[Background, Necessity and Methodology of the S3 Guideline "Perioperative Management of Gastrointestinal Tumours (POMGAT)"]. / Hintergrund, Notwendigkeit und Methodik der S3-Leitlinie "Perioperatives Management bei gastrointestinalen Tumoren (POMGAT)".

Malignancies are among the most common diseases, especially in old age, and are responsible for 25% of all deaths in Germany. Especially carcinomas of the gastrointestinal tract can be cured in most cases only through extensive surgery with significant morbidity. About 25 years ago, the multimodal, perioperative Fast Track (FT) concept for reducing postoperative complications was introduced and additional elements were added in the following years. Meanwhile, there is growing evidence that adherence to the key elements of more than 70% leads to reduction in postoperative adverse events as well as a shorter hospital stay and could be associated with an improved oncological outcome. Despite the high level of awareness and the proven advantages of the FT concept, the implementation and maintenance of the measures is difficult and results in an adherence of only 20 - 40%. There are many reasons for this: In addition to a lack of interdisciplinary and interprofessional cooperation and the time consuming and extended logistical efforts, limited human resources are often listed as one of the main causes. We took these aspects as an opportunity and started to develop a S3 guideline for perioperative treatment to accelerate the recovery of patients with gastrointestinal malignancies. By creating a consensus- and evidence-based, multidisciplinary guideline, many of the problems listed above could probably be solved by optimising and standardising interdisciplinary care, which is particularly important in a setting with many different disciplines and their competing interests. Furthermore, the standardisation of the perioperative procedures will reduce the time and logistical effort. The presentation of the evidence allows increased transparency and justifies the additional personnel expenditure on hospital medicine and health insurance companies. In addition, the evidence-based quality indicators generated during the development of the guideline make it possible to include perioperative standards in certification systems and thus to measure and check the quality of perioperative care.

Feasibility, acceptance, safety, and effectiveness of antibiotic therapy as alternative treatment approach to appendectomy in uncomplicated acute appendicitis.

PURPOSE: Based on results from randomized controlled trials, there is an increasing discussion if antibiotic treatment is an equivalent therapeutic approach to appendectomy in uncomplicated acute appendicitis. This observational prospective study evaluates its feasibility, safety, and effectiveness in clinical practice. METHODS: The study included all consecutive adults treated for acute appendicitis over an 18-month period in one hospital. Patients receiving antibiotics were compared to those treated surgically. Follow-up comprised 1 year. The primary endpoint was treatment success, defined as no secondary appendectomy during follow-up (antibiotic group) or successful appendectomy (primary surgical group). Secondary endpoints were complications, duration of hospital stay, pain intensity, and length of absence from work. RESULTS: 54/124 (43.6%) patients were primarily treated with antibiotics and 70/124 (56.4%) surgically. Treatment success at 1 year was 77.1% (95%-CI 62.8-88%) for antibiotic and 100% for surgical treatment. Complications were non-significantly less frequent both among all patients treated with antibiotics and among patients undergoing secondary appendectomy compared to patients undergoing primary appendectomy (20.8% vs. 27.1% and 9.1% vs. 27.1%). The initial hospital stay was significantly shorter in the antibiotic group (mean 3.6 vs. 4.8 days, median 3 days, p = 0.03). After 1 year, the cumulative hospital stay was not different between groups. CONCLUSIONS: Appendectomy remains the most effective treatment for the definitive cure of acute appendicitis. However, antibiotic therapy can be a safe alternative approach for selected patients with uncomplicated acute appendicitis. TRIAL REGISTRATION: DRKS00010401.

MTL, a composite measure for objectively profiling hospitals on surgical performance in colorectal cancer surgery.

PURPOSE: MTL is a composite outcome measure based on routine administrative data defined as (a) postoperative mortality and/or (b) postoperative transfer to another hospital and/or (c) length of hospital stay ≥ the prespecified time period. Aim of the present study was to investigate MTL for profiling hospitals on surgical performance in colorectal cancer surgery, using data from the national registers of the German Society of General and Visceral Surgery (DGAV) and to determine the time interval for length of stay with the highest accuracy regarding major complications (Clavien-Dindo grade ≥ 3). METHODS: All patients undergoing colorectal cancer resection between January 2010 and February 2017 were included. MTL rates were calculated and compared to well-established single outcome measures using multivariate regression analysis. For each outcome measure, postoperative complications were tested regarding their predictability. RESULTS: Data from 14,978 patients were analyzed. Length of stay was significantly prolonged if postoperative complications occurred (p < 0.0001). Thirty-day mortality and the indication for a transfer to another hospital mainly resulted from cardiopulmonary complications. MTL occurs significantly more often than any of the single-outcome parameters. The time interval of 22 days demonstrated the highest accuracy regarding severe complications (Clavien-Dindo grade ≥ 3). CONCLUSIONS: MTL reflects the complete spectrum of postoperative complications. Compared to individual surgical outcome parameters, MTL may have a better discriminatory power and is therefore suitable to mirror surgical quality. Because of its high accuracy regarding surgical major morbidity, 22 days is the best cut-off for length of stay within the German healthcare system.

Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation.

BACKGROUND: A parastomal hernia is defined as an incisional hernia related to a stoma, and belongs to the most common stoma-related complications. Many factors, which are considered to influence the incidence of parastomal herniation, have been investigated. However, it remains unclear whether the enterostomy should be placed through, or lateral to the rectus abdominis muscle, in order to prevent parastomal herniation and other important stoma complications. OBJECTIVES: To assess if there is a difference regarding the incidence of parastomal herniation and other stoma complications, such as ileus and stenosis, in lateral pararectal versus transrectal stoma placement in people undergoing elective or emergency abdominal wall enterostomy. SEARCH METHODS: For this update, we searched for all types of published and unpublished randomized and non-randomized studies in four medical databases: CENTRAL, PubMed, LILACS, Science Ciation Index, and two trials registers: ICTRP Search Portal and ClinicalTrials.gov to 9 November 2018. We applied no language restrictions. SELECTION CRITERIA: Randomized and non-randomized studies comparing lateral pararectal versus transrectal stoma placement with regard to parastomal herniation and other stoma-related complications. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. We conducted data analyses according to the recommendations of Cochrane and the Cochrane Colorectal Cancer Group (CCCG). We rated quality of evidence according to the GRADE approach. MAIN RESULTS: Randomized controlled trials (RCT)Only one RCT met the inclusion criteria. The participants underwent enterostomy placement in the frame of an operation for: rectal cancer (37/60), ulcerative colitis (14/60), familial adenomatous polyposis (7/60), and other (2/60).The results between the lateral pararectal and the transrectal approach groups were inconclusive for the incidence of parastomal herniation (risk ratio (RR) 1.34, 95% confidence interval (CI) 0.40 to 4.48; low-quality evidence); development of ileus or stenosis (RR 2.0, 95% CI 0.19 to 20.9; low-quality evidence); or skin irritation (RR 0.67, 95% CI 0.21 to 2.13; moderate-quality evidence). The results were also inconclusive for the subgroup analysis in which we compared the effect of ileostomy versus colostomy on parastomal herniation. The study did not measured other stoma-related morbidities, or stoma-related mortality, but did measure quality of life, which was not one of our outcomes of interest.Non-randomized studies (NRS)Ten retrospective cohort studies, with a total of 864 participants, met the inclusion criteria. The indications for enterostomy placement and the baseline characteristics of the participants (age, co-morbidities, disease-severity) varied between studies. All included studies reported results for the primary outcome (parastomal herniation) and one study also reported data on one of the secondary outcomes (stomal prolapse).The effects of different surgical approaches on parastomal herniation (RR 1.22, 95% CI 0.84 to 1.75; 10 studies, 864 participants; very low-quality evidence) and the occurrence of stomal prolapse (RR 1.23, 95% CI 0.39 to 3.85; 1 study, 145 participants; very low-quality evidence) are uncertain.None of the included studies measured other stoma-related morbidity or stoma-related mortality. AUTHORS' CONCLUSIONS: The present systematic review of randomized and non-randomized studies found inconsistent results between the two compared interventions regarding their potential to prevent parastomal herniation.In conclusion, there is still a lack of high-quality evidence to support the ideal surgical technique of stoma formation. The available moderate-, low-, and very low-quality evidence, does not support or refute the superiority of one of the studied stoma formation techniques over the other.

Early postoperative pancreatitis following pancreaticoduodenectomy: what is clinically relevant postoperative pancreatitis?

BACKGROUND/OBJECTIVES: Postoperative pancreatitis (POP) has recently been shown to be the cause of pancreatic fistula (POPF) following pancreaticoduodenectomy (PD). The aim of the present study was to document the perioperative outcome associated with POP and determine potential risk factors for POP. METHODS: Patients undergoing PD between 2009 and 2015 were identified from the prospective data base at a single center. The previous suggested definition of POP by Connor was used. Complications were graded according to the Clavien-Dindo classification and by the grading proposed for POP. Risk factors for POP were analyzed by univariate and multivariate analysis. RESULTS: Of 190 patients, a total of 100 patients (53%) developed POP of whom 22 (12%) and 13 (7%) had grade B and grade C complications, respectively. Elevated serum CRP-levels on postoperative day (POD) 2 and elevated serum lipase on POD 1 were associated with onset of cr-POP. CONCLUSION: The proposed definition of POP constitutes a valuable tool to assess a serious pancreatic-surgery associated complication. Routine serum CRP and serum lipase levels on the first two postoperative days enable sufficient discrimination of clinically relevant POP.

Barriers and Facilitating Factors for Research Involvement in Cancer Centers: A Survey of Colorectal Cancer Center Coordinators in Germany, Austria, and Switzerland.

Improvements in health care depend on research involving health-care providers (HCPs) and health-care organizations (HCOs). Existing research suggests that involvement in research studies is still much lower than it could be. This study investigates factors that may impede or facilitate research involvement. A standardized online questionnaire was used to carry out a survey, in 3 countries, of key informants in colorectal cancer centers that hold certification in accordance with the requirements of the German Cancer Society. A total of 184 individuals responded (response rate 65%). The respondents found it difficult to identify studies suitable for their patients (40% agreement), criticized the small overall number of studies available (48%), and found that many studies are not worthwhile financially (56%). Among respondents who were not involved in studies as the principal investigators (PIs), 66% agreed they lacked the research infrastructure needed and 81% that they did not have enough staff. Among respondents who were involved as PIs, only 22% indicated that their hospital management encouraged them to initiate and conduct clinical trials. Eighty-five percent of the respondents agreed that the general population lacks information about the importance of studies. Five recommendations for health policy makers are derived from these findings for ways of increasing the involvement of HCPs and HCOs in research, and in cancer research in particular.

Duodenal localization is a negative predictor of survival after small bowel adenocarcinoma resection: A population-based, propensity score-matched analysis.

BACKGROUND AND OBJECTIVES: This study assessed the influence of tumor localization of small bowel adenocarcinoma on survival after surgical resection. METHODS: Patients with resected small bowel adenocarcinoma, ACJJ stage I-III, were identified from the Surveillance, Epidemiology, and End Results database from 2004 to 2013. The impact of tumor localization on overall and cancer-specific survival was assessed using Cox proportional hazard regression models with and without risk-adjustment and propensity score methods. RESULTS: Adenocarcinoma was localized to the duodenum in 549 of 1025 patients (53.6%). There was no time trend for duodenal localization (P = 0.514). The 5-year cancer-specific survival rate was 48.2% (95%CI: 43.3-53.7%) for patients with duodenal carcinoma and 66.6% (95%CI: 61.6-72.1%) for patients with cancer located in the jejunum or ileum. Duodenal localization was associated with worse overall and cancer-specific survival in univariable (HR = 1.73; HR = 1.81, respectively; both P < 0.001), multivariable (HR = 1.52; HR = 1.65; both P < 0.001), and propensity score-adjusted analyses (HR = 1.33, P = 0.012; HR = 1.50, P = 0.002). Furthermore, young age, retrieval of more than 12 regional lymph nodes, less advanced stage, and married matrimonial status were positive, independent prognostic factors. CONCLUSIONS: Duodenal localization is an independent risk factor for poor survival after resection of adenocarcinoma.

Clinical and Histopathologic Features of Colorectal Adenocarcinoma in Crohn's Disease.

GOALS: The aim of this study was to assess the histopathologic characteristics of colorectal carcinomas (CRC) in patients with Crohn's disease (CD). BACKGROUND: A higher frequency of microsatellite instability (MSI) is seen in mucinous compared with nonmucinous CRC which suggests that its pathogenesis involves distinct molecular pathways. Several publications reported a higher percentage of mucinous adenocarcinoma in CD patients with CRC. So far, there has been no investigation of MSI in CD patients with mucinous CRC. STUDY: The medical records of patients who underwent surgery for CRC were reviewed and those with a history of CD identified. The data of histologic classification and MSI status of the tumor were investigated. RESULTS: Fourteen patients with CD-associated CRC were identified (5 female, 9 male) resulting in 20 CRC in total. Histologic investigation revealed 7 adenocarcinomas without a mucinous or signet ring cell component. All other CRCs harbored a mucinous (n=11) and/or signet ring cell (n=6) component. All tumors assessed for MSI were found to be microsatellite stable. CONCLUSIONS: Our data indicate that CRCs with signet ring cell and mucinous components were much more common in patients with CD than in patients with sporadic CRC. This observation suggests that CRC in CD represent an own entity with distinct histopathologic and molecular features. This may implicate potential consequences for diagnosis and therapy of CRC in CD in the future as well as new factors to identify patients with an increased risk for developing CRC in CD.

Risk factors for early postoperative complications and length of hospital stay in ileocecal resection and right hemicolectomy for Crohn's disease: a single-center experience.

PURPOSE: To determine risk factors for early postoperative complications and longer hospital stay after ileocecal resection and right hemicolectomy in a single-center cohort of patients with Crohn's disease (CD). METHODS: A retrospective analysis of the prospectively maintained surgical database for patients with CD at our institution was performed. All consecutive patients operated on between January 2010 and December 2016 were included. RESULTS: A total of 305 patients were included. Median length of hospital stay was 7 days (interquartile range, IQR 6-10). Major postoperative complications were observed in 9.5% of patients (n = 29). Anastomotic leak was observed in five patients (1.8% of all patients with anastomosis). The rate of local septic complications was 4.3% (n = 13, anastomotic leak, postoperative abscess, and/or postoperative fistula). In multivariable analysis, independent risk factors for major postoperative complications were bowel perforation (odds ratio (OR) = 12.796, 95% CI = 1.144-143.178); elevated preoperative leucocyte levels (OR = 1.115, 95% CI = 1.013-1.228); and low levels of preoperative albumin (OR = 0.885, 95% CI = 0.827-0.948). The cutoff value for albumin was 32.5 g/L (sensitivity 75.9%, specificity 62.6%). CONCLUSIONS: In this large cohort of patients surgically treated for CD in a tertiary referral center, 9.5% of the patients developed major postoperative complications. Preoperative albumin levels > 32.5 g/L significantly reduce the risk for postoperative complications and shorten the length of hospital stay. In a multidisciplinary concept with adequate preoperative management, surgery can be performed with a low rate of major complications and a very low rate of anastomotic leakage.

Impact of adjuvant chemotherapy on patients with ypT0-2 ypN0 rectal cancer after neoadjuvant chemoradiation: a cohort study from a tertiary referral hospital.

BACKGROUND: To investigate the importance of adjuvant chemotherapy in locally advanced rectal cancer (≥ cT3 or N+) staged ypT0-2 ypN0 on final histological work-up after neoadjuvant chemoradiation and radical resection. METHODS: The clinical course of patients with rectal cancer and ypT0-2 ypN0 stages after neoadjuvant chemoradiation and radical resection was analyzed from 1999 to 2012. Patients were divided into two groups depending on whether adjuvant chemotherapy was administered or not. Overall survival, distant metastases, and local recurrence were compared between both groups. RESULTS: Fifty-four patients with adjuvant (ACT) and 50 patients without adjuvant chemotherapy (NACT) after neoadjuvant chemoradiation followed by radical resection for rectal cancer were included in the analysis. Mean follow-up was 68 ± 33.7 months. One patient without adjuvant chemotherapy and none in the ACT group developed a local recurrence. Five patients in the NACT group and three patients in the ACT group had distant recurrences. Median disease-free survival for all patients was 65.5 ± 34.5 months. Multivariate analysis showed adjuvant chemotherapy to be the most relevant factor for disease-free and overall survival. Patients staged ypT2 ypN0 showed a significantly better disease-free survival after application of adjuvant chemotherapy. Disease-free survival in ypT0-1 ypN0 patients showed no correlation to the administration of adjuvant chemotherapy. CONCLUSION: Administration of adjuvant chemotherapy after neoadjuvant chemoradiation and radical resection in rectal cancer improved disease-free and overall survival of patients with ypT0-2 ypN0 tumor stages in our study. In particular, ypT2 ypN0 patients seem to profit from adjuvant treatment.

Shifting cancer care towards Multidisciplinarity: the cancer center certification program of the German cancer society.

BACKGROUND: Over the last decades numerous initiatives have been set up that aim at translating the best available medical knowledge and treatment into clinical practice. The inherent complexity of the programs and discrepancies in the terminology used make it difficult to appreciate each of them distinctly and compare their specific strengths and weaknesses. To allow comparison and stimulate dialogue between different programs, we in this paper provide an overview of the German Cancer Society certification program for multidisciplinary cancer centers that was established in 2003. MAIN BODY: In the early 2000s the German Cancer Society assessed the available information on quality of cancer care in Germany and concluded that there was a definite need for a comprehensive, transparent and evidence-based system of quality assessment and control. This prompted the development and implementation of a voluntary cancer center certification program that was promoted by scientific societies, health-care providers, and patient advocacy groups and based on guidelines of the highest quality level (S3). The certification system structures the entire process of care from prevention to screening and multidisciplinary treatment of cancer and places multidisciplinary teams at the heart of this program. Within each network of providers, the quality of care is documented using tumor-specific quality indicators. The system started with breast cancer centers in 2003 and colorectal cancer centers in 2006. In 2017, certification systems are established for the majority of cancers. Here we describe the rationale behind the certification program, its history, the development of the certification requirements, the process of data collection, and the certification process as an example for the successful implementation of a voluntary but powerful system to ensure and improve quality of cancer care. CONCLUSION: Since 2003, over 1 million patients had their primary tumors treated in a certified center. There are now over 1200 sites for different tumor entities in four countries that have been certified in accordance with the program and transparently report their results from multidisciplinary treatment for a substantial proportion of cancers. This led to a fundamental change in the structure of cancer care in Germany and neighboring countries within one decade.

German S3 guidelines: anal abscess and fistula (second revised version).

BACKGROUND: The incidence of anal abscess and fistula is relatively high, and the condition is most common in young men. METHODS: This is a revised version of the German S3 guidelines first published in 2011. It is based on a systematic review of pertinent literature. RESULTS: Cryptoglandular abscesses and fistulas usually originate in the proctodeal glands of the intersphincteric space. Classification depends on their relation to the anal sphincter. Patient history and clinical examination are diagnostically sufficient in order to establish the indication for surgery. Further examinations (endosonography, MRI) should be considered in complex abscesses or fistulas. The goal of surgery for an abscess is thorough drainage of the focus of infection while preserving the sphincter muscles. The risk of abscess recurrence or secondary fistula formation is low overall. However, they may result from insufficient drainage. Primary fistulotomy should only be performed in case of superficial fistulas. Moreover, it should be done by experienced surgeons. In case of unclear findings or high fistulas, repair should take place in a second procedure. Anal fistulas can be treated only by surgical intervention with one of the following operations: laying open, seton drainage, plastic surgical reconstruction with suturing of the sphincter (flap, sphincter repair, LIFT), and occlusion with biomaterials. Only superficial fistulas should be laid open. The risk of postoperative incontinence is directly related to the thickness of the sphincter muscle that is divided. All high anal fistulas should be treated with a sphincter-saving procedure. The various plastic surgical reconstructive procedures all yield roughly the same results. Occlusion with biomaterial results in lower cure rate. CONCLUSION: In this revision of the German S3 guidelines, instructions for diagnosis and treatment of anal abscess and fistula are described based on a review of current literature.

Transabdominal laparoscopic retroperitoneal neurectomy for chronic pain after inguinal hernia repair and appendicectomy -a matched-pair study.

BACKGROUND: Chronic debilitating pain is a rare but significant cause of postoperative morbidity after inguinal surgery. Such pain is usually of neuropathic origin and frequently caused by intraoperative nerve damage. In this retrospective matched-pair study we analysed results of a minimal-invasive approach to neurectomy on quality of life and pain relief. METHODS: From March 2010 to January 2012, 9 patients developing chronic neuropathic pain after inguinal hernia repair (8 patients) or open appendicectomy (one patient) were operated using a laparoscopic transabdominal approach in our department. Clinical examinations and specific questionnaires on pain and quality of life (PainDetect, SF-36) were completed 6 months to 3 years after neurectomy. Every patient was matched with one patient without chronic pain. RESULTS: Seven of nine patients had severe or very severe pain before neurectomy, two had mild pain but refused a conservative treatment. Four patients were free of pain after neurectomy, three described an improved pain status, whereas two did not observe any change in pain. Within a follow-up period of 14,3 months, no deterioration of pain or other complications were observed. Patients who underwent neurectomy had significantly lower quality of life compared to the control group. No postoperative complications were observed. CONCLUSIONS: Laparoscopic transabdominal neurectomy represents a possible surgical approach in treating patients with chronic disabling postoperative groin pain requiring surgery. This technique was feasible, safe, and effective in our series to relieve chronic debilitating pain in the majority of our patients with comparable results to other published approaches.

Quality of Life and Timing of Stoma Closure in Patients With Rectal Cancer Undergoing Low Anterior Resection With Diverting Stoma: A Multicenter Longitudinal Observational Study.

BACKGROUND: After low anterior resection for rectal cancer, creation of a diverting stoma is recommended. Data on the impact of a diverting stoma on quality of life are conflicting. Optimal timing of stoma closure in the setting of adjuvant chemotherapy is unclear. OBJECTIVE: The purpose of this study was to investigate the impact of a diverting stoma on quality of life in patients undergoing rectal cancer resection before and after stoma closure. Furthermore, the study was conducted to look at the timing of stoma reversal and the potential influence of factors such as adjuvant chemotherapy. DESIGN: This was a longitudinal, observational, multicenter study. SETTINGS: The study was conducted at 17 German colorectal centers. PATIENTS: Patients with rectal cancer who planned for elective curative surgery with creation of temporary diverting stoma were included. MAIN OUTCOME MEASURES: This longitudinal observational study assessed quality of life at 3 occasions using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire/Colorectal Cancer Module before cancer resection, before stoma closure, and 6 months after stoma closure. Furthermore, the timing of stoma closure and continence were evaluated. RESULTS: A total of 120 patients (64% men; mean age, 63.2 ± 11.5 years) were analyzed. Longitudinal global quality of life was not influenced by the presence of a stoma. Several functional and GI symptom scales were markedly impaired after stoma creation. Physical, role functioning, and sexual interest recovered after stoma closure. Social functioning stayed impaired (p < 0.0001). Median time to stoma closure was 5 months (range, 17 days to 18 months). A total of 3.4% of patients had very early stoma closure (within 30 days). Adjuvant chemotherapy delayed stoma closure (median, 5.6 vs 3.4 months without chemotherapy; p = 0.0001). LIMITATIONS: The study was limited by its missing quality-of-life data for sexual function. CONCLUSIONS: The presence of a stoma had a negative impact on social functioning and GI symptoms. However, this had no clinically relevant influence on global quality of life. Time to stoma closure was nearly doubled when patients underwent adjuvant chemotherapy.

CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer.

BACKGROUND: Current evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage. However, relevant stoma morbidity after rectal cancer surgery exists and has a significant impact on quality of life. Moreover, a diverting stoma has an influence on completeness of chemotherapy but it remains unclear in which way. There is no evidence regarding optimal timing for stoma closure in relation to adjuvant chemotherapy. Two randomised controlled trials have studied early stoma closure after low anterior resection in patients with rectal cancer, one of them showing that early closure around day 8 after resection is possible without increasing morbidity. METHODS/DESIGN: CoCStom is a randomised multicentre trial comparing completeness of adjuvant chemotherapy as primary endpoint after early (8-10 days after resection, before starting adjuvant therapy) versus late (~26 weeks after resection and completion of adjuvant therapy) stoma closure in patients with locally advanced rectal cancer undergoing low anterior resection after neoadjuvant therapy. After exclusion of post-operative anastomotic leakage 257 patients from 30 German hospitals are planned to be included in order to assure a power of 80% for the confirmatory analysis of at least 214 evaluable cases. An absolute increase of 20% for the rate of completely administered adjuvant chemotherapy is regarded as a clinically meaningful step forward and serves as basis for sample size calculation. Quality of life, stoma-related complications, individual completeness of chemotherapy rate, percentage of patients stopping adjuvant therapy or undergoing dose modifications or delay, oncological outcomes, cumulative days of hospitalisation and number of readmissions, rate of symptomatic anastomotic leaks after stoma closure, mortality, post-operative complications and toxicity of adjuvant chemotherapy are secondary endpoints. DISCUSSION: The CoCStom trial aims to clarify optimal timing of stoma closure in the context of adjuvant chemotherapy. Depending on the results of the trial, patients could benefit either from early or late stoma closure in regard to long term oncological survival due to a higher rate of completeness of adjuvant chemotherapy treatment and thus better effectiveness. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00005113. Registered 28 August 2013.

Clinical relevance of morphologic MRI criteria for the assessment of lymph nodes in patients with rectal cancer.

AIM: The aim of this study is the evaluation of lymph node staging by magnetic resonance imaging (MRI) within clinical routine in patients with rectal cancer. METHOD: Routine MRI reports (3 T) of 65 consecutive patients with rectal cancer were retrospectively categorized in lymph node tumor positive or negative (mriN+; mriN0) and compared to the final histopathological results (pN+; pN0). Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and accuracy were calculated. The original MRI readings were then reanalyzed in order to identify the longest short-axis lymph node diameter for each patient. A receiver operating characteristic (ROC) curve was used to calculate a possible cutoff value for the short-axis lymph node diameter. RESULTS: Overall sensitivity was 94 %, specificity 13 %, NPV 86 %, PPV 28 %, and accuracy 34 %. The best accuracy could be calculated for a short-diameter cutoff of ≤5 mm (83 %); pN+ and pN0 groups were then significantly different (p < 0.0001). CONCLUSION: In clinical routine, lymph node assessment in patients with rectal cancer through MRI tends to overstage malignant lymphadenopathy. A ≤5-mm cutoff value for the short-axis lymph node diameter of benign nodes is able to improve the accuracy and has potential to lower the risk of overstaging.

Oncologic colorectal resection after endoscopic treatment of malignant polyps: does endoscopy have an adverse effect on oncologic and surgical outcomes?

BACKGROUND: Early colorectal cancer is increasingly treated by endoscopic removal. In cases of incomplete resection or high-risk carcinoma, additional surgery is necessary. OBJECTIVE: To evaluate the frequency of subsequent oncologic surgery after endoscopic resection of colorectal cancer, the rate of lymph node metastasis, residual cancer, and morbidity and mortality rates of the operation. Any eventual adverse effect of the prior endoscopic therapy on the surgical and oncologic outcome was assessed. DESIGN: Retrospective review of prospectively collected data. SETTING: University hospital. PATIENTS: Sixty-six consecutive patients with incomplete endoscopic treatment and need for additional surgery between 2004 and 2011. INTERVENTION: The data of these patients were compared with those of a group of patients with surgery for early colorectal cancer during the same period without prior endoscopic resection as the control group. MAIN OUTCOME MEASUREMENTS: Rate of lymph node metastasis and residual cancer, perioperative morbidity and mortality. RESULTS: The lymph node metastasis rate after oncologic resection was 8.6%, and the residual cancer rate was 41%. Risk factors for residual cancer were macroscopic incomplete resection (P < .0001), positive resection margins (P = .03), and piecemeal resection (P = .004). No mortality was observed. Perioperative morbidity, mortality, and oncologic outcome were not significantly different in the group with prior endoscopic resection compared with the primarily operated group. LIMITATIONS: Retrospective study. CONCLUSION: Endoscopic treatment of malignant polyps does not worsen surgical and oncologic outcomes in cases of subsequent surgery. Because mortality and morbidity are low, oncologic resection generally should be done in the presence of risk factors for residual cancer.

Pharmacologic prevention and therapy of postoperative paralytic ileus after gastrointestinal cancer surgery - systematic review and meta-analysis.

BACKGROUND: Postoperative paralytic ileus (POI) is a significant concern following gastrointestinal tumor surgery. Effective preventive and therapeutic strategies are crucial but remain elusive. Current evidence from randomized-controlled trials on pharmacological interventions for prevention or treatment of POI are systematically reviewed to guide clinical practice and future research. MATERIALS AND METHODS: Literature was systematically searched for prospective randomized-controlled trials testing pharmacological interventions for prevention or treatment of POI after gastrointestinal tumor surgery. Meta-analysis was performed using a random effects model to determine risk ratios and mean differences with 95% confidence intervals. Risk of bias and evidence quality were assessed. RESULTS: Results from 55 studies, involving 5078 patients who received experimental interventions, indicate that approaches of opioid-sparing analgesia, peripheral opioid antagonism, reduction of sympathetic hyperreactivity, and early use of laxatives effectively prevent POI. Perioperative oral Alvimopan or intravenous administration of Lidocaine or Dexmedetomidine, while safe regarding cardio-pulmonary complications, demonstrated effectiveness concerning various aspects of postoperative bowel recovery (Lidocaine: -5.97 [-7.20 - -4.74]h, P<0.0001; Dexmedetomidine: -13.00 [-24.87 - -1.14]h, P=0.03 for time to first defecation; Alvimopan: -15.33 [-21.22 - -9.44]h, P<0.0001 for time to GI-2) and length of hospitalization (Lidocaine: -0.67 [-1.24 - -0.09]d, P=0.02; Dexmedetomidine: -1.28 [-1.96 - -0.60]d, P=0.0002; Alvimopan: -0.58 [-0.84 - -0.32]d, P<0.0001) across wide ranges of evidence quality. Perioperative non-opioid analgesic use showed efficacy concerning bowel recovery as well as length of hospitalization (-1.29 [-1.95 - -0.62]d, P=0.0001). Laxatives showed efficacy regarding bowel movements, but not food tolerance and hospitalization. Evidence supporting pharmacological treatment for clinically evident POI is limited. Results from one single study suggest that Neostigmine reduces time to flatus and accelerates bowel movements (-37.06 [-40.26 - -33.87]h, P<0.0001 and -42.97 [-47.60 - -38.35]h, P<0.0001, respectively) with low evidence quality. CONCLUSION: Current evidence concerning pharmacological prevention and treatment of POI following gastrointestinal tumor surgery is limited. Opioid-sparing concepts, reduction of sympathetic hyperreactivity, and laxatives should be implemented into multimodal perioperative approaches.

Pathohistological subtype predicts survival in patients with intraductal papillary mucinous neoplasm (IPMN) of the pancreas.

OBJECTIVE: To investigate different subtypes of intraductal papillary mucinous neoplasms (IPMNs) of the pancreas and their prognostic value. BACKGROUND: IPMNs of the pancreas are estimated to have a better prognosis than pancreatic ductal adenocarcinomas (PDACs). In addition to the different growth types (ie, main duct vs. branch duct types), the histological subtypes of IPMNs (ie, intestinal, pancreatobiliary, gastric, and oncocytic type) are prognostically relevant. These subtypes can be characterized by different mucin (MUC) expression patterns. In this study, we analyzed the IPMNs from 2 pancreatic cancer referral centers by correlating the MUC expression, histological subtype, and clinical outcome. METHODS: We re-evaluated all resections due to a pancreatic tumor over a period of 15 years. Cases with IPMNs were identified, and the subtypes were distinguished using histopathological analysis, including the immunohistochemical analysis of MUC (ie, MUC1, MUC2, and MUC5AC) expression. Furthermore, we determined clinical characteristics and patient outcome. RESULTS: A total of 103 IPMNs were identified. On the basis of the MUC profile, histopathological subtypes were classified into the following categories: intestinal type [n = 45 (44%)], pancreatobiliary type [n = 41 (40%)], gastric type [n = 13 (12%)], and oncocytic type [n = 4 (4%)]. The following types of resections were performed: pancreatic head resections [n = 77 (75%)], tail resections [n = 16 (15%)], total pancreatectomies [n = 5 (5%)], and segment resections [n = 5 (5%)]. The 5-year survival of patients with intestinal IPMNs was significantly better than pancreatobiliary IPMNs (86.6% vs. 35.6%; P < 0.001). The pancreatobiliary subtype was strongly associated with malignancy [odds ratio (OR): 6.76], recurrence (P < 0.001), and long-term survival comparable with that of PDAC patients. CONCLUSIONS: Evaluation of IPMN subtypes supports postoperative patient prognosis prediction. Therefore, subtype differentiation could lead to improvements in clinical management. Potentially identifying subgroups with the need for adjuvant therapy may be possible.