A randomized trial of laparoscopic versus open surgery for rectal cancer.

Background Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], −2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, −1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, −1.6 to 7.8). Conclusions Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.

Health services research in colorectal cancer: a quasi-experimental interventional pilot study on in- and outpatient oncology

Introduction Due to frequent treatment side effects and weight loss, colorectal cancer patients require oncologic care and nutritional counseling both during and after hospitalization. The current study evaluated differences in discharge and side effects management and nutritional behavior between colorectal cancer patients of a control group without systematic counseling and of an intervention group with access to structured in- and outpatient oncology nurse and nutritional counseling. Methods The presented explorative, quantitative, single-center, interventional pilot study is a health services research project with a quasi-experimental design. Using a self-designed standardized questionnaire, data were collected from the control group (n = 75) before and from the intervention group (n = 114) after the introduction of in- and outpatient oncology nurse and structured systematic nutritional counseling. The in- and outpatient counseling services were developed and evaluated in the form of a structured nurse-led counseling concept. Results Intervention group patients profited significantly from inpatient oncology nurse counseling in seven different areas of discharge management. No differences were observed concerning patient-reported general and gastrointestinal side effects except for xerostomia and dysphagia, but of the patients participating in both in- and outpatient oncology nurse counseling, 90.0% were better able to cope with general side effects of treatment. Patients with in- and outpatient structured systematic nutritional counseling more frequently received nutritional information (p = 0.001), were better at gauging food intolerances (p = 0.023), and followed the dietician's advice in cases of gastrointestinal side effects significantly more often (p = 0.003) than control patients. Counselor-reported outcomes concerning gastrointestinal side effects showed improvement in most of the patients taking part in systematic in- and outpatient nutritional counseling, except for weight loss in 4 patients. Conclusion In- and outpatient counseling in discharge and side effects management and nutrition improve the outcomes of colorectal cancer patients. Outpatient counseling should be further developed and evaluated in future studies

Contribution of CD3+CD8- and CD3+CD8+ T Cells to TNF-α Overexpression in Crohn Disease–Associated Perianal Fistulas and Induction of Epithelial-Mesenchymal Transition in HT-29 Cells

Background Fistulas represent a frequent and severe complication in patients with Crohn disease (CD). Tumor necrosis factor-alpha (TNF-α), transforming growth factor-beta, and interleukin (IL)-13 are known to trigger epithelial-mesenchymal transition (EMT), promoting fistula formation. Here, we investigated the role of T-lymphocytes (T cells) in fistula pathogenesis. Methods CD3+CD8-, CD3+CD8+, or CD45+CD3- cells from healthy volunteers, patients with CD, and patients with CD with perianal fistula were co-cultured with HT-29 cells. The EMT, cytokine production, and mRNA expression were analyzed. Perianal CD fistula specimens were immunohistochemically stained for cytokines and their receptors. The effect of cytokines on EMT induction was investigated using an EMT spheroid model. Results Patients with CD with fistula revealed more CD3+CD8- and less CD3+CD8+ T cells in blood than healthy control patients and patients with CD without fistula. In perianal fistula specimens, CD4+ cells—and to a lesser extent CD8+ cells—were highly present around fistula tracts. When co-cultured with HT-29 cells, both cell subsets promoted EMT-related gene expression and TNF-α production in a time-dependent manner. The CD3+CD8- T cells from patients with CD with fistula also produced higher amounts of IL-13 than cells from healthy control patients or patients with CD without a fistula. We found that IL-22 and IL-22Rα1 were highly expressed in perianal CD fistula specimens and that IL-22 cotreatment potentiated TNF-α-induced EMT in HT-29 spheroids. Conclusions Our data indicate that both CD3+CD8- and CD3+CD8+ T cells play an important role in the pathogenesis of perianal CD fistulas by the secretion of TNF-α. Our data support clinical evidence indicating that anti-TNF-α therapy is effective in fistula treatment and identify IL-13 and IL-22 as possible novel therapeutic targets for fistula therapy

A randomized trial of laparoscopic versus open surgery for rectal cancer.

Background Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], −2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, −1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, −1.6 to 7.8). Conclusions Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.

S3 guideline anal carcinoma Diagnostics, therapy and follow-up of anal canal and anal margin carcinomas

Anal cancer is a relatively rare tumor but has shown a continuous increase of new diseases with a doubling of the incidence in the last 20 years. Nearly all anal cancers are induced by a persisting infection with human papillomavirus (HPV). In the guidelines program for oncology for the first time German language S3 guidelines for optimization of the diagnostics, treatment and aftercare of anal cancer have been compiled under the patronage of the German Society of Coloproctology. Suggestions for recommendations were compiled in interdisciplinary working groups based on the formulated key questions, which were modified and graded within a nominal consensus procedure. After the systematic literature search the endpoint-related assessment and classification of the evidence was carried out within the framework of the GRADE procedure. A total of 93 recommendations and statements were formulated with respect to the topics prevention and screening, diagnostics and staging, supportive measures before and after targeted tumor treatment, treatment of anal cancer in stages I-III, response evaluation following primary chemoradiotherapy, aftercare, treatment of residual and recurrent anal cancer, treatment of metastatic anal cancer (stage IV), palliative care and rehabilitation. The new guidelines provide a foundation for the optimization of interdisciplinary and cross-sectoral care of anal cancer patients. Based on quality indicators future health services research should investigate whether the guideline recommendations are taken into consideration and whether these contribute to an improvement in care

A randomized trial of laparoscopic versus open surgery for rectal cancer

BACKGROUND Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. METHODS In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2: 1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. RESULTS A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). CONCLUSIONS Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surger