Intraoperative use of IndoCyaninE Green fluorescence imaging to prevent anastomotic leakage in colorectal surgery : systematic Review, Meta-Analysis and Study Protocol for the ICEberG Trial

Intraoperative use of IndoCyaninE Green fluorescence imaging to prevent anastomotic leakage in colorectal surgery: systematic review, meta-analysis and study protocol for the ICEberG trial Aim: ICG fluorescence imaging has been increasingly considered as a potential tool to assess anastomosis perfusion. This study aims to validate its efficacy in reducing anastomotic leakage (AL) rate in colorectal surgery. Method:A systematic review and a meta-analysis of studies comparing fluorescence imaging with standard care were conducted. Furthermore, a prospective randomised controlled trial (RCT) was proposed. Results: 1302 patients from 5 studies were included. Fluorescence imaging significantly reduced AL risk in cancer surgery (OR:0.34; CI:0.16-0.74; P=0.006). Low AL rates were shown in rectal surgery (ICG:1.1% vs non-ICG:6.1%; P=0.02). There was no significant AL rate decrease when procedures for benign and malignant indication were combined. To date, there are no published RCTs, though 3 ongoing trials were identified. Conclusions: Fluorescence imaging seems to reduce AL rate following colorectal surgery for cancer. However, large well-design RCTs are needed to provide evidence for its routine use. The proposed ICEberG trial would address this need.Objectiu: L'ús d'imatges per fluorescència amb verd d'indocianina s'està considerant cada cop més com una potencial eina per l'avaluació de la perfusió de l'anastomosi. L'objectiu d'aquest estudi és validar la seva eficàcia en la reducció de la taxa de fuita anastomòtica en la cirurgia colorectal. Mètodes: S'ha realitzat una revisió sistemàtica i un meta-anàlisi dels estudis que comparaven l'ús d'imatges per fluorescència amb la pràctica habitual. A més, s'ha proposat un assaig controlat aleatori (ACA) prospectiu. Resultats: 1302 pacients de 5 estudis van ser inclosos a l'anàlisi. L'ús d'imatges per fluorescència va reduir significativament el risc de fuita en cirurgia per càncer (OR:0.34; CI:0.16-0.74; P=0.006). Es va veure una baixa taxa de fuita anastomòtica en cirurgia de recte (ICG:1.1% vs no-ICG:6.1%; P=0.02). No es va trobar un descens significatiu en la taxa de fuita anastomòtica quan es van combinar procediments amb indicació benigna i maligna. Actualment no existeixen ACA publicats, tot i que s'han identificat 3 assaigs en curs. Conclusions: L'ús d'imatges per fluorescència sembla reduir la taxa de fuita anastomòtica després de cirurgia colorectal per càncer. No obstant, es necessiten grans ACA que proporcionin evidència en l'ús d'aquesta tècnica a la pràctica habitual. El proposat ACA ICEberG abordaria aquesta necessitat

Updated European guidelines for clinical management of familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), gastric adenocarcinoma, proximal polyposis of the stomach (GAPPS) and other rare adenomatous polyposis syndromes: a joint EHTG-ESCP revision

European guidelines; Familial adenomatous polyposis; Gastric adenocarcinomaDirectrices europeas; Poliposis adenomatosa familiar; Adenocarcinoma gástricoDirectrius europees; Poliposi adenomatosa familiar; Adenocarcinoma gàstricBackground: Hereditary adenomatous polyposis syndromes, including familial adenomatous polyposis and other rare adenomatous polyposis syndromes, increase the lifetime risk of colorectal and other cancers. Methods: A team of 38 experts convened to update the 2008 European recommendations for the clinical management of patients with adenomatous polyposis syndromes. Additionally, other rare monogenic adenomatous polyposis syndromes were reviewed and added. Eighty-nine clinically relevant questions were answered after a systematic review of the existing literature with grading of the evidence according to Grading of Recommendations, Assessment, Development, and Evaluation methodology. Two levels of consensus were identified: consensus threshold (≥67% of voting guideline committee members voting either 'Strongly agree' or 'Agree' during the Delphi rounds) and high threshold (consensus ≥ 80%). Results: One hundred and forty statements reached a high level of consensus concerning the management of hereditary adenomatous polyposis syndromes. Conclusion: These updated guidelines provide current, comprehensive, and evidence-based practical recommendations for the management of surveillance and treatment of familial adenomatous polyposis patients, encompassing additionally MUTYH-associated polyposis, gastric adenocarcinoma and proximal polyposis of the stomach and other recently identified polyposis syndromes based on pathogenic variants in other genes than APC or MUTYH. Due to the rarity of these diseases, patients should be managed at specialized centres.This research was supported financially by the British Journal of Medicine and by the ESCP (European Society of Coloproctology)

A Risk-Based Screening Approach to Patients Needing Surgery During the De-Escalation Phase of COVID-19 Pandemic

Since the outbreak of COVID-19 pandemic, many national and international surgical societies have produced guidelines regarding the management of surgical patients. During the mitigation phase of the pandemic, most documents suggested to consider postponing elective procedures, unless this might have impacted the life expectancy of patients. As awareness and knowledge about COVID-19 are gradually increasing, and as we enter a phase when surgical services are resuming their activities, surgical strategies have to adapt to this rapidly evolving scenario. This is particularly relevant when considering screening policies and the associated findings. We herein describe a risk-based approach to the management of patients with surgical diseases, which might be useful in order to limit the risks for healthcare workers and patients, while allowing for resuming elective surgical practice safely

Transparency in surgical randomised controlled trials: cross-sectional, observational study

Objective To explore transparency in surgical randomised controlled trials with respect to trial registration, disclosure of funding sources, conflicts of interest, and data sharing.Design Cross sectional review of published randomised controlled trials.Setting Surgical randomised controlled trials involving human participants undergoing any kind of invasive surgery Data sources Ten high impact journals were systematically searched for randomised controlled trials, published in the years 2009, 2012, 2015, and 2018. Data was extracted following manual inspection of manuscripts. Main outcome measure Four domains of transparency were explored. These included trial registration on a public-accessible database, presence of a funding statement, presence of a conflict of interest statement, and presence of a statement relating to data sharing.Results Of 611 published trials, 475 were eligible for analysis. Three-hundred and ninety-seven (83.6%) were registered, of which 190 (47.9%) were done prospectively. Compliance to prospective registration increased over time (26.0% in 2009, 33.0% in 2012, 53.5% in 2015, and 72.7% in 2018). Funding statements were provided in 55%, 65%, 69.4%, and 75.4% of manuscripts, respectively. Conflicts of interest statements were provided in 49.5%, 89.1%, 94.6%, and 98.3% of manuscript, respectively. Data sharing statements were present in only 15 (3.2%) RCTs. Eleven of these were in studies published most recently in 2018. Conclusion Trial registration, presence of funding statements, and disclosure of personal conflicts in surgical RCTs have improved rapidly over the last 10 years. In contrast, disclosure of data sharing plans is exceptionally low. This may contribute to research waste and represents an essential target for improvement. Strengths and limitations of this studyStrengths:• Surgical RCTs published between 2008-2018 were considered in this study, which permitted an assessment of transparency over time. Limitations:• Included RCTs were from a sample of high impact surgical and general medical journals, which restricts the generalisability of findings across a broader population• The study considered author-reported statements of funding, conflicts, and data sharing, which may introduce bias or inaccuracies due to self-reporting.<br/

COVID-19-related absence among surgeons: development of an international surgical workforce prediction model

Background: During the initial COVID-19 outbreak up to 28.4 million elective operations were cancelled worldwide, in part owing to concerns that it would be unsustainable to maintain elective surgery capacity because of COVID-19-related surgeon absence. Although many hospitals are now recovering, surgical teams need strategies to prepare for future outbreaks. This study aimed to develop a framework to predict elective surgery capacity during future COVID-19 outbreaks. Methods: An international cross-sectional study determined real-world COVID-19-related absence rates among surgeons. COVID-19-related absences included sickness, self-isolation, shielding, and caring for family. To estimate elective surgical capacity during future outbreaks, an expert elicitation study was undertaken with senior surgeons to determine the minimum surgical staff required to provide surgical services while maintaining a range of elective surgery volumes (0, 25, 50 or 75 per cent). Results: Based on data from 364 hospitals across 65 countries, the COVID-19-related absence rate during the initial 6 weeks of the outbreak ranged from 20.5 to 24.7 per cent (mean average fortnightly). In weeks 7-12, this decreased to 9.2-13.8 per cent. At all times during the COVID-19 outbreak there was predicted to be sufficient surgical staff available to maintain at least 75 per cent of regular elective surgical volume. Overall, there was predicted capacity for surgeon redeployment to support the wider hospital response to COVID-19. Conclusion: This framework will inform elective surgical service planning during future COVID-19 outbreaks. In most settings, surgeon absence is unlikely to be the factor limiting elective surgery capacit

Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study

Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p < 0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p < 0·001). Interpretation: Countries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication

Timing of surgery following SARS-CoV-2 infection:an international prospective cohort study

Peri-operative SARS-CoV-2 infection increases postoperative mortality. The aim of this study was to determine the optimal duration of planned delay before surgery in patients who have had SARS-CoV-2 infection. This international, multicentre, prospective cohort study included patients undergoing elective or emergency surgery during October 2020. Surgical patients with pre-operative SARS-CoV-2 infection were compared with those without previous SARS-CoV-2 infection. The primary outcome measure was 30-day postoperative mortality. Logistic regression models were used to calculate adjusted 30-day mortality rates stratified by time from diagnosis of SARS-CoV-2 infection to surgery. From 140,231 patients (116 countries), 3127 patients (2.2%) had a pre-operative SARS-CoV-2 diagnosis. Adjusted 30-day mortality in patients without SARS-CoV-2 infection was 1.5% (95%CI 1.4-1.5). In patients with a pre-operative SARS-CoV-2 diagnosis, mortality was increased in patients having surgery within 0-2 weeks, 3-4 weeks and 5-6 weeks of the diagnosis (odd ratio (95%CI) 4.1 (3.3-4.8), 3.9 (2.6-5.1) and 3.6 (2.0-5.2), respectively). Surgery performed ≥ 7 weeks after SARS-CoV-2 diagnosis was associated with a similar mortality risk to baseline (odd ratio (95%CI) 1.5 (0.9-2.1)). After a ≥ 7 week delay in undertaking surgery following SARS-CoV-2 infection, patients with ongoing symptoms had a higher mortality than patients whose symptoms had resolved or who had been asymptomatic (6.0% (95%CI 3.2-8.7) vs. 2.4% (95%CI 1.4-3.4) vs. 1.3% (95%CI 0.6-2.0), respectively). Where possible, surgery should be delayed for at least 7 weeks following SARS-CoV-2 infection. Patients with ongoing symptoms ≥ 7 weeks from diagnosis may benefit from further delay.</p

Updated European guidelines for clinical management of familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), gastric adenocarcinoma, proximal polyposis of the stomach (GAPPS) and other rare adenomatous polyposis syndromes : a joint EHTG-ESCP revision

BACKGROUND: Hereditary adenomatous polyposis syndromes, including familial adenomatous polyposis and other rare adenomatous polyposis syndromes, increase the lifetime risk of colorectal and other cancers. METHODS: A team of 38 experts convened to update the 2008 European recommendations for the clinical management of patients with adenomatous polyposis syndromes. Additionally, other rare monogenic adenomatous polyposis syndromes were reviewed and added. Eighty-nine clinically relevant questions were answered after a systematic review of the existing literature with grading of the evidence according to Grading of Recommendations, Assessment, Development, and Evaluation methodology. Two levels of consensus were identified: consensus threshold (≥67% of voting guideline committee members voting either 'Strongly agree' or 'Agree' during the Delphi rounds) and high threshold (consensus ≥ 80%). RESULTS: One hundred and forty statements reached a high level of consensus concerning the management of hereditary adenomatous polyposis syndromes. CONCLUSION: These updated guidelines provide current, comprehensive, and evidence-based practical recommendations for the management of surveillance and treatment of familial adenomatous polyposis patients, encompassing additionally MUTYH-associated polyposis, gastric adenocarcinoma and proximal polyposis of the stomach and other recently identified polyposis syndromes based on pathogenic variants in other genes than APC or MUTYH. Due to the rarity of these diseases, patients should be managed at specialized centres.Peer reviewe

Elective surgery cancellations due to the COVID-19 pandemic: global predictive modelling to inform surgical recovery plans.

BACKGROUND: The COVID-19 pandemic has disrupted routine hospital services globally. This study estimated the total number of adult elective operations that would be cancelled worldwide during the 12 weeks of peak disruption due to COVID-19. METHODS: A global expert response study was conducted to elicit projections for the proportion of elective surgery that would be cancelled or postponed during the 12 weeks of peak disruption. A Bayesian β-regression model was used to estimate 12-week cancellation rates for 190 countries. Elective surgical case-mix data, stratified by specialty and indication (surgery for cancer versus benign disease), were determined. This case mix was applied to country-level surgical volumes. The 12-week cancellation rates were then applied to these figures to calculate the total number of cancelled operations. RESULTS: The best estimate was that 28 404 603 operations would be cancelled or postponed during the peak 12 weeks of disruption due to COVID-19 (2 367 050 operations per week). Most would be operations for benign disease (90·2 per cent, 25 638 922 of 28 404 603). The overall 12-week cancellation rate would be 72·3 per cent. Globally, 81·7 per cent of operations for benign conditions (25 638 922 of 31 378 062), 37·7 per cent of cancer operations (2 324 070 of 6 162 311) and 25·4 per cent of elective caesarean sections (441 611 of 1 735 483) would be cancelled or postponed. If countries increased their normal surgical volume by 20 per cent after the pandemic, it would take a median of 45 weeks to clear the backlog of operations resulting from COVID-19 disruption. CONCLUSION: A very large number of operations will be cancelled or postponed owing to disruption caused by COVID-19. Governments should mitigate against this major burden on patients by developing recovery plans and implementing strategies to restore surgical activity safely

Global wealth disparities drive adherence to COVID-safe pathways in head and neck cancer surgery

Peer reviewe