Impact of human wound exudate on the bactericidal efficacy of commercial antiseptic products.

OBJECTIVE: By default, the antimicrobial efficacy of antiseptics used in wound management is tested in vitro under standardised conditions according to European standard DIN EN 13727, with albumin and sheep erythrocytes used as organic challenge. However, it is not clear whether these testing conditions adequately reflect the wound bed environment and its interaction with antiseptic products intended to be used in wounds in humans. METHOD: This study compared the efficacy of different commercial antiseptic products based on octenidine dihydrochloride (OCT), polyhexamethylene biguanide (PHMB) and povidone-iodine under challenge with human wound exudate collected from the hard-to-heal wounds of patients, compared to the standardised organic load, in an in vitro setting according to DIN EN 13727. RESULTS: The bactericidal efficacy of the tested products was reduced to a different extent when challenged with human wound exudate, compared to the standardised conditions. Overall, OCT-based products showed the necessary germ count reductions at the shortest exposure times (e.g., 15 seconds for Octenisept (Schülke & Mayr GmbH, Germany)). PHMB-based products were the least efficient. In addition to the protein content, other components of wound exudate, such as the microbiota, seem to influence the efficacy of antiseptics. CONCLUSION: This study demonstrated that the standardised in vitro test conditions may only partially reflect actual wound bed conditions in humans.

Machine learning-based typing of Salmonella enterica O-serogroups by the Fourier-Transform Infrared (FTIR) Spectroscopy-based IR Biotyper system.

BACKGROUND: Salmonella enterica is among the major burdens for public health at global level. Typing of salmonellae below the species level is fundamental for different purposes, but traditional methods are expensive, technically demanding, and time-consuming, and therefore limited to reference centers. Fourier transform infrared (FTIR) spectroscopy is an alternative method for bacterial typing, successfully applied for classification at different infra-species levels. AIM: This study aimed to address the challenge of subtyping Salmonella enterica at O-serogroup level by using FTIR spectroscopy. We applied machine learning to develop a novel approach for S. enterica typing, using the FTIR-based IR Biotyper® system (IRBT; Bruker Daltonics GmbH & Co. KG, Germany). We investigated a multicentric collection of isolates, and we compared the novel approach with classical serotyping-based and molecular methods. METHODS: A total of 958 well characterized Salmonella isolates (25 serogroups, 138 serovars), collected in 11 different centers (in Europe and Japan), from clinical, environmental and food samples were included in this study and analyzed by IRBT. Infrared absorption spectra were acquired from water-ethanol bacterial suspensions, from culture isolates grown on seven different agar media. In the first part of the study, the discriminatory potential of the IRBT system was evaluated by comparison with reference typing method/s. In the second part of the study, the artificial intelligence capabilities of the IRBT software were applied to develop a classifier for Salmonella isolates at serogroup level. Different machine learning algorithms were investigated (artificial neural networks and support vector machine). A subset of 88 pre-characterized isolates (corresponding to 25 serogroups and 53 serovars) were included in the training set. The remaining 870 samples were used as validation set. The classifiers were evaluated in terms of accuracy, error rate and failed classification rate. RESULTS: The classifier that provided the highest accuracy in the cross-validation was selected to be tested with four external testing sets. Considering all the testing sites, accuracy ranged from 97.0% to 99.2% for non-selective media, and from 94.7% to 96.4% for selective media. CONCLUSIONS: The IRBT system proved to be a very promising, user-friendly, and cost-effective tool for Salmonella typing at serogroup level. The application of machine learning algorithms proved to enable a novel approach for typing, which relies on automated analysis and result interpretation, and it is therefore free of potential human biases. The system demonstrated a high robustness and adaptability to routine workflows, without the need of highly trained personnel, and proving to be suitable to be applied with isolates grown on different agar media, both selective and unselective. Further tests with currently circulating clinical, food and environmental isolates would be necessary before implementing it as a potentially stand-alone standard method for routine use.

Comparing susceptibility and contagiousness in concurrent outbreaks with a non-VOC and the VOC SARS-CoV-2 variant B.1.1.7 in daycare centers in Hamburg, Germany.

We describe two outbreaks of SARS-CoV-2 in daycare centers in the metropolitan area of Hamburg, Germany. The outbreaks occurred in rapid chronological succession, in neighborhoods with a very similar sociodemographic structure, thus allowing for cross-comparison of these events. We combined classical and molecular epidemiologic investigation methods to study infection entry, spread within the facilities, and subsequent transmission of infections to households. Epidemiologic and molecular evidence suggests a superspreading event with a non-variant of concern (non-VOC) SARS CoV-2 strain at the root of the first outbreak. The second outbreak involved two childcare facilities experiencing infection activity with the variant of concern (VOC) B.1.1.7 (Alpha). We show that the index cases in all outbreaks had been childcare workers, and that children contributed substantially to secondary transmission of SARS-CoV-2 infection from childcare facilities to households. The frequency of secondary transmissions in households originating from B.1.1.7-infected children was increased compared to children with non-VOC infections. Self-reported symptoms, particularly cough and rhinitis, occurred more frequently in B.1.1.7-infected children. Especially in light of the rapidly spreading VOC B.1.617.2 (Delta), our data underline the notion that rigorous SARS-CoV-2 testing in combination with screening of contacts regardless of symptoms is an important measure to prevent SARS-CoV-2 infection of unvaccinated individuals in daycare centers and associated households.

Classification of Salmonella enterica of the (Para-)Typhoid Fever Group by Fourier-Transform Infrared (FTIR) Spectroscopy.

Typhoidal and para-typhoidal Salmonella are major causes of bacteraemia in resource-limited countries. Diagnostic alternatives to laborious and resource-demanding serotyping are essential. Fourier transform infrared spectroscopy (FTIRS) is a rapidly developing and simple bacterial typing technology. In this study, we assessed the discriminatory power of the FTIRS-based IR Biotyper (Bruker Daltonik GmbH, Bremen, Germany), for the rapid and reliable identification of biochemically confirmed typhoid and paratyphoid fever-associated Salmonella isolates. In total, 359 isolates, comprising 30 S. Typhi, 23 S. Paratyphi A, 23 S. Paratyphi B, and 7 S. Paratyphi C, respectively and other phylogenetically closely related Salmonella serovars belonging to the serogroups O:2, O:4, O:7 and O:9 were tested. The strains were derived from clinical, environmental and food samples collected at different European sites. Applying artificial neural networks, specific automated classifiers were built to discriminate typhoidal serovars from non-typhoidal serovars within each of the four serogroups. The accuracy of the classifiers was 99.9%, 87.0%, 99.5% and 99.0% for Salmonella Typhi, Salmonella Paratyphi A, B and Salmonella Paratyphi C, respectively. The IR Biotyper is a promising tool for fast and reliable detection of typhoidal Salmonella. Hence, IR biotyping may serve as a suitable alternative to conventional approaches for surveillance and diagnostic purposes.

Influence of human wound exudate on the bactericidal efficacy of antiseptic agents in quantitative suspension tests on the basis of European Standards (DIN EN 13727).

The antimicrobial efficacy of antiseptics used in wound management is tested in vitro under standardised conditions according to DIN EN 13727, with albumin and sheep erythrocytes used as organic challenge. However, these testing conditions do not adequately simulate the wound bed environment. Thus, the aim of this study was to compare the efficacy of different antiseptics such as octenidine dihydrochloride (OCT), chlorhexidine digluconate (CHX), polyhexamethylene biguanide (PHMB), and povidone-iodine under challenge with human wound exudate instead of standardised organic load in an in vitro setting according to DIN EN 13727. Moreover, protein contents, pH, and temperature were compared with standardised testing conditions. The tested antiseptic agents were reduced to different extents based on their bactericidal efficacy, when challenged with human wound exudate compared with standardised conditions. Overall, 0.10% OCT showed the highest effects reaching full efficacy after 30 seconds. CHX and PHMB were the least efficient. Next to the protein content, other components of wound exudate, such as the microflora, seem to influence the efficacy of antiseptics. In summary, the optimisation of in vitro testing conditions in future applications, to more adequately simulate the wound bed environment, will allow a more realistic picture on the potential performance of antiseptics in clinical practice.

Loop-mediated isothermal amplification-based detection of typhoid fever on an automated Genie II Mk2 system - A case-control-based approach.

Typhoid fever, caused by the bacterium Salmonella enterica subsp. enterica serovar Typhi, is an important cause of blood stream infections in the tropics, for which easy-to-apply molecular diagnostic approaches are desirable. The diagnostic performance of a newly introduced and a previously described loop-mediated isothermal amplification (LAMP) approach using different primer sets on a Genie II Mk2 device for the identification of Salmonella enterica ssp. enterica ser. Typhi was evaluated with well-characterized residual materials from the tropics in a case control-based approach. After in-vitro confirmation of binding characteristics of both LAMP primer sets with culture isolates (n = 112), sensitivity and specificity were 100% for the newly designed new LAMP primer set 1 with incubated blood culture materials, while specificity was reduced to 97.1% for primer set 2. For 170 EDTA blood samples, sensitivity and specificity were 10% and 98.3% for primer set 1 as well as 38.0% and 83.3% for primer set 2, respectively; qPCR from EDTA blood did not score much better with 10% sensitivity and 100% specificity. LAMP using a Genie II Mk2 device is suitable for the identification of Salmonella enterica spp. enterica ser. Typhi from incubated blood culture materials. Sensitivity and specificity were insufficient for diagnosis directly from EDTA blood samples but LAMP showed similar sensitivity as qPCR.

Microbiological screenings for infection control in unaccompanied minor refugees: the German Armed Forces Medical Service's experience.

BACKGROUND: The German Military Medical Service contributed to the medical screening of unaccompanied minor refugees (UMRs) coming to Germany in 2014 and 2015. In this study, a broad range of diagnostic procedures was applied to identify microorganisms with clinical or public health significance. Previously, those tests had only been used to screen soldiers returning from tropical deployments. This instance is the first time the approach has been studied in a humanitarian context. METHODS: The offered screenings included blood cell counts, hepatitis B serology and microscopy of the stool to look for protozoa and worm eggs as well as PCR from stool samples targeting pathogenic bacteria, protozoa and helminths. If individuals refused certain assessments, their decision to do so was accepted. A total of 219 apparently healthy male UMRs coming from Afghanistan, Egypt, Somalia, Eritrea, Syria, Ghana, Guinea, Iran, Algeria, Iraq, Benin, Gambia, Libya, Morocco, Pakistan, and Palestine were assessed. All UMRs who were examined at the study department were included in the assessment. RESULTS: We detected decreasing frequencies of pathogens that included diarrhoea-associated bacteria [Campylobacter (C.) jejuni, enteropathogenic Escherichia (E.) coli (EPEC), enterotoxic E. coli (ETEC), enteroaggregative E. coli (EAEC), enteroinvasive E. coli (EIEC)/Shigella spp.), Giardia (G.) duodenalis, helminths (comprising Schistosoma spp., Hymenolepis (H.) nana, Strongyloides (S.) stercoralis] as well as hepatitis B virus. Pathogenic microorganisms dominated the samples by far. While G. duodenalis was detected in 11.4% of the assessed UMRs, the incidence of newly identified cases in the German population was 4.5 cases per 100,000 inhabitants. CONCLUSIONS: We conclude that the applied in-house PCR screening systems, which have proven to be useful for screening military returnees from tropical deployments, can also be used for health assessment of immigrants from the respective sites. Apparently healthy UMRs may be enterically colonized with a broad variety of pathogenic and apathogenic microorganisms. Increased colonization rates, as shown for G. duodenalis, can pose a hygiene problem in centralized homes for asylum seekers.

Are female daycare workers at greater risk of cytomegalovirus infection? A secondary data analysis of CMV seroprevalence between 2010 and 2013 in Hamburg, Germany.

BACKGROUND: Close contact with asymptomatic children younger than three years is a risk factor for a primary cytomegalovirus (CMV) infection. In pregnant women, such primary infection increases the risk of CMV-induced feto- or embryopathy. Daycare providers have therefore implemented working restrictions for pregnant daycare workers (DCWs) in accordance with legislation and guidelines for maternity protection. However, little is known about the infection risk for DCWs. We therefore compared the prevalence of CMV antibodies of pregnant DCWs to that of female blood donors (BDs). METHOD: In a secondary data analysis, the prevalence of anti-CMV IgG among pregnant DCWs (N=509) in daycare centers (DCCs) was compared to the prevalence of female first-time BDs (N=14,358) from the greater region of Hamburg, Germany. Data collection took place between 2010 and 2013. The influence of other risk factors such as age, pregnancies and place of residence was evaluated using logistic regression models. RESULTS: The prevalence of CMV antibodies in pregnant DCWs was higher than in female BDs (54.6 vs 41.5%; OR 1.6; 95%CI 1.3-1.9). The subgroup of BDs who had given birth to at least one child and who lived in the city of Hamburg (N=2,591) had a prevalence of CMV antibodies similar to the prevalence in pregnant DCWs (53.9 vs 54.6%; OR 0.9; 95%CI 0.8-1.2). Age, pregnancy history and living in the center of Hamburg were risk factors for CMV infections. CONCLUSION: The comparison of pregnant DCWs to the best-matching subgroup of female first-time BDs with past pregnancies and living in the city of Hamburg does not indicate an elevated risk of CMV infection among DCWs. However, as two secondary data sets from convenience samples were used, a more detailed investigation of the risk factors other than place of residence, age and maternity was not possible. Therefore, the CMV infection risk in DCWs should be further studied by taking into consideration the potential preventive effect of hygiene measures.

Risk factors for HIV and STI diagnosis in a community-based HIV/STI testing and counselling site for men having sex with men (MSM) in a large German city in 2011-2012.

BACKGROUND: In recent years community-based voluntary counselling and testing sites (CB-VCT) for men having sex with men (MSM) have been established in larger cities in Germany to offer more opportunities for HIV testing. Increasingly, CB-VCTs also offer testing for other bacterial sexually transmitted infections. In Hamburg, tests in CB-VCTs are offered free and anonymously. Data on demographics and sexual risk behaviours are collected with a paper questionnaire. METHODS: Questionnaire data from the MSM CB-VCT in Hamburg were linked with serological test results for HIV and syphilis, and with rectal and pharyngeal swab results for gonorrhoea and chlamydia. MSM were defined as males reporting male sex partners. CB-VCT clients were characterized demographically, and associations between sexual behaviour variables and diagnosis of HIV and sexually transmitted infections (STI) were analysed by bivariate and multivariate logistic regression analysis. RESULTS: Among the male clients of the CB-VCT in 2011-2012 who were tested for HIV or any STI 1476 reported male sex partners. Unprotected anal intercourse (UAI) was reported as reason for testing by 61% of the clients. Forty-one of 1413 clients testing for HIV were tested positive (2.9%). Twenty-four of 1380 clients testing for syphilis required treatment (1.7%). Tests for simultaneous detection of N. gonorrhoea and Chlamydia trachomatis were conducted on 882 pharyngeal and 642 rectal swabs, revealing 58 (=6.6%) pharyngeal and 71 (=11.1%) rectal infections with one or both pathogens. In multivariate logistic regression analysis number of partners, UAI (OR=2.42) and relying on visual impression when selecting sex partners (OR = 2.92) were associated with increased risks for diagnosis of syphilis or a rectal STI. Syphilis or rectal STI diagnosis (OR=4.52) were associated with increased risk for HIV diagnosis. CONCLUSIONS: The MSM CB-VCT in Hamburg reaches clients at high risk for HIV and STIs. The diagnosis of syphilis or a rectal STI was associated with increased odds of testing positive for HIV. Due to the high prevalence of curable bacterial STI among clients and because syphilis and rectal bacterial STI may facilitate HIV transmission, MSM asking for HIV tests in CB-VCTs should also be offered tests for other bacterial STIs.

Positive surgical margin appears to have negligible impact on survival of renal cell carcinomas treated by nephron-sparing surgery.

BACKGROUND: The occurrence of positive surgical margins (PSMs) after partial nephrectomy (PN) is rare, and little is known about their natural history. OBJECTIVE: To identify predictive factors of cancer recurrence and related death in patients having a PSM following PN. DESIGN, SETTING, AND PARTICIPANTS: Some 111 patients with a PSM were identified from a multicentre retrospective survey and were compared with 664 negative surgical margin (NSM) patients. A second cohort of NSM patients was created by matching NSM to PSM for indication, tumour size, and tumour grade. MEASUREMENTS: PSM and NSM patients were compared using student t tests and chi-square tests on independent samples. A Cox proportional hazards regression model was used to test the independent effects of clinical and pathologic variables on survival. RESULTS AND LIMITATIONS: Mean age at diagnosis was 61+/-12.5 yr. Mean tumour size was 3.5+/-2 cm. Imperative indications accounted for 39% (43 of 111) of the cases. Some 18 patients (16%) underwent a second surgery (partial or total nephrectomy). With a mean follow-up of 37 mo, 11 patients (10%) had recurrences and 12 patients (11%) died, including 6 patients (5.4%) who died of cancer progression. Some 91% (10 of 11) of the patients who had recurrences and 83% of the patients (10 of 12) who died belonged to the group with imperative surgical indications. Rates of recurrence-free survival, of cancer-specific survival, and of overall survival were the same among NSM patients and PSM patients. The multivariable Cox model showed that the two variables that could predict recurrence were the indication (p=0.017) and tumour location (p=0.02). No other variable, including PSM status, had any effect on recurrence. None of the studied parameters had any effect on the rate of cancer-specific survival. CONCLUSIONS: PSM status occurs more frequently in cases in which surgery is imperative and is associated with an increased risk of recurrence, but PSM status does not appear to influence cancer-specific survival. Additional follow-up is needed.

Laparoscopic partial nephrectomy using FloSeal for hemostasis: technique and experiences in 102 patients.

OBJECTIVES: The authors report their techniques, perioperative data, and oncological outcome for laparoscopic partial nephrectomy in a single-center experience with 3 different surgeons. PATIENTS AND METHODS: A total of 102 consecutive patients underwent laparoscopic transperitoneal partial nephrectomy for exophytic tumors using FloSeal for hemostasis. Mean age was 58 years (range = 26-79 years), and median tumor size was 2.6 cm (range = 0.5-8.5 cm). In 84 cases, the renal artery was clamped using endoscopic bulldog clamps, and tumor resection was performed using scissors or the harmonic scalpel. Hemostasis was achieved by application of FloSeal; lesions of the collecting system were closed with Lahodny sutures in 33 cases (31%). Frozen sections were obtained for margin status. RESULTS: All 102 procedures were successful with no intraoperative complications. Mean surgical time was 201 minutes (range = 60-355 minutes); clamping time was 25.8 minutes (range = 6-75 minutes) in 64 cases. Margins were negative in 92 cases; in 8 cases secondary resection was necessary to achieve negative margin status, and in 2 cases radical nephrectomy was performed. Histological findings were clear-cell carcinoma in 51 (50.0%), papillary carcinoma in 26 (25.5%), and others in 25 (24.5%) cases. At a mean follow-up of 32 months (12-62 months), no recurrence was observed. CONCLUSIONS: Laparoscopic partial nephrectomy with the use of FloSeal is a feasible and safe method for treatment of small renal masses. The technique is reproducible by surgeons who are used to complex laparoscopic procedures. Patient outcome during follow-up was comparable with data published for open standard procedures.

Kidney transplantation into urinary conduits with ureteroureterostomy between transplant and native ureter: single-center experience.

OBJECTIVES: To evaluate the functional outcomes and complications after allogeneic kidney transplantation into recipients with a urinary conduit using ureteroureterostomy between the transplant and native ureter. METHODS: We performed a retrospective study of 6 patients with a pre-existing urinary conduit undergoing kidney transplantation at a single tertiary academic center from May 1982 to February 2007. RESULTS: The study included 1 female and 5 males aged 16 to 65 years. Two patients received a living donor transplant. The indications for pretransplant conduit formation were neurogenic bladder in 3 and bladder contraction with vesicoureteral reflux in 3. One patient received a colon conduit. All patients underwent kidney transplantation into a urinary conduit using ureteroureterostomy between the transplant ureter and the ipsilateral native ureter. The average interval between conduit formation and kidney transplantation was 83.5 months and the average time of requiring hemodialysis was 56.3 months. The mean follow-up was 5.3 years. The patient and graft survival rate was 100% and 83.3%, respectively. The 3-year serum creatinine averaged 1.4 mg/dL. One graft was lost because of chronic rejection. Transplant ureter obstruction occurred in 2 patients and required endoscopy or open revision. Four patients underwent post-transplant native nephrectomy for recurrent pyelonephritis. Three patients were hospitalized for treatment of graft pyelonephritis. CONCLUSIONS: In our experience, ureteroureterostomy between the transplant and native ureter is technically feasible and provides good functional results despite a high incidence of urinary tract infection. We recommend this approach in renal transplant recipients with a short contracted conduit or in those in whom the donor ureter is too short to warrant a tension-free ureteroileal anastomosis.

Outcomes of transplanting deceased-donor kidneys between elderly donors and recipients.

Rate of acceptance of deceased-donor kidneys decreases with donor age despite the growing number of aged transplant candidates on the waiting list. In the Eurotransplant Senior Program, HLA-unmatched kidneys from deceased donors aged > or = 65 yr are transplanted regionally into recipients aged > or = 65 yr. Because we have become more willing to accept kidneys from donors aged > or = 75 yr than previous years, we performed a retrospective analysis of this subgroup. Kidneys were accepted from donors aged > or = 75 yr provided a normal creatinine on admission to the hospital, a Cockcroft-Gault creatinine clearance > 80 ml/min, and an absence of comorbidities. We compared outcomes of kidneys from donors aged > or = 75 yr with both younger-donor kidneys transplanted in the Eurotransplant Senior Program and with younger-donor HLA-matched kidneys transplanted into recipients > or = 60 yr. There were no differences in 5-yr graft and patient survival or rate of delayed graft function between groups. Graft function, measured by creatinine and creatinine clearance, differed without pattern at only three of 12 time points during 5 yr of follow-up. In conclusion, our data suggest that kidneys from deceased donors aged > or = 75 yr can be transplanted safely into recipients aged > or = 65 yr if similar donor criteria and local allocation practices are used.

Complications, urinary continence, and oncologic outcome of 1000 laparoscopic transperitoneal radical prostatectomies-experience at the Charité Hospital Berlin, Campus Mitte.

OBJECTIVES: Laparoscopic transperitoneal radical prostatectomy (LRP) is an alternative to open radical prostatectomy, but data based on large populations are not frequently available. This study was initiated to evaluate LRP with regard to complications, urinary continence, and oncologic outcome. METHODS: We retrospectively reviewed 1000 consecutive patients with a mean age of 62 yr (SD+/-6 yr) and clinically localized prostate cancer. Between May 1999 and October 2004, all 1000 patients underwent LRP performed by eight urologists at one institution (Charité Hospital Berlin, Campus Mitte). The review procedure was based on complete patient documents (hospital stay, n=1000) and an interview by one physician. Histopathologic results, intraoperative and early and late complications, continence rate, and time to first PSA increase (n=952) were recorded. Erectile function was not part of this review. Twenty-two patients received neoadjuvant treatment for >2 mo. RESULTS: The median follow-up was 28.8 mo (range: 7.2 to 69.7). Intraoperative and early complications occurred in 11.8% of patients. In 77.6% the urethrovesical anastomosis tested by cystography at day 5 or 6 after LRP was intact; 76% used none or not more than one pad per 24h. The overall PSA-free survival was more than 90% for pT2, 80.3% for pT3a, and 72.4% for pT3b until July 2005. The mortality rate was 0.3%. CONCLUSIONS: In the present series of 1000 patients, a specific disadvantage of LRP compared with the open approach, as reported in the literature, could not be shown. On the basis of short-term follow-up data, our retrospective evaluation confirms that LRP provides satisfactory results. We believe that laparoscopic radical prostatectomy can be the technique of choice in the future.

Laparoscopic partial nephrectomy in renal cell cancer--results and reproducibility by different surgeons in a high volume laparoscopic center.

OBJECTIVES: With increasing surgical skills and novel methods of hemostasis laparoscopic Partial nephrectomy has become an attractive treatment option for selected renal tumors. We report techniques, perioperative data and oncological outcome in a single center experience with three different surgeons. PATIENTS AND METHODS: Between March 2001 and October 2004, 44 patients underwent laparoscopic transperitoneal partial nephrectomy for exophytic tumors. Median tumor size was 3 cm (1-5 cm). In 25 cases the renal artery was clamped using endoscopic bulldog clamps and tumor resection was performed with scissors or the harmonic scalpel. Hemostasis was achieved by application of FloSeal only; closure of the collecting system with Lahodny sutures was performed, if necessary. Frozen sections were obtained in all cases. RESULTS: All procedures were successful with no intraoperative complications. Mean surgical time was 210 min (115-355 min); clamping time was 21 min (7-41 min) in 25 cases. In 8 cases suturing of the collecting system was required. Margins were negative in 37 cases, in five cases secondary resection was necessary to achieve negative margin status; in two cases radical nephrectomy was performed. There were no significant differences between surgeons in terms of patient data and results. At a mean follow-up of 15 months (6-37 months) no recurrence was observed. CONCLUSIONS: Laparoscopic partial nephrectomy using FloSeal is a feasible and safe method for treatment of small renal masses. The technique is reproducible by surgeons who are used to complex laparoscopic procedures like expected in high volume laparoscopic centers.

Phase II trial of weekly paclitaxel and carboplatin chemotherapy in patients with advanced transitional cell cancer.

OBJECTIVE: We investigated the efficacy and toxicity of a first-line combination chemotherapy using weekly paclitaxel and carboplatin in patients with metastatic transitional cell cancer (TCC). PATIENTS AND METHODS: Thirty-three patients with advanced measurable TCC of the urothelium were entered onto this trial. Patients were treated once weekly with a combination therapy of paclitaxel (100mg/m(2)) and carboplatin (AUC 2, according to the Calvert formula). Therapy courses were administered for six consecutive weeks. After two cycles, a re-staging was carried out to evaluate response. RESULTS: Objective response rate was 57.6% with 6 complete (18.2%) and 13 partial remissions (39.4%). Seven patients had stable disease (21.2%) and 7 patients had progressed at the first evaluation of response (21.2%). Median progression-free interval and median survival was 6.5 (1-35) and 12 (2.5-58) months, respectively. Toxicity was moderate and manageable with grade 3 and 4 neutropenia in 8 patients (24%), but no case of neutropenic fever. Other hematological grade 3 toxicities occurred in 9 patients (27%) and grade 3 peripheral neuropathy in 2 patients (6%). There was no treatment-related death. Dose reduction or short delay of treatment was necessary in 3 patients. CONCLUSIONS: Combination therapy using weekly paclitaxel and carboplatin was active in patients with advanced TCC and adverse prognostic features. The weekly dosing used in this trial warrants further investigation as an alternative first-line approach in patients with poor renal reserve and/or performance status or as a second-line management of advanced TCC.

Laparoscopic radical cystectomy with continent urinary diversion (rectosigmoid pouch) performed completely intracorporeally: an intermediate functional and oncologic analysis.

OBJECTIVES: To present our experience with the first series of rectosigmoid pouch creation performed completely laparoscopically for continent urinary diversion after radical cystectomy to treat transitional cell carcinoma of the bladder. We evaluated the intermediate functional and oncologic outcomes. METHODS: Between April 2000 and January 2004, 20 patients underwent laparoscopic radical cystectomy with urinary diversion for transitional cell carcinoma at the Department of Urology, Charite Hospital, Campus Mitte. Of the 20 patients, 12 received a rectosigmoid pouch for urinary diversion. The procedures were performed completely laparoscopically, including free-hand laparoscopic suturing and in situ knot tying techniques. The mobilized specimens were removed in an endoscopy bag by way of the rectum or vagina. RESULTS: All operations were completed laparoscopically by two surgeons without conversion to open surgery. The median operating time was 485 minutes. One patient needed a blood transfusion of 2 U. All specimens had negative surgical margins. Two patients required reoperation. The median follow-up was 33 months. All patients were continent during the day, and 11 patients were continent at night. One patient developed unilateral hydronephrosis with loss of kidney function. No patient developed local recurrence, but 3 patients had systemic progression. Two of the three died of metastatic disease. CONCLUSIONS: This is the first series of laparoscopic radical cystectomy using an intracorporeal rectosigmoid pouch. Our functional data for continence and upper urinary tract obstruction were comparable with those of open rectosigmoid pouch studies. We were able to demonstrate an oncologic outcome similar to that achieved by the open surgical approach.