Clinical and oncological outcomes of pelvic exenteration surgery for anal squamous cell carcinoma.

AIM: Anal cancer incidence and mortality rates are rising in the United Kingdom (UK). Surgery is an important treatment modality for persistent or recurrent disease. There is a paucity of data on outcomes for patients undergoing pelvic exenteration for anal squamous cell carcinoma (SCC) for persistent or recurrent disease. The aim of this study was to investigate the outcomes for patients who were treated with pelvic exenteration for anal SCC from two high-volume, high-complexity pelvic exenteration units in the UK. METHOD: A retrospective review of prospectively maintained databases from 2011 to 2020 was undertaken. Primary endpoints included R0 resection rates, overall and disease-free survival at 2 and 5 years. RESULTS: From 2011 to 2020, 35 patients with anal SCC were selected for exenteration. An R0 resection was achieved in 26 patients (77%). Of the remaining patients, seven patients had an R1 resection and one had a R2 resection. One further patient was excluded from additional analysis as the disease was inoperable at the time of laparotomy. With a median follow-up of 19.5 months (interquartile range 7.9-53.5 months), overall survival was 50% (17/34). Patients with an R1/2 resection had a significantly poorer overall survival [0.27 (0.09-0.76), p = 0.021] than those patients in whom R0 resection was achieved. Disease-free survival was 38.2% (13/34) and an R1/R2 resection was associated with a significantly reduced disease-free survival [0.12 (0.04-0.36), p < 0.001]. CONCLUSION: Complete R0 resection for recurrent or persistent anal SCC is possible in the majority of patients and improves overall and disease-free survival compared with R1/R2 resection.

Pathological determinants of outcome following resection of locally advanced or locally recurrent rectal cancer.

INTRODUCTION: Pathological factors that influence and predict survival following pelvic exenteration (PE) for locally advanced (LARC) or locally recurrent rectal cancer (LRRC), especially LRRC, remain poorly understood. A clear resection margin has previously been demonstrated to be of most significance. MATERIALS AND METHODS: A retrospective cohort study was performed for all patients undergoing a curative PE for LARC or LRRC between 2008 and 2021 at a tertiary referral UK specialist colorectal hospital. Cox regression analysis was planned to identify pathological factors associated with overall (OS), disease free (DFS) and local recurrence free survival (LRFS). RESULTS: 388 patients were included in the analysis with 256 resections for LARC and 132 for LRRC. 62.4% of patients were male with a median age of 59 years (IQR 49-67). 247 (64%) partial pelvic exenterations and 141 (36%) total pelvic exenterations performed. Overall R0 rate 86.6%. Poorly differentiated tumours and a positive resection margin independently influenced OS, DFS and LRFS on multivariate analysis in LARC. On multivariate analysis venous invasion negatively influenced DFS and poorly differentiated lesions negatively influenced LRFS in LRRC. CONCLUSIONS: A positive resection margin and poorly differentiated tumours are significant negative prognostic markers for survival and recurrence in LARC. The results of this study support the need to look for alternative prognostic markers beyond that in the existing standard reporting dataset for rectal cancers. With increasing R0 rates, novel prognostic pathological markers are required to help guide treatment and surveillance for patients with LRRC.

The use of, and outcomes for, inflammatory bowel disease services during the Covid-19 pandemic: a nationwide observational study.

BACKGROUND: Inflammatory bowel disease (IBD) services have been particularly affected by the Covid-19 pandemic. Delays in referral to secondary care and access to investigations and surgery have been exacerbated. AIMS: To investigate the use of and outcomes for emergency IBD care during the Covid-19 pandemic. METHODS: Nationwide observational study using administrative data for England (2015-2020) comparing cohorts admitted from 1 January 2015, to 31 January 2020 (pre-pandemic) and from 1 February 2020, to 31 January 2021 (pandemic). Autoregressive integrated moving average forecast models were run to estimate the counterfactual IBD admissions and procedures for February 2020 to January 2021. RESULTS: Large decreases in attendances to hospital for emergency treatment were observed for both acute ulcerative colitis (UC, 16.4%) and acute Crohn's disease (CD, 8.7%). The prevalence of concomitant Covid-19 during the same episode was low [391/16 494 (2.4%) and 349/15 613 (2.2%), respectively]. No significant difference in 30-day mortality was observed. A shorter median length of stay by 1 day for acute IBD admissions was observed (P < 0.0001). A higher rate of emergency readmission within 28 days for acute UC was observed (14.1% vs 13.4%, P = 0.012). All IBD procedures and investigations showed decreases in volume from February 2020 to January 2021 compared with counterfactual estimates. The largest absolute deficit was in endoscopy (17 544 fewer procedures, 35.2% reduction). CONCLUSION: There is likely a significant burden of untreated IBD in the community. Patients with IBD may experience clinical harm or protracted decreases in quality of life if care is not prioritised.

Empty pelvis syndrome: a systematic review of reconstruction techniques and their associated complications.

AIM: Empty pelvis syndrome is a major contributor to morbidity following pelvic exenteration. Several techniques for filling the pelvis have been proposed; however, there is no consensus on the best approach. We evaluated and compared the complications associated with each reconstruction technique with the aim of determining which is associated with the lowest incidence of complications related to the empty pelvis. METHOD: The systematic review protocol was prospectively registered with PROSPERO (CRD42021239307). PRISMA-P guidelines were used to present the literature. PubMed and MEDLINE were systematically searched up to 1 February 2021. A dataset containing predetermined primary and secondary outcomes was extracted. RESULTS: Eighteen studies fulfilled our criteria; these included 375 patients with mainly rectal and gynaecological cancer. Only three studies had a follow-up greater than 2 years. Six surgical interventions were identified. Mesh reconstruction and breast prosthesis were associated with low rates of small bowel obstruction (SBO), entero-cutaneous fistulas and perineal hernia. Findings for myocutaneous flaps were similar; however, they were associated with high rates of perineal wound complications. Omentoplasty was found to have a high perineal wound infection rate (40%). Obstetric balloons were found to have the highest rates of perineal wound dehiscence and SBO. Silicone expanders effectively kept small bowel out of the pelvis, although rates of pelvic collections remained high (20%). CONCLUSION: The morbidity associated with an empty pelvis remains considerable. Given the low quality of the evidence with small patient numbers, strong conclusions in favour of a certain technique and comparison of these interventions remains challenging.

Towards Standardisation of Technique for En Bloc Sacrectomy for Locally Advanced and Recurrent Rectal Cancer.

Treatment strategies for advanced or recurrent rectal cancer have evolved such that the ultimate surgical goal to achieve a cure is complete pathological clearance. To achieve this where the sacrum is involved, en bloc sacrectomy is the current standard of care. Sacral resection is technically challenging and has been described; however, the technique has yet to be streamlined across units. This comprehensive review aims to outline the surgical approach to en bloc sacrectomy for locally advanced or recurrent rectal cancer, with standardisation of the operative steps of the procedure and to discuss options that enhance the technique.

Delays in referral from primary care worsen survival for patients with colorectal cancer: a retrospective cohort study.

BACKGROUND: Delays in referral for patients with colorectal cancer may occur if the presenting symptom is falsely attributed to a benign condition. AIM: To investigate whether delays in referral from primary care are associated with a later stage of cancer at diagnosis and worse prognosis. DESIGN AND SETTING: A national retrospective cohort study in England including adult patients with colorectal cancer identified from the cancer registry with linkage to Clinical Practice Research Datalink, who had been referred following presentation to their GP with a 'red flag' or 'non-specific' symptom. METHOD: The hazard ratios (HR) of death were calculated for delays in referral of between 2 weeks and 3 months, and >3 months, compared with referrals within 2 weeks. RESULTS: A total of 4527 (63.5%) patients with colon cancer and 2603 (36.5%) patients with rectal cancer were included in the study. The percentage of patients presenting with red-flag symptoms who experienced a delay of >3 months before referral was 16.9% of those with colon cancer and 13.5% of those with rectal cancer, compared with 35.7% of patients with colon cancer and 42.9% of patients with rectal cancer who presented with non-specific symptoms. Patients referred after 3 months with red-flag symptoms demonstrated a significantly worse prognosis than patients who were referred within 2 weeks (colon cancer: HR 1.53; 95% confidence interval [CI] = 1.29 to 1.81; rectal cancer: HR 1.30; 95% CI = 1.06 to 1.60). This association was not seen for patients presenting with non-specific symptoms. Delays in referral were associated with a significantly higher proportion of late-stage cancers. CONCLUSION: The first presentation to the GP provides a referral opportunity to identify the underlying cancer, which, if missed, is associated with a later stage in diagnosis and worse survival.

Comparison of cancer diagnosis recording between the Clinical Practice Research Datalink, Cancer Registry and Hospital Episodes Statistics.

INTRODUCTION: The Clinical Practice Research Datalink (CPRD) is a large electronic dataset of primary care medical records. For the purpose of epidemiological studies, it is necessary to ensure accuracy and completeness of cancer diagnoses in CPRD. METHOD: Cases included had a colorectal, oesophagogastric (OG), breast, prostate or lung cancer diagnosis recorded in a least one of CPRD, Cancer Registry (CR) or Hospital Episodes Statistics(HES) between 2000 and 2013. Agreement in diagnosis between the datasets, difference in dates, survival at one and five-years, and whether patient characteristics differed according to the dataset or the timing of diagnosis were investigated. RESULTS: 116,769 patients were included. For each cancer, approximately 10% of cases identified from CPRD or HES were not confirmed in the CR. 25.5% colorectal, 26.0% OG, 8.9% breast, 32.0% lung and 18.6% prostate cases identified from the CR were missing in CPRD. The diagnosis date was recorded later in CPRD compared with CR for each cancer, ranging from 81.1% for prostate to 59.6% for colorectal, especially if the diagnosis was an emergency. Compared with the CR and HES, the adjusted risk of a missing diagnosis in CPRD was significantly higher if the patient was older, had more co-morbidities or was diagnosed as an emergency. Survival at one and five-years was highest for CPRD. CONCLUSION: Patient demographics and the route of diagnosis impact the accuracy of cancer diagnosis in CPRD. Although CPRD provides invaluable primary care data, patients should ideally be identified from the CR to reduce bias.

Cohort analysis of outcomes in 69†490 emergency general surgical admissions across an international benchmarking collaborative.

OBJECTIVE: This study aims to use the Dr Foster Global Comparators Network (GC) database to examine differences in outcomes following high-risk emergency general surgery (EGS) admissions in participating centres across 3 countries and to determine whether hospital infrastructure factors can be linked to the delivery of high-quality care. DESIGN: A retrospective cohort analysis of high-risk EGS admissions using GC's international administrative data set. SETTING: 23 large hospitals in Australia, England and the USA. METHODS: Discharge data for a cohort of high-risk EGS patients were collated. Multilevel hierarchical logistic regression analysis was performed to examine geographical and structural differences between GC hospitals. RESULTS: 69 490 patients, admitted to 23 centres across Australia, England and the USA from 2007 to 2012, were identified. For all patients within this cohort, outcomes defined as: 7-day and 30-day inhospital mortality, readmission and length of stay appeared to be superior in US centres. A subgroup of 19 082 patients (27%) underwent emergency abdominal surgery. No geographical differences in mortality were seen at 7 days in this subgroup. 30-day mortality (OR=1.47, p<0.01) readmission (OR=1.42, p<0.01) and length of stay (OR=1.98, p<0.01) were worse in English units. Patient factors (age, pathology, comorbidity) were significantly associated with worse outcome as were structural factors, including low intensive care unit bed ratios, high volume and interhospital transfers. Having dedicated EGS teams cleared of elective commitments with formalised handovers was associated with shorter length of stay. CONCLUSIONS: Key factors that influence outcomes were identified. For patients who underwent surgery, outcomes were similar at 7 days but not at 30 days. This may be attributable to better infrastructure and resource allocation towards EGS in the US and Australian centres.

International recommendations for national patient safety incident reporting systems: an expert Delphi consensus-building process.

BACKGROUND: Patient safety incident reporting systems (PSRS) have been established for over a decade, but uncertainty remains regarding the role that they can and ought to play in quantifying healthcare-related harm and improving care. OBJECTIVE: To establish international, expert consensus on the purpose of PSRS regarding monitoring and learning from incidents and developing recommendations for their future role. METHODS: After a scoping review of the literature, semi-structured interviews with experts in PSRS were conducted. Based on these findings, a survey-based questionnaire was developed and subsequently completed by a larger expert panel. Using a Delphi approach, consensus was reached regarding the ideal role of PSRSs. Recommendations for best practice were devised. RESULTS: Forty recommendations emerged from the Delphi procedure on the role and use of PSRS. Experts agreed reporting system should not be used as an epidemiological tool to monitor the rate of harm over time or to appraise the relative safety of hospitals. They agreed reporting is a valuable mechanism for identifying organisational safety needs. The benefit of a national system was clear with respect to medication error, device failures, hospital-acquired infections and never events as these problems often require solutions at a national level. Experts recommended training for senior healthcare professionals in incident investigation. Consensus recommendation was for hospitals to take responsibility for creating safety solutions locally that could be shared nationally. CONCLUSIONS: We obtained reasonable consensus among experts on aims and specifications of PSRS. This information can be used to reflect on existing and future PSRS, and their role within the wider patient safety landscape. The role of PSRS as instruments for learning needs to be elaborated and developed further internationally.

Understanding The Strengths And Weaknesses Of Public Reporting Of Surgeon-Specific Outcome Data.

Public reporting of outcome data is increasingly being used at the institutional and clinician levels and has become mandatory in some parts of the United States and the United Kingdom. The intended benefits are to drive quality improvement, demonstrate transparency, facilitate patient choice, and allow identification of poor performance. Public reporting of surgeon-specific mortality data, however, may have unintended consequences that include causing surgeons to become risk-averse, discouraging innovation, having an impact on training, and prompting "gaming" in health care. Given the small number of some surgical operations performed by individual surgeons, such data are unlikely to identify outliers or poor performers in a valid way. If metrics are deemed necessary and required to be reported publicly, they should be procedure specific; account for sample size; and focus not solely on mortality but also on other outcomes such as quality of life, patient satisfaction, and experience.

A Systematic Review of the Impact of Dedicated Emergency Surgical Services on Patient Outcomes.

OBJECTIVE: This review aims to assess the impact of implementing dedicated emergency surgical services, in particular acute care surgery, on clinical outcomes. BACKGROUND: The optimal model for delivering high-quality emergency surgical care remains unknown. Acute Care Surgery (ACS) is a health care model combining emergency general surgery, trauma, and critical care. It has been adopted across the United States in the management of surgical emergencies. METHOD: A systematic review was performed after PRISMA recommendations using the MEDLINE, Embase, and Psych-Info databases. Studies assessing different care models and institutional factors affecting the delivery of emergency general surgery were included. RESULTS: Twenty-seven studies comprising 744,238 patients were included in this review. In studies comparing ACS with traditional practice, mortality and morbidity were improved. Moreover, time to senior review, delays to operating theater, and financial expenditure were often reduced. The elements of ACS models varied but included senior clinicians present onsite during office hours and dedicated to emergency care while on-call. Referrals were made to specialist centers with primary surgical assessments taking place on surgical admissions units rather than in the emergency department. Twenty-four-hour access to dedicated emergency operating rooms was also described. CONCLUSIONS: ACS models as well as centralized units and hospitals with dedicated emergency operating rooms, access to radiology and intensive care facilities (ITU) are all factors associated with improved clinical and financial outcomes in the delivery of emergency general surgery. There is, however, no consensus on the elements that constitute an ideal ACS model and how it can be implemented into current surgical practice.

Linked Hospital and Primary Care Database Analysis of the Incidence and Impact of Psychiatric Morbidity Following Gastrointestinal Cancer Surgery in England.

OBJECTIVE: To evaluate risk of psychiatric morbidity and its impact on survival in gastrointestinal surgery. BACKGROUND: Psychiatric morbidity related to surgery is poorly understood, and may be evaluated using linked hospital and primary care data. METHODS: Patients undergoing gastrointestinal surgery from 2000 to 2011 with linkage of Clinical Practice Research Datalink (CPRD), Hospital Episodes Statistics (HES), Office of National Statistics (ONS), and National Cancer Intelligence Network (NCIN) databases were studied. Psychiatric morbidity was defined as a diagnosis code in CPRD or HES, or a prescription code for psychiatric medication in the 36 months before (preoperative) or 12 months after (postoperative) surgery. Newly diagnosed psychiatric morbidity was measured in patients without preoperative psychiatric morbidity. RESULTS: In our study, 14,797 (23.8%) and 47,279 (76.2%) patients had surgery for cancer and benign disease, respectively. Postoperative psychiatric morbidity was observed in 10.1% (1500/14797) of patients undergoing cancer surgery. Logistic regression revealed that when adjusted for other factors, cancer diagnosis [odds ratio (OR) = 1.19] independently predicted postoperative psychiatric morbidity (P < 0.05). Hepatopancreaticobiliary resection (OR = 2.40) and esophagogastrectomy (OR = 2.55) carried the highest risks of postoperative psychiatric morbidity (P < 0.05). Preoperative psychiatric morbidity (OR = 1.16) and newly diagnosed psychiatric morbidity (OR = 1.87) were associated with increased 1-year mortality in cancer patients only (P < 0.05). CONCLUSIONS: Postoperative psychiatric morbidity affected a tenth of patients who underwent gastrointestinal cancer surgery and was associated with increased mortality. Strategies to identify patients at risk preoperatively and to reduce the observed adverse impact of postoperative psychiatric morbidity should be part of perioperative care in complex cancer patients.

Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data.

BACKGROUND: The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems. METHODS: This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure. FINDINGS: 5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were significantly negatively associated with incident reports. Patient satisfaction and mortality outcomes were not significantly associated with reporting rates. Staff survey responses revealed that keeping reports confidential, keeping staff informed about incidents and giving feedback on safety initiatives increased reporting rates [r = 0.26 (p<0.01), r = 0.17 (p = 0.04), r = 0.23 (p = 0.01), r = 0.20 (p = 0.02)]. CONCLUSION: The NRLS is the largest patient safety reporting system in the world. This study did not demonstrate many hospital characteristics to significantly influence overall reporting rate. There were no association between size of hospital, number of staff, mortality outcomes or patient satisfaction outcomes and incident reporting rate. The study did show that hospitals where staff reported more incidents had reduced litigation claims and when clinician staffing is increased fewer incidents reporting patient harm are reported, whilst near misses remain the same. Certain specialties report more near misses than others, and doctors report more harm incidents than near misses. Staff survey results showed that open environments and reduced fear of punitive response increases incident reporting. We suggest that reporting rates should not be used to assess hospital safety. Different healthcare professionals focus on different types of safety incidents and focusing on these areas whilst creating a responsive, confidential learning environment will increase staff engagement with error disclosure.

Reducing the burden of surgical harm: a systematic review of the interventions used to reduce adverse events in surgery.

OBJECTIVE: To perform a systematic review of interventions used to reduce adverse events in surgery. BACKGROUND: Many interventions, which aim to improve patient safety in surgery, have been introduced to hospitals. Little is known about which methods provide a measurable decrease in morbidity and mortality. METHODS: MEDLINE, EMBASE, and Cochrane databases were searched from inception to Week 19, 2012, for systematic reviews, randomized controlled trials (RCTs), and cross-sectional and cohort studies, which reported an intervention aimed toward reducing the incidence of adverse events in surgical patients. The quality of observational studies was measured using the Newcastle-Ottawa Scale. RCTs were assessed using the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: Ninety-one studies met inclusion criteria, 26 relating to structural interventions, 66 described modifying process factors. Only 17 (of 42 medium to high quality studies) reported an intervention that produced a significant decrease in morbidity and mortality. Structural interventions were: improving nurse to patient ratios (P = 0.008) and Intensive Care Unit (ITU) physician involvement in postoperative care (P < 0.05). Subspecialization in surgery reduced technical complications (P < 0.01). Effective process interventions were submission of outcome data to national audit (P < 0.05), use of safety checklists (P < 0.05), and adherence to a care pathway (P < 0.05). Certain safety technology significantly reduced harm (P = 0.02), and team training had a positive effect on patient outcome (P = 0.001). CONCLUSIONS: Only a small cohort of medium- to high-quality interventions effectively reduce surgical harm and are feasible to implement. It is important that future research remains focused on demonstrating a measurable reduction in adverse events from patient safety initiatives.

The role of caseload in determining outcome following laparoscopic colorectal cancer resection: an observational study.

BACKGROUND: This study aimed to evaluate using national data the role of surgeon laparoscopic caseload in determining outcome following elective laparoscopic colorectal cancer resection. METHODS: All patients who underwent an elective laparoscopic primary colorectal cancer resection between 2002 and 2008 were included from the Hospital Episode Statistics database. Surgeon teams were divided into tertiles according to the mean laparoscopic caseload per year. High volume corresponded to more than 12 laparoscopic procedures per year and low volume corresponded to seven or fewer procedures per year. Outcome measures were 30-day in-hospital mortality, return to theatre (RTT), 30-day medical morbidity, 365-day medical morbidity, length of stay (LOS), and unplanned 28-day readmission. RESULTS: There was a significant increase in the number of surgeons selecting patients for the laparoscopic approach between 2002-2003 and 2007-2008. In 2002-2003, a total of 41 surgeon teams performed laparoscopic resections whereas in 2007-2008 there were 398 surgeon teams. The patients of high-volume surgeon teams had a shorter LOS [OR 0.88 (0.85-0.91), p < 0.0001]. Patients of medium-volume surgeon teams had the highest medical morbidity rates [30-day medical morbidity: OR 1.24 (1.04-1.48), p = 0.015; 365-day medical morbidity: OR 1.22 (1.04-1.45), p = 0.018]. There were no differences between the high- and low-volume groups in terms of mortality, morbidity, RTT, or readmission. CONCLUSION: Although there has been a significant increase in the number of surgeon teams offering the minimal access approach, this study has not found a consistent relationship between surgeon laparoscopic cancer surgery caseload and outcome. WHAT'S NEW IN THIS MANUSCRIPT: This is the first national study to explore the role of surgical volume in determining outcome following laparoscopic surgery. This study questions the impact of surgeon caseload on laparoscopic surgical outcome.