Stapled intestinal anastomoses are more cost effective than hand-sewn anastomoses in a diagnosis related group system.

PURPOSE: Creation of an optimal bowel anastomosis with low postoperative leakage rate is an immanent part of colorectal surgery contributing to recovery, length of hospital stay and overall hospital costs. We aimed to investigate costs of small and large bowel resection, length of hospital stay, anastomotic leakage rate and its risk factors depending on the anastomotic technique. METHODS: Retrospective analysis of 198 patients (67 stapled and 131 hand-sewn anastomoses) undergoing elective bowel resection with a single anastomosis without protective ileostomy either stapled or in double-rowed running suture technique between 1st October 2012 and 30th September 2018 at Charité University Hospital Berlin, Campus Benjamin Franklin. We analyzed costs of treatment, total length of hospital stay, rate of anastomotic leakage and possible risk factors for anastomotic leak. RESULTS: No significant difference between both anastomotic techniques could be detected for hospital stay (p = 0.754), 30-day-readmission rate (p = 0.827), or anastomotic leakage (p = 606). Neither comorbidities (p = 0.449), underlying disease (p = 0.132), experience of the surgical team (p = 0.828) nor scheduling of the operation (p = 0.531) were associated with anastomotic leakage. Stapled anastomoses took 22 min less operation time than sutured anastomoses (130 vs. 152 min. Median) (p = 0.001). Operations with stapled anastomoses saved 183 € in operation costs and 496 € in overall hospital costs. CONCLUSION: Stapled and hand-sewn bowel anastomoses can be performed equally safe without differences in postoperative outcome. No patient, procedure or surgeon related risk factors for anastomotic leakage could be detected. Bowel resections with stapled anastomoses take less time and save operation and overall hospital costs.

The effectiveness of two silicone dressings for sacral and heel pressure ulcer prevention compared with no dressings in high-risk intensive care unit patients: a randomized controlled parallel-group trial.

BACKGROUND: There is a high incidence of pressure ulcers in high-risk settings such as intensive care. There is emerging evidence that the application of dressings to pressure ulcer predilection areas (sacrum and heels) improves prevention strategies. OBJECTIVES: To determine whether preventive dressings, applied to the sacrum and heels of high-risk patients in intensive care units, in addition to standard prevention, reduces the incidence of pressure ulcers. METHODS: Between June 2015 and July 2018, a randomized, controlled, two-arm, superiority pragmatic study was performed with a concealed 1 : 1 allocation to the intervention and control group. Patients assigned to the intervention group had dressings applied to the sacrum and heels. RESULTS: In total, 7575 patients were screened for eligibility and 475 patients were included and allocated to both groups. Finally, 212 patients in the intervention group and 210 in the control group were analysed. The mean age was 63·5 years and the majority of patients were male (65·4%). The cumulative pressure ulcer incidence category II and above was 2·8% in the intervention, and 10·5% in the control group (P = 0·001). Compared with the control group, the relative risk in the intervention group was 0·26 [95% confidence interval (CI) 0·11-0·62] and the absolute risk reduction was 0·08 (95% CI 0·03-0·13). CONCLUSIONS: The results indicate that the application of dressings, in addition to standard prevention, in high-risk intensive care unit patients is effective in preventing pressure ulcers at the heels and sacrum. What's already known about this topic? Pressure ulcers are severe soft tissue injuries and wounds, which occur worldwide in all healthcare settings. Despite preventive interventions, pressure ulcers still develop. There is emerging evidence that dressings help to prevent pressure ulcers. What does this study add? The incidence of pressure ulcers in intensive care units among high-risk patients remains high. The application of dressings to the sacrum and heels, in addition to standard preventive measures, reduces the relative and absolute risks for the development of pressure ulcers. The application of preventive dressings at the heels and sacrum seems to be feasible in intensive care settings.

First-line treatment with R-CHOP or rituximab-bendamustine in patients with follicular lymphoma grade 3A-results of a retrospective analysis.

Based on centroblast frequency, follicular lymphoma (FL) is subdivided into grades 1-2, 3A, and 3B. Grade FL3A frequently coexists with FL1-2 (FL1-2-3A). Based on clinical trials, FL1-2 is treated with rituximab (R) or obinutuzumab plus bendamustine (B) or CHOP, while FL3B is treated with R-CHOP. In contrast, there are little data guiding therapy in FL3A. We present a retrospective, multicenter analysis of 95 FL3A or FL1-2-3A and 203 FL1-2 patients treated with R-CHOP or R-B first-line. R-CHOP facilitated a higher response rate (95% versus 76%) and longer overall survival (OS) (3-year OS 89% versus 73%, P = 0.008) in FL3A or FL1-2-3A, whereas the difference in progression-free survival (PFS) did not reach statistical significance. While transformation rates into aggressive lymphoma were similar between both groups, there were more additional malignancies after R-B compared with R-CHOP (6 versus 2 cases). In FL1-2, R-B achieved a higher 3-year PFS (79% versus 47%, P < 0.01), while there was no significant difference regarding OS or transformation. With the limitations of a retrospective analysis, these results suggest a benefit for R-CHOP over R-B in FL3A or FL1-2-3A. Confirmatory data from prospective clinical trials are needed.

Influence of pelvic volume on surgical outcome after low anterior resection for rectal cancer.

BACKGROUND: Low anterior resection (LAR) for rectal cancer is a potentially challenging operation due to limited space in the pelvis. CT pelvimetry allows to quantify pelvic space, so that its relationship with outcome after LAR may be assessed. Studies investigating this, however, yielded conflicting results. We hypothesized that a small pelvis is associated with a higher rate of incomplete mesorectal excision, anastomotic leakages, and increased rate of urinary dysfunction in patients operated for rectal cancer. METHODS: In a single-center retrospective analysis, we studied 74 patients that underwent LAR for rectal cancer with primary anastomosis. Thin-layered multi-slice CT datasets were used for slice by slice depiction of the inner pelvic surface, and the inner pelvic volume was automatically compounded. The primary outcome was quality of total mesorectal excision (TME; Mercury grading); secondary outcomes were anastomotic leakage and urinary dysfunction with regard to pelvic dimensions. Univariate analyses and multiple logistic regression analyses were performed for the primary and the secondary outcomes. RESULTS: Shorter obstetric conjugate diameters were associated with a higher probability of a worse TME quality (110.8 ± 10.2 vs. 105.0 ± 8.6 mm; OR 0.85; 95% CI 0.73-0.99; p = 0.038). Short interspinous distance showed a trend towards an increased risk for deteriorated TME quality (OR 0.88; 95% CI 0.76-1.0; p = 0.06). Anastomotic leakage was associated with anemia (OR 2.77; 95% CI 1.0-7.7; p = 0.047). Association between pelvic diameters or pelvic volume and anastomotic leakage or urinary dysfunction was not observed. Perioperative blood transfusions were administered more often in patients with postoperative urinary dysfunction (OR 17.67; 95% CI 2.44-127.7; p = 0.004). CONCLUSION: Shorter obstetric conjugate diameter might be a risk factor for incompleteness of total mesorectal excision. Anastomotic leakage seems to be influenced more by clinical factors such as anemia rather than pelvic dimensions. Further studies have to prove the influence of pelvic diameter on local recurrence of rectal cancer after LAR.

Necessity of subcutaneous suction drains in ileostomy reversal (DRASTAR)-a randomized, controlled bi-centered trial.

PURPOSE: Data regarding length of hospital stay of patients undergoing ileostomy reversal are very heterogeneous. There are many factors that may have an influence on the length of postoperative hospital stay, such as postoperative wound infections. One potential strategy to reduce their incidence and to decrease hospital stay is to insert subcutaneous suction drains. The purpose of this study was to examine the influence of the insertion of subcutaneous suction drains on hospital stay and postoperative wound infections in ileostomy reversal. Risk factors for postoperative wound infection were determined. METHODS: This is a randomized controlled two-center non-inferiority trial with two parallel groups. The total length of hospital stay as primary endpoint and the occurrence of a surgical site infection, the colonization of the abdominal wall with bacteria, and the occurrence of hematomas/seromas as secondary endpoints were monitored. RESULTS: One hundred eighteen patients with elective ileostomy reversal were included. Fifty-nine patients were randomly assigned to insertion of a subcutaneous suction drain, and 59 patients were randomly assigned to receive no drain. After 3 months of follow-up, 50 patients in the group with drain and 53 patients in the group without drain could be analyzed. Median total length of hospital stay was 8 days in the SD group and 9 days in the group without SD (p = 0.17). Fourteen percent of patients with SD and 17 % without SD developed SSI, p = 0.68. Multivariate analysis revealed anemia (p < 0.01), intraoperative bowel perforation (p = 0.02) and resident (p = 0.04) or fellow (p = 0.048) performing the operation as risk factors for SSI. CONCLUSIONS: This trial shows that the omission of subcutaneous suction drains is not inferior to the use of subcutaneous suction drains after ileostomy reversal in terms of length of hospital stay, surgical site infections, and hematomas/seromas.

Effect of minoxidil topical foam on frontotemporal and vertex androgenetic alopecia in men: a 104-week open-label clinical trial.

BACKGROUND: Topical minoxidil formulations have been shown to be effective in treating androgenetic alopecia (AGA) for 12 months. Efficacy and safety in both frontotemporal and vertex regions over longer application periods have not been studied so far. OBJECTIVES: To evaluate the effect of 5% minoxidil topical foam (5% MTF) in the frontotemporal and vertex areas in patients with moderate AGA over 104 weeks. METHODS: An 80-week, open-label extension phase was performed, following a 24-week randomized, double-blind, placebo-controlled study in men with AGA grade IIIvertex to VI. Group 1 (n = 22) received ongoing 5% MTF for 104 weeks, Group 2 (n = 23) received placebo topical foam (plaTF) until week 24, followed by 5% MTF until week 104 during the extension phase. Frontotemporal and vertex target area non-vellus hair counts (f-TAHC, v-TAHC) and cumulative hair width (f-TAHW, v-TAHW) were assessed at baseline and at weeks 24, 52, 76 and 104. RESULTS: In Group 1, f-TAHW and f-TAHC showed a statistically significant increase from baseline to week 52 and week 76, respectively, returning to values comparable to baseline at week 104. No significant differences were found between baseline and week 104 in v-TAHC in Group 1 as well as f-TAHC, v-TAHC, f-TAHW and v-TAHW values in Group 2. CONCLUSIONS: 5% MTF is effective in stabilizing hair density, hair width and scalp coverage in both frontotemporal and vertex areas over an application period of 104 weeks, while showing a good safety and tolerability profile with a low rate of irritant contact dermatitis.

Impact of prior treatment on outcome of transformed follicular lymphoma and relapsed de novo diffuse large B cell lymphoma: a retrospective multicentre analysis.

Transformation of follicular lymphoma (FL) into aggressive disease and relapse of de novo diffuse large B cell lymphoma (DLBCL) are considered highly unfavourable events. However, most published data were acquired when rituximab was not routinely used. We retrospectively analysed 50 patients with transformed FL (tFL) in a multicenter study and compared them to 50 individuals with relapsed DLBCL (rDLBCL) who all obtained rituximab for the treatment of their disease. Our goal was to identify factors that predict a more favourable prognosis. After a median follow-up of 5.4 years from diagnosis, there was no significant difference in median overall survival (OS) from the date of transformation (tFL) or date of the first relapse (rDLBCL) (1.9 versus 3.9 years, P = .542). Of note, 5-year OS of patients with tFL was 46 %. Follicular lymphoma patients, treatment naïve prior to transformation, fared significantly better than pretreated patients (median not reached versus 1.4 years, P = .014). Regarding rDLBCL, female gender (13.9 versus 1.8 years, P = .019) and absence of rituximab prior to the first relapse (14.0 versus 1.8 years, P = .035) were favourable prognostic factors in a uni- and multivariate analysis. Only a proportion of patients received high-dose chemotherapy with autologous stem cell transplantation (HDT-ASCT), i.e. 38 and 52 % of patients with tFL and rDLBCL, respectively. Our data indicate that a favourable prognosis is conferred by treatment naivety in tFL and by rituximab naivety in rDLBCL. In contrast, we did not find a prognostic impact of HDT-ASCT in our series.

Transformation and additional malignancies are leading risk factors for an adverse course of disease in marginal zone lymphoma.

BACKGROUND: Marginal zone lymphoma (MZL) is a non-Hodgkin lymphoma that occurs as extra nodal, nodal, or splenic. While MZL is generally considered an indolent disease, a substantial percentage of patients follow an unfavorable course. The objective of this retrospective analysis was to identify predictors for a reduced overall survival (OS), or conversely an increased OS. PATIENTS AND METHODS: One hundred and ninety-seven MZL patients were analyzed. Apart from assessing previously published risk factors, concomitant morbidity at diagnosis, transformation into aggressive lymphoma, and occurrence of additional malignancies were evaluated. RESULTS: Next to the known risk factors, i.e. above 60 years of age and elevated serum lactate dehydrogenase (LDH), we demonstrate that transformation into aggressive lymphoma, as well as additional malignancies, are important independent risk factors for a shortened OS in a multivariate analysis, irrespective of the MZL localization. Impressively, in the group of patients lacking LDH elevation, transformation, and/or additional malignancies, only 1 of 63 patients died during follow-up compared with 37 of 87 patients in the high-risk group (HR = 22.8; 95% confidence interval 3.1-167.0; P = 0.002). CONCLUSIONS: Our analysis proposes novel risk factors and warrants for a continuous follow-up to detect the occurrence of transformation and additional malignancies early on.

Analysis of quantitative changes in hair growth during treatment with chemotherapy or tamoxifen in patients with breast cancer: a cohort study.

BACKGROUND: In women with breast cancer, chemotherapy-induced alopecia is a highly feared but common side-effect of antineoplastic treatment. The onset, pattern and amount of hair loss differ depending on the therapy regimen and have not yet been quantified using standardized techniques. OBJECTIVES: To evaluate objectively and compare the effect of antineoplastic therapy with chemotherapy or tamoxifen on hair loss, quantifying trichological parameters. METHODS: Female patients with breast cancer were included (n = 34), who were receiving chemotherapy (group C, n = 17) or tamoxifen (group T, n = 17) after surgery. Trichological parameters were evaluated once before [week 0 (w0)], twice during (w3, w6) and twice after (w18, w28) the normal 16-week course of chemotherapy, or at corresponding time points during continuous tamoxifen intake. At each visit, anagen and telogen hairs and hair density were quantified by automated phototrichogram in two defined areas: frontal and occipital. RESULTS: Group T generally showed no changes in anagen and telogen hairs or hair density. In group C, anagen hairs and hair density generally followed the same course, decreasing until w6, remaining at a low level during w6-18 and increasing after cessation of chemotherapy, reaching values comparable with or higher than baseline at w28. Telogen hairs increased until w3 then decreased until w6, remaining stable afterwards. CONCLUSIONS: Diffuse hair loss begins shortly after initiation of chemotherapy, mainly as anagen effluvium, with a proportion of anagen to telogen conversion. Hair loss is most prominent after 6 weeks of chemotherapy. Within 3 months after cessation of chemotherapy, hair growth rate returns to baseline values. Tamoxifen did not affect hair growth parameters.

Postnatal maturation of skin barrier function in premature infants.

BACKGROUND: In preterm infants, skin barrier maturation entails regional variability. OBJECTIVES: To characterize postnatal skin barrier development in covered, uncovered and diapered regions in healthy premature infants over a longitudinal observation period. METHODS: Transepidermal water loss (TEWL), stratum corneum hydration (SCH), pH and sebum were measured at postnatal ages of 1-7 days and 2-7 weeks on the forehead, abdomen, thigh and buttock of preterm infants (gestational age 30-37 weeks; n = 48) under monitored ambient conditions. A standard minimal skin care regimen was practised. RESULTS: TEWL increased significantly on the buttock (p = 0.007), while remaining stable on the forehead, abdomen and thigh. SCH and sebum remained stable in all studied body regions with increasing age. On the buttock, pH increased (p = 0.049), while other body regions exhibited a significant decrease (p ≤ 0.019). TEWL (p < 0.001) and SCH (p ≤ 0.002) revealed significantly higher values on the buttock, compared to other body regions. CONCLUSIONS: Stable TEWL, SCH and sebum values may indicate a lack of skin barrier maturation. Postnatal decrease in skin pH suggests an adaptation process with acid mantle formation. Differences in skin barrier development were observed between anatomical regions. SCH, TEWL and pH values demonstrated a distinct course in the diaper area, indicating an impaired skin barrier function in this region.

Hair shaft abnormalities after chemotherapy and tamoxifen therapy in patients with breast cancer evaluated by optical coherence tomography.

BACKGROUND: Antineoplastic treatment for breast cancer is frequently associated with alopecia. Increasingly, changes in the texture and shape of regrowing hair after chemotherapy have been reported, without evaluation on a scientific basis. Optical coherence tomography (OCT) provides highly reproducible measurements of hair shaft parameters. OBJECTIVES: This study aims to evaluate hair shaft alterations using OCT in chemotherapy-induced alopecia and in patients taking tamoxifen. METHODS: The measurements of this prospective case series were performed on women aged 29-68 years, receiving either tamoxifen (n = 17) or chemotherapy (n = 17) prior to (T1) and after (T2) treatment. Each time, 20 hairs from two different sites of the scalp (frontal, occipital) were examined by OCT. The hair parameters were characterized by cross section (CS) and form factor (FF). The ratio of maximal to minimal hair diameters determined the FF. RESULTS: After chemotherapy, the CS of hairs was significantly lower compared with hairs taken at T1. The FF did not vary between T1 and T2 for the frontal area, but it did for the occipital area. In patients treated with tamoxifen, changes were observed neither in CS nor in FF. However, comparing both therapeutic groups, there were significant differences in CS and FF for T2, but not for T1. CONCLUSIONS: Reported changes in hair structure after chemotherapy may be due to reduction of hair shaft calibre and increase of FF in regrowing hair. The OCT technique is a promising method to gain more insight into chemotherapy-induced changes of hair morphology.

Reduction of wound infections in laparoscopic-assisted colorectal resections by plastic wound ring drapes (REDWIL)?--A randomized controlled trial.

INTRODUCTION: Surgical site infections (SSIs) are frequent complications in colorectal surgery and may lead to burst abdomen, incisional hernia, and increased perioperative costs. Plastic wound ring drapes (RD) were introduced some decades ago to protect the abdominal wound from bacteria and reduce SSIs. There have been no controlled trials examining the benefit of RD in laparoscopic colorectal surgery. The Reduction of wound infections in laparoscopic assisted colorectal resections by plastic wound ring drapes (REDWIL) trial was thus designed to assess their effectiveness in preventing SSIs after elective laparoscopic colorectal resections. MATERIALS/METHODS: REDWIL is a randomized controlled monocenter trial with two parallel groups (experimental group with RD and control group without RD). Patients undergoing elective laparoscopic colorectal resection were included. The primary endpoint was SSIs. Secondary outcomes were colonization of the abdominal wall with bacteria, reoperations/readmissions, early/late postoperative complications, and cost of hospital stay. The duration of follow-up was 6 months. RESULTS: Between January 2008 and October 2010, 109 patients were randomly assigned to the experimental or control group (with or without RD). Forty-six patients in the RD group and 47 patients in the control group completed follow-up. SSIs developed in ten patients with RD (21.7 %) and six patients without RD (12.8 %) (p = 0.28). An intraoperative swab taken from the abdominal wall was positive in 66.7 % of patients with RD and 57.5 % without RD (p = 0.46). The number of species cultured within one swab was significantly higher in those without RD (p = 0.03). The median total inpatient costs including emergency readmissions were 3,402 ± 4,038 in the RD group and 3,563 ± 1,735 in the control group (p = 0.869). CONCLUSIONS: RD do not reduce the rate of SSIs in laparoscopic colorectal surgery. The inpatient costs are similar with and without RD.

Prognostic relevance of circulating tumor cells in metastatic uveal melanoma.

OBJECTIVE: Uveal melanoma primarily metastasizes hematogenously with metastases often confined to the liver. The aim of this study was to investigate the presence of circulating tumor cells (CTC) in patients with metastatic disease as a marker for systemic disease and to determine their prognostic relevance. METHODS: Blood samples from 68 patients were collected at the time of initial treatment of metastases. mRNA expression of tyrosinase and MelanA/MART1 as a surrogate marker for the presence of CTC was analyzed by real-time RT-PCR and compared with patient characteristics. RESULTS: CTC were detected in 63% of all patients and in 67% of the 48 patients with only liver metastases. Univariate and multivariate analyses revealed PCR results and serum lactate dehydrogenase as independent prognostic factors for progression-free (hazard ratios 2.2/3.5) and overall survival (hazard ratios 4.0/6.5). Combination of PCR and lactate dehydrogenase divided the patient cohort into 3 groups with distinct prognosis. CONCLUSION: CTC as evidence for systemic disease can be found in the majority of patients with metastatic uveal melanoma, including patients with visible disease confined to the liver. Detection of CTC-specific mRNA transcripts for tyrosinase and MelanA/MART1 by PCR is a poor prognostic factor for progression-free and overall survival. Characterization of CTC could improve the understanding of their biology.

Short-term outcomes from a prospective randomized trial comparing laparoscopic and open surgery for colorectal cancer.

BACKGROUND: Randomized trials in low-risk populations have failed to show any benefit for laparoscopic compared with open colorectal resection in terms of morbidity. Furthermore, it is not known whether laparoscopic colorectal resection would yield advantages if randomization were revealed during surgery after a diagnostic laparoscopy. METHODS: Patients with cancer of the colon or upper rectum were randomly assigned to laparoscopic or open resection. All patients underwent diagnostic laparoscopy to assess whether laparoscopic resection was feasible and the result of randomization was then revealed to the surgeon. Main endpoints were overall, general and surgical morbidity, and mortality. RESULTS: Some 679 patients underwent diagnostic laparoscopy which led to the exclusion of 207; 250 patients were allocated to laparoscopic and 222 to open resection. Conversion to laparotomy occurred in 28 patients (11.2 per cent). There were no differences in morbidity (overall 25.2 versus 23.9 per cent) or mortality (1.2 versus 0.9 per cent) between laparoscopic and open groups. Postoperative hospital stay was shorter after laparoscopic resection (median (range) 10 (1-123) versus 12 (4-109) days; P = 0.032). CONCLUSION: Laparoscopic resection of colorectal cancer is associated with increased operating time but does not decrease morbidity even in a moderate-risk population.

[Therapy for peripapillary located and large choroidal haemangioma with PDT 'paint-brush technique']. / Behandlung peripapillärer und grosser Aderhauthämangiome mittels PDT-"Paint-Brush-Technik"

BACKGROUND: Today photodynamic therapy (PDT) with Verteporfin is the standard treatment option for symptomatic choroidal haemangiomas. Nevertheless, peripapillary or large haemangiomas pose a therapeutic dilemma, since severe adverse events have been demonstrated in cases where the optic disc was included in the treatment spot. In addition due to the size and the shape of the laser spot, peripapillary and large haemangiomas can only be undertreated or overtreated (with overlapping multiple spots). With the presented new "paint-brush technique" it is possible to treat peripapillary and large choroidal haemangiomas completely without danger for the optic disc and without overtreatment. MATERIAL AND METHODS: With the new technique the application of the laser spot is performed in a "paint-brush fashion" by moving he spot with constant speed excentrically around the lesion's centre over the entire tumour surface. This allows under visual control a complete and confluent PDT of the whole tumour surface without overlapping and/or missing areas or treating the optic disc. In total, 13 eyes of 13 patients (6 with peripapillary and 7 with large choroidal haemangiomas) have been treated. The mean follow-up time was 25.6, respectively, 14.5 months. RESULTS: The PDT with the "paint-brush technique" allows an effective treatment of the leakage in both groups. The mean increase of visual acuity was 1, respectively, 1.4 ETDRS lines 3 months after therapy, which could be maintained over the whole follow-up period. At the last examination visual acuity was unchanged or better in 12 / 13 (92 %) of eyes. After 3 months the tumour height was significantly (p = 0.031 and 0.018) reduced to 1.7 mm (52 %), respectively, 1.3 mm (30 %), which was stable during the whole follow-up. No significant side effects could be detected. CONCLUSION: The use of the PDT "paint-brush technique" allows complete treatment of choroidal haemangiomas under visual control. Sensitive structures like the optic disc could be excluded from treatment without double- or undertreatment. The functional and anatomic results are good. The technique is a safe and effective amendment in the treatment of symptomatic choroidal haemangiomas.

[ITAP - 6-month results of a prospective, randomised phase 3 study for evaluation of the combination therapy of PDT and intravitreal triamcinolone in exudative AMD]. / ITAP - 6-Monats-Ergebnisse einer prospektiven und randomisierten Phase-3-Studie zur Evaluation der Kombinationstherapie aus PDT und intravitrealem Triamcinolon bei der exsudativen AMD.

BACKGROUND: Combination therapy of photodynamic therapy (PDT) with intravitreal triamcinolone (IVTA) for choroidal neovascularisation (CNV) in age-related macular degeneration is thought to improve the prognosis. It is therefore widely used, although results are mostly based upon non-randomised and retrospective studies. Here we present the 6-month results of our prospective, randomised, multicentre ITAP trial (Intravitreal Triamcinolone and PDT) for the evaluation of the combination therapy as compared to PDT alone. PATIENTS: This prospective, randomised, multicentre phase III trial was performed for the evaluation of the efficacy and safety of combination therapy (PDT and IVTA) as compared to PDT alone. Three randomised therapy groups (A: PDT alone, B: IVTA on the same day 1 hour after PDT C: IVTA 1 week before PDT) were monitored over 1 year. The patients included had wet AMD with predominantly classic CNV, minimal classic CNV smaller than 4 papillary diameters or occult CNV with recent disease progression. Re-treatment was performed when persistent leakage of the CNV was visible at follow-up. Primary outcome criteria were the comparison between combination therapy and PDT monotherapy concerning visual acuity, and, second, the comparison between the two groups of combination therapy. RESULTS: 92 patients were included in the study. Before treatment, mean best corrected ETDRS letter score was 52, 53 and 51 in groups A, B and C, respectively. At the 6 months follow-up, mean best corrected letter score was 40, 47 and 47, respectively, with only group A loosing more than 10 letters. This change, however, was not statistically significant between the groups. Mean retinal thickness as measured with optical coherence tomography decreased in all groups, and reached statistical significance in both combination groups. Re-treatment rates did not differ significantly between the three groups at 6 months follow-up, nor was there a significant cataract progression requiring operation. CONCLUSION: At 6 months there was no significant difference between mono- and combination therapy groups concerning visual acuity.

Serotherapy with thymoglobulin and alemtuzumab differentially influences frequency and function of natural killer cells after allogeneic stem cell transplantation.

Although thymoglobulin and alemtuzumab are frequently used in hematopoietic stem cell transplantation (HSCT), little is known of their effects on NK cells, which mediate important functions in post-transplantation immunology. In the present study, we determined NK cell death in vitro using propidium iodide and Annexin V. The NK cell activity in 34 patients at day +30 after allogeneic HSCT was assessed using the CD107a assay. Alemtuzumab and thymoglobulin were similarly very potent in inducing NK cell death in vitro. Even in low concentrations (<1 microg/ml) the antibodies induced apoptosis and necrosis in a relevant percentage of NK cells (>30%). However, the number of tumor reactive (CD107a+) NK cells was 13.16 per mul and 1.15 per microl (mean) in patients receiving T-cell depletion with 6 mg/kg thymoglobulin and in patients receiving 100 mg alemtuzumab, respectively (P=0.02). Although thymoglobulin and alemtuzumab are equally NK cell toxic in vitro, the recovery of NK cell frequency and anti-tumor reactivity is reduced in recipients of alemtuzumab. Our findings can be explained by a longer half-life of alemtuzumab as compared to active thymoglobulin under therapeutic conditions. Prolonged immunosuppression with increased risk of infections and tumor relapse are a potential threat to patients undergoing HCST and receiving alemtuzumab as T-cell depletion.

Noninvasive monitoring of plant-based formulations on skin barrier properties in infants with dry skin and risk for atopic dermatitis.

BACKGROUND: Dry skin and the associated impaired epidermal barrier function are postulated to constitute a major element in the development of atopic dermatitis. OBJECTIVE: The aim of this study was to evaluate the effect of two plant-based formulations on the epidermal barrier function in a defined cohort of infants with a predisposition for atopic dermatitis. METHODS: Over a period of 16 weeks, 25 infants who were ages 3 to 12 months and had an atopic predisposition and dry skin received two emollients that contained pressed juice of the ice plant. The infants received both cream and lotion on the forearm, only cream on the face, and only lotion on the leg. Stratum corneum hydration (SCH), transepidermal water loss (TEWL), skin surface pH, and sebum were assessed on the infants' forehead, leg, and forearm. The Scoring Atopic Dermatitis (SCORAD) index was used for the clinical assessment. RESULTS: SCH significantly increased in all body regions that were assessed. The forearm and leg revealed stable levels of pH and TEWL, but a decline in pH (week 16) and TEWL (week 4) was noted on the forehead. At week 16, sebum levels were lower on the forehead compared with those at baseline. SCORAD scores improved significantly during the study. CONCLUSION: A daily application of both emollients was associated with increased SCH levels and a stable course of TEWL, pH, and sebum on the forehead except for the forehead when compared with the forearm and leg. Clinically, improved SCORAD scores were noted.

Bloodstream infections in neutropenic patients: early detection of pathogens and directed antimicrobial therapy due to surveillance blood cultures.

Bloodstream infections (BSIs) are frequent infectious complications in neutropenic patients. In order to determine the efficacy of surveillance blood cultures (BCs) to detect BSIs prior to clinical manifestation we performed a prospective trial. One hundred patients with haematological malignancies and long-term neutropenia following intensive cytotoxic therapies were recruited. BCs were taken thrice weekly during neutropenia. Forty-two patients were diagnosed with BSI. In 18 (43%) of those patients surveillance BC results were positive and identified microorganisms prior to onset of fever. In patients with positive surveillance BCs modification of the clinical management (specific antimicrobial therapy, CVC removal) resulted in a shorter time to defervescence (median 1.5 days) compared with patients with BCs positive after onset of fever (median 3.5 days, P = 0.004). In conclusion we detected causative microorganisms in more than one-third of BSIs prior to onset of clinical manifestation. The impact of surveillance BCs on the outcome has to be assessed in randomized studies.

Risk factors for reoperation after ileostomy reversal - Results from a prospective cohort study.

BACKGROUND: Ileostomy reversal is frequently performed in abdominal surgery. Postoperative complications after ileostomy reversal are encountered in around 20% of patients. Data regarding risk factors for reoperation after ileostomy closure are scarce. The purpose of this prospective trial was to determine risk factors for operative revision after ileostomy closure. MATERIALS AND METHODS: This is an additional post hoc analysis of a two center prospective trial. After enrollment, patient characteristics and intraoperative details were analyzed. Patients were followed up at one postoperative visit before discharge and at a three months postoperative visit by standardized questionnaire. All reoperations occurring in the three months period after surgery were analyzed, and immediate reoperations which were directly related to the ileostomy reversal were analyzed separately. RESULTS: 118 patients with elective ileostomy reversal were included in the trial. 12 out of 106 patients (11.3%) underwent any reoperation within three months after surgery (Clavien-Dindo grade IIIb). On multivariate analysis, anemia was associated with any reoperation p = 0.004; OR 6.93 (95% CI 1.37-30.07). Six out of 114 patients (5.3%) required an immediate reoperation (small bowel perforation, anastomotic leakage, postoperative ileus, deep wound infection) due to surgical complications directly related to the ileostomy reversal. Higher body mass index and anemia were associated with immediate reoperations (BMI: p = 0.038; OR 0.73 (95% CI 0.55-0.98); anemia: p = 0.001; OR 25.50 (95% CI 3.87-168.21). CONCLUSION: Surgical complications after ileostomy reversal occurred to a substantial extent. Rate of reoperations was associated with anemia and high body mass index. Optimizing patients in terms of preoperative hemoglobin and BMI may reduce surgical complications after ileostomy closure.