Multicentre randomized clinical trial of the effect of chewing gum after abdominal surgery.

BACKGROUND: Postoperative ileus is a common complication of abdominal surgery, leading to patient discomfort, morbidity and prolonged postoperative length of hospital stay (LOS). Previous studies suggested that chewing gum stimulates bowel function after abdominal surgery, but were underpowered to evaluate its effect on LOS and did not include enhanced recovery after surgery (ERAS)-based perioperative care. This study evaluated whether chewing gum after elective abdominal surgery reduces LOS and time to bowel recovery in the setting of ERAS-based perioperative care. METHODS: A multicentre RCT was performed of patients over 18 years of age undergoing abdominal surgery in 12 hospitals. Standard postoperative care (control group) was compared with chewing gum three times a day for 30 min in addition to standard postoperative care. Randomization was computer-generated; allocation was concealed. The primary outcome was postoperative LOS. Secondary outcomes were time to bowel recovery and 30-day complications. RESULTS: Between 2011 to 2015, 1000 patients were assigned to chewing gum and 1000 to the control arm. Median LOS did not differ: 7 days in both arms (P = 0·364). Neither was any difference found in time to flatus (24 h in control group versus 23 h with chewing gum; P = 0·873) or time to defaecation (60 versus 52 h respectively; P = 0·562). The rate of 30-day complications was not significantly different either. CONCLUSION: The addition of chewing gum to an ERAS postoperative care pathway after elective abdominal surgery does not reduce the LOS, time to bowel recovery or the rate of postoperative complications. Registration number: NTR2594 (Netherlands Trial Register).

Meta-analysis of internal herniation after gastric bypass surgery.

BACKGROUND: The aim of this study was to provide a systematic and quantitative summary of the association between laparoscopic Roux-en-Y gastric bypass (LRYGB) and the reported incidence of internal herniation (IH). The route of the Roux limb and closure of mesenteric and/or mesocolonic defects are described as factors of influence. METHODS: MEDLINE, Embase, the Cochrane Library and Web of Science were searched for relevant literature, references and citations according to the PRISMA statement. Two independent reviewers selected studies that evaluated incidence of IH after LRYGB and possible techniques for prevention. Data were pooled by route of the Roux limb and closure/non-closure of the mesenteric and/or mesocolonic defects. RESULTS: Forty-five articles included data on 31 320 patients. Lowest IH incidence was in the antecolic group, with closure of all defects (1 per cent; P < 0·001), followed by the antecolic group, with all defects left open and the retrocolic group with closure of the mesenteric and mesocolonic defect (both 2 per cent; P < 0·001). The incidence of IH was highest in the antecolic group, with closure of the jejunal defect, and in the retrocolic group, with closure of all defects (both 3 per cent). CONCLUSION: The present systematic review includes a random-effects meta-analysis. The antecolic procedure, with closure of both the mesenteric and Petersen defects, has the lowest internal herniation incidence following laparoscopic Roux-en-Y gastric bypass.

Evaluating national practice of preoperative radiotherapy for rectal cancer based on clinical auditing.

OBJECTIVES: Internationally, the use of preoperative radiotherapy (RT) for rectal cancer varies largely, related to different decision-making based on the harm-benefit ratio. In the Dutch guideline, RT is indicated in all cT2-4 tumours. We aimed to evaluate the use of RT in the Netherlands and to discuss Dutch practice in the context of current literature. METHODS: Data of the Dutch Surgical Colorectal Audit (DSCA) were used and 6784 patients surgically treated for primary rectal cancer in 2009-2011 were included. The application and type of RT were described according to age, comorbidity, tumour localization and tumour stage at population level with analysis of hospital variation for specific subsets. RESULTS: In total, 85% of patients who underwent resection for rectal cancer received RT. Comorbidity (Charlson Comorbidity Index 2+) and older age (≥70 years) were associated with a slight decrease in application of RT (75 and 80% respectively). In stage I tumours, 77% of patients received RT, but large hospital variation existed (0-100%). The proportion chemoradiotherapy of the whole group of RT increased with increasing N-stage, increasing T-stage, decreasing distance from the anus, younger age and less comorbidity with hospital variation from 0 to 73%. CONCLUSION: From a European perspective, a high percentage of rectal cancer patients are treated with RT in the Netherlands. Considerable hospital variation was observed for RT in stage I and the proportion of chemoradiotherapy among all RT schemes. Data from clinical auditing enable evaluation of national practice and current standards from both a scientific and international perspective.

The Dutch surgical colorectal audit.

INTRODUCTION: In 2009, the nationwide Dutch Surgical Colorectal Audit (DSCA) was initiated by the Association of Surgeons of the Netherlands (ASN) to monitor, evaluate and improve colorectal cancer care. The DSCA is currently widely used as a blueprint for the initiation of other audits, coordinated by the Dutch Institute for Clinical Auditing (DICA). This article illustrates key elements of the DSCA and results of three years of auditing. METHODS: Key elements include: a leading role of the professional association with integration of the audit in the national quality assurance policy; web-based registration by medical specialists; weekly updated online feedback to participants; annual external data verification with other data sources; improvement projects. RESULTS: In two years, all Dutch hospitals participated in the audit. Case-ascertainment was 92% in 2010 and 95% in 2011. External data verification by comparison with the Netherlands Cancer Registry (NCR) showed high concordance of data items. Within three years, guideline compliance for diagnostics, preoperative multidisciplinary meetings and standardised reporting increased; complication-, re-intervention and postoperative mortality rates decreased significantly. DISCUSSION: The success of the DSCA is the result of effective surgical collaboration. The leading role of the ASN in conducting the audit resulted in full participation of all colorectal surgeons in the Netherlands. By integrating the audit into the ASNs' quality assurance policy, it could be used to set national quality standards. Future challenges include reduction of administrative burden; expansion to a multidisciplinary registration; and addition of financial information and patient reported outcomes to the audit data.

Failure-to-rescue after colorectal cancer surgery and the association with three structural hospital factors.

BACKGROUND: This study was designed to evaluate the association between structural hospital characteristics and failure-to-rescue (FTR) after colorectal cancer surgery. A growing body of evidence suggests a large hospital variation concerning mortality rates in patients with a severe complication (FTR) in colorectal cancer surgery. Which structural hospital factors are associated with better FTR rates remains largely unclear. METHODS: All patients undergoing colorectal cancer surgery from 2009 through 2011 in 92 Dutch hospitals were analysed. Univariate and multivariate logistic regression models, including casemix, hospital volume, teaching status, and different levels of intensive care unit (ICU) facilities, were used to analyse risk-adjusted FTR rates. RESULTS: A total of 25,591 patients from 92 hospitals were included. The FTR rate ranged between 0 and 39 %. In univariate analysis, high hospital volume (>200 vs. ≤200 patients/year), teaching status (academic vs. teaching vs. nonteaching hospitals) and high level of ICU facilities (highest level 3 vs. lowest level 1) were associated with lower FTR rates. Only the higher levels of ICU facilities (2 or 3 compared with level 1) were independently associated with lower failure-to-rescue rates (odds ratio 0.72; 95 % confidence interval 0.65-0.88) in multivariate analysis. DISCUSSION: Hospital type and annual hospital volume were not independently associated with FTR rates in colorectal cancer surgery. Instead, the lowest level of ICU facilities was independently associated with higher rates. This suggests that a more advanced ICU may be an important factor that contributes to better failure-to-rescue rates, although individual hospitals perform well with lower ICU levels.

Optimal time interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer.

BACKGROUND: Neoadjuvant chemoradiotherapy (CRT) has been proven to increase local control in rectal cancer, but the optimal interval between CRT and surgery is still unclear. The purpose of this study was to analyse the influence of variations in clinical practice regarding timing of surgery on pathological response at a population level. METHODS: All evaluable patients who underwent preoperative CRT for rectal cancer between 2009 and 2011 were selected from the Dutch Surgical Colorectal Audit. The interval between radiotherapy and surgery was calculated from the start of radiotherapy. The primary endpoint was pathological complete response (pCR; pathological status after chemoradiotherapy (yp) T0 N0). RESULTS: A total of 1593 patients were included. The median interval between radiotherapy and surgery was 14 (range 6-85, interquartile range 12-16) weeks. Outcome measures were calculated for intervals of less than 13 weeks (312 patients), 13-14 weeks (511 patients), 15-16 weeks (406 patients) and more than 16 weeks (364 patients). Age, tumour location and R0 resection rate were distributed equally between the four groups; significant differences were found for clinical tumour category (cT4: 17·3, 18·4, 24·5 and 26·6 per cent respectively; P = 0·010) and clinical metastasis category (cM1: 4·4, 4·8, 8·9 and 14·9 per cent respectively; P < 0·001). Resection 15-16 weeks after the start of CRT resulted in the highest pCR rate (18·0 per cent; P = 0·013), with an independent association (hazard ratio 1·63, 95 per cent confidence interval 1·20 to 2·23). Results for secondary endpoints in the group with an interval of 15-16 weeks were: tumour downstaging, 55·2 per cent (P = 0·165); nodal downstaging, 58·6 per cent (P = 0·036); and (near)-complete response, 23·2 per cent (P = 0·124). CONCLUSION: Delaying surgery until the 15th or 16th week after the start of CRT (10-11 weeks from the end of CRT) seemed to result in the highest chance of a pCR.

Hospital variation in failure to rescue after colorectal cancer surgery: results of the Dutch Surgical Colorectal Audit.

BACKGROUND: Postoperative mortality is frequently used in hospital comparisons as marker for quality of care. Differences in mortality between hospitals may be explained by varying complication rates. A possible modifying factor may be the ability to let patients with a serious complication survive, referred to as failure to rescue (FTR). The purpose of this study was to evaluate how hospital performance on postoperative mortality is related to severe complications or to FTR and to explore the value of FTR in quality improvement programs. METHODS: All patients operated for colorectal cancer from 2009 to 2011, registered in the Dutch Surgical Colorectal Audit, were included. Logistic regression models were used to obtain adjusted mortality, complication, and FTR rates. Hospitals were grouped into 5 quintiles according to adjusted mortality. Outcomes were compared between quintiles. RESULTS: A total of 24,667 patients were included. Severe complications ranged from 19 % in the lowest to 25 % in the highest mortality quintile (odds ratio 1.5, 95 % confidence interval 1.37-1.67). Risk-adjusted FTR rates showed a marked difference between the quintiles, ranging from 9 % to 26 % (odds ratio 3.0, 95 % confidence interval 2.29-3.98). There was significant variability in FTR rates. Seven hospitals had significantly lower FTR rates than average. CONCLUSIONS: High-mortality hospitals had slightly higher rates of severe complications than low-mortality hospitals. However, FTR was three times higher in high-mortality hospitals than in low-mortality hospitals. In quality improvement projects, feedback to hospitals of FTR rates, along with complication rates, may illustrate shortcomings (prevention or management of complications) per hospital, which may be an important step in reducing mortality.

Focusing on desired outcomes of care after colon cancer resections; hospital variations in 'textbook outcome'.

AIMS: We propose a summarizing measure for outcome indicators, representing the proportion of patients for whom all desired short-term outcomes of care (a 'textbook outcome') is realized. The aim of this study was to investigate hospital variation in the proportion of patients with a 'textbook outcome' after colon cancer resections in the Netherlands. METHODS: Patients who underwent a colon cancer resection in 2010 in the Netherlands were included in the Dutch Surgical Colorectal Audit. A textbook outcome was defined as hospital survival, radical resection, no reintervention, no ostomy, no adverse outcome and a hospital stay < 14 days. We calculated the number of hospitals with a significantly higher (positive outlier) or lower (negative outlier) Observed/Expected (O/E) textbook outcome than average. As quality measures may be more discriminative in a low-risk population, analyses were repeated for low-risk patients only. RESULTS: A total of 5582 patients, treated in 82 hospitals were included. Average textbook outcome was 49% (range 26-71%). Eight hospitals were identified as negative outliers. In these hospitals a 'textbook outcome' was realized in 35% vs. 52% in average hospitals (p < 0.01). In a sub-analysis for low-risk patients, only one additional negative outlier was identified. CONCLUSIONS: The textbook outcome, representing the proportion of patients with a perfect hospitalization, gives a simple comprehensive summary of hospital performance, while preventing indicator driven practice. Therewith the 'textbook outcome' is meaningful for patients, providers, insurance companies and healthcare inspectorate.

Increasing prevalence of comorbidity in patients with colorectal cancer in the South of the Netherlands 1995-2010.

Comorbidity has large impact on colorectal cancer (CRC) treatment and outcomes and may increase as the population ages. We aimed to evaluate the prevalence and time trends of comorbid diseases in patients with CRC from 1995 to 2010. The Eindhoven Cancer Registry registers comorbidity in all patients with primary CRC in the South of the Netherlands. We analyzed the prevalence of serious comorbid diseases in four time frames from 1995 to 2010. Thereby, we addressed its association with age, gender and socio-economic status (SES). The prevalence of comorbidity was registered in 27,339 patients with primary CRC. During the study period, the prevalence of comorbidity increased from 47% to 62%, multimorbidity increased from 20% to 37%. Hypertension and cardiovascular diseases were most prevalent and increased largely over time (respectively 16-29% and 12-24%). Pulmonary diseases increased in women, but remained stable in men. Average age at diagnosis increased from 68.3 to 69.5 years (p = 0.004). A low SES and male gender were associated with a higher risk of comorbidity (not changing over time). This study indicates that comorbidity among patients with CRC is common, especially in males and patients with a low SES. The prevalence of comorbidity increased from 1995 to 2010, in particular in presumably nutritional diseases. Ageing, increased life expectancy and life style changes may contribute to more comorbid diseases. Also, improved awareness among health care providers on the importance of comorbidity may have resulted in better registration. The increasing burden of comorbidity in patients with CRC emphasizes the need for more focus on individualized medicine.

Meta-analysis of the risk for anastomotic leakage, the postoperative mortality caused by leakage in relation to the overall postoperative mortality.

BACKGROUND: Availability of anastomotic leakage rates and mortality rates following anastomotic leakage is essential when informing patients with rectal cancer preoperatively. We performed a meta-analysis of studies describing anastomotic leakage and the subsequent postoperative mortality in relation to the overall postoperative mortality after low anterior resection for rectal cancer. METHODS: A systematic search was performed of the published literature. Data on the definition and incidence rate of AL, postoperative mortality caused by AL, and overall postoperative mortality were extracted. Data were pooled and a meta-analysis was performed. RESULTS: Twenty-two studies with 10,343 patients in total were analyzed. Meta-analysis of the data showed an average AL rate of 9%, postoperative mortality caused by leakage of 0.7% and overall postoperative mortality of 2%. The studies showed variation in incidence, definition and measurement of all outcomes. CONCLUSION: We found a considerable overall AL rate and a large contribution of AL to the overall postoperative mortality. The variability of definitions and measurement of AL, postoperative mortality caused by leakage and overall postoperative mortality may hinder providing reliable risk information. Large-scale audit programs may provide accurate and valid risk information which can be used for preoperative decision making.

Combining process indicators to evaluate quality of care for surgical patients with colorectal cancer: are scores consistent with short-term outcome?

OBJECTIVE: To determine if composite measures based on process indicators are consistent with short-term outcome indicators in surgical colorectal cancer care. DESIGN: Longitudinal analysis of consistency between composite measures based on process indicators and outcome indicators for 85 Dutch hospitals. SETTING: The Dutch Surgical Colorectal Audit database, the Netherlands. PARTICIPANTS: 4732 elective patients with colon carcinoma and 2239 with rectum carcinoma treated in 85 hospitals were included in the analyses. MAIN OUTCOME MEASURES: All available process indicators were aggregated into five different composite measures. The association of the different composite measures with risk-adjusted postoperative mortality and morbidity was analysed at the patient and hospital level. RESULTS: At the patient level, only one of the composite measures was negatively associated with morbidity for rectum carcinoma. At the hospital level, a strong negative association was found between composite measures and hospital mortality and morbidity rates for rectum carcinoma (p<0.05), and hospital morbidity rates for colon carcinoma. CONCLUSIONS: For individual patients, a high score on the composite measures based on process indicators is not associated with better short-term outcome. However, at the hospital level, a good score on the composite measures based on process indicators was consistent with more favourable risk-adjusted short-term outcome rates.