A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer

Background: Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5-20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. Methods/Study design: In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. Discussion: The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion TME surgery. Trial registration:NCT02371304, registration date: February 2015

Design guidelines for participative business modelling projects - lessons from an unsuccesful case study

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Cardiac resynchronisation therapy: results from daily practice in Rijnstate Hospital, Arnhem

Contains fulltext : 80275.pdf (publisher's version ) (Closed access)BACKGROUND: Cardiac resynchronisation therapy (CRT) is an effective treatment to improve the clinical outcome of selected patients with heart failure. Clinical trials have studied clinical outcome and reported clinical improvements, but clinical consequences and results in daily practice are less well known. We evaluated clinical outcome in all patients with CRT implantation in our centre. METHODS: Data of 119 consecutive patients who met the criteria for CRT implantation in Rijnstate Hospital, Arnhem in the period 28 November 2000 until 1 January 2006 were collected. We analysed implantation procedure, hospitalisation for heart failure or other causes, mortality and device-related events. RESULTS: In total 119 patients (83 men, 36 women; mean age 69 years) were eligible for CRT. Before implantation they had received optimal pharmacological therapy. Implantation was successful in 97% of patients. Procedural-related complications were seen in eight patients. During follow-up, 22 patients (18.5%: 14 men, 8 women) died. Causes of death were heart failure (11 patients), sudden cardiac death (4 patients) and noncardiac death (7 patients). Hospitalisation occurred 81 times, of which 77 for cardiac reasons. In follow-up the estimated five-year cumulative survival was 70%. CONCLUSION: This retrospective study from a single centre showed a high procedural success rate, low prevalence of complications and low mortality in comparison to other studies. Despite better functional capacity, the hospitalisation rate due to heart failure was high. (Neth Heart J 2009;17:6-8.)

Acute chest pain in a patient treated with capecitabine

A 61-year-old male with a history of metastatic colorectal cancer was referred to our hospital for primary coronary intervention because of acute ST-elevation myocardial infarction. Coronary angiography, however, revealed no significant stenoses. When asked, the patient revealed that capecitabine (Xeloda®) was started by his oncologist one day before admission. It is known that this oral 5-FU analogue drug, used in metastatic colorectal cancer, can cause coronary artery spasms. The main treatment of capecitabine-induced vasospasm is discontinuation of the drug. Indeed, after cessation of the drug the patient remained free of symptoms and the ECG abnormalities normalised. (Neth Heart J 2009;17:288-91.

Treatment patterns of non-ST-elevation acute coronary syndrome patients presenting at non-PCI centres in the Netherlands and possible logistical consequences of adopting same-day transfer to PCI centres: a registry-based evaluation

BACKGROUND: European Society of Cardiology (ESC) guidelines recommend same-day transfer to a percutaneous coronary intervention (PCI) centre for angiography in high-risk (ESC-HR) patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). We describe the treatment patterns of NSTE-ACS patients presenting at non-PCI centres and evaluate the logistical consequences of adopting same-day transfer. METHODS: From August 2016 until January 2017, all consecutive NSTE-ACS patients presenting at 23 non-PCI centres in the Netherlands were recorded. We built an online case report form in collaboration with the National Cardiovascular Database Registry to collect information on risk stratification by the attending physician, timing and location of angiography, and treatment. RESULTS: We included 871 patients (mean age 69.1+/- 12.8). 55.8% were considered ESC-HR. Overall, angiography at non-PCI centres was 55.1% and revascularisation was 54.1%. Among ESC-HR patients, angiography at non-PCI centres was 51.4% and revascularisation was 54.9%. Angiography <24h was 55.6% in patients with angiography at a non-PCI centre and 74.3% in patients with angiography at a PCI-centre. Assuming patients would receive similar treatment, adoption of same-day transfer would increase transfers of ESC-HR patients who undergo PCI (44.3%), but also increases transfers of medically treated patients (36.2%) and patients awaiting coronary bypass artery grafting (9.1%). CONCLUSIONS: In this registry of NSTE-ACS patients at non-PCI centres, the majority of ESC-HR patients underwent angiography at a non-PCI centre. Same-day transfer occurred in one-quarter of the ESC-HR patients, despite guideline recommendation. Nonselective adoption of same-day transfer to a PCI centre would increase transfers of ESC-HR patients who undergo PCI, however, equally increases transfers of patients who are medically treated

Effect of rate or rhythm control on quality of life in persistent atrial fibrillation - Results from the Rate Control Versus Electrical Cardioversion (RACE) study

OBJECTIVES We studied the influence of rate control or rhythm control in patients with persistent atrial fibrillation (AF) on quality of fife (QoL). BACKGROUND Atrial fibrillation may cause symptoms like fatigue and dyspnea. This can impair QoL. Treatment of AF with either rate or rhythm control may influence QoL. METHODS Quality of life was assessed in patients included in the Rate Control Versus Electrical Cardioversion for Persistent Atrial Fibrillation (RACE) study (rate vs. rhythm control in persistent AF). Rate control patients (n = 175) were given negative chronotropic drugs and oral anticoagulation. Rhythm control patients (n = 177) received serial electrocardioversion, antiarrhythmic drugs, and oral anticoagulation, as needed. Quality of life was studied using the Short Form (SF)-36 health survey questionnaire at baseline, one year, and the end of the study (after 2 to 3 years of follow-up). At baseline, QoL was compared with that of healthy control subjects. Patient characteristics related to QoL changes were determined. RESULTS Mean follow-up was 2.3 years. At baseline, QoL was lower in patients than in age-matched healthy controls. At study end, under rate control, three subscales of the SF-36 improved. Under rhythm control, no significant changes occurred compared with baseline. At study end, QoL was comparable between both groups. The presence of complaints of AF at baseline, a short duration of AF, and the presence of sinus rhythm (SR) at the end of follow-up, rather than the assigned strategy, were associated with QoL improvement. CONCLUSIONS Quality of life is impaired in patients with AF compared with healthy controls. Treatment strategy does not affect QoL. Patients with complaints related to AF, however, may benefit from rhythm control if SR can be maintained. (C) 2004 by the American College of Cardiology Foundation