Time to Surgery Following Short-Course Radiotherapy in Rectal Cancer and its Impact on Postoperative Outcomes. A Population-Based Study Across the English National Health Service, 2009-2014.

AIMS: Preoperative short-course radiotherapy (SCRT) is an important treatment option for rectal cancer. The length of time between completing SCRT and surgery may influence postoperative outcomes, but the evidence available to determine the optimal interval is limited and often conflicting. MATERIALS AND METHODS: Information was extracted from a colorectal cancer data repository (CORECT-R) on all surgically treated rectal cancer patients who received SCRT in the English National Health Service between April 2009 and December 2014. The time from radiotherapy to surgery was described across the population. Thirty-day postoperative mortality, returns to theatre, length of stay and 1-year survival were investigated in relation to the interval between radiotherapy and surgery. RESULTS: Within the cohort of 3469 patients, the time to surgery was 0-7 days for 76% of patients, 8-14 days for 19% of patients and 15-27 days for 5% of patients. There was a clear variation in relation to different patient characteristics. There was, however, no evidence of differences in postoperative outcomes in relation to interval length. CONCLUSIONS: This study suggests that the time interval between SCRT and surgery does not influence postoperative outcomes up to a year after surgery. The study provides population-level, real-world evidence to complement that from clinical trials.

Wide Variation in the Use of Radiotherapy in the Management of Surgically Treated Rectal Cancer Across the English National Health Service.

AIMS: Radiotherapy is an important treatment modality in the multidisciplinary management of rectal cancer. It is delivered both in the neoadjuvant setting and postoperatively, but, although it reduces local recurrence, it does not influence overall survival and increases the risk of long-term complications. This has led to a variety of international practice patterns. These variations can have a significant effect on commissioning, but also future clinical research. This study explores its use within the large English National Health Service (NHS). MATERIALS AND METHODS: Information on all individuals diagnosed with a surgically treated rectal cancer between April 2009 and December 2010 were extracted from the Radiotherapy Dataset linked to the National Cancer Data Repository. Individuals were grouped into those receiving no radiotherapy, short-course radiotherapy with immediate surgery (SCRT-I), short-course radiotherapy with delayed surgery (SCRT-D), long-course chemoradiotherapy (LCCRT), other radiotherapy (ORT) and postoperative radiotherapy (PORT). Patterns of use were then investigated. RESULTS: The study consisted of 9201 individuals; 4585 (49.3%) received some form of radiotherapy. SCRT-I was used in 12.1%, SCRT-D in 1.2%, LCCRT in 29.5%, ORT in 4.7% and PORT in 2.3%. Radiotherapy was used more commonly in men and in those receiving an abdominoperineal excision and less commonly in the elderly and those with comorbidity. Significant and substantial variations were also seen in its use across all the multidisciplinary teams managing this disease. CONCLUSION: Despite the same evidence base, wide variation exists in both the use of and type of radiotherapy delivered in the management of rectal cancer across the English NHS. Prospective population-based collection of local recurrence and patient-reported early and late toxicity information is required to further improve patient selection for preoperative radiotherapy.

The Effect of the UK Coordinating Centre for Cancer Research Anal Cancer Trial (ACT1) on Population-based Treatment and Survival for Squamous Cell Cancer of the Anus.

Between 1987 and 1994, three randomised phase III trials showed that chemoradiotherapy with mitomycin C and 5-fluorouracil was superior to radiotherapy alone (ACT1, European Organization for Research and Treatment of Cancer) or radiotherapy with 5-fluorouracil (Radiation Therapy Oncology Group 87-04, Eastern Cooperative Oncology Group 1289) for squamous cell carcinoma of the anus. We explored the population-based changes in England before, during and after the UK-based ACT1 trial. Information was extracted from the National Cancer Data Repository on patients diagnosed with squamous cell anal cancer in England between 1981 and 2010 (n = 11 743). Robust treatment information was available for the Yorkshire region (n = 1065). Changes in treatment patterns and 3 year survival were investigated in 7 year cohorts before, during and after the ACT1 trial. In Yorkshire, the proportion of patients receiving surgery alone fell from 61.6% before, 29.8% during and 12.5% after ACT1; the proportion of patients receiving primary chemoradiotherapy rose from 6.5% before, 17.7% during and 58.8% after ACT1 and continued to rise to 70.3% in the subsequent period. Three year survival improved during the study period from 59.5% (95% confidence interval 56.6-62.2) before ACT1 to 73.6% (95% confidence interval 71.9-75.2) after the trial. Survival in Yorkshire was comparable with that in England. The treatment for squamous cell carcinoma of the anus changed dramatically during the study period. The predominant use of surgery before ACT1, a transition phase during the trial and a dramatic increase in the use of chemoradiotherapy after ACT1 provide strong evidence of the effect of the trial on population-based practice. Survival continued to increase during this period.

Model for risk adjustment of postoperative mortality in patients with colorectal cancer.

BACKGROUND: A model was developed for risk adjustment of postoperative mortality in patients with colorectal cancer in order to make fair comparisons between healthcare providers. Previous models were derived in relatively small studies with the use of suboptimal modelling techniques. METHODS: Data from adults included in a national study of major surgery for colorectal cancer were used to develop and validate a logistic regression model for 90-day mortality. The main risk factors were identified from a review of the literature. The association with age was modelled as a curved continuous relationship. Bootstrap resampling was used to select interactions between risk factors. RESULTS: A model based on data from 62 314 adults was developed that was well calibrated (absolute differences between observed and predicted mortality always smaller than 0·75 per cent in deciles of predicted risk). It discriminated well between low- and high-risk patients (C-index 0·800, 95 per cent c.i. 0·793 to 0·807). An interaction between age and metastatic disease was included as metastatic disease was found to increase postoperative risk in young patients aged 50 years (odds ratio 3·53, 95 per cent c.i. 2·66 to 4·67) far more than in elderly patients aged 80 years (odds ratio 1·48, 1·32 to 1·66). CONCLUSION: Use of this model, estimated in the largest number of patients with colorectal cancer to date, is recommended when comparing postoperative mortality of major colorectal cancer surgery between hospitals, clinical teams or individual surgeons.

The rising incidence of anal cancer in England 1990-2010: a population-based study.

AIM: Although anal cancer is rare, its incidence has been reported to be rising in several countries. This study aimed to determine whether there have been any changes in incidence over time in England. METHOD: In the cancer registry component of the English National Cancer Data Repository, 13 940 patients were identified with a primary diagnosis of anal cancer made between 1990 and 2010. Tumours were grouped according to the ICD-O morphology codes into squamous cell carcinoma, basaloid and cloacogenic carcinoma, adenocarcinoma and other cancer types. The incidence over this period was investigated in relation to type of tumour, age and sex. RESULTS: In men there was a 69% increase in squamous cell anal carcinoma from 0.43 per 100 000 population in 1990-94 to 0.73 in 2006-10. For women these rates were 0.50 in 1990-94 and 1.13 in 2006-10, a rise of 126%. CONCLUSION: The study showed that between 1990 and 2010 there was a substantial rise in the incidence of anal cancer in England. This effect was more marked in women than men.

Nonresectional management of colorectal cancer: multidisciplinary factors that influence treatment strategy.

AIM: Surgical resection of a primary colorectal tumour remains the treatment of choice and offers the best chance of cure. However, in some patients, resection is not achieved. There are few published data on this group of patients. The aim of this study was to evaluate this group to determine the frequency and reasons for nonresection, and to analyse the subsequent management. METHOD: A retrospective review was performed using a Trust colorectal cancer database and individual electronic patient records. Patients who presented to our unit with a diagnosis of primary colorectal cancer managed by nonresectional intervention over a 2-year period were identified. Data analysed included: patient demographics, radiological staging, histological data, nonsurgical therapy, tumour-specific complications and requirement for palliative surgical procedures. RESULTS: A total of 671 patients were identified with primary colorectal cancer. One hundred and fifty-six (23%) were managed without resection, following discussion at a multidisciplinary team meeting. Of 156 patients, histological confirmation was obtained in 131 (84%), with the remainder of the diagnoses being based on unequivocal radiological imaging and/or operative findings. Complete radiological staging was achieved in 150 (96%) patients. The predominant reasons for nonresectional management were: advanced metastatic disease (66%), significant medical comorbidity (19%) and patient refusal (6%). Fifty-nine of 156 patients (38%) subsequently received palliative chemotherapy, 9 (6%) radiotherapy and or 9 (6%) combination chemo-radiotherapy. Seventy-nine (51%) of 156 patients received no therapy other than best supportive palliative care, for reasons including significant medical comorbidity (62%) and patient refusal (19%). Following the initial decision not to resect, 68 (44%) patients did at some point undergo some form of palliative intervention (stenting, stoma or bypass) for obstruction - 44 (28%) electively and 24 (15%) as an emergency. CONCLUSION: Nonresectional management of patients with primary colorectal cancer is not an uncommon outcome following discussion at a multidisciplinary meeting. In these patients, nonsurgical palliation should be employed when necessary, though is frequently limited by comorbidity. However, subsequent surgical palliation is still required in a substantial proportion of cases.

Population-based study of laparoscopic colorectal cancer surgery 2006-2008.

BACKGROUND: Clinical guidelines recommend that, where clinically appropriate, laparoscopic tumour resections should be available for patients with colorectal cancer. This study aimed to examine the introduction of laparoscopic surgery in the English National Health Service. METHODS: Data were extracted from the National Cancer Data Repository on all patients who underwent major resection for a primary colorectal cancer diagnosed between 2006 and 2008. Laparoscopic procedures were identified from codes in the Hospital Episode Statistics and National Bowel Cancer Audit Project data in the resource. Trends in the use of laparoscopic surgery and its influence on outcomes were examined. RESULTS: Of 58 135 resections undertaken over the study period, 10 955 (18·8 per cent) were attempted laparoscopically. This increased from 10·0 (95 per cent confidence interval (c.i.) 8·1 to 12·0) per cent in 2006 to 28·4 (25·4 to 31·4) per cent in 2008. Laparoscopic surgery was used less in patients with advanced disease (modified Dukes' stage 'D' versus A: odds ratio (OR) 0·45, 95 per cent c.i. 0·40 to 0·50), rectal tumours (OR 0·71, 0·67 to 0·75), those with more co-morbidity (Charlson score 3 or more versus 0: OR 0·69, 0·58 to 0·82) or presenting as an emergency (OR 0·15, 0·13 to 0·17). A total of 1652 laparoscopic procedures (15·1 per cent) were converted to open surgery. Conversion was more likely in advanced disease (modified Dukes' stage 'D' versus A: OR 1·56, 1·20 to 2·03), rectal tumours (OR 1·29, 1·14 to 1·46) and emergencies (OR 2·06, 1·54 to 2·76). Length of hospital stay (OR 0·65, 0·64 to 0·66), 30-day postoperative mortality (OR 0·55, 0·48 to 0·64) and risk of death within 1 year (hazard ratio 0·60, 0·55 to 0·65) were reduced in the laparoscopic group. CONCLUSION: Laparoscopic surgery was used more frequently in low-risk patients.

Early mortality from colorectal cancer in England: a retrospective observational study of the factors associated with death in the first year after diagnosis.

BACKGROUND: The United Kingdom performs poorly in international comparisons of colorectal cancer survival with much of the deficit owing to high numbers of deaths close to the time of diagnosis. This retrospective cohort study investigates the patient, tumour and treatment characteristics of those who die in the first year after diagnosis of their disease. METHODS: Patients diagnosed with colon (n=65,733) or rectal (n=26,123) cancer in England between 2006 and 2008 were identified in the National Cancer Data Repository. Multivariable logistic regression was used to investigate the odds of death within 1 month, 1-3 months and 3-12 months after diagnosis. RESULTS: In all, 11.5% of colon and 5.4% of rectal cancer patients died within a month of diagnosis: this proportion decreased significantly over the study period. For both cancer sites, older age, stage at diagnosis, deprivation and emergency presentation were associated with early death. Individuals who died shortly after diagnosis were also more likely to have missing data about important prognostic factors such as disease stage and treatment. CONCLUSION: Using routinely collected data, at no inconvenience to patients, we have identified some important areas relating to early deaths from colorectal cancer, which merit further research.

A retrospective observational study examining the characteristics and outcomes of tumours diagnosed within and without of the English NHS Bowel Cancer Screening Programme.

BACKGROUND: Colorectal cancer is common in England and, with long-term survival relatively poor, improving outcomes is a priority. A major initiative to reduce mortality from the disease has been the introduction of the National Health Service (NHS) Bowel Cancer Screening Programme (BCSP). Combining data from the BCSP with that in the National Cancer Data Repository (NCDR) allows all tumours diagnosed in England to be categorised according to their involvement with the BCSP. This study sought to quantify the characteristics of the tumours diagnosed within and outside the BCSP and investigate its impact on outcomes. METHODS: Linkage of the NCDR and BCSP data allowed all tumours diagnosed between July 2006 and December 2008 to be categorised into four groups; screen-detected tumours, screening-interval tumours, tumours diagnosed in non-participating invitees and tumours diagnosed in those never invited to participate. The characteristics, management and outcome of tumours in each category were compared. RESULTS: In all, 76 943 individuals were diagnosed with their first primary colorectal cancer during the study period. Of these 2213 (2.9%) were screen-detected, 623 (0.8%) were screening-interval cancers, 1760 (2.3%) were diagnosed in individuals in non-participating invitees and 72 437 (94.1%) were diagnosed in individuals not invited to participate in the programme due to its ongoing roll-out over the time period studied. Screen-detected tumours were identified at earlier Dukes' stages, were more likely to be managed with curative intent and had significantly better outcomes than tumours in other categories. CONCLUSION: Screen-detected cancers had a significantly better prognosis than other tumours and this would suggest that the BCSP should reduce mortality from colorectal cancer in England.

Low abdominoperineal excision rates are associated with high-workload surgeons and lower tumour height. Is further specialization needed?

AIM: Wide variation, independent of disease extent and case mix, has been observed in the rate of use of abdominoperineal excision (APE) for rectal cancer. Previous analyses have, however, been confounded by failure to adjust for the location of the tumour within the rectum. This population-based study sought to examine whether variations in tumour height explained differences in APE use. METHOD: Information was obtained on all individuals who underwent a major resection for a rectal tumour diagnosed between 1998 and 2005 across the Northern and Yorkshire regions of the UK. Median distances from the dentate line were calculated for all tumours excised by APE and compared with rates of use of APE between specialists and nonspecialist surgeons and across hospital trusts. RESULTS: The completeness of pathological reporting of height of tumour within the rectum was variable. A low rate of APE use was associated with a lower median distance of tumours from the dentate line. Specialist colorectal cancer surgeons performed fewer APEs on patients with a tumour located lower in the rectum than nonspecialist surgeons. CONCLUSION: Variations in the height of tumour did not explain the variation in APE use. Specialist high-volume surgeons undertook fewer APEs and those they performed were closer to the dentate line than low-volume nonspecialist surgeons.

Measurement of anal cushions in continent women.

AIM: Anal cushions are connective tissue complexes thought to be involved in anal continence. This study aimed to assess them in continent subjects. METHOD: Continent women undergoing a transvaginal ultrasound scan for gynaecological reasons were included. The anal cushions were visualized at the mid-canal level. The cross-sectional area within the internal anal sphincter (Area 1) and the area enclosed within the anal cushions (Area 2) were measured and a Cushion:Canal (C:C) ratio was derived for each patient. The measurements were repeated in the semi-erect position. RESULTS: One hundred and two patients with a median age of 41 (IQR 32-49) years were included. The median C:C ratio was 0.68 (IQR 0.61-0.73). Inter-observer error was 0.98 and intra-observer error was 0.99. There was no significant correlation between age and C:C ratio. The C:C ratio was significantly higher in parous than in nulliparous women (P = 0.04). A history of obstetric trauma or minimal haemorrhoidal symptoms did not influence C:C ratio. There was a significant increase in C:C ratio in the erect position. (P = 0.04). CONCLUSION: There was a wide range of variability in the measurement of anal cushions in normal continent women. These were not influenced by age.

Prognostic factors for survival after curative resection of Dukes' B colonic cancer.

AIM: Data on the prognostic factors for survival in patients with locally advanced, node-negative colon cancer are limited. This study aimed to determine which factors might predict survival in patients with Dukes' B (T3 or T4, N0) colon cancer. METHOD: One hundred and eighty (93 male; median age 75 [range, 38-96] years) consecutive patients who had resection of a primary Dukes' B (on final histopathological analysis) colonic cancer between 1998 and 2003 were studied. No patient received neoadjuvant chemotherapy. Multivariate Cox regression modelling was used to assess the prognostic value of variables. Median follow up was 85 (60-125) months. RESULTS: Thirteen (7%) patients had a perforation at presentation. The median distance from tumour to the nearest longitudinal resection margin was 6 (0.3-27) cm. One hundred and twenty-four (69%) patients had a lymph node yield of 12 or more nodes. Actual 5-year survival was 59%. On multivariate regression analysis, tumour perforation (perforation vs no perforation, 5-year survival, 23%vs 61%; hazard ratio (HR), 3.7; 95% confidence interval (CI), 1.6-8.4; P = 0.002), tumour-to-margin distance (< 5 cm vs ≥ 5 cm, 48%vs 65%; HR, 1.7; 95% CI, 1.1-2.7; P = 0.039) and older age (≥ 75 years vs < 75 years, 45%vs 72%; HR, 3; 95% CI, 1.8-5; P < 0.001) were independent significant variables. CONCLUSION: A lymph node yield of 12 or more nodes is not a significant prognostic factor for survival after resection of Dukes' B colonic cancer. Patients with tumour perforation or limited resection have worse prognosis.

Measurement of anal cushions in idiopathic faecal incontinence.

BACKGROUND: Faecal incontinence affects a heterogeneous population and aetiology can be multifactorial. In a subset of patients the aetiology remains idiopathic despite standard investigations. Anal cushions are important in normal continence, but have rarely been studied. The aim of this study was to measure the size of the anal cushions and to evaluate their role in patients with idiopathic faecal incontinence. METHODS: Women in whom idiopathic faecal incontinence was diagnosed after standard anorectal investigations underwent transvaginal ultrasonography. The area of the anal cushions was measured and a cushion : canal (C : C) ratio derived, which was compared with that in a control group of women without faecal incontinence. RESULTS: Some 21 patients with incontinence (median age 60 years) and 102 asymptomatic controls (median age 41 years) underwent scanning. The median (interquartile range) C : C ratio in the symptomatic group was significantly lower than that for controls (0.57 (0.54-0.66) versus 0.68 (0.61-0.73) respectively; P = 0.001). C : C ratio was not influenced by age (r = 0.023, P = 0.821). CONCLUSION: The C : C ratio was reduced in patients with idiopathic faecal incontinence.

Morbidity and mortality after closure of loop ileostomy.

BACKGROUND: A temporary loop ileostomy is commonly used to protect low pelvic anastomoses. Closure is associated with morbidity and mortality. This study investigated patterns of complications after loop ileostomy closure and factors associated with morbidity and mortality. METHOD: A review was performed of patients who underwent loop ileostomy closure between 1999 and 2005. RESULTS: Three hundred and twenty-five patients underwent closure of loop ileostomy. Reasons for primary surgery were: anterior resection for cancer (n = 160, 49%), ileal pouch-anal anastomosis (n = 114, 35%), diverticular disease (n = 25, 8%), Crohn's colitis (n = 4, 1%) and other conditions (n = 22, 7%). Overall mortality was 2.5% (n = 8) and morbidity was 22.8% (n = 74). Thirty-two patients (10%) developed small bowel obstruction, of whom seven required operative intervention. Overall, the re-operation rate in this series was 28 patients (8.6%). Thirteen (4%) patients had an anastomotic leak of whom 12 patients had re-operation. Preoperative anaemia was significantly associated with leakage (Hb < 11 g/dl; n = 65, P = 0.033). The leakage rate was lower after a stapled anastomosis than a hand-sutured anastomosis (4/203 vs 9/122; P = 0.039). Hypo-albuminaemia (albumin < 34 g/l) was significantly associated with mortality (n = 46, P < 0.001). CONCLUSIONS: Loop ileostomy closure is associated with morbidity and mortality. Anaemia and hypo-albuminaemia may be associated with poor outcome.

Efficacy of the anal fistula plug in complex anorectal fistulae.

OBJECTIVE: The treatment of complex anorectal and rectovaginal fistulae remains a difficult problem. The options are fistulotomy, setons, fibrin glue and a variety of flap procedures. Recently, there have been several reports of a new plug; the Surgisis AFP plug. Reports from various centres do not give consistent results. The aim of this study was to assess the efficacy of the Surgisis AFP fistula plug in a wide spectrum of patients with anorectal, rectovaginal and pouch vaginal fistulae. METHOD: Between March 2006 and September 2007, patients with a variety of anal fistulae were selected for fistula plug insertion in the coloproctology units at Leeds, UK, and Aarhus, Denmark. Demographic and fistulae details were obtained. Postoperatively, all patients had a course of oral antibiotics. RESULTS: Forty-three patients with a median age of 45 (range 18-65) years underwent a total of 45 procedures. Seventy-five per cent (n = 32) had a fistula secondary to cryptoglandular abscess. Median follow up was 47 (range 12-77) weeks. The success rate for complete healing was 44%. Dislodgement caused failure on 10 (22%) occasions. CONCLUSION: Our study shows a moderate success rate for treatment with fistula plugs. The complex nature of the fistulae selected may be the reason for the low success rate.