Outcomes following local excision of early anal squamous cell carcinomas of the anal canal and perianal margin.

AIM: There is a paucity of data on outcomes from local excision (LE) of early anal squamous cell carcinomas (ASCCs). This study aimed to assess survival outcomes according to tumour location, perianal (PAT) or anal canal (ACT), and to determine factors associated with R1 excision and outcomes according to T-category. METHODS: This was a retrospective cohort study of consecutive patients with early ASCC treated by LE from 2007 to 2019. Data were collected on baseline demographics, tumour location, staging, excision histology, adjuvant treatment, site and timing of recurrence. The main outcome measures were R1 resection, locoregional recurrence (LRR), disease-free survival and overall survival. RESULTS: Of 367 patients treated for ASCC, 39 (10.6%) patients with complete follow-up data underwent LE: 15 ACTs and 24 PATs. R1 resections were obtained in 27 patients (69.2%) and occurred more frequently in ACTs than PATs (93.3% vs. 54.2%, P = 0.006). Eighteen of 27 patients (66.7%) received adjuvant therapy (chemoradiotherapy [n = 11], radiotherapy alone [n = 7]) for R1 excision or re-excision, following which LRR developed in one of 10 (10.0%) patients in the ACT cohort and one of eight (12.5%) patients in the PAT cohort. There was no difference in 5-year LRR-free survival (82.0% vs. 70.1%, P = 0.252), disease-free survival (58.2% vs. 78.4%, P = 0.200) or overall survival (86.2% vs. 95.7%, P = 0.607) between the ACT and PAT cohorts. CONCLUSIONS: LE is a feasible treatment option for early ASCCs of the perianal margin but not the anal canal. Acceptable long-term outcomes can still be achieved with adjuvant therapy in the presence of a positive margin. Larger prospective studies to assess LE as a treatment strategy, such as the ACT3 trial, are warranted.

Factors associated with early postoperative feeding: An observational study in a colorectal surgery population.

BACKGROUND AND AIMS: Early post-operative feeding is recommended within enhanced recovery after surgery programmes. This study aimed to describe post-operative feeding patterns and associated factors among patients following colorectal surgery, using a post-hoc analysis of observational data from a previous RCT on chewing gum after surgery. METHODS: Data from 301 participants (59% male, median age 67 years) were included. Amounts of meals consumed on post-operative days (POD) 1-5 were recorded as: none, a quarter, half, three-quarters, all. 'Early' consumers were those who ate ≥a quarter of a meal on POD1. 'Early' tolerance was the consumption of at least half of three meals on POD1 or 2 without vomiting. Exploration of selected peri-operative factors with early feeding and tolerance were assessed using logistic regression. RESULTS: 222 people (73.8%) consumed solid food early, and 109 people (36.2%) tolerated solid food early. Several factors were associated with postoperative feeding: provision of pre-operative bowel preparation was associated with delayed consumption [odds ratio (OR) 0.34, 95% confidence interval (CI) 0.14-0.83] and tolerance (OR 0.35, 95% CI 0.16-0.81) of food; and laparoscopic/laparoscopic assisted (vs. open/converted to open surgery) was associated with early tolerance of food (OR 1.99, 95% CI 1.17-3.39). CONCLUSIONS: While three-quarters of the study population ate solid food early, only one-third tolerated solid food early. Findings suggest that bowel preparation and surgery type are factors warranting further investigation in future studies to improve uptake of early post-operative feeding.

Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.

BACKGROUND: Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. OBJECTIVE: To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. DESIGN: Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. SETTING: Usual NHS care. PARTICIPANTS: Patients undergoing elective/non-elective abdominal surgery, including caesarean section. INTERVENTIONS: Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'. MAIN OUTCOME MEASURES: Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. DATA SOURCES: Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals. RESULTS: Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. LIMITATIONS: Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. CONCLUSIONS: A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks. TRIAL REGISTRATION: Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

Wound infections are common after surgery. Some are cured with simple treatment, but others may lead to serious problems. Reducing the risk of a wound infection is important. We do not know if the type of dressing, or not using a dressing, influences the risk of infection. A study that allocated patients to receive different dressings (or no dressing) would answer this question. We did preliminary research to explore whether or not such a study is possible. We interviewed doctors, nurses and patients about their views on dressings and a future study. We also described dressings currently being used in the NHS and found that simple dressings and tissue adhesive (glue) 'as-a-dressing' are used most frequently. We studied existing evidence and interviewed experts to develop a questionnaire, completed by patients, to identify wound infections after patients leave hospital and tested its accuracy. We also explored taking photographs of wounds. We investigated whether or not a major study would be worth the cost and designed a pilot study to test its feasibility. The pilot study recruited 394 patients undergoing abdominal operations in five NHS hospitals. These patients were allocated to have a simple dressing, glue-as-a-dressing or no dressing, and 92% received the allocated dressing method. Patients and their doctors and nurses found the dressing methods to be acceptable. We showed that the new patient questionnaire accurately identified infections. Patients or their carers also found it acceptable to photograph their wounds. Our research suggests that a future large study would be worth the investment and is possible.

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial.

BACKGROUND: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered. METHODS/DESIGN: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial. DISCUSSION: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed. TRIAL REGISTRATION: ISRCTN49328913 . Registered on 20 October 2015.

The association between referral source and outcome in patients with colorectal cancer.

AIM: The colorectal two-week wait fast track (FT) referral system was nationally implemented in the UK in 2000 to ensure patients with colorectal cancer (CRC) received prompt access to specialized services. The aim of this study was to determine the association between the mechanism of referral to colorectal services and the 5-year outcomes for patients with CRC. METHODS: Consecutive patients with newly diagnosed CRC presenting between October 2002 and September 2004 were identified retrospectively. Analysis for survival and recurrence of disease at 5 years from presentation was undertaken. Outcomes for patients were compared between fast track (FT), non-fast track (NFT) and emergency referral (ER) routes, using Kaplan-Meier survival estimates. RESULTS: Out of 189 patients, 96 (51%) presented via the FT, 41 (22.5%) via the NFT and 52 (27.5%) via the ER referral route. The 5-year overall survival was 52.6% ± 5.1, 41.5% ± 7.7 and 38.5% ± 6.7 for the FT-, NFT- and ER groups respectively (p = 0.075). The 5-year cancer specific survival was 60.3% ± 5.2, 58.8% ± 5.3 and 43.5% ± 7.2 for the FT-, NFT- and ER groups respectively (p = 0.056). Patients referred as emergencies had worse 5-year overall survival; 49.3% ± 4.3 (FT&NFT) vs. 38.5% ± 6.7 (ER) (p = 0.042) and 5-year cancer specific survival 59.8% ± 4.4 (FT&NFT) vs. 43.5% ± 7.2 (ER) (p = 0.016). A total of 136 patients (FT n = 71, NFT n = 34, ER n = 31) underwent potentially curative surgery. Differences in 5-year survival did not reach statistical significance in these patients. CONCLUSION: Referral route to specialist services for patients with CRC via the fast track pathway compared to non-fast track pathway was not associated with improved survival.

Improving dosing of gentamicin in the obese patient: a 3-cycle drug chart and case note audit.

OBJECTIVES: To assess the use of an electronic dose calculator to improve accuracy in the use of a complex Gentamicin prescription policy and assess turnaround time of blood sampling to dose delivery in an NHS hospital. DESIGN: Retrospective review of drug chart, case notes and hospital antibiotic database. SETTING: University Hospitals Bristol, UK PARTICIPANTS: Patients receiving once daily intravenous gentamicin using the trust protocol, during the same time window for 3 consecutive years. MAIN OUTCOME MEASURES: i) Accuracy of dose and frequency prescription of Gentamicin. ii) Time frame for measurement of serum Gentamicin levels. RESULTS: Following the introduction of the online calculator, prescribing errors in obese patients dropped from 43% to 20%, a similar level as in non-obese patients. Errors in frequency calculations dropped from 12.8% to 4%. On average, drug doses could be administered within 2.5 hours of a blood sample being taken. CONCLUSIONS: Online tools can be used to improve prescribing for the complex dosing policies that will increasingly been required to tailor prescribing in obese patients. Serum gentamicin levels can be measured within a 2.5 hour time frame in the environment of an NHS hospital.

Massive traumatic abdominal hernia repair with biologic mesh.

Traumatic abdominal wall hernias (TAWHs) are rare. They can arise from either high or low impact trauma and can be associated with significant associated injury. We present the case of a 27-year-old male involved in a high-impact road traffic accident resulting in a TAWH. He sustained significant disruption to the abdominal wall and sustained injuries to the thoracic cage. Operative management was undertaken with a porcine dermal collagen mesh, using a bridge technique.

Assessment of body image in patients undergoing surgery for colorectal cancer.

PURPOSE: This study tested the scale properties and validity of the ten-item body image scale (BIS) in patients undergoing surgery for colorectal cancer (CRC). METHODS: Patients completed the BIS and a validated measure of health-related quality of life (European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30) after open or laparoscopic resection. A sample of the patients had also previously completed questionnaires before and after surgery. Multi-trait scaling and factor analysis were used to examine the questionnaire scaling, and tests of reliability, clinical and construct validity were performed. RESULTS: Eighty-two patients (48 male, 59 open, 23 laparoscopic) participated. Scaling analyses suggested a nine-item scale and one single item. This revised scale structure demonstrated good test-retest reliability (r = 0.94) and no overlap with the key domains of the EORTC QLQ-C30 (r < 0.40). Patients with a stoma reported significantly poorer BIS scores than those undergoing simple resection (p = 0.005). CONCLUSIONS: This study provides psychometric and clinical evidence for a revised scale structure for the BIS in CRC, and the questionnaire is suitable to assess body image in CRC clinical trials.

Long-term outcomes for laparoscopic versus open resection of nonmetastatic colorectal cancer.

BACKGROUND: Skepticism prevails over the role of minimally invasive surgery in the treatment of colorectal cancer. Long-term data on the safety and efficacy of this technique remain scarce. A nonrandomized, prospective comparison of laparoscopic colorectal cancer surgery (LS) with open surgery (OS) was undertaken to evaluate long-term survival. METHODS: A total of 233 patients with nonmetastatic colorectal cancer underwent either a laparoscopic (n = 116) or an open (n = 117) potentially curative resection. Almost all patients between July 1996 and December 2002 were randomized within two consecutive trials; however, prior to this, a significant proportion of patients received open surgery. The primary endpoints were overall survival, disease-free survival, and cumulative disease recurrence. Analysis was by intention to treat. RESULTS: Median follow-up was 40 months for the LS group and 58 months for the OS group. No statistically significant difference was found between the LS and OS groups regarding overall survival (P = 0.603 for colon cancer and P = 0.841 for rectal cancer), disease-free survival (P = 0.684 for colon cancer and P = 0.625 for rectal cancer), and overall recurrence (P = 0.383 for colon cancer and P = 0.166 for rectal cancer). Cumulative recurrence rate in colon cancer favors OS (P = 0.018). In rectal cancer, this did not differ between the two treatment modalities (P = 0.965). Tumor resection margins and lymph node harvest were similar in the two surgery groups. Perioperative mortality in the LS group was also no different from the OS group (P = 0.644 for 30-day mortality and P = 0.692 for in-hospital mortality). CONCLUSION: Long-term survival data support LS as a safe, effective alternative to conventional surgery for treating potentially curative colorectal cancer. However, the higher cumulative recurrence associated with LS in the colonic cancer group needs further research into its underlying cause.

Takayasu's arteritis following Crohn's disease in a young woman: any evidence for a common pathogenesis?

Takayasu's arteritis and Crohn's disease are chronic inflammatory diseases of uncertain aetiology. They rarely occur together, with only twenty nine cases of co-existent Takayasu's arteritis and Crohn's disease reported in the literature. In 88% of these cases, Takayasu's arteritis was diagnosed simultaneously or following a diagnosis of Crohn's disease. We present a case of a young Caucasian medical student, incidentally found to have bilateral carotid bruits on auscultation by a colleague. Magnetic resonance angiography revealed stenoses of the common carotid arteries with established collaterals, and a diagnosis of Type 1 Takayasu's arteritis was made. An 18(F)-fluorodeoxyglucose positron emission tomography scan revealed no active disease. Nine months later, she presented with a short history of abdominal pain, vomiting and abdominal distension. Barium follow-through and computer tomography revealed a terminal ileal stricture and proximal small bowel dilation. An extended right hemicoloectomy was performed and histopathology supported a diagnosis of Crohn's disease. This case report is presented with a particular focus on the temporal relationship between these two disease processes and explores whether their concurrence is more than just co-incidence.

Colonic vascular anomalies and colon cancer in neurofibromatosis: report of a case.

We report a case of neurofibromatosis with synchronous adenocarcinomas in the sigmoid and transverse colon. There was widespread intimal proliferation in arteries in the region of the tumors and also in the cecum. Such vascular lesions are associated with von Recklinghausen's disease. The cecal lesion produced mural thickening visible on computed tomography. This case supports a possible genetic link between neurofibromatosis and adenocarcinoma of the colon.