Systematic review of preoperative and intraoperative colorectal Anastomotic Leak Prediction Scores (ALPS).

OBJECTIVE: To systematically review preoperative and intraoperative Anastomotic Leak Prediction Scores (ALPS) and validation studies to evaluate performance and utility in surgical decision-making. Anastomotic leak (AL) is the most feared complication of colorectal surgery. Individualised leak risk could guide anastomosis and/or diverting stoma. METHODS: Systematic search of Ovid MEDLINE and Embase databases, 30 October 2020, identified existing ALPS and validation studies. All records including >1 risk factor, used to develop new, or to validate existing models for preoperative or intraoperative use to predict colorectal AL, were selected. Data extraction followed CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies guidelines. Models were assessed for applicability for surgical decision-making and risk of bias using Prediction model Risk Of Bias ASsessment Tool. RESULTS: 34 studies were identified containing 31 individual ALPS (12 colonic/colorectal, 19 rectal) and 6 papers with validation studies only. Development dataset patient populations were heterogeneous in terms of numbers, indication for surgery, urgency and stoma inclusion. Heterogeneity precluded meta-analysis. Definitions and timeframe for AL were available in only 22 and 11 ALPS, respectively. 26/31 studies used some form of multivariable logistic regression in their modelling. Models included 3-33 individual predictors. 27/31 studies reported model discrimination performance but just 18/31 reported calibration. 15/31 ALPS were reported with external validation, 9/31 with internal validation alone and 4 published without any validation. 27/31 ALPS and every validation study were scored high risk of bias in model analysis. CONCLUSIONS: Poor reporting practices and methodological shortcomings limit wider adoption of published ALPS. Several models appear to perform well in discriminating patients at highest AL risk but all raise concerns over risk of bias, and nearly all over wider applicability. Large-scale, precisely reported external validation studies are required. PROSPERO REGISTRATION NUMBER: CRD42020164804.

Implementation of a batched stepped wedge trial evaluating a quality improvement intervention for surgical teams to reduce anastomotic leak after right colectomy.

BACKGROUND: Large-scale quality improvement interventions demand robust trial designs with flexibility for delivery in different contexts, particularly during a pandemic. We describe innovative features of a batched stepped wedge trial, ESCP sAfe Anastomosis proGramme in CoLorectal SurgEry (EAGLE), intended to reduce anastomotic leak following right colectomy, and reflect on lessons learned about the implementation of quality improvement programmes on an international scale. METHODS: Surgical units were recruited and randomised in batches to receive a hospital-level education intervention designed to reduce anastomotic leak, either before, during, or following data collection. All consecutive patients undergoing right colectomy were included. Online learning, patient risk stratification and an in-theatre checklist constituted the intervention. The study was powered to detect an absolute risk reduction of anastomotic leak from 8.1 to 5.6%. Statistical efficiency was optimised using an incomplete stepped wedge trial design and study batches analysed separately then meta-analysed to calculate the intervention effect. An established collaborative group helped nurture strong working relationships between units/countries and a prospectively designed process evaluation will enable evaluation of both the intervention and its implementation. RESULTS: The batched trial design allowed sequential entry of clusters, targeted research training and proved to be robust to pandemic interruptions. Staggered start times in the incomplete stepped wedge design with long lead-in times can reduce motivation and engagement and require careful administration. CONCLUSION: EAGLE's robust but flexible study design allowed completion of the study across globally distributed geographical locations in spite of the pandemic. The primary outcome analysed in conjunction with the process evaluation will ensure a rich understanding of the intervention and the effects of the study design. TRIAL REGISTRATION: National Institute of Health Research Clinical Research Network portfolio IRAS ID: 272,250. Health Research Authority approval 18 October 2019. CLINICALTRIALS: gov, identifier NCT04270721, protocol ID RG_19196.

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks.

Altered anal slow-wave pressure activity in low anterior resection syndrome: short case series in two independent specialist centres provide new mechanistic insights.

AIM: Conventional parameters (anal resting and squeeze pressures) measured with anorectal manometry (ARM) fail to identify anal sphincter dysfunction in many patients with low anterior resection syndrome (LARS). We aimed to assess whether there are differences in anal canal slow-wave pressure activity in LARS patients and healthy individuals. METHOD: High-resolution ARM (HR-ARM) traces of 21 consecutive male LARS patients referred to the Royal London Hospital, UK (n = 12) and Aarhus University Hospital, Denmark (n = 9) were compared with HR-ARM data from 37 healthy men. RESULTS: Qualitatively (by visual inspection of HR-ARM recordings), the frequency of slow-wave pressure activity was strikingly different in 11/21 (52.4%) LARS patients from that observed in all the healthy individuals. Quantitative analysis showed that peaks of the mean spectrum in these 11 LARS patients occurred at approximately 6-7 cycles per minute (cpm), without activity at higher frequencies. An equivalent pattern was found in only 2/37 (5.4%) healthy individuals (P < 0.0001). Peaks of the mean spectrum in healthy individuals were concentrated at 16 cpm and 3-4 cpm. CONCLUSION: Over half of the male LARS patients studied had altered anal slow-wave pressure activity based on analysis of HR-ARM recordings. Further studies could investigate the relative contributions of sex, human baseline variance and neoadjuvant/surgical therapies on anal slow waves, and correlate the presence of abnormal activity with symptom severity.

Current margin practice and effect on re-excision rates following the publication of the SSO-ASTRO consensus and ABS consensus guidelines: a national prospective study of 2858 women undergoing breast-conserving therapy in the UK and Ireland.

INTRODUCTION: There is variation in margin policy for breast conserving therapy (BCT) in the UK and Ireland. In response to the Society of Surgical Oncology and American Society for Radiation Oncology (SSO-ASTRO) margin consensus ('no ink on tumour' for invasive and 2 mm for ductal carcinoma in situ [DCIS]) and the Association of Breast Surgery (ABS) consensus (1 mm for invasive and DCIS), we report on current margin practice and unit infrastructure in the UK and Ireland and describe how these factors impact on re-excision rates. METHODS: A trainee collaborative-led multicentre prospective study was conducted in the UK and Ireland between 1st February and 31st May 2016. Data were collected on consecutive BCT patients and on local infrastructure and policies. RESULTS: A total of 79 sites participated in the data collection (75% screening units; average 372 cancers annually, range 70-900). For DCIS, 53.2% of units accept 1 mm and 38% accept 2-mm margins. For invasive disease 77.2% accept 1 mm and 13.9% accept 'no ink on tumour'. A total of 2858 patients underwent BCT with a mean re-excision rate of 17.2% across units (range 0-41%). The re-excision rate would be reduced to 15% if all units applied SSO-ASTRO guidelines and to 14.8% if all units followed ABS guidelines. Of those who required re-operation, 65% had disease present at margin. CONCLUSION: There continues to be large variation in margin policy and re-excision rates across units. Altering margin policies to follow either SSO-ASTRO or ABS guidelines would result in a modest reduction in the national re-excision rate. Most re-excisions are for involved margins rather than close margins.