The costs of surgical site infection after abdominal surgery in middle-income countries: Key resource use In Wound Infection (KIWI) study.

BACKGROUND: Surgical site infection (SSI) is the most common complication of abdominal surgery, with substantial costs to patients and health systems. Heterogeneity in costing methods in existing SSI studies makes multi-country comparison challenging. The objective of the study was to assess the costs of SSI across middle-income countries. METHODS: Centres from a randomized controlled trial assessing interventions to reduce SSI (FALCON, ClinicalTrials.gov, NCT03700749NCT) were sampled from two upper-middle- (India, Mexico) and two lower-middle- (Ghana, Nigeria) income countries. The Key resource use In Wound Infection (KIWI) study collected data on postoperative resource use and costs from consecutive patients undergoing abdominal surgery with an incision >5 cm (including caesarean section) that were recruited to FALCON between April and October 2020. The overall costs faced by patients with and without SSI were compared by operative field contamination (clean-contaminated vs contaminated-dirty), country and timing (inpatient vs outpatient). FINDINGS: A total of 335 patients were included in KIWI; SSI occurred in 7% of clean-contaminated cases and 27% of contaminated-dirty cases. Overall, SSI was associated with an increase in postoperative healthcare costs by 75.3% (€412 international Euros) after clean-contaminated surgery and 66.6% (€331) after contaminated-dirty surgery. The highest and lowest cost increases were in India for clean-contaminated cases (€517) and contaminated-dirty cases (€223), respectively. Overall, inpatient costs accounted for 96.4% of the total healthcare costs after clean-contaminated surgery and 92.5% after contaminated-dirty surgery. CONCLUSION: SSI was associated with substantial additional postoperative costs across a range of settings. Investment in health technologies to reduce SSI may mitigate the financial burden to patients and low-resource health systems.

Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation.

BACKGROUND: Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterise the stage of innovation for bioabsorbable mesh devices used during both midline closure prophylaxis and complex abdominal wall reconstruction and to evaluate the quality of current evidence. METHODS: A systematic review of published and ongoing studies was performed until 31st December 2019. Inclusion criteria were studies where bioabsorbable mesh was used to support fascial closure either prophylactically after midline laparotomy or for repair of incisional hernia with midline incision. Exclusion criteria were: (1) study design was a systematic review, meta-analysis, letter, review, comment, or conference abstract; (2) included less than p patients; (3) only evaluated biological, synthetic or composite meshes. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the risk of bias in non-randomised studies of interventions (ROBINS-I) criteria for study quality. RESULTS: Twelve studies including 1287 patients were included. Three studies considered mesh prophylaxis and nine studies considered hernia repair. There were only two published studies of IDEAL 2B. The remainder was IDEAL 2A studies. The quality of the evidence was categorised as having a risk of bias of a moderate, serious or critical level in nine of the twelve included studies using the ROBINS-I tool. CONCLUSION: The evidence base for bioabsorbable mesh is limited. Better reporting and quality control of surgical techniques are needed. Although new trial results over the next decade will improve the evidence base, more trials in emergency and contaminated settings are required to establish the limits of indication.

An audit of process and outcome for emergency colectomy in England and Wales.

AIM: The aim of this work was to describe process and outcome for patients undergoing emergency colectomy for colitis in England and Wales. METHOD: The National Emergency Laparotomy Audit (NELA) is a national audit including patients undergoing emergency laparotomy and laparoscopic resectional procedures. Data from adult patients under 65 years of age who underwent emergency subtotal colectomy or panproctocolectomy for colitis between 2013 and 2016 were analysed. RESULTS: In total 1204 patients were included. Although approximately a third of patients underwent a colectomy within 5 days of admission [37% (440/1204)], 32% (383/1204) were admitted for more than 10 days prior to surgery. Colorectal surgeons were present at operation in 72% (869/1204) of cases and consultant surgeons attended 94% (1137/1204) of procedures. Laparoscopy was attempted in 32% (390/1204) of operations with wide institutional variation in its use (0-100% of cases). The overall 30-day inpatient mortality was 2.9% (35/1204). On multivariable regression analysis, age > 55 years [OR 3.59 (1.05-12.21), P = 0.041], female gender [OR 2.88 (1.27-6.52), P = 0.011] and American Society of Anesthesiologists grade 5 [OR 37.43 (2.72-514.52), P = 0.007] were associated with increased mortality. CONCLUSION: There is a consultant-driven service that is largely delivered by specialist colorectal surgeons. Laparoscopy rates were high although there was wide variation in use across institutions. Preoperative delays were evident, and further work is necessary to determine the underlying reasons for these.

Systematic review of the stage of innovation of biological mesh for complex or contaminated abdominal wall closure.

BACKGROUND: Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterize the stage of innovation for biological mesh devices used during complex abdominal wall reconstruction and to evaluate the quality of current evidence. METHODS: A systematic review was performed of published and ongoing studies between January 2000 and September 2017. Eligible studies were those where a biological mesh was used to support fascial closure, either prophylactically after midline laparotomy, or for reinforcement after repair of incisional hernia with midline incision. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the GRADE criteria for study quality. RESULTS: Thirty-five studies including 2681 patients were included. Four studies considered mesh prophylaxis, 23 considered hernia repair, and eight reported on both. There was one published randomized trial (IDEAL stage 3), none of which was of high quality; the others were non-randomized studies (IDEAL stage 2a). A detailed description of surgical technique was provided in most studies (27 of 35); however, no study reported outcomes according to the European Hernia Society consensus statement and only two described quality control of surgical technique during the study. From 21 ongoing randomized trials and observational studies, 11 considered repair of incisional hernia and 10 considered prophylaxis (seven in elective settings). CONCLUSION: The evidence base for biological mesh is limited, and better reporting and quality control of surgical techniques are needed. Although results of ongoing trials over the next decade will improve the evidence base, further study is required in the emergency and contaminated settings.

The Association of Coloproctology of Great Britain and Ireland consensus guidelines in surgery for inflammatory bowel disease.

AIM: There is a requirement of an expansive and up to date review of surgical management of inflammatory bowel disease (IBD) that can dovetail with the medical guidelines produced by the British Society of Gastroenterology. METHODS: Surgeons who are members of the ACPGBI with a recognised interest in IBD were invited to contribute various sections of the guidelines. They were directed to produce a procedure based document using literature searches that were systematic, comprehensible, transparent and reproducible. Levels of evidence were graded. An editorial board was convened to ensure consistency of style, presentation and quality. Each author was asked to provide a set of recommendations which were evidence based and unambiguous. These recommendations were submitted to the whole guideline group and scored. They were then refined and submitted to a second vote. Only those that achieved >80% consensus at level 5 (strongly agree) or level 4 (agree) after 2 votes were included in the guidelines. RESULTS: All aspects of surgical care for IBD have been included along with 157 recommendations for management. CONCLUSION: These guidelines provide an up to date and evidence based summary of the current surgical knowledge in the management of IBD and will serve as a useful practical text for clinicians performing this type of surgery.

Patient and healthcare professional perceptions of colostomy-related problems and their impact on quality of life following rectal cancer surgery.

BACKGROUND: The perception of colostomy-related problems and their impact on health-related quality of life (QoL) may differ between patients and healthcare professionals. The aim of this study was to investigate this using the Colostomy Impact Score (CIS) tool. METHODS: Healthcare professionals including consultant colorectal surgeons, stoma nurses, ward nurses, trainees and medical students were recruited. An online survey was designed. From the 17 items used to develop the CIS, participants chose the seven factors they thought to confer the strongest negative impact on the QoL of patients with a colostomy. They were then asked to rank the 12 responses made by patients to the final seven factors contained in the CIS. Results were compared with the original patient rankings at the time of development of the CIS. RESULTS: A total of 156 healthcare professionals (50·4 per cent of the pooled professionals) from 17 countries completed the survey. Of the original seven items in the CIS, six were above the threshold for random selection. Ranking the responses, a poor match between participants and the original score was detected for 49·7 per cent of the professionals. The most under-rated item originally present in the CIS was stool consistency, reported by 47 of the 156 professionals (30·1 per cent), whereas frequency of changing the stoma bag was the item not included in the CIS that was chosen most often by professionals (124, 79·5 per cent). Significant differences were not observed between different groups of professionals. CONCLUSION: The perspective of colostomy-related problems differs between patients with a colostomy and healthcare professionals.

The impact of ileal pouch-anal anastomosis on graft survival following liver transplantation for primary sclerosing cholangitis.

BACKGROUND: Liver transplantation is the only life-extending intervention for primary sclerosing cholangitis (PSC). Given the co-existence with colitis, patients may also require colectomy; a factor potentially conferring improved post-transplant outcomes. AIM: To determine the impact of restorative surgery via ileal pouch-anal anastomosis (IPAA) vs retaining an end ileostomy on liver-related outcomes post-transplantation. METHODS: Graft survival was evaluated across a prospectively accrued transplant database, stratified according to colectomy status and type. RESULTS: Between 1990 and 2016, 240 individuals with PSC/colitis underwent transplantation (cumulative 1870 patient-years until first graft loss or last follow-up date), of whom 75 also required colectomy. A heightened incidence of graft loss was observed for the IPAA group vs those retaining an end ileostomy (2.8 vs 0.4 per 100 patient-years, log-rank P = 0.005), whereas rates between IPAA vs no colectomy groups were not significantly different (2.8 vs 1.7, P = 0.1). In addition, the ileostomy group experienced significantly lower graft loss rates vs. patients retaining an intact colon (P = 0.044). The risks conferred by IPAA persisted when taking into account timing of colectomy as related to liver transplantation via time-dependent Cox regression analysis. Hepatic artery thrombosis and biliary strictures were the principal aetiologies of graft loss overall. Incidence rates for both were not significantly different between IPAA and no colectomy groups (P = 0.092 and P = 0.358); however, end ileostomy appeared protective (P = 0.007 and 0.031, respectively). CONCLUSION: In PSC, liver transplantation, colectomy + IPAA is associated with similar incidence rates of hepatic artery thrombosis, recurrent biliary strictures and re-transplantation compared with no colectomy. Colectomy + end ileostomy confers more favourable graft outcomes.

Restorative surgery after colectomy for ulcerative colitis in England and Sweden: observations from a comparison of nationwide cohorts.

AIM: A longstanding disparity exists between the approaches to restorative surgery after colectomy for patients with ulcerative colitis (UC) in England and Sweden. This study aims to compare rates of colectomy and restorative surgery in comparable national cohorts. METHOD: The English Hospital Episode Statistics (HES) and Swedish National Patient Register (NPR) were interrogated between 2002 and April 2012. Patients with two diagnostic episodes for UC (age ≥ 15 years) were included. Patients were excluded if they had an episode of inflammatory bowel disease or colectomy before 2002. The cumulative incidences of colectomy and restorative surgery were calculated using the Kaplan-Meier method. RESULTS: A total of 98 691 patients were included in the study, 76 129 in England and 22 562 in Sweden. The 5-year cumulative incidence of all restorative surgery after colectomy in England was 33% vs 46% in Sweden (P-value < 0.001). Of the patients undergoing restorative surgery, 92.3% of English patients had a pouch vs 38.8% in Sweden and 7.7% vs 59.1% respectively had an ileorectal anastomosis (IRA). The 5-year cumulative incidence of colectomy in this study cohort was 13% in England and 6% in Sweden (P-value < 0.001). CONCLUSION: Following colectomy for UC only one-third of English patients and half of Swedish patients underwent restorative surgery. In England nearly all these patients underwent pouches, in Sweden a less significant majority underwent IRAs. It is surprising to demonstrate this discrepancy in a comparable cohort of patients from similar healthcare systems. The causes and consequences of this international variation in management are not fully understood and require further investigation.

The colostomy impact score: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. A population-based study.

AIM: The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. METHOD: In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. RESULTS: The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥ 10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. CONCLUSION: This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally.

Diagnosing acute appendicitis: surgery or imaging?

AIM: Investigation of suspected appendicitis varies widely across different countries, which creates variation in outcome for patients. Use of imaging drives much of this variation, with concerns over delay of imaging and radiation exposure of computed tomography being balanced against the risks of unnecessary surgery. METHOD: Two national, prospective snapshot audits (UK n = 3326 and Netherlands n = 1934) reported investigation, management and outcome of appendicectomy and can be compared to generate treatment recommendations. RESULTS: Preoperative imaging was conducted in 32.8% of UK patients in contrast to 99.5% of patients in the Netherlands. A large difference in the normal appendicectomy rate was observed (20.6% in the UK vs 3.2% in the Netherlands) and the connection between these two outcome differences cannot be neglected. CONCLUSION: This article discusses the role of imaging in the diagnostic work-up of patients who are suspected of acute appendicitis, comparing national snapshot studies as a model to do so.

The effect of ethnicity on in-hospital mortality following emergency abdominal surgery: a national cohort study using Hospital Episode Statistics.

OBJECTIVES: Ethnicity has complex effects on health and the delivery of health care in part related to language and cultural barriers. This may be important in patients requiring emergency abdominal surgery where delays have profound impact on outcomes. The aim here was to test if variations in outcomes (e.g. in-hospital mortality) exist by ethnic group following emergency abdominal surgery. STUDY DESIGN: Retrospective cohort study using population-level routinely collected administrative data from England (Hospital Episode Statistics). METHODS: Adult patients undergoing emergency abdominal operations between April 2008 and March 2012 were identified. Operations were divided into: 'major', 'hepatobiliary' or 'appendectomy/minor'. The primary outcome was all cause in-hospital mortality. Univariable and multivariable analysis odds ratios (OR with 95% confidence intervals, CI) adjusting for selected factors were performed. RESULTS: 359,917 patients were identified and 80.7% of patients were White British, 4.7% White (Other), 2.4% Afro-Caribbean, 1.6% Indian, 2.6% Chinese, 3.1% Asian (Other) and 4.9% not known, with crude in-hospital mortality rates of 4.4%, 3.1%, 2.0%, 2.6%, 1.6%, 1.7% and 5.17%, respectively. The majority of patients underwent appendectomy/minor (61.9%) compared to major (20.9%) or hepatobiliary (17.2%) operations (P < 0.001) with an in-hospital mortality of 1.7%, 11.5% and 3.9% respectively. Adjusted mortality was largely similar across ethnic groups except where ethnicity was not recorded (compared to White British patients following major surgery OR 2.05, 95% 1.82-2.31, P < 0.01, hepatobiliary surgery OR 2.78, 95% CI 2.31-3.36, P = 0.01 and appendectomy/minor surgery OR 1.78, 95% 1.52-2.08, P < 0.01). CONCLUSIONS: Ethnicity is not associated with poorer outcomes following emergency abdominal surgery. However, ethnicity is not recorded in 5% of this cohort and this represents an important, yet un-definable, group with significantly poorer outcomes.

Influence of day of surgery on mortality following elective colorectal resections.

BACKGROUND: The aim of this study was to investigate whether the increased mortality previously identified for surgery performed on Fridays was apparent following major elective colorectal resections and how this might be affected by case mix. METHODS: Patients undergoing elective colorectal resections in England from 2001 to 2011 were identified using Hospital Episode Statistics. Propensity scores were used to match patients having operations on a Friday in a 1 : 1 ratio with those undergoing surgery on other weekdays. Multivariable analyses were used to investigate overall deaths within 1 year of operation. RESULTS: A total of 204,669 records were extracted for patients undergoing major elective colorectal resections. Patients who had surgery on Fridays were more deprived (4780 (17.1 per cent) of 27,920 versus 28,317 (16.0 per cent) of 176,749; P < 0.001), a greater proportion had had an emergency admission in the 3 previous months (7870 (28.2 per cent) of 27,920 versus 48,623 (27.5 per cent) of 176,749; P = 0.019), underwent minimal access surgery (4565 (16.4 per cent) of 27,920 versus 23,783 (13.5 per cent) of 176,749; P < 0.001) and had surgery for benign diagnoses (6502 (23.3 per cent) of 27,920 versus 38,725 (21.9 per cent) of 176,749; P < 0.001) than those who had surgery on Mondays to Thursdays. In a matched analysis the odds ratio for 30-day mortality after colorectal resections performed on Fridays compared with other weekdays was 1.25 (95 per cent c.i. 1.13 to 1.37); odds ratios for 90-day and 1-year mortality were 1.16 (1.07 to 1.25) and 1.10 (1.04 to 1.16) respectively. CONCLUSION: Patients selected for colorectal resections on Fridays had a higher mortality rate than patients operated on from Monday to Thursday and had different characteristics, suggesting that increased mortality may reflect patient factors rather than hospital variables alone.

A detailed analysis of outcome reporting from randomised controlled trials and meta-analyses of inguinal hernia repair.

INTRODUCTION: Evidence is needed to justify whether investment in an internationally agreed core outcome set for inguinal hernia surgery is needed. This study aimed to assess outcome reporting from randomised controlled trials (RCTs) and meta-analyses in inguinal hernia surgery. METHODS: RCTs and meta-analyses comparing surgical technique or mesh type for primary inguinal hernia repair were systematically identified. Verbatim details, type, frequency and definition of clinician-observed and -assessed outcomes were summarised. Patient-reported outcome measures (PROMs) were analysed for instrument validity and frequency of domain reporting. RESULTS: 40 RCTs (10,810 patients) and 7 meta-analyses (17,280 patients) were identified. No single PROM was reported by all studies. There were 58 different clinician-observed outcomes, with recurrence (n = 47, 100%), wound infection (n = 33, 70.2%), haematoma (n = 31, 77.5%) and seroma formation (n = 22, 46.8%) being most frequently reported. All studies measured patients' views, although only 12 (30.0%) used validated instruments. The SF36 was the most commonly used multi-dimensional valid PROM (n = 7), and a visual analogue scale assessing pain (n = 32) was the most frequently used unidimensional scale. Non-validated questionnaires assessed 25 other aspects of patients' health. Two meta-analyses defined recurrence and three chronic pain although neither ensured that included RCTs adhered to the definitions. CONCLUSIONS: Outcome reporting from RCTs concerning inguinal hernia repair is inconsistent and poorly defined, limiting meta-analyses, which themselves do not control for the differing definitions of assessed outcomes. This study justifies investment in a standardised core outcome set for inguinal hernia surgery, to improve outcome reporting and evidence synthesis.

Reinforcement of closure of stoma site using a biological mesh.

Incisional hernia at the site of stoma closure is an under-reported problem, having been recently shown to occur in up to 30 % of patients. This technical note describes a technique for the placement of intraperitoneal biological mesh to prophylactically reinforce stoma closure sites. Seven consecutive patients underwent mesh placement as part of a pilot study. Following closure of the stoma through a trephine incision, 6 anchoring sutures were placed between the peritoneum/deep fascia and the edges of the mesh circumferentially. The mesh was delivered into the peritoneal cavity and parachuted up against the abdominal wall, and the sutures tied. If closure was performed through a midline laparotomy, the anchoring sutures were placed in a similar fashion through the midline incision. The fascia above the mesh and soft tissues was then closed. The mesh was successfully placed in all 7 patients. Follow-up at 30 days showed one superficial wound infection. An ultrasound scan of this patient revealed that the mesh was still in place and that the infection did not breach the fascia. No other early adverse events occurred. Prophylactic biological mesh reinforcement of stoma closure sites is technically feasible and safe in the short term. Longer-term results from a prospective randomised trial are needed, including clinical and radiological assessment for hernia rates, to establish what if any are the realisable benefits of this technique.