34 research outputs found
Outcomes from elective colorectal cancer surgery during the SARS-CoV-2 pandemic
This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic
Outcomes from elective colorectal cancer surgery during the SARS‐CoV‐2 pandemic
Aim This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic.Method This was an international cohort study of patients undergoing elective resection of colon or rectal cancer without preoperative suspicion of SARS-CoV-2. Centres entered data from their first recorded case of COVID-19 until 19 April 2020. The primary outcome was 30-day mortality. Secondary outcomes included anastomotic leak, postoperative SARS-CoV-2 and a comparison with prepandemic European Society of Coloproctology cohort data.Results From 2073 patients in 40 countries, 1.3% (27/2073) had a defunctioning stoma and 3.0% (63/2073) had an end stoma instead of an anastomosis only. Thirty-day mortality was 1.8% (38/2073), the incidence of postoperative SARS-CoV-2 was 3.8% (78/2073) and the anastomotic leak rate was 4.9% (86/1738). Mortality was lowest in patients without a leak or SARS-CoV-2 (14/1601, 0.9%) and highest in patients with both a leak and SARS-CoV-2 (5/13, 38.5%). Mortality was independently associated with anastomotic leak (adjusted odds ratio 6.01, 95% confidence interval 2.58-14.06), postoperative SARS-CoV-2 (16.90, 7.86-36.38), male sex (2.46, 1.01-5.93), age >70 years (2.87, 1.32-6.20) and advanced cancer stage (3.43, 1.16-10.21). Compared with prepandemic data, there were fewer anastomotic leaks (4.9% versus 7.7%) and an overall shorter length of stay (6 versus 7 days) but higher mortality (1.7% versus 1.1%).Conclusion Surgeons need to further mitigate against both SARS-CoV-2 and anastomotic leak when offering surgery during current and future COVID-19 waves based on patient, operative and organizational risks
Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries
Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)
Outcomes from elective colorectal cancer surgery during the SARS-CoV-2 pandemic
AbstractAim: This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic.Methods: This was an international cohort study of patients undergoing elective resection of colon or rectal cancer without preoperative suspicion of SARS-CoV-2. Centres entered data from their first recorded case of COVID-19 until 19 April 2020. The primary outcome was 30-day mortality. Secondary outcomes included anastomotic leak, postoperative SARS-CoV-2 and a comparison with prepandemic European Society of Coloproctology cohort data.Results: From 2073 patients in 40 countries, 1.3% (27/2073) had a defunctioning stoma and 3.0% (63/2073) had an end stoma instead of an anastomosis only. Thirty-day mortality was 1.8% (38/2073), the incidence of postoperative SARS-CoV-2 was 3.8% (78/2073) and the anastomotic leak rate was 4.9% (86/1738). Mortality was lowest in patients without a leak or SARS-CoV-2 (14/1601, 0.9%) and highest in patients with both a leak and SARS-CoV-2 (5/13, 38.5%). Mortality was independently associated with anastomotic leak (adjusted odds ratio 6.01, 95% confidence interval 2.58–14.06), postoperative SARS-CoV-2 (16.90, 7.86–36.38), male sex (2.46, 1.01–5.93), age >70 years (2.87, 1.32–6.20) and advanced cancer stage (3.43, 1.16–10.21). Compared with prepandemic data, there were fewer anastomotic leaks (4.9% versus 7.7%) and an overall shorter length of stay (6 versus 7 days) but higher mortality (1.7% versus 1.1%).Conclusion: Surgeons need to further mitigate against both SARS-CoV-2 and anastomotic leak when offering surgery during current and future COVID-19 waves based on patient, operative and organizational risks.Appendix1 Writing group (*denotes joint first authors)Elizabeth Li*, James C. Glasbey*, Dmitri Nepogodiev*, Joana F. F. Simoes*, Omar M. Omar, Mary L. Venn, Jonathan P. Evans, Kaori Futaba, Charles H. Knowles, Ana Minaya-Bravo, Helen Mohan, Manish Chand, Peter Pockney, Salomone Di Saverio, Neil Smart, Abigail Vallance, Dale Vimalachandran, Richard J. W. Wilkin, Aneel Bhangu (Overall guarantor).2 Statistical analysisOmar M. Omar (Lead statistician), Elizabeth Li, James C. Glasbey, Aneel Bhangu.3 CovidSurg Operations CommitteeKwabena Siaw-Acheampong, Ruth A. Benson, Edward Bywater, Daoud Chaudhry, Brett E. Dawson, Jonathan P. Evans, James C. Glasbey, Rohan R. Gujjuri, Emily Heritage, Conor S. Jones, Sivesh K. Kamarajah, Chetan Khatri, Rachel A. Khaw, James M. Keatley, Andrew Knight, Samuel Lawday, Elizabeth Li, Harvinder S. Mann, Ella J. Marson, Kenneth A. McLean, Siobhan C. Mckay, Emily C. Mills, Dmitri Nepogodiev, Gianluca Pellino, Maria Picciochi, Elliott H. Taylor, Abhinav Tiwari, Joana F. F. Simoes, Isobel M. Trout, Mary L. Venn, Richard J. W. Wilkin, Aneel Bhangu.4 International Cancer Leads (*denotes specialty principal Investigator)James C. Glasbey (Chair); Colorectal: Neil J. Smart*, Ana Minaya-Bravo*, Jonathan P. Evans, Gaetano Gallo, Susan Moug, Francesco Pata, Peter Pockney, Salomone Di Saverio, Abigail Vallance, Dale Vimalchandran.5 Dissemination CommitteeJoana F. F. Simoes (Chair); Tom E. F. Abbott, Sadi Abukhalaf, Michel Adamina, Adesoji O. Ademuyiwa, Arnav Agarwal, Murat Akkulak, Ehab Alameer, Derek Alderson, Felix Alakaloko, Markus Albertsmeiers, Osaid Alser, Muhammad Alshaar, Sattar Alshryda, Alexis P. Arnaud, Knut Magne Augestad, Faris Ayasra, José Azevedo, Brittany K. Bankhead-Kendall, Emma Barlow, David Beard, Ruth A. Benson, Ruth Blanco-Colino, Amanpreet Brar, Ana Minaya-Bravo, Kerry A. Breen, Chris Bretherton, Igor Lima Buarque, Joshua Burke, Edward J. Caruana, Mohammad Chaar, Sohini Chakrabortee, Peter Christensen, Daniel Cox, Moises Cukier, Miguel F. Cunha, Giana H. Davidson, Anant Desai, Salomone Di Saverio, Thomas M. Drake, John G. Edwards, Muhammed Elhadi, Sameh Emile, Shebani Farik, Marco Fiore, J. Edward Fitzgerald, Samuel Ford, Tatiana Garmanova, Gaetano Gallo, Dhruv Ghosh, Gustavo Mendonça Ataíde Gomes, Gustavo Grecinos, Ewen A. Griffiths, Madalegna Gründl, Constantine Halkias, Ewen M. Harrison, Intisar Hisham, Peter J. Hutchinson, Shelley Hwang, Arda Isik, Michael D. Jenkinson, Pascal Jonker, Haytham M. A. Kaafarani, Debby Keller, Angelos Kolias, Schelto Kruijff, Ismail Lawani, Hans Lederhuber, Sezai Leventoglu, Andrey Litvin, Andrew Loehrer, Markus W. Löffler, Maria Aguilera Lorena, Maria Marta Madolo, Piotr Major, Janet Martin, Hassan N. Mashbari, Dennis Mazingi, Symeon Metallidis, Ana Minaya-Bravo, Helen M. Mohan, Rachel Moore, David Moszkowicz, Susan Moug, Joshua S. Ng-Kamstra, Mayaba Maimbo, Ionut Negoi, Milagros Niquen, Faustin Ntirenganya, Maricarmen Olivos, Kacimi Oussama, Oumaima Outani, Marie Dione Parreno-Sacdalanm, Francesco Pata, Carlos Jose Perez Rivera, Thomas D. Pinkney, Willemijn van der Plas, Peter Pockney, Ahmad Qureshi, Dejan Radenkovic, Antonio Ramos-De la Medina, Keith Roberts, April C. Roslani, Martin Rutegård, Irène Santos, Sohei Satoi, Raza Sayyed, Andrew Schache, Andreas A Schnitzbauer, Justina O. Seyi-Olajide, Neil Sharma, Richard Shaw, Sebastian Shu, Kjetil Soreide, Antonino Spinelli, Grant D Stewart, Malin Sund, Sudha Sundar, Stephen Tabiri, Philip Townend, Georgios Tsoulfas, Gabrielle H. van Ramshorst, Raghavan Vidya, Dale Vimalachandran, Oliver J. Warren, Duane Wedderburn, Naomi Wright, EuroSurg, European Society of Coloproctology (ESCP), Global Initiative for Children’s Surgery (GICS), GlobalSurg, GlobalPaedSurg, ItSURG, PTSurg, SpainSurg, Italian Society of Colorectal Surgery (SICCR), Association of Surgeons in Training (ASiT), Irish Surgical Research Collaborative (ISRC), Transatlantic Australasian Retroperitoneal Sarcoma Working Group (TARPSWG), Italian Society of Surgical Oncology (SICO).6 Collaboratoring authors (*denotes site principal investigators)Argentina: Alurralde C., Caram E. L., Eskinazi D* (Sanatorio 9 De Julio Sa); Badra R., García J.S., Lucchini S.M.* (Sanatorio Allende).Australia: Cecire J., Salindera S.*, Sutherland A. (Coffs Harbour Health Campus); Ahn J.H., Chen S., Gauri N., Jang S., Jia F., Mulligan C., Yang W., Ye G., Zhang H. (Concord Repatriation General Hospital); Moss J.*, Richards T., Thian A., Vo U. G. (Fiona Stanley Hospital); Bagraith K., Chan E., Ho D., Jeyarajan E., Jordan S., Nolan G. J., Von Papen M., Wullschleger M. (Gold Coast University Hospital); Egoroff N., Gani J., Lott N., Pockney P.* (John Hunter Hospital); Phan D., Townend D.* (Lismore Base Hospital); Bong C., Gundara J.* (Logan Hospital); Bowman S.*, Guerra G. R. (Queen Elizabeth II Jubilee Hospital); Dudi-Venkata N. N., Kroon H. M.*, Sammour T. (Royal Adelaide Hospital); Mitchell D.*, Swinson B. (Royal Brisbane and Women’s Hospital).Austria: Messner F., Öfner D.* (Medical University of Innsbruck); Emmanuel K., Grechenig M., Gruber R., Harald M., Öhlberger L., Presl J.*, Wimmer A. (Paracelsus Medical University Salzburg).Barbados: Barker D., Boyce R., Doyle A., Eastmond A., Gill R., O’Shea M., Padmore G.*, Paquette N., Phillips E., St John S., Walkes K. (Queen Elizabeth Hospital).Belgium: Flamey N., Pattyn P.* (Az Delta); Oosterlinck W.*, Van den Eynde J., Van den Eynde R. (Uz Leuven).Bulgaria: Sokolov M.* (University Hospital Alexandrovska).Canada: Boutros M.*, Caminsky N. G., Ghitulescu G. (Jewish General Hospital); Boutros M.*, Demyttenaere S.*, Garfinkle R. (St Mary’s Hospital); Nessim C.*, Stevenson J. (The Ottawa Hospital).Croatia: Bačić G., Karlović D., Kršul D., Zelić M.* (University Hospital Center Rijeka); Bakmaz B., Ćoza I., Dijan E., Katusic Z., Mihanovic J.*, Rakvin I. (Zadar General Hospital).Cyprus: Frantzeskou K., Gouvas N.*, Kokkinos G., Papatheodorou P., Pozotou I., Stavrinidou O., Yiallourou A.* (Nicosia General Hospital).Czechia: Martinek L., Skrovina M.*, Szubota I. (Hospital and Oncological Centre Novy Jicin).Denmark: Ebbehøj A. L., Krarup P., Schlesinger N., Smith H.* (Bispebjerg Hospital).Egypt: Al Sayed M., Ashoush F.*, Elazzazy E., Essam E., Eweda M., Hassan E., Metwalli M., Mourad M., Qatora M. S., Sabry A.*, Samih A., Samir Abdelaal A., Shehata S.*, Shenit K. (Alexandria Main University Hospital); Attia D., Kamal N., Osman N.* (Alexandria Medical Research Institute); Alaa S., Hamza H. M., M. elghazaly S., Mohammed M. M.*, Nageh M. A., Saad M. M.*, Yousof E. A. (Assiut University Hospital); Eldaly A. S.* (El-Menshawy Hospital); Amira G., Sallam I.*, Sherief M., Sherif A. (Misr Cancer Center); Ghaly G.*, Hamdy R., Morsi A., Salem H.*, Sherif G. (National Cancer Institute); Abdeldayem H., Abdelkader Salama I.*, Balabel M., Fayed Y., Sherif A. E.* (National Liver Institute, Menoufia University).Finland: Kauppila J. H.*, Sarjanoja E. (Länsi-Pohja Central Hospital); Helminen O., Huhta H., Kauppila J. H.* (Oulu University Hospital).France: Beyrne C., Jouffret L.*, Marie-Macron L. (Centre Hospitalier Avignon); Lakkis Z.*, Manfredelli S. (CHU Besançon); Chebaro A.*, El Amrani M., Lecolle K., Piessen G.*, Pruvot F. R., Zerbib P. (CHU Lille); Ballouhey Q.*, Barrat B., Taibi A. (Chu Limoges); Bergeat D., Merdrignac A. (CHU Rennes – General Surgery); Le Roy B., Perotto L. O., Scalabre A.* (Chu Saint Etienne); Aimé A., Ezanno A.*, Malgras B. (Hia Begin); Bouche P. A.*, Tzedakis S.* (Hôpital Cochin – APHP); Cotte E., Glehen O., Kepenekian V., Passot G. (Hopital Lyon Sud); D’Urso A., Mutter D., Seeliger B.* (Strasbourg University Hospitals/IHU-Strasbourg); Bonnet S., Denet C., Fuks D., Laforest A., Pourcher G., Seguin-Givelet A.*, Tribillon E. (Institut Mutualiste Montsouris); Duchalais E.* (Nantes University Hospital).Germany: Bork U.*, Fritzmann J., Praetorius C., Weitz J., Welsch T. (Carl-Gustav-Carus University Hospital, TU Dresden); Beyer K., Kamphues C.*, Lauscher J. C., Loch F. N., Schineis C. (Charité University Medicine, Campus Benjamin Franklin); Becker R.*, Jonescheit J. (Heilig-Geist Hospital Bensheim); Pergolini I., Reim D.* (Klinikum Rechts der Isar TUM School of Medicine); Boeker C., Hakami I.*, Mall J.* (KRH Nordstadt-Siloah Hospitals); Albertsmeier M.*, Kappenberger A., Schiergens T., Werner J. (LMU Klinikum Campus Innenstadt); Nowak K.*, Reinhard T.* (Romed Klinikum Rosenheim); Kleeff J., Michalski C., Ronellenfitsch U.* (University Hospital Halle (Saale)); Bertolani E., Königsrainer A.*, Löffler M. W., Quante M.*, Steidle C., Überrück L., Yurttas C. (University Hospital Tuebingen); Izbicki J., Nitschke C., Perez D., Uzunoglu F. G.* (University Medical Center Hamburg–Eppendorf).Greece: Antonakis P., Contis I., Dellaportas D., Gklavas A., Konstadoulakis M., Memos N.*, Papaconstantinou I.*, Polydorou A., Theodosopoulos T., Vezakis A. (Aretaieion Hospital); Antonopoulou M. I., Manatakis D. K.*, Tasis N. (Athens Naval and Veterans Hospital); Arkadopoulos N., Danias N., Economopoulou P., Frountzas M., Kokoropoulos P., Larentzakis A., Michalopoulos N.*, Parasyris S., Selmani J., Sidiropoulos T., Vassiliu P. (Attikon University General Hospital); Bouchagier K.*, Klimopoulos S., Paspaliari D., Stylianidis G. (Evaggelismos General Hospital); Baxevanidou K., Bouliaris K., Chatzikomnitsa P., Efthimiou M., Giaglaras A., Kalfountzos C.*, Koukoulis G., Ntziovara A. M., Petropoulos K., Soulikia K., Tsiamalou I., Zervas K., Zourntou S. (General Hospital of Larissa ‘Koutlimpaneio and Triantafylleio’); Baloyiannis I., Diamantis A., Perivoliotis K., Tzovaras G.* (General University Hospital of Larissa); Christidis P., Ioannidis O.*, Loutzidou L. (George Papanikolaou General Hospital of Thessaloniki); Karaitianos I.*, Tsirlis T. (Henry Dunant Hospital Center); Charalabopoulos A., Liakakos T., Baili E., Schizas D.*, Spartalis E., Syllaios A., Zografos C. (Laiko University Hospital); Athanasakis E., Chrysos E., Tsiaoussis I., Xenaki S.*, Xynos E.* (University Hospital of Heraklion Crete and Interclinic Hospital of Crete).Hong Kong: Futaba K.*, Ho M. F., Hon S. F., Mak T. W. C., Ng S. S. M. (Prince of Wales Hospital); Foo C. C.* (Queen Mary Hospital).Hungary: Banky B.*, Suszták N. (Szent Borbála Kórház).India: Bhat G. A., Chowdri N. A., Mehraj A.*, Parray F., Shah Z. A., Wani R. (Sher-I-Kashmir Institute of Medical Sciences); Ahmed Z., Bali R., Bhat M. A., Laharwal A., Mahmood M., Mir I., Mohammad Z., Muzamil J., Rashid A.* (SMHS Hospital, Government Medical College).Ireland: Aremu M.*, Canas-Martinez A., Cullivan O., Murphy C., Owens P., Pickett L. (Connolly Hospital Blanchardstown); Corrigan M.*, Daly A., Fleming C.*, Jordan P., Killeen S., Lynch N., O’Brien S., Syed W. A. S., Vernon L. (Cork University Hospital); Fahey B. A., Larkin J. O.*, McCormick P., Mehigan B. J., Mohan H., Shokuhi P., Smith. J (St James’s Hospital); Bashir Y., Bass G. A., Connelly T. M., Creavin B., Earley H., Elliott J. A.*, Gillis A. E., Kavanagh D. O., Neary P. C., O’Riordan J. M., Reynolds I. S., Rice D., Ridgway P. F., Umair M., Whelan M. (Tallaght University Hospital); Corless K., Finnegan L., Fowler A., Hogan A., Lowery A.*, McKevitt K.*, Ryan É. (University Hospital Galway); Coffey J. C., Cunningham R. M., Devine M., Nally D.*, Peirce C. (University Hospital Limerick); Hardy N. P., Neary P. M., O’Malley S.*, Ryan M. (University Hospital Waterford/University College Cork).Italy: Macina S.* (ASST Mantua); Mariani N. M.*, Opocher E., Pisani Ceretti A. (ASST Santi Paolo E. Carlo); Bianco F.* (ASST Papa Giovanni XXIII – Bergamo); Marino M. V.*, Mirabella A., Vaccarella G. (Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello); Agostini C., Alemanno G., Bartolini I., Bergamini C., Bruscino A., De Vincenti R., Di Bella A., Fortuna L., Maltinti G., Muiesan P.*, Prosperi P.*, Ringressi M. N., Risaliti M., Taddei A.*, Tucci R. (Azienda Ospedaliera Universitaria Careggi); Campagnaro T.*, Guglielmi A., Pedrazzani C., Rattizzato S., Ruzzenente A., Turri G. (Azienda Ospedaliera Universitaria Integrata di Verona); Bellora P., D’Aloisio G., Ferrari M., Francone E., Gentilli S.*, Nikaj H. (Azienda Ospedaliero Universitaria Maggiore della Carità); Bianchini M., Chiarugi M., Coccolini F., Di Franco G., Furbetta N., Gianardi D., Guadagni S., Morelli L.*, Palmeri M., Tartaglia D.* (Azienda Ospedaliero Universitaria Pisana); Anania G.*, Carcoforo P.*, Chiozza M., De Troia A., Koleva Radica M., Portinari M., Sibilla M. G., Urbani A. (Azienda Ospedaliero Universitaria San’anna); Fabbri N., Feo C. V.*, Gennari S., Parini S., Righini E. (Azienda Unità Sanitaria Locale di Ferrara, Università di Ferrara); Annessi V., Castro Ruiz C., Montella M. T., Zizzo M.* (Azienda Unità Sanitaria Locale – IRCCS di Reggio Emilia); Grossi U., Novello S., Romano M., Rossi S., Zanus G.* (Ca’ Foncello Treviso – DISCOG – Università di Padova); Esposito G., Frongia F., Pisanu A., Podda M.* (Cagliari University Hospital); Belluco C., Lauretta A.*, Montori G., Moras L., Olivieri M.; Feo C. F., Perra T.*, Porcu A.*, Scanu A. M. (Cliniche San Pietro, Aou Sassari); Aversano A., Carbone F., Delrio P.*, Di Lauro K., Fares Bucci A., Rega D.*, Spiezio G. (Colorectal Surgical Oncology Unit – Istituto Nazionale Tumori Fondazione, Pascale IRCCS); Calabrò M.*, Farnesi F., Lunghi E. G., Muratore A.*, Pipitone Federico N. S. (Edoardo Agnelli); De Palma G. D., Luglio G.*, Pagano G., Tropeano F. P. (Federico II University Hospital); Baldari L.*, Boni L.*, Cassinotti E.* (Fondazione IRCCS Ca’ Granda – Ospedale Maggiore Policlinico di Milano); Cosimelli M., Fiore M.*, Guaglio M.*, Sorrentino L. (Fondazione IRCCS Istituto Nazionale dei Tumori, Milano); Agnes A., Alfieri S., Belia F., Biondi A., Cozza V., D’Ugo D., De Simone V., Litta F., Lorenzon L., Marra A. A., Marzi F., Parello A., Persiani R., Ratto C., Rosa F., Scrima O., Sganga G. (Fondazione Policlinico Universitario Agostino Gemelli IRCCS); Belli A.*, Izzo F., Patrone R. (HPB Surgical Oncology Unit – Istituto Nazionale Tumori Fondazione, Pascale IRCCS); Carrano F. M., Carvello M. M., Di Candido F., Maroli A., Spinelli A.* (Humanitas Clinical and Research Center IRCCS, Rozzano (Mi) and Humanitas University, Department of Biomedical Sciences, Pieve Emanuele (Mi)); Aprile A., Batistotti P., Massobrio A., Pertile D., Scabini S.*, Soriero D. (IRCCS Ospedale Policlinico San Martino); De Manzoni Garberini A.* (Ospedale Civile Spirito Santo); Federico P., Maida P., Marra E., Marte G., Petrillo A., Tammaro P., Tufo A.* (Ospedale del Mare); Berselli M.*, Borroni G.*, Cocozza E., Conti L., Desio M., Rizzi A. (ASST Sette Laghi-Varese); Baldi C.*, Corbellini C., Sampietro G. M. (Ospedale di Rho – ASST Rhodense); Baldini E.*, Capelli P., Conti L., Isolani S. M., Ribolla M. (Ospedale Guglielmo da Saliceto Piacenza); Bondurri A., Colombo F.*, Ferrario L., Guerci C., Maffioli A. (Ospedale Luigi Sacco Milano); Armao T., Ballabio M.*, Bisagni P., Gagliano A., Longhi M., Madonini M., Pizzini P. (Ospedale Maggiore di Lodi); Mochet S.*, Usai A. (Ospedale Regionale Umberto Parini); Bianco F.*, Incollingo P. (Ospedale S. Leonardo – Asl Napoli 3 Sud, Castellammare di Stabia); Mancini S., Marino Cosentino L.*, Sagnotta A.* (Ospedale San Filippo Neri); Nespoli L. C., Tamini N.* (Ospedale San Gerardo); Anastasi A., Bartalucci B., Bellacci A., Canonico G.*, Capezzuoli L., Di Martino C., Ipponi P., Linari C., Montelatici M., Nelli T., Spagni G., Tirloni L., Vitali A. (Ospedale San Giovanni di Dio); Abate E., Casati M.*, Casiraghi T., Laface L., Schiavo M. (Ospedale Vittorio Emanuele III – Carate Brianza); Arminio A., Cotoia A., Lizzi V.*, Vovola F. (Ospedali Riuniti Azienda Ospedaliera Universitaria Foggia); Vergari R.* (Ospedali Riuniti di Ancona); D’Ugo S.*, Depalma N., Spampinato M. G. (Vito Fazzi, Leece); Brachini G., Chiappini A., Cicerchia P. M., Cirillo B., De Toma G., Fiori E., Fonsi G. B., Iannone I., La Torre F., Lapolla P.*, Meneghini S., Mingoli A., Sapienza P., Zambon M. (Policlinico Umberto I Sapienza University of Rome); Capolupo G. T.*, Mazzotta E. (Policlinico Universitario Campus Bio Medico of Rome); Gattolin A., Migliore M., Rimonda R., Sasia D.*, Travaglio E. (Regina Montis Regalis Hospital, Mondovì); Cervellera M., Gori A., Sartarelli L., Tonini V.* (S. Orsola-Malpighi Hospital); Chessa A.*, Fiorini A., Norcini C. (San Giovanni di Dio); Colletti G., Confalonieri M., Costanzi A.*, Frattaruolo C., Mari G., Monteleone M. (San Leopoldo Mandic); De Nardi P.*, Parise P., Vignali A. (San Raffaele Scientific Institute, Milan); Belvedere A., Bernante P., Jovine E., Neri J., Parlanti D., Pezzuto A. P., Poggioli G., Rottoli M.*, Tanzanu M., Violante T. (IRCCS Azienda Ospedaliero – Universitaria di Bologna; Alma Mater Studiorum University of Bologna); Borghi F., Cianflocca D., Di Maria Grimaldi S., Donati D., Gelarda E., Giraudo G., Giuffrida M. C., Marano A.*, Palagi S., Pellegrino L., Peluso C., Testa V.* (Santa Croce E. Carle Hospital, Cuneo); Agresta F.*, Prando D.*, Zese M.* (Santa Maria degli Angeli Hospital ULSS 5 – Adria); Armatura G.*, Frena A., Scotton G.* (St Moritz Hospital); Gallo G.*, Sammarco G., Vescio G. (University ‘Magna Graecia’ of Catanzaro); Di Marzo F.* (Valtiberina); Fontana T.* (‘Vittorio Emanuele’ – Gela).Japan: Kanemitsu Y.*, Moritani K. (National Cancer Center Hospital).Jordan: Al Abdallah M.*, Ayasra F., Ayasra Y., Qasem A. (Al-Basheer Hospital); Fahmawee T., Hmedat A., Obeidat K.* (King Abdullah University Hospital); Abou Chaar M. K., Al-Masri M.*, Al-Najjar H., Alawneh F. (King Hussein Cancer Center).Libya: Alkadeeki G.*, Al Maadany F. S. (Al-Jalaa Hospital); Aldokali N., Senossi O., Subhi M. T. (Alkhadra Hospital); Burgan D.*, Kamoka E., Kilani A. I. (National Cancer Institute, Sabratha); Ellojli I.*, Kredan A. (Tripoli University Hospital).Lithuania: Bradulskis S., Dainius E., Kubiliute E., Kutkevičius J., Parseliunas A., Subocius A., Venskutonis D.* (Lithuanian University of Health Sciences Kaunas Clinical Hospital).Madagascar: Rasoaherinomenjanahary F.*, Razafindrahita J. B., Samison L. H. (Joseph Ravoahangy Andrianavalona Hospital).Malaysia: Hamdan K. H., Ibrahim M. R., Tan J. A., Thanapal M. R.* (Hospital Kuala Lumpur); Amin Sahid N., Hayati F.*, Jayasilan J., Sriram R. K.*, Subramaniam S. (Queen Elizabeth Hospital and Universiti Malaysia Sabah, Kota Kinabalu, Sabah); Che Jusoh M. A., Hussain A. H., Mohamed Sidek A. S., Mohd Yunus M. F., Soh J. Y., Wong M., Zakaria A. D.*, Zakaria Z. (School of Medical Sciences and Hospital, Universiti Sains Malaysia); Fathi N. Q., Xavier R. G., Roslani A. C.* (University Malaya Medical Centre).Mexico: Buerba G. A., Mercado M. Á.*, Posadas-Trujillo O. E., Salgado-Nesme N., Sarre C. (Instituto Nacional de Ciencias Médicas y Nutrición ‘Salvador Zubirán’).Morocco: Amrani L., El Ahmadi B., El Bouazizi Y., Majbar A. M., Benkabbou A., Mohsine R., Souadka A.* (Institut National d’Oncologie, Université Mohammed V Rabat).Netherlands: Hompes R.*, Meima-van Praag E. M., Pronk A. J. M., Sharabiany S. (Amsterdam UMC, University of Amsterdam); Grotenhuis B.*, Hartveld L. (Antoni Van Leeuwenhoek Ziekenhuis); Posma-Bouman L.* (Slingeland Ziekenhuis); Derksen T., Franken J., Oosterling S.* (Spaarne Gasthuis); Konsten J.*, Van Heinsbergen M. (Viecuri Medisch Centrum).Nigeria: Olaogun J.* (Ekiti State University Teaching Hospital); Abdur-Rahman L.*, Adeyeye A.*, Bello J., Olasehinde O., Popoola A. (University of Ilorin Teaching Hospital).Pakistan: Jamal A., Kerawala A. A.* (Cancer Foundation Hospital); Memon A. S.*, Nafees Ahmed R., Rai .L*
The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study
Aim: The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery.
Methods: This was an international prospective cohort study of consecutive colorectalcancer patients with a decision for curative surgery (January–April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision,in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored theeffects of delay in elective patients only. The impact of longer delays was explored in asensitivity analysis. The primary outcome was complete resection, defined as curative
resection with an R0 margin.
Results: Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operatedpatients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks.Delayed patients were more likely to be older, men, more comorbid, have higher bodymass index and have rectal cancer and early stage disease. Delayed patients had higherunadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates ofemergency surgery (4.5% vs. 22.5%, P < 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90–1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69–1.27, P = 0.672). Longer delays were not associated with poorer outcomes.
Conclusion: One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long- term survival attributable to delays is likely to be due to micro-metastatic disease
The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study
Aim The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. Methods This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. Results Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P < 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90-1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69-1.27, P = 0.672). Longer delays were not associated with poorer outcomes. Conclusion One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease
Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE) : Pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries
Background
Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks.
Methods
The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned.
Results
A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31).
Conclusion
Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)
The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study
AIM: The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. METHODS: This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. RESULTS: Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P < 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90-1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69-1.27, P = 0.672). Longer delays were not associated with poorer outcomes. CONCLUSION: One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease
Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries
Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks.Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned.Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31).Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)
Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE):pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries
BACKGROUND: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks.METHODS: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned.RESULTS: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31).CONCLUSION: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov).</p
