Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206).

OBJECTIVE: To determine whether circular plastic wound edge protectors (CWEPs) significantly reduce the rate of surgical site infections (SSIs) in comparison to standard surgical towels in patients undergoing laparotomy. BACKGROUND: SSIs cause substantial morbidity, prolonged hospitalization, and costs and remain one of the most frequent surgical complications. CWEPs have been proposed as a measure to reduce the incidence of SSIs. METHODS: In this randomized controlled, multicenter, 2-arm, parallel-group design, patient- and observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels. Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a 30-day postoperative period. RESULTS: Between September 2010 and November 2012, 608 patients undergoing laparotomy were randomized at 16 centers across Germany. Three patients in the device group and 11 patients in the control group did not undergo laparotomy. Patients' and procedural characteristics were well balanced between the 2 groups. Forty-eight patients discontinued the study prematurely, mainly because of relaparotomy (control, n=9; intervention, n=9) and death (control, n=4; intervention, n=7). A total of 79 patients experienced SSIs within 30 days of surgery, 27 of 274 (9.9%) in the device group and 52 of 272 (19.1%) in the control group (odds ratio=0.462, 95% confidence interval: 0.281-0.762; P=0.002). Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery, and in clean-contaminated/contaminated surgeries. CONCLUSIONS: Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery.

Single-port cholecystectomy versus multi-port cholecystectomy: a prospective cohort study with 222 patients.

BACKGROUND: The aim of this study was to compare single-port access cholecystectomy (SPA) with the standard laparoscopic technique (LC) regarding the duration of the operation, complications, learning curve, late postoperative quality of life (QoL) and the incidence of incisional hernias. METHODS: Between June 2009 and December 2011, a total of 122 SPA cholecystectomies were performed in our hospital. Simultaneously, 310 patients were operated on with the LC technique. In the LC group, 100 patients met the same criteria defined for SPA surgery. The two groups (SPA and LC) were compared by multivariable regression analysis. Endpoints of this study were quality of life (QoL) after 6 months by the EQ-5D questionnaire 5L and the incidence of incisional hernia 1 year after surgery. Operating time, hospital stay, and perioperative complications were also measured and compared. The median follow-up was 9.2 months (3-25 months). RESULTS: The patients in the SPA group were younger and more often female. The mean operating time for group SPA was 73 min (35-136 min)-significantly longer than that for group LC with 60 min (33-190 min) (p < 0.001). Additional trocars were used in 8 of 122 (6.5 %) SPA patients. A conversion to open cholecystectomy was not necessary in SPA patients. The conversion rate in the LC group to open cholecystectomy was 2 % (2/100). The perioperative and postoperative complications and incisional hernia (5.5 %) were the same in both groups. QoL was significantly better in the SPA group in terms of mobility (p = 0,002), usual activity (p = 0.036), and overall anxiety (p = 0.026). CONCLUSIONS: SPA cholecystectomy is safe, although the operation is significantly longer. No differences in terms of major complications or the incidence of incisional hernia were seen after 1 year. QoL was significantly better in patients operated on with the SPA technique.

Combined targeted treatment to eliminate tumorigenic cancer stem cells in human pancreatic cancer.

BACKGROUND & AIMS: Pancreatic cancers contain exclusively tumorigenic cancer stem cells (CSCs), which are highly resistant to chemotherapy, resulting in a relative increase in CSC numbers during gemcitabine treatment. Signaling through sonic hedgehog and mammalian target of rapamycin (mTOR), respectively, may be essential for CSC self-renewal and could represent putative targets for novel treatment modalities. METHODS: We used in vitro and in vivo models of pancreatic cancer to examine the effects of sonic hedgehog inhibition (cyclopamine/CUR199691) and mTOR blockade (rapamycin) on the tumorigenic CSC population. RESULTS: Surprisingly, neither cyclopamine nor rapamycin alone or as supplements to chemotherapy were capable of effectively diminishing the CSC pool. Only the combined inhibition of both pathways together with chemotherapy reduced the number of CSCs to virtually undetectable levels in vitro and in vivo. Most importantly, in vivo administration of this triple combination in mice with established patient-derived pancreatic tumors was reasonably tolerated and translated into significantly prolonged long-term survival. CONCLUSIONS: The combined blockade of sonic hedgehog and mTOR signaling together with standard chemotherapy is capable of eliminating pancreatic CSCs. Further preclinical investigation of this promising approach may lead to the development of a novel therapeutic strategy to improve the devastating prognosis of patients with pancreatic cancer.

Physical Activity and Nutrition in Primary and Tertiary Prevention of Colorectal Cancer.

BACKGROUND: Lifestyle factors play a pivotal role in the primary and tertiary prevention of colorectal cancer. The purpose of this review article is to summarize data concerning the effect of the lifestyle factors physical activity (PA) and nutrition in primary and, more importantly, tertiary prevention of colorectal cancer (CRC). METHODS: Focusing on the influence of lifestyle factors on prognosis und quality of life (QOL), a comprehensive literature search of clinical studies published mainly in the years 2000 until 2015 was performed and the current knowledge based on these clinical studies reviewed. RESULTS: Besides avoiding risk factors (such as smoking and overindulgence in alcohol), healthy weight, regular and moderate PA as well as a diet which contains fruit, vegetables, poultry, and fish (so-called 'Mediterranean' diet) may reduce the risk of the disease significantly. Patients already diagnosed with CRC can also actively improve the prognosis of CRC and QOL by changing their lifestyle. Patients commencing moderate exercise and modifying their eating habits in terms of a 'Mediterranean' diet can reduce cancer-specific and overall mortality by up to 40% and significantly increase their quality of life already during chemotherapy. Therefore, moderate physical exercise, calorie restriction, and a Mediterranean dietary pattern for patients with CRC should be recommended by physicians treating these patients. In fact, the World Cancer Research Fund/American Institute for Cancer Research (AICR/WCRF) systematic literature review from 2007 shows that the lifestyle changes recommended after diagnosis are the same for primary prevention of this disease. CONCLUSION: Lifestyle changes such as moderate PA and a Mediterranean diet significantly improve the QOL as well as the prognosis of patients suffering from colorectal disease. However, the effect of lifestyle changes is mostly based on observational studies, while only few studies are prospective and none are randomized. Therefore, these observational studies warrant controlled randomized trials to prove the effectiveness of lifestyle interventions on QOL and cancer recurrence.

Physical activity in the prevention and treatment of colorectal carcinoma.

BACKGROUND: Colorectal carcinoma is the most common type of tumor in Western countries. The risk of developing colorectal carcinoma depends both on genetic factors (familial predisposition) and on lifestyle-related factors such as body-mass index, level of physical activity, and nutritional behavior. Regular physical activity is important in primary prevention, and there is also evidence that the prognosis after treatment of a colorectal carcinoma can be improved by exercise. METHODS: The PubMed database was searched for relevant articles that appeared in the last 10 years, and selected articles were evaluated. RESULTS: Cross-sectional studies have shown that regular physical activity (ca. 7 hours of brisk walking per week) lowers the risk of colon carcinoma by 40%. Physical activity also improves the outcome of patients already diagnosed with colorectal carcinoma: for example, patients with advanced disease (UICC stage II or III) have been found to survive significantly longer if they perform 4 hours of brisk walking per week, or the equivalent degree of physical exercise. CONCLUSIONS: Cross-sectional studies show that physically active persons are less likely to develop colorectal carcinoma than physically inactive persons, and that they have better outcomes in the event that they do develop the disease. The positive findings with respect to secondary prevention still need to be confirmed in interventional trials, but in primary prevention, at least, physical activity should be actively promoted, along with other beneficial lifestyle habits and screening measures.

Postoperative care following pancreatic surgery: surveillance and treatment.

BACKGROUND: After pancreatic surgery, some patients have complications that require treatment. METHOD: Review article based on a selective literature search and the German S3 guideline on pancreatic carcinoma. RESULTS: Detailed knowledge of the surgical procedure and its potential early and late complications is a prerequisite for the recognition and treatment of problems occurring after pancreatic surgery. These may be due either to the operation itself or to the progression of the underlying pancreatic disease. Both diabetes mellitus and exocrine insufficiency are common long-term sequelae. If persistent pain should arise, its cause must be identified and treated. To prevent malnutrition and vitamin deficiency after pancreatic resection, patients should be given a diet with an increased fat content and with supplemental enzymes. CONCLUSION: Appropriate methods are available for the accurate diagnosis and, in most cases, successful treatment of complications arising after pancreatic surgery.