruction techniques were found for selected QoL scales up to 12 months, all in favor of CJP. Patients with SEA or SCA reported a clinically relevant deterioration for TOI and CSS at 6 months, those with SCA for CSS also at 12 months after TME. Patients with CJP remained stable., Conclusions: Although the three reconstruction techniques differ in their effects on QoL at months 6 and 12, these differences did not persist over the whole observation period of 24 months. Patients with a colon J-pouch may benefit with respect to QoL in the short-term.

Objective: To compare, in a phase 3, prospective, randomized, multi-center clinical trial functional outcome of reconstruction procedures following total mesorectal excision (TME)., Summary Background Data: Intestinal continuity reconstruction following TME is accompanied by postoperative defecation dysfunctions known as "anterior resection syndrome." Commonly used reconstruction techniques are straight colorectal anastomosis (SCA), colon J -pouch (CJP), and side-to-end anastomosis (SEA). Comparison of their functional outcomes in prospective, randomized, multi-center studies, including long-term assessments, is lacking., Methods: Patients requiring TME for histologically proven rectal tumor, with or without neoadjuvant treatment, age ≥ 18 years, normal sphincter function without history of incontinence, any pretreatment staging or adenoma, expected R0-resection, were randomized for standardized SCA, CJP, or SEA procedures. Primary endpoint was comparison of composite evacuation scores 12 months after TME. Comparison of composite evacuation and incontinence scores at 6, 18 and 24 months after surgery, morbidity, and overall survival represented secondary endpoints. Analysis was based on "per protocol" (PP) population, fully complying with trial requirements, and intention-to treat (ITT) population., Results: Three hundred thirty-six patients from 15 hospitals were randomized. PP population included 257 patients (JCP = 63; SEA = 95; SCA = 99). Composite evacuation scores of PP and ITT populations did not show statistically significant differences among the 3 groups at any time point. Similarly, composite incontinence scores for PP and ITT populations showed no statistically significant difference among the 3 trial arms at any time point., Conclusions: Within boundaries of investigated procedures, surgeons in charge may continue to perform reconstruction of intestinal continuity following TME at their technical preference.

Background: Surgical drains are widely used despite limited evidence in their favor. This study describes the associations between drains and surgical site infections (SSI)., Methods: This prospective observational double center study was performed in Switzerland between February 2013 and August 2015., Results: The odds of SSI in the presence of drains were increased in general (OR 2.41, 95%CI 1.32-4.30, p = 0.004), but less in vascular and not in orthopedic trauma surgery. In addition to the surgical division, the association between drains and SSI depended significantly on the duration of surgery (p = 0.01) and wound class (p = 0.034). Furthermore, the duration of drainage (OR 1.24, 95%CI 1.15-1.35, p < 0.001), the number (OR 1.74, 95%CI 1.09-2.74, p = 0.019) and type of drains (open versus closed: OR 3.68, 95%CI 1.88, 6.89, p < 0.001) as well as their location (overall p = 0.002) were significantly associated with SSI., Conclusions: The general use of drains is discouraged. However, drains may be beneficial in specific surgical procedures., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: The long-term follow up data of 2 prospective phase II trials is reported (NCT00072033, NCT00445861), which investigated neoadjuvant chemoradiation followed by surgery in patients with esophageal carcinoma. Postoperative complications as well as prognostic factors and patterns of relapse during long-term observation are shown., Summary of Background Data: Long-term follow-up is often missing in the complex setting of multimodal treatments of esophageal carcinoma; this leads to rather undifferentiated follow-up guidelines for this tumor entity., Methods: In the first trial, patients received induction chemotherapy followed by chemoradiation and surgery. In the second trial, cetuximab was added to the same neoadjuvant treatment concomitant with induction chemotherapy and chemoradiation., Results: Eighty-two patients underwent surgery; the median follow-up time was 6.8 and 6.4 years, respectively. Fifty-five percent were diagnosed with adenocarcinoma, 80% clinically node-positive, 68% received transthoracic esophagectomy, and 32% transhiatal or transmediastinal resection. Five patients died postoperatively in-hospital due to complications (6%). The median overall survival was 4.3 years, and the median event-free survival was 2.7 years. Patients with adenocarcinoma rarely relapsed after a 3-year event-free survival. Whereas patients with residual tumor cells after neoadjuvant therapy primarily experienced relapse within the first 2 postoperative years, this in contrast to several patients with complete remission who also experienced late relapses 4 years after surgery., Conclusion: After curative surgery in a multimodal setting, the histological type and the response to neoadjuvant therapy predicted the time frame of relapse; this knowledge may influence further follow-up guidelines for esophageal carcinoma.

Background: Surgical site infections (SSI) are a major cause of morbidity and mortality in surgical patients. Postoperative and total hospital length of stay (LOS) are known to be prolonged by the occurrence of SSI. Preoperative LOS may increase the risk of SSI. This study aims at identifying the associations of pre- and postoperative LOS in hospital and intensive care with the occurrence of SSI., Methods: This observational cohort study includes general, orthopedic trauma and vascular surgery patients at two tertiary referral centers in Switzerland between February 2013 and August 2015. The outcome of interest was the 30-day SSI rate., Results: We included 4596 patients, 234 of whom (5.1%) experienced SSI. Being admitted at least 1 day before surgery compared to same-day surgery was associated with a significant increase in the odds of SSI in univariate analysis (OR 1.65, 95% CI 1.25-2.21, p < 0.001). More than 1 day compared to 1 day of preoperative hospital stay did not further increase the odds of SSI (OR 1.08, 95% CI 0.77-1.50, p = 0.658). Preoperative admission to an intensive care unit (ICU) increased the odds of SSI as compared to hospital admission outside of an ICU (OR 2.19, 95% CI 0.89-4.59, p = 0.057). Adjusting for potential confounders in multivariable analysis weakened the effects of both preoperative admission to hospital (OR 1.38, 95% CI 0.99-1.93, p = 0.061) and to the ICU (OR 1.89, 95% CI 0.73-4.24, p = 0.149)., Conclusion: There was no significant independent association between preoperative length of stay and risk of SSI while SSI and postoperative LOS were significantly associated.

Background: Several studies investigated the impact of preoperative weight loss on bariatric surgery outcome. However, they mostly focus on small groups of patients or lack updated statistical support., Methods: Two hundred and thirty-nine consecutive patients undergoing laparoscopic, proximal Roux-en-Y gastric bypass at our institution between September 2009 and November 2015 were studied. Patients were operated by the same surgeon, applying a standardized technique and followed a 500-kcal/day preoperative diet, starting 14 days before surgery. Body weight was measured before diet, at surgery, and at least three times postoperatively. A linear mixed effects (LME) model and Benedict and Harris formula were used to assess association of pre- and postoperative weight loss up to 2 years postoperatively., Results: Patients' (184 females) initial weight was 121.7 kg (females 117.2 kg; males 136.6 kg). They lost on average 5.3 kg (females 4.7 kg; males 7.0 kg) pre- and 36.8 kg (females 36.7 kg; males 37.0 kg) postoperatively, within 2 years. Average excess weight loss (EWL) was 67.2% (females 66.6%; males 67.4%). In 205 patients (154 females), EWL exceeded 50%. Longitudinal data analysis according to LME showed a significant impact of pre- on postoperative weight loss (p < 0.001, likelihood-ratio test, LRT). These effects were undetectable if patients were evaluated by non-parametric analysis based on application of the Benedict and Harris formula., Conclusions: Preoperative dietary success is associated with postoperative weight loss. Effects predicted by the LME model are most pronounced in the first 4-6 months after surgery and are fading away within 24 months postoperatively. External factors not considered in this study might dominate in later phases.

Background: Routine preoperative blood work is not recommended but selected biochemical markers may predict the risk of surgical site infection (SSI). This study examines the association between preoperative biochemical markers and the risk of SSI., Methods: This observational cohort study, nested in a randomized controlled trial, was conducted at two tertiary referral centers in Switzerland., Results: 122 (5.8%) of 2093 patients experienced SSI. Preoperative increasing levels of albumin (OR 0.93), CRP (OR 1.34), hemoglobin (OR 0.87) and eGFR (OR 0.90) were significantly associated with the odds of SSI. The same accounts for categorized parameters. The highest area under the curve from ROC curves was 0.62 for albumin. Positive predictive values ranged from 6.4% to 9.5% and negative predictive values from 94.8% to 95.7%. The association of CRP, mildly and moderately decreased eGFR and hemoglobin with the odds of SSI remained significant on multivariate analysis., Conclusions: Our results do not support generally delaying elective surgery based on preoperative blood results. However, it may be considered in situations with potentially severe sequelae of SSI., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background Medication discrepancies often occur at transition of care such as hospital admission and discharge. Obtaining a complete and accurate medication history on admission is essential as further treatment is based on it. Objective The goal of this study was to reduce the proportion of patients with at least one medication discrepancy in the medication history at admission by implementing an IT-guided checklist. Setting Surgery ward focused on vascular and visceral surgery at a Swiss Cantonal Hospital. Method The study was divided into two phases, before and after implementation of an IT-guided checklist. For both phases a pharmacist collected and compared the medication history (defined as gold standard) with that of the admitting physician. Medication discrepancies were subdivided in omissions and commissions, incorrect medications or dose changes, and incorrect dosage forms or strength. Main outcome measure The proportion of patients with at least one medication discrepancy in the medication history before and after intervention was assessed. Results Out of 415 admissions, 228 patients that met the inclusion criteria were enrolled in the study, 113 before and 115 patients after intervention. After intervention, medication discrepancies declined from 69.9 to 29.6% (p < 0.0001) of patients, the mean medication discrepancy per patient was reduced from 2.3 to 0.6 (p < 0.0001), and the most common error, omission of a regularly used medication, was reduced from 76.4 to 44.1% (p < 0.001). Conclusion The implementation of the IT-guided checklist is associated with a significant reduction of medication discrepancies at admission and potentially improves the medication safety for the patient.

Background: Based on observational studies, administration of surgical antimicrobial prophylaxis (SAP) for the prevention of surgical site infection (SSI) is recommended within 60 min before incision. However, the precise optimum timing is unknown. This trial compared early versus late administration of SAP before surgery., Methods: In this phase 3 randomised controlled superiority trial, we included general surgery adult inpatients (age ≥18 years) at two Swiss hospitals in Basel and Aarau. Patients were randomised centrally and stratified by hospital according to a pre-existing computer-generated list in a 1:1 ratio to receive SAP early in the anaesthesia room or late in the operating room. Patients and the outcome assessment team were blinded to group assignment. SAP consisted of single-shot, intravenous infusion of 1·5 g of cefuroxime, a commonly used cephalosporin with a short half-life, over 2-5 min (combined with 500 mg metronidazole in colorectal surgery). The primary endpoint was the occurrence of SSI within 30 days of surgery. The main analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01790529., Findings: Between Feb 21, 2013, and Aug 3, 2015, 5580 patients were randomly assigned to receive SAP early (2798 patients) or late (2782 patients). 5175 patients (2589 in the early group and 2586 in the late group) were analysed. Median administration time was 42 min before incision in the early group (IQR 30-55) and 16 min before incision in the late group (IQR 10-25). Inpatient follow-up rate was 100% (5175 of 5175 patients); outpatient 30-day follow-up rate was 88·8% (4596 of 5175), with an overall SSI rate of 5·1% (234 of 4596). Early administration of SAP did not significantly reduce the risk of SSI compared with late administration (odds ratio 0·93, 95% CI 0·72-1·21, p=0·601)., Interpretation: Our findings do not support any narrowing of the 60-min window for the administration of a cephalosporin with a short half-life, thereby obviating the need for increasingly challenging SAP timing recommendations., Funding: Swiss National Science Foundation, Hospital of Aarau, University of Basel, Gottfried und Julia Bangerter-Rhyner Foundation, Hippocrate Foundation, and Nora van Meeuwen-Häfliger Foundation., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Introduction: Laparoscopy has become the gold standard for many abdominal procedures. Among young surgeons, experience in laparoscopic surgery increasingly outweighs experience in open surgery. This study was conducted to compare residents' performance in laparoscopic versus open bench-model task., Methods: In an international surgical skills course, we compared trainees' performance in open versus laparoscopic cholecystectomy in a cadaveric animal bench-model. Both exercises were evaluated by board-certified surgeons using an 8-item checklist and by the trainees themselves., Results: 238 trainees with a median surgical experience of 24 months (interquartile range 14-48) took part. Twenty-two percent of the trainees had no previous laparoscopic and 62% no previous open cholecystectomy experience. Significant differences were found in the overall score (median difference of 1 (95% CI: 1, 1), p < 0.001), gallbladder perforation rate (73% vs. 29%, p < 0.001), safe dissection of the Calot's triangle (98% vs. 90%, p = 0.001) and duration of surgery (42 (13) minutes vs. 26 (10) minutes (mean differences 17.22 (95% CI: 15.37, 19.07), p < 0.001)), all favouring open surgery. The perforation rate in open and laparoscopic cholecystectomies was not consistently decreasing with increasing years of experience or number of previously performed procedures. Self-assessment was lower than the assessment by board-certified surgeons., Conclusion: Despite lower experience in open compared to laparoscopic cholecystectomy, better performance was observed in open task. It may be explained by a wider access with easier preparation. Open cholecystectomy is the rescue manoeuvre and therefore, it is important to provide also enough training opportunities in open surgery., (Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.)

Background: Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis., Methods/design: In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years., Discussion: The results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics., Trial Registration: This trial is registered on ClinicalTrials.gov under the identifier NCT01790529.

Objective: To evaluate the feasibility of implementation of the refined window for routine antimicrobial prophylaxis (RAP) of 30-74 minutes before skin incision compared to the World Health Organization (WHO) standard of 0-60 minutes., Design: Prospective study on timing of routine antimicrobial prophylaxis in 2 different time periods., Setting: Tertiary referral university hospital with 30,000 surgical procedures per year., Methods: In all consecutive vascular, visceral, and trauma procedures, the timing was prospectively recorded during a first time period of 2 years (A; baseline) and a second period of 1 year (B; after intervention). An intensive intervention program was initiated after baseline. The primary outcome parameter was timing; the secondary outcome parameter was surgical site infection (SSI) rate in the subgroup of patients undergoing cholecystectomy/colon resection., Results: During baseline time period A (3,836 procedures), RAP was administered 30-74 minutes before skin incision in 1,750 (41.0%) procedures; during time period B (1,537 procedures), it was administered in 914 (56.0%; [Formula: see text]). The subgroup analysis did not reveal a significant difference in SSI rate., Conclusions: This bundle of interventions resulted in a statistically significant improvement of timing of RAP even at a shortened window compared to the WHO standard.

Surgical site infections (SSIs) significantly increase post-operative morbidity and mortality. SSI surveillance is an established monitoring tool and reduces SSI rates. The purpose of this study was to compare prospective in-hospital SSI surveillance (I) by the surgical staff and (II) additionally by an infection control team (ICT). The reference method (III) was defined by data generated by the surgical team, supplemented by the ICT and completed by post-discharge surveillance with a post-operative follow-up of one year representing the sum of all available resources. During 24 months, all consecutive inpatient procedures (N=6283) were prospectively recorded by the surgical staff until patients' discharge (I). SSI rates were compared with the surveillance performed by the ICT (II) and with the reference method (III). The overall SSI rate (reference method) was 4.7% (N=293), of which 187 (63.8%) were detected in-hospital and 106 (36.2%) after discharge. (I) The surgical staff detected 91/187 (48.7%) of in-hospital SSIs [91/293 (31.0%) of the reference], (II) the ICT an additional 96/187 (51.3%) during hospitalisation [96/293 (32.8%) of the reference]. Further cross-checking as performed in the visceral surgery department increased the surgeons' detection rate (I) to 59/105 (56.2%) of in-hospital SSIs [59/147 (40.1%) of the reference]. SSI surveillance by the surgical staff detects almost half of all in-hospital SSIs and has the potential to increase the detection rate by simple interventions such as cross-checking. Such a relatively inexpensive surveillance system is an option for hospitals without an ICT or for low risk surgical procedures. Moreover, trends in SSI rates can easily be detected, allowing early intervention., (Copyright 2009 The Hospital Infection Society. Published by Elsevier Ltd. All rights reserved.)

Fecal incontinence is underestimated in its prevalence. Therapeutic approaches vary; in mild-to-moderate cases, dietary changes and biofeedback sessions accompanied by specific medications can achieve a salutary effect. In cases of severe fecal incontinence, a conservative approach is ineffective and surgical intervention is indicated. However, several technical innovations and devices enable surgeons to offer patients reliable solutions for this functional disorder. While dynamic graciloplasty uses native muscle contraction ability to function as a new sphincter, the artificial bowel sphincter achieves the same goal by an inflatable cuff. A novel approach, which is suitable for selected patients with muscular and neurological defects alike, is the sacral nerve stimulator. It is crucial to choose the right procedure as determined by the underlying pathology.

Background: The purpose of the study was to investigate allogeneic blood transfusion (ABT) and preoperative anemia as risk factors for surgical site infection (SSI)., Study Design and Methods: A prospective, observational cohort of 5873 consecutive general surgical procedures at Basel University Hospital was analyzed to determine the relationship between perioperative ABT and preoperative anemia and the incidence of SSI. ABT was defined as transfusion of leukoreduced red blood cells during surgery and anemia as hemoglobin concentration of less than 120 g/L before surgery. Surgical wounds and resulting infections were assessed to Centers for Disease Control standards., Results: The overall SSI rate was 4.8% (284 of 5873). In univariable logistic regression analyses, perioperative ABT (crude odds ratio [OR], 2.93; 95% confidence interval [CI], 2.1 to 4.0; p < 0.001) and preoperative anemia (crude OR, 1.32; 95% CI, 1.0 to 1.7; p = 0.037) were significantly associated with an increased odds of SSI. After adjusting for 13 characteristics of the patient and the procedure in multivariable analyses, associations were substantially reduced for ABT (OR, 1.25; 95% CI, 0.8 to 1.9; p = 0.310; OR, 1.07; 95% CI, 0.6 to 2.0; p = 0.817 for 1-2 blood units and >or=3 blood units, respectively) and anemia (OR, 0.91; 95% CI, 0.7 to 1.2; p = 0.530). Duration of surgery was the main confounding variable., Conclusion: Our findings point to important confounding factors and strengthen existing doubts on leukoreduced ABT during general surgery and preoperative anemia as risk factors for SSIs.

Hypothesis: Clinically apparent surgical glove perforation increases the risk of surgical site infection (SSI)., Design: Prospective observational cohort study., Setting: University Hospital Basel, with an average of 28,000 surgical interventions per year., Participants: Consecutive series of 4147 surgical procedures performed in the Visceral Surgery, Vascular Surgery, and Traumatology divisions of the Department of General Surgery., Main Outcome Measures: The outcome of interest was SSI occurrence as assessed pursuant to the Centers of Disease Control and Prevention standards. The primary predictor variable was compromised asepsis due to glove perforation., Results: The overall SSI rate was 4.5% (188 of 4147 procedures). Univariate logistic regression analysis showed a higher likelihood of SSI in procedures in which gloves were perforated compared with interventions with maintained asepsis (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.4-2.8; P < .001). However, multivariate logistic regression analyses showed that the increase in SSI risk with perforated gloves was different for procedures with vs those without surgical antimicrobial prophylaxis (test for effect modification, P = .005). Without antimicrobial prophylaxis, glove perforation entailed significantly higher odds of SSI compared with the reference group with no breach of asepsis (adjusted OR, 4.2; 95% CI, 1.7-10.8; P = .003). On the contrary, when surgical antimicrobial prophylaxis was applied, the likelihood of SSI was not significantly higher for operations in which gloves were punctured (adjusted OR, 1.3; 95% CI, 0.9-1.9; P = .26)., Conclusion: Without surgical antimicrobial prophylaxis, glove perforation increases the risk of SSI.

Background: Despite availability of other training forms, tutorial assistance cannot be entirely replaced in surgical education. Concerns exist that tutorial assistance may lead to an increased rate of surgical site infection (SSI). The purpose of the present study was to investigate whether the risk of SSI is higher after surgery with tutorial assistance than after surgery performed autonomously by a fully trained surgeon., Methods: All consecutive visceral, vascular, and traumatological inpatient procedures at a Swiss University Hospital were prospectively recorded during a 24-month period, and the patients were followed for 12 months to ascertain the occurrence of SSI. Using univariable and multivariable logistic regressions, we assessed the association of tutorial assistance surgery with SSI in 6,103 interventions., Results: Autonomously performed surgery was associated with SSI in univariable analysis (5.36% SSI vs. 3.81% for tutorial assistance, p = 0.006). In multivariable analysis, the odds of SSI for tutorial assistance was no longer significantly lower (Odds Ratio [OR] = 0.82; 95% Confidence Interval [CI]: 0.62-1.09; p = 0.163)., Conclusions: Surgical training does not lead to higher SSI rate if trainees are adequately supervised and interventions are carefully selected. Although other forms of training are useful, tutorial assistance in the operating room continues to be the mainstay of surgical education.

Objective: Research has shown 1.5 minutes of surgical hand antisepsis with alcohol-based hand rub to be at least as effective under experimental conditions as the 3-minute reference disinfection recommended by European Norm 12791. The aim of the present study was to validate the effectiveness of 1.5 minutes of surgical hand antisepsis in a clinical setting by comparing the effectiveness of 1.5- and 3-minute applications of alcohol-based hand rub (45% vol/vol 2-propanol, 30% vol/vol 1-propanol, and 0.2% mecetronium ethylsulphate)., Design: Prospective crossover trial in which each surgeon served as his or her own control, with individual randomization to the 1.5- or the 3-minute group during the first part of the trial., Setting: Basel University Hospital, Switzerland., Participants: Thirty-two surgeons with different levels of postdoctoral training., Methods: We measured the bactericidal effectiveness of 1.5 minutes and 3 minutes of surgical hand antisepsis with alcohol-based hand rub by assessing the mean (+/-SD) log10 number of colony-forming units before the application of hand rub (baseline), after the application of hand rub (immediate effect), and after surgery (sustained effect) so as to follow European Norm 12791 as closely as possible., Results: The immediate mean (+/-SD) log10 reduction in colony-forming units (cfu) was 2.26 +/- 1.13 log10 cfu for the 1.5-minute group and 3.01 +/- 1.06 log10 cfu for the 3-minute group (P = .204). Similarly, there was no statistically significant difference between the 2 groups with respect to the sustained effect; the mean (+/-SD) log10 increase in bacterial density during surgery was 1.08 +/- 1.13 log10 cfu for the 1.5-minute group and 0.95 +/- 1.27 log10 cfu for the 3-minute group (P = .708). No adverse effects were recorded., Conclusion: In this clinical trial, surgical hand antisepsis with alcohol-based hand rub resulted in a similar bacterial reduction, regardless of whether it was applied for 3 or 1.5 minutes, which confirms experimental data generated with healthy volunteers.

Background: Whereas specimen radiography (SR) is an established strategy for intraoperative resection margin analysis during breast-conserving surgery for nonpalpable lesions, the use of frozen section analysis (FSA) is still a matter of debate., Methods: A retrospective review was conducted of 115 consecutive operations in which the two objectives sought were the excision of nonpalpable malignant lesions and breast conservation. Breast surgery was performed in the Gynecology and the Surgery Departments at the Basel University Hospital Breast Center. Whereas one department preferably uses SR for intraoperative margin assessments of lesions involving ductal carcinoma in situ (DCIS) or atypical ductal hyperplasia, the other uses FSA to increase the rate of complete removal of these lesions with a single procedure. The respective accuracy and therapeutic impact of these two techniques are compared here., Results: Intraoperative resection margin assessments were performed with FSA in 80 and SR in 35 of a total of 115 operations performed on 111 patients with pTis, pT1, or pT2 nonpalpable breast cancer. FSA diagnostic accuracy, sensitivity, and specificity were 83.8%, 80.0%, and 87.5%, respectively, compared to 60%, 60%, and 60%, respectively, for SR. FSA tended to have a stronger therapeutic impact than SR in terms of the number of patients in whom initially positive margins were rendered margin-negative thanks to intraoperative analysis and immediate reexcision or mastectomy (27.5% vs. 14.3%; p = 0.124). More importantly, significantly fewer secondary reexcisions were performed in the FSA series than in the SR series (12.5% vs. 37.1%; p = 0.002). Finally, the intraoperative detection of invasive cancer with FSA led to a significantly lower number of secondary procedures for axillary lymph node staging (5% vs. 25.7%; p = 0.001)., Conclusions: The present results suggest that FSA may be more accurate than SR for analyzing intraoperative resection margins during breast-conserving surgery for nonpalpable lesions.

Objective: To quantify the economic burden of in-hospital surgical site infections (SSIs) at a European university hospital., Design: Matched case-control study nested in a prospective observational cohort study., Setting: Basel University Hospital in Switzerland, where an average of 28,000 surgical procedures are performed per year., Methods: All in-hospital occurrences of SSI associated with surgeries performed between January 1, 2000, and December 31, 2001, by the visceral, vascular, and traumatology divisions at Basel University Hospital were prospectively recorded. Each case patient was matched to a control patient by age, procedure code, and National Nosocomial Infection Surveillance System risk index. The case-control pairs were analyzed for differences in cost of hospital care and in provision of specialized care., Results: A total of 6,283 procedures were performed: 187 SSIs were detected in inpatients, 168 of whom were successfully matched with a control patient. For case patients, the mean additional hospital cost was SwF-19,638 (95% confidence interval [CI], SwF-8,492-SwF-30,784); the mean additional postoperative length of hospital stay was 16.8 days (95% CI, 13-20.6 days); and the mean additional in-hospital duration of antibiotic therapy was 7.4 days (95% CI, 5.1-9.6 days). Differences were primarily attributable to organ space SSIs (n = 76)., Conclusions: In a European university hospital setting, SSIs are costly and constitute a heavy and potentially preventable burden on both patients and healthcare providers.

Objective: To obtain precise information on the optimal time window for surgical antimicrobial prophylaxis., Summary Background Data: Although perioperative antimicrobial prophylaxis is a well-established strategy for reducing the risk of surgical site infections (SSI), the optimal timing for this procedure has yet to be precisely determined. Under today's recommendations, antibiotics may be administered within the final 2 hours before skin incision, ideally as close to incision time as possible., Methods: In this prospective observational cohort study at Basel University Hospital we analyzed the incidence of SSI by the timing of antimicrobial prophylaxis in a consecutive series of 3836 surgical procedures. Surgical wounds and resulting infections were assessed to Centers for Disease Control and Prevention standards. Antimicrobial prophylaxis consisted in single-shot administration of 1.5 g of cefuroxime (plus 500 mg of metronidazole in colorectal surgery)., Results: The overall SSI rate was 4.7% (180 of 3836). In 49% of all procedures antimicrobial prophylaxis was administered within the final half hour. Multivariable logistic regression analyses showed a significant increase in the odds of SSI when antimicrobial prophylaxis was administered less than 30 minutes (crude odds ratio = 2.01; adjusted odds ratio = 1.95; 95% confidence interval, 1.4-2.8; P < 0.001) and 120 to 60 minutes (crude odds ratio = 1.75; adjusted odds ratio = 1.74; 95% confidence interval, 1.0-2.9; P = 0.035) as compared with the reference interval of 59 to 30 minutes before incision., Conclusions: When cefuroxime is used as a prophylactic antibiotic, administration 59 to 30 minutes before incision is more effective than administration during the last half hour.

After formation of a stoma patients quality of life can be compromised. This includes body image, capacity to work, leisure time and sexual activity. After leaving the hospital it is essential, that stoma patients are supported by professionals on the long run. This can be achieved by a network of stoma-care nurses, social workers and psychology professionals.

Background: Carbon dye, when peritumourally injected, permanently marks the drainage site of sentinel lymph nodes (SLN). The objective of the current study was to evaluate whether the use of carbon dye facilitated the detection of small nodal tumour infiltrates in colon cancer patients., Methods: In a prospective trial, 19 patients underwent open, oncological resections of localized colon cancer and SLN procedure according to a standardized protocol. Isosulfan blue 1% and sterile filtered carbon dye (mixed 1:1) were injected into the subserosa circumferentially around the tumour. Lymph nodes staining blue were marked as SLN. Serial sections of each SLN were stained with hematoxylin and eosin (H&E) and with the pancytokeratin marker AE1/AE3. The intranodal presence and site of carbon particles were noted and compared with the location of possible tumour infiltrates., Results: Identification of at least one SLN was successful in 18 patients (identification rate 95%). Four patients (22%) were pN+, 11 (61%) were pN0(i-). Three patients (17%) were upstaged from pN0(i-) to pN0(i+) as isolated tumour cells were detected in their SLN: in two (11%) of the three patients, carbon dye and isolated tumour cells were found in the same nodal compartment, hence facilitating the recognition of isolated tumour cells by the pathologist., Conclusion: The use of carbon dye in the SLN procedure for colon cancer may facilitate the detection of small nodal tumour infiltrates.

We performed a prospective analysis of two consecutive biopsy cohorts investigated by the same team to compare the Mammotome system with the ABBI procedure. From April 1997 to August 2003 a series of 413 nonpalpable mammographic lesions in 387 women (median age 56 years, range 30-84 years) were stereotactically biopsied in the University Hospital of Basel, Switzerland. Until October 1999 the ABBI system was applied exclusively, it was subsequently superseded by the Mammotome device in our clinic. Main outcome measures were accuracy, technical demand, and morbidity. Sensitivity (97.3%/96.8%), negative predictive value (99.2%/98.7%), and diagnostic accuracy (99.4%/99.1%) regarding the detection of malignancy were excellent for both techniques (ABBI/ Mammotome). The Mammotome procedure was faster and less invasive, thus causing significantly less morbidity. The larger specimen obtained by the ABBI procedure resulted in more detailed histology. In conclusion, recommend the Mammotome system as the method of choice for detecting nonpalpable early breast cancer.

Recombinant poxviruses expressing immunomodulatory molecules together with specific antigens represent powerful vaccines for cancer immunotherapy. Recently, we and others have demonstrated, in vitro and in vivo, that coexpression of CD80 and CD86 costimulatory molecules enhances the immunogenic capacity of a recombinant vaccinia virus (rVV) encoding different tumor-associated antigens. To further investigate the capacity of these vectors to provide ligands for different costimulatory pathways relevant in the generation of T cell responses, we constructed a recombinant virus (rVV) expressing CD40 ligand or CD154 (CD154rVV). Upon binding the CD40 receptor expressed on antigen presenting cells (APC), this molecule, physiologically expressed on activated CD4+ T cells, increases their antigen presentation and immunostimulatory capacities. Therefore, we evaluated the effects of CD154rVV infection on APC activation and its consequences on T cell stimulation. CD154rVV infection of autologous fibroblasts, monocytes, or iDC promoted the expression of a number of cytokines, including GM-CSF, TNF-alpha, and IL-15 in iDC. Most importantly, IL-12 p40 gene expression and protein secretion were induced by CD154rVV but not by wild-type VV (WT VV) in either CD14+ cells or iDC, and these effects could be blocked by anti-CD40 monoclonal antibodies. Furthermore, phenotypic characterization of CD154rVV infected iDC revealed enhanced expression of CD83 and CD86 surface markers as compared with wild-type vaccinia virus infection. As expected, VV infection triggered cytokines gene expression in cultures including APC and T cells from VV immune donors. However, cytokine genes typically expressed by T cell receptor triggered T cells such as those encoding IL-2 and IFN-gamma, or T cell proliferation, were detectable to a significantly higher extent in CD154rVV infected cultures, as compared with WT VV. Activation of specific CD8+ T cells was then investigated using MART-1/Melan-A(27-35) epitope as the model of tumor-associated antigen (TAA). In the presence of CD154rVV activated APCs, significantly higher numbers of specific cytotoxic CD8+ T cells were detected, as compared with cultures performed in the presence of WT VV or in the absence of virus. Taken together, these data indicate that functional CD154 expression from rVV infected cells promotes APC activation, thereby enhancing antigen-specific T cell generation. Such a recombinant vector might help bypass the requirement for activated helper cells during CTL priming, thus qualifying as a potentially relevant vector in the generation of CD8+ T cell responses in cancer immunotherapy.

Objective: To assess the axillary recurrence rate in breast cancer patients with negative sentinel lymph node (SLN) or SLN micrometastases (>0.2 mm to 0.2 mm to

Background: We report one safe and standardized technique of seton placement and management., Conclusions: A simplified way to manage cutting setons helps to minimize manipulation and may reduce pain. In most patients our technique can be used with no additional anesthesia and in an outpatient setting.

Tumour-associated antigens (TAA)-specific vaccination requires highly immunogenic reagents capable of inducing cytotoxic T cells (CTL). Soluble peptides are currently used in clinical applications despite an acknowledged poor immunogenicity. Encapsulation into liposomes has been suggested to improve the immunogenicity of discrete antigen formulations. We comparatively evaluated the capacity of HLA-A2.1 restricted Melan-A/MART-1 epitopes in soluble form (S) or following inclusion into sterically stabilised liposomes (SSL) to be recognised by specific CTL, to stimulate their proliferation and to induce them in healthy donors' peripheral blood mononuclear cells (PBMC), as well as in melanoma-derived tumour-infiltrating lymphocytes (TIL). HLA-A2.1(+), Melan-A/MART-1-NA-8 melanoma cells served as targets of specific CTL in 51Cr release assays upon pulsing by untreated or human plasma-treated soluble or SSL-encapsulated Melan-A/MART-1 27-35 (M27-35) or 26-35 (M26-35) epitopes. These reagents were also used to stimulate CTL proliferation, measured as 3H-thymidine incorporation, in the presence of immature dendritic cells (iDC), as antigen-presenting cells (APC). Induction of specific CTL upon stimulation with soluble or SSL-encapsulated peptides was attempted in healthy donors' PBMC or melanoma-derived TIL, and monitored by 51Cr release assays and tetramer staining. Na-8 cells pulsing with SSL M27-35 resulted in a five-fold more effective killing by specific CTL as compared with equal amounts of S M27-35. Encapsulation into SSL also provided a partial (50%) protection of M27-35 from plasma hydrolysis. No specific advantages regarding M26-35 were detectable in these assays. However, at low epitope concentrations (

Recent studies have shown that the sentinel lymph node (SLN) procedure might improve staging in colon cancer. However, low SLN identification and high false negative rates have also been reported. In a two-institution study, the SLN procedure with isosulfan blue 1% was performed according to a standardized protocol in 31 patients with open resections for colon cancer. Data were collected prospectively. The database was analyzed retrospectively to determine factors contributing to a low identification rate. The SLN identification rate was 87% and the false negative rate was 50%. Successful SLN identification was significantly associated with application of higher volumes of dye relative to the tumor diameter ( p = 0.04) and more frequent tumor localization in the sigmoid colon ( p = 0.04) as compared to missing SLN identification. The tumor diameter was not significantly different in the two groups. Sentinel lymph node identification in colon cancer depends on the amount of dye injected relative to the tumor size. Application of only 1 ml of dye-the amount generally recommended in the literature-is not sufficient in large tumors.

Background: The objective of the present investigation was to assess the prognostic significance of disseminated tumour cells in peritoneal lavage, and peripheral and mesenteric venous blood in patients undergoing curative resection of colorectal cancer., Methods: The prognostic impact of perioperative cytological and immunocytochemical detection of disseminated colorectal cancer cells was evaluated prospectively. Peritoneal lavage fluid, and peripheral and mesenteric venous blood from 53 consecutive patients undergoing curative surgery for colorectal cancer were analysed. The dichotomous results (positive versus negative) from the cytological and immunocytochemical analysis were used as a predictor along with other co-variates in proportional hazard regression models of disease-free and overall survival., Results: Disseminated colorectal cancer cells were found in 13 of 53 patients (25 per cent) using cytology (CYT) and/or immunocytochemistry (ICC). The median follow-up at the time of the analysis was 37 months. In multivariate proportional hazard regression models CYT/ICC status was a significant predictor for disease-free (P = 0.002) and overall (P = 0.006) survival., Conclusion: Disseminated tumour cells detected by CYT and ICC represent an independent prognostic factor in patients undergoing surgery for colorectal cancer and may identify patients at high risk of recurrence., (Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Mesothelioma are primary malignant neoplasms of the serous membranes. They usually involve the pleura and rarely the pericardium, the peritoneum and the tunica vaginalis testis. About 90% are associated with exposure to asbestos. The exposure is generally occupational, an environmental inhalation of asbestos and asbestiform fibers in areas in Turkey has been observed and presents a major health problem. This report of a patient from Anatolia with peritoneal mesothelioma after environmental exposure outlines the importance of considering this pathology in the differential diagnosis of a Turkish patient presenting with ascites.

Objective: To evaluate the clinical relevance of real-time quantitative polymerase chain reaction (qPCR) detection of CEA and CK20 transcripts, as potentially related to tumor cell dissemination, in blood and peritoneal lavage from patients undergoing surgery for colorectal cancer., Summary Background Data: Dissemination of single colorectal cancer cells in the peritoneal cavity, as well as in tumor drainage and peripheral blood vessels, might play a role in the metastasis process, thus affecting the clinical course. However, this phenomenon needs further elucidation., Methods: In a prospective study the authors evaluated the potential of qPCR in the detection of CEA and/or CK20 transcripts in the peritoneal lavage fluid and in the peripheral and mesenteric venous blood of 39 patients undergoing curative resection for colorectal cancer. Peritoneal lavage and peripheral blood was sampled before and after tumor resection; mesenteric venous blood was sampled from the major tumor-draining vein immediately before clamping. After RNA extraction and reverse transcription, qPCR was performed using specific cDNA primers and probes for CEA and CK20. The dichotomous results from the qPCR were used as a predictor along with other covariates in Cox proportional hazard regression models of long-term outcome (disease-free survival and overall survival)., Results: Of 39 patients, 11 were positive. The median follow-up at analysis was 31 months for all patients. The dichotomous qPCR covariate was significant, with P =.001 and.0035 for disease-free survival and overall survival, respectively, in the proportional hazard regression models with only qPCR. In seven patients, disseminated colorectal cancer cells were found in the peritoneal lavage fluid but not in blood specimens; five of these patients (71%) had recurrence., Conclusions: These data suggest that detection of mRNA coding for CEA and/or CK20 using qPCR has potential clinical utility as a prognostic marker and should be evaluated in larger clinical studies. Identification of patients at high risk for metastatic disease after curative resection of colorectal cancer might be improved by analyzing peritoneal lavage specimens in addition to blood samples. This is based on the observation that in more than half of qPCR-positive patients, disseminated colorectal cancer cells were detected in peritoneal lavage specimens but not in blood samples, and that 71% of them had recurrence.