Intraoperative left-sided colorectal anastomotic testing in clinical practice: a multi-treatment machine-learning analysis of the iCral3 prospective cohort.
Air-leak test
Anastomotic leakage
Colorectal surgery
ICG fluorescent angiography
Left-sided colorectal resection
Journal
Updates in surgery
ISSN: 2038-3312
Titre abrégé: Updates Surg
Pays: Italy
ID NLM: 101539818
Informations de publication
Date de publication:
20 May 2024
20 May 2024
Historique:
received:
27
02
2024
accepted:
13
05
2024
medline:
20
5
2024
pubmed:
20
5
2024
entrez:
20
5
2024
Statut:
aheadofprint
Résumé
Current evidence about intraoperative anastomotic testing after left-sided colorectal resections is still controversial. The aim of this study was to analyze the impact of Indocyanine Green fluorescent angiography (ICG-FA) and air-leak test (ALT) over standard assessment on anastomotic leakage (AL) rates according to surgeon's perception of anastomosis perfusion and/or integrity in clinical practice. A database of 2061 patients who underwent left-sided colorectal resections was selected from patients enrolled in a prospective multicenter study. It was retrospectively analyzed through a multi-treatment machine-learning model considering standard visual assessment (NW; No. = 899; 43.6%) as the reference treatment arm, compared to ICG-FA alone (WP; No. = 409; 19.8%), ALT alone (WI; No. = 420; 20.4%) or both (WPI; No. = 333; 16.2%). Twenty-four covariates potentially affecting the outcomes were included and balanced into the model within the subgroups. The primary endpoint was AL, the secondary endpoints were overall morbidity (OM), major morbidity (MM), reoperation for AL, and mortality. All the results were reported as odds ratio (OR) with 95% confidence intervals (95%CI). The WPI subgroup showed significantly higher AL risk (OR 1.91; 95% CI 1.02-3.59; p 0.043), MM risk (OR 2.35; 95% CI 1.39-3.97; p 0.001), and reoperation for AL risk (OR 2.44; 95% CI 1.12-5.31; p 0.025). No other significant differences were recorded. This study showed that the surgeons' perception of both anastomotic perfusion and integrity (WPI subgroup) was associated to a significantly higher risk of AL and related morbidity, notwithstanding the extensive use of both ICG-FA and ALT testing.
Sections du résumé
BACKGROUND
BACKGROUND
Current evidence about intraoperative anastomotic testing after left-sided colorectal resections is still controversial. The aim of this study was to analyze the impact of Indocyanine Green fluorescent angiography (ICG-FA) and air-leak test (ALT) over standard assessment on anastomotic leakage (AL) rates according to surgeon's perception of anastomosis perfusion and/or integrity in clinical practice.
METHODS
METHODS
A database of 2061 patients who underwent left-sided colorectal resections was selected from patients enrolled in a prospective multicenter study. It was retrospectively analyzed through a multi-treatment machine-learning model considering standard visual assessment (NW; No. = 899; 43.6%) as the reference treatment arm, compared to ICG-FA alone (WP; No. = 409; 19.8%), ALT alone (WI; No. = 420; 20.4%) or both (WPI; No. = 333; 16.2%). Twenty-four covariates potentially affecting the outcomes were included and balanced into the model within the subgroups. The primary endpoint was AL, the secondary endpoints were overall morbidity (OM), major morbidity (MM), reoperation for AL, and mortality. All the results were reported as odds ratio (OR) with 95% confidence intervals (95%CI).
RESULTS
RESULTS
The WPI subgroup showed significantly higher AL risk (OR 1.91; 95% CI 1.02-3.59; p 0.043), MM risk (OR 2.35; 95% CI 1.39-3.97; p 0.001), and reoperation for AL risk (OR 2.44; 95% CI 1.12-5.31; p 0.025). No other significant differences were recorded.
CONCLUSIONS
CONCLUSIONS
This study showed that the surgeons' perception of both anastomotic perfusion and integrity (WPI subgroup) was associated to a significantly higher risk of AL and related morbidity, notwithstanding the extensive use of both ICG-FA and ALT testing.
Identifiants
pubmed: 38767835
doi: 10.1007/s13304-024-01883-7
pii: 10.1007/s13304-024-01883-7
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Paolo Ciano
(P)
Michele Benedetti
(M)
Leonardo Antonio Montemurro
(LA)
Matteo Di Carlo
(M)
Marco Clementi
(M)
Simone Cicconi
(S)
Elisa Bertocchi
(E)
Gaia Masini
(G)
Amedeo Altamura
(A)
Francesco Rubichi
(F)
Marco Migliore
(M)
Lorenzo Pandolfini
(L)
Alessandro Falsetto
(A)
Marcella Lodovica Ricci
(ML)
Sarah Molfino
(S)
Gianluca Garulli
(G)
Daniele Parlanti
(D)
Gabriele Vago
(G)
Felice Pirozzi
(F)
Antonio Sciuto
(A)
Paolo Delrio
(P)
Ugo Pace
(U)
Andrea Fares Bucci
(AF)
Raffaele De Luca
(R)
Michele Simone
(M)
Gianandrea Baldazzi
(G)
Diletta Cassini
(D)
Ferdinando Ficari
(F)
Francesco Giudici
(F)
Fabio Cianchi
(F)
Walter Siquini
(W)
Alessandro Cardinali
(A)
Stefano D'Ugo
(S)
Marcello Spampinato
(M)
Stefano Scabini
(S)
Alessandra Aprile
(A)
Domenico Soriero
(D)
Marco Caricato
(M)
Gabriella Teresa Capolupo
(GT)
Giusto Pignata
(G)
Jacopo Andreuccetti
(J)
Ilaria Canfora
(I)
Andrea Liverani
(A)
Giuseppe Lamacchia
(G)
Claudia Franceschilli
(C)
Roberto Campagnacci
(R)
Angela Maurizi
(A)
Pierluigi Marini
(P)
Grazia Maria Attinà
(GM)
Ugo Elmore
(U)
Francesco Puccetti
(F)
Francesco Corcione
(F)
Umberto Bracale
(U)
Roberto Peltrini
(R)
Roberto Santoro
(R)
Pietro Amodio
(P)
Massimo Carlini
(M)
Domenico Spoletini
(D)
Rosa Marcellinaro
(R)
Antonio Giuliani
(A)
Giovanni Del Vecchio
(G)
Mario Sorrentino
(M)
Massimo Stefanoni
(M)
Giovanni Ferrari
(G)
Pietro Carnevali
(P)
Alberto Di Leo
(A)
Lorenzo Crepaz
(L)
Augusto Verzelli
(A)
Andrea Budassi
(A)
Giuseppe Sica
(G)
Giulia Bagaglini
(G)
Stefano Rausei
(S)
Silvia Tenconi
(S)
Davide Cavaliere
(D)
Leonardo Solaini
(L)
Giorgio Ercolani
(G)
Marco Milone
(M)
Giovanni Domenico De Palma
(GD)
Giovanni Ciaccio
(G)
Paolo Locurto
(P)
Giovanni Domenico Tebala
(GD)
Antonio Di Cintio
(A)
Luigi Boni
(L)
Ludovica Baldari
(L)
Elisa Cassinotti
(E)
Stefano Mancini
(S)
Andrea Sagnotta
(A)
Mario Guerrieri
(M)
Monica Ortenzi
(M)
Roberto Persiani
(R)
Alberto Biondi
(A)
Andrea Lucchi
(A)
Giulia Vitali
(G)
Dario Parini
(D)
Maurizio De Luca
(M)
Antonino Spinelli
(A)
Francesco Carrano
(F)
Michele Genna
(M)
Francesca Fior
(F)
Vincenzo Bottino
(V)
Antonio Ferronetti
(A)
Andrea Coratti
(A)
Giuseppe Giuliani
(G)
Roberto Benigni
(R)
Dario Scala
(D)
Battistino Puppio
(B)
Alessio Vagliasindi
(A)
Andrea Muratore
(A)
Patrizia Marsanic
(P)
Nicoletta Sveva Pipitone Federico
(NSP)
Maurizio Pavanello
(M)
Carlo Di Marco
(C)
Umberto Rivolta
(U)
Camillo Leonardo Bertoglio
(CL)
Micaela Piccoli
(M)
Francesca Pecchini
(F)
Carlo Talarico
(C)
Vincenzo Greco
(V)
Alessandro Carrara
(A)
Michele Motter
(M)
Giuseppe Tirone
(G)
Mauro Totis
(M)
Nicolò Tamini
(N)
Franco Roviello
(F)
Riccardo Piagnerelli
(R)
Alessandro Anastasi
(A)
Giuseppe Canonico
(G)
Giuseppe Maria Ettorre
(GM)
Marco Colasanti
(M)
Mauro Montuori
(M)
Enrico Pinotti
(E)
Pierpaolo Mariani
(P)
Roberta Carminati
(R)
Nicolò de Manzini
(N)
Edoardo Osenda
(E)
Annibale Donini
(A)
Luigina Graziosi
(L)
Mariano Fortunato Armellino
(MF)
Ciro De Martino
(C)
Lucio Taglietti
(L)
Arianna Birindelli
(A)
Gabriele Anania
(G)
Matteo Chiozza
(M)
Mariantonietta Di Cosmo
(M)
Daniele Zigiotto
(D)
Carlo Vittorio Feo
(CV)
Fioralba Pindozzi
(F)
Paolo Millo
(P)
Manuela Grivon
(M)
Corrado Pedrazzani
(C)
Cristian Conti
(C)
Silvio Guerriero
(S)
Lorenzo Organetti
(L)
Andrea Costanzi
(A)
Michela Monteleone
(M)
Nereo Vettoretto
(N)
Emanuele Botteri
(E)
Federico Marchesi
(F)
Giorgio Dalmonte
(G)
Massimo Basti
(M)
Diletta Frazzini
(D)
Graziano Longo
(G)
Simone Santoni
(S)
Moreno Cicetti
(M)
Gabriele La Gioia
(G)
Informations de copyright
© 2024. Italian Society of Surgery (SIC).
Références
Catarci M, Ruffo G, Viola MG et al (2022) ERAS program adherence-institutionalization, major morbidity and anastomotic leakage after elective colorectal surgery: the iCral2 multicenter prospective study. Surg Endosc 36:3965–3984
pubmed: 34519893
doi: 10.1007/s00464-021-08717-2
Italian ColoRectal Anastomotic Leakage (iCral) study group (2023) Patient-reported outcomes, return to intended oncological therapy and enhanced recovery pathways after colorectal surgery: a prospective multicenter observational investigation by the Italian ColoRectal anastomotic leakage (iCral 3) study group. Ann Surg Open 4:e267
doi: 10.1097/AS9.0000000000000267
Renna MS, Grzeda MT, Bailey J, Hainsworth A, Ourselin S, Ebner M, Vercauteren T, Schizas A, Shapey J (2023) Intraoperative bowel perfusion assessment methods and their effects on anastomotic leak rates: meta-analysis. BJS 110:1131–1142
doi: 10.1093/bjs/znad154
Sell NM, Francone TD (2021) Anastomotic troubleshooting. Clin Colon Rectal Surg 34:385–390
pubmed: 34853559
pmcid: 8610636
doi: 10.1055/s-0041-1735269
Shogan BD, Carlisle EM, Alverdy JC, Umanskiy K (2013) Do we really know why colorectal anastomoses leak? J Gastrointest Surg 17(9):1698–1707
pubmed: 23690209
doi: 10.1007/s11605-013-2227-0
Tsalikidis C, Mitsala A, Mentonis V, Romanidis K, Pappas-Gogos G, Tsaroucha AK, Pitiakoudis M (2023) Predictive factors for anastomotic leakage following colorectal cancer surgery: where are we and where are we going? Curr Oncol 30:3111–3137
pubmed: 36975449
pmcid: 10047700
doi: 10.3390/curroncol30030236
Zhao Y, Li B, Sun Y, Liu Q, Cao Q, Li T, Li J (2022) Risk factors and preventive measures for anastomotic leak in colorectal cancer. Technol Cancer Res Treat 21:15330338221118984
pubmed: 36172641
pmcid: 9523838
doi: 10.1177/15330338221118983
Huisman DE, Murie Y, Reudink I et al (2022) A prospective study to identify perioperative modifiable risk factors for anastomotic leakage in colorectal surgery. Ann Surg 275:e189–e197
pubmed: 32511133
doi: 10.1097/SLA.0000000000003853
Woodfield JC, Pettigrew RA, Plank LD, Landmann M, van Rij AM (2007) Accuracy of the surgeons’ clinical prediction of perioperative complications using a visual analog scale. World J Surg 31:1912–1920
pubmed: 17674096
doi: 10.1007/s00268-007-9178-0
Farges O, Vibert E, Cosse C et al (2014) ‘“Surgeons” intuition’’ versus ‘“prognostic models”’: predicting the risk of liver resections. Ann Surg 260:923–928
pubmed: 25379862
doi: 10.1097/SLA.0000000000000961
Sevdalis N, Jacklin R (2008) Opening the ‘“black box”’ of surgeons’ risk estimation: from intuition to quantitative modeling. World J Surg 32:324–325
pubmed: 17938999
doi: 10.1007/s00268-007-9249-2
Karliczek A, Harlaar NJ, Zeebregts CJ et al (2009) Surgeons lack predictive accuracy for anastomotic leakage in gastrointestinal surgery. Int J Colorectal Dis 24:569–576
pubmed: 19221768
doi: 10.1007/s00384-009-0658-6
Sammour T, Lewis M, Thomas ML et al (2017) A simple web-based risk calculator (Www.Anastomoticleak.Com) is superior to the surgeon’s estimate of anastomotic leak after colon cancer resection. Tech Coloproctol 21:35–41
pubmed: 27995423
doi: 10.1007/s10151-016-1567-7
Venn ML, Hooper RH, Pampiglione T, Morton DG, Nepogodiev D, Knowles CH (2023) Systematic review of preoperative and intraoperative colorectal anastomotic leak prediction scores (ALPS). BMJ Open 13:e073085
pubmed: 37463818
pmcid: 10357690
doi: 10.1136/bmjopen-2023-073085
Nakayama S, Hasegawa S, Nagayama S et al (2011) The importance of precompression time for secure stapling with a linear stapler. Surg Endosc 25:2382–2386
pubmed: 21184102
doi: 10.1007/s00464-010-1527-7
Alverdy JC, Schardey HM (2021) Anastomotic leak: toward an understanding of its root causes. J Gastrointest Surg 25:2966–2975
pubmed: 34100248
pmcid: 8815793
doi: 10.1007/s11605-021-05048-4
Sparreboom CL, van Groningen JT, Lingsma HF, Wouters MWJM, Menon AG, Kleinrensink G-J, Jeekel J, Lange JF (2018) Different risk factors for early and late colorectal anastomotic leakage in a nationwide audit. Dis Colon Rectum 61:1258–1266
pubmed: 30239395
doi: 10.1097/DCR.0000000000001202
He J, He M, Tang JH, Wang XH (2023) Anastomotic leak risk factors following colon cancer resection: a systematic review and meta-analysis. Langenbeck’s Arch Surg 408:252–263
doi: 10.1007/s00423-023-02989-z
Catarci M, Guadagni S, Masedu F, Montemurro LA, Ciano P, Benedetti M, Delrio P, Garulli G, Pirozzi F, Scatizzi M, Italian ColoRectal Anastomotic Leakage (iCral) Study Group (2023) Blood transfusions and adverse events after colorectal surgery: a propensity-score-matched analysis of a hen-egg issue. Diagnostics (Basel) 13(5):952
pubmed: 36900095
doi: 10.3390/diagnostics13050952
Catarci M, Guadagni S, Masedu F, Ruffo G, Viola MG, Borghi F, Baldazzi G, Scatizzi M, on behalf of the the Italian ColoRectal Anastomotic Leakage (iCral) study group (2023) Three- versus two-rows circular staplers for left-sided colorectal anastomosis: a propensity score-matched analysis of the iCral 2 and 3 prospective cohorts. Int J Surg 109:2312–2323
pubmed: 37195782
pmcid: 10442086
doi: 10.1097/JS9.0000000000000480
Armstrong G, Croft J, Corrigan N et al (2018) IntAct: intra-operative fluorescence angiography to prevent anastomotic leak in rectal cancer surgery: a randomized controlled trial. Colorectal Dis 20:226–234
doi: 10.1111/codi.14257
Rudnicki Y, White I, Tiomkin V, Lahav L, Raguan B, Avital S (2021) Intraoperative evaluation of colorectal anastomotic integrity: a comparison of air leak and dye leak tests. Tech Coloproctol 25:841–847
pubmed: 33905010
doi: 10.1007/s10151-021-02453-4
Vardhan S, Deshpande SG, Singh A, Kumar CA, Bisen YT, Dighe OR (2023) Techniques for diagnosing anastomotic leaks intraoperatively in colorectal surgeries: a review. Cureus 15:e34168
pubmed: 36843691
pmcid: 9949993
Baiocchi GL, Guercioni G, Vettoretto N et al (2021) ICG fluorescence imaging in colorectal surgery: a snapshot from the ICRAL study group. BMC Surg 21(1):190
pubmed: 33838677
pmcid: 8035779
doi: 10.1186/s12893-021-01191-6
Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213
pubmed: 15273542
pmcid: 1360123
doi: 10.1097/01.sla.0000133083.54934.ae
Katayama H, Kurokawa Y, Nakamura K et al (2016) Extended Clavien–Dindo classification of surgical complications: Japan clinical oncology group postoperative complications criteria. Surg Today 46(6):668–685
pubmed: 26289837
doi: 10.1007/s00595-015-1236-x
Rahbari NN, Weitz J, Hohenberger W et al (2010) Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the international study group of rectal cancer. Surgery 147(3):339–351
pubmed: 20004450
doi: 10.1016/j.surg.2009.10.012
Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR (1996) A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol 49(12):1373–1379
pubmed: 8970487
doi: 10.1016/S0895-4356(96)00236-3
McCaffrey DF, Beth Ann Griffin BA, Almirall D, Slaughter ME, Ramchand R, Burgette LF (2013) A tutorial on propensity score estimation for multiple treatments using generalized boosted models. Stat Med 32(19):3388–3414
pubmed: 23508673
pmcid: 3710547
doi: 10.1002/sim.5753
Lee BK, Lessler J, Stuart EA (2010) Improving propensity score weighting using machine learning. Stat Med 29(3):337–346
pubmed: 19960510
pmcid: 2807890
doi: 10.1002/sim.3782
Brookhart MA, Schneeweiss S, Rothman KJ, Glynn RJ, Avorn J, Stürmer T (2006) Variable selection for propensity score models. Am J Epidemiol 163(12):1149–1156
pubmed: 16624967
doi: 10.1093/aje/kwj149
Kaiser MJ, Bauer JM, Ramsch C et al (2009) Validation of the mini nutritional assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging 13(9):782
pubmed: 19812868
doi: 10.1007/s12603-009-0214-7
Emile SH, Khan SM, Wexner SD (2022) Impact of change in the surgical plan based on indocyanine green fluorescence angiography on the rates of colorectal anastomotic leak: a systematic review and meta-analysis. Surg Endosc 36:2245–2257
pubmed: 35024926
doi: 10.1007/s00464-021-08973-2
Bencurik V, Škrovina M, Martínek L et al (2021) Intraoperative fluorescence angiography and risk factors of anastomotic leakage in mini-invasive low rectal resections. Surg Endosc 35:5015–5023
pubmed: 32970211
doi: 10.1007/s00464-020-07982-x
Bonadio L, Iacuzzo C, Cosola D et al (2020) Indocyanine green-enhanced fluorangiography (ICGf) in laparoscopic extraperitoneal rectal cancer resection. Updates Surg 72:477–482
pubmed: 32072407
doi: 10.1007/s13304-020-00725-6
Dinallo AM, Kolarsick P, Boyan WP, Protyniak B, James A, Dressner RM, Arvanitis ML (2019) Does routine use of indocyanine green fluorescence angiography prevent anastomotic leaks? A retrospective cohort analysis. Am J Surg 218:136–139
pubmed: 30360896
doi: 10.1016/j.amjsurg.2018.10.027
Kin C, Vo H, Welton L, Welton M (2015) Equivocal effect of intraoperative fluorescence angiography on colorectal anastomotic leaks. Dis Colon Rectum 58:582–587
pubmed: 25944430
doi: 10.1097/DCR.0000000000000320
Jafari MD, Wexner SD, Martz JE et al (2015) Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study. J Am Coll Surg 220:82–92
pubmed: 25451666
doi: 10.1016/j.jamcollsurg.2014.09.015
De Nardi P, Elmore U, Maggi G et al (2020) Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial. Surg Endosc 34:53–60
pubmed: 30903276
doi: 10.1007/s00464-019-06730-0
Alekseev M, Rybakov E, Shelygin Y, Chernyshov S, Zarodnyuk I (2020) A study investigating the perfusion of colorectal anastomoses using fluorescence angiography: results of the FLAG randomized trial. Colorectal Dis 22:1147–1153
pubmed: 32189424
doi: 10.1111/codi.15037
Jafari MD, Pigazzi A, McLemore EC et al (2021) Perfusion assessment in left-sided/low anterior resection (PILLAR III): a randomized, controlled, parallel, multicenter study assessing perfusion outcomes with PINPOINT near-infrared fluorescence imaging in low anterior resection. Dis Colon Rectum 64:995–1002
pubmed: 33872284
doi: 10.1097/DCR.0000000000002007
Meijer RPJ, Faber RA, Bijlstra OD et al (2022) AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery. BMJ Open 12:e051144
pubmed: 35365509
pmcid: 8977759
doi: 10.1136/bmjopen-2021-051144
Safiejko K, Tarkowski R, Kozlowski TP, Koselak M, Jachimiuk M, Tarasik A, Pruc M, Smereka J, Szarpak L (2022) Safety and efficacy of indocyanine green in colorectal cancer surgery: a systematic review and meta-analysis of 11,047 patients. Cancers 14:1036
pubmed: 35205784
pmcid: 8869881
doi: 10.3390/cancers14041036
Kondo A, Naoya Y, Nobuya K et al (2024) A novel fluorescence-based leak test method for rectal anastomoses using aerosolized indocyanine green. Dis Colon Rectum 67:168–174
pubmed: 37787549
doi: 10.1097/DCR.0000000000002897
Lazorthes F, Chiotassol P (1986) Stapled colorectal anastomoses: peroperative integrity of the anastomosis and risk of postoperative leakage. Int J Colorectal Dis 1:96–98
pubmed: 3611941
doi: 10.1007/BF01648414
Kryzauskas M, Poskus E, Dulskas A et al (2020) The problem of colorectal anastomosis safety. Medicine 99:2–6
doi: 10.1097/MD.0000000000018560
Farzaneh C, Uppal A, Jafari MD et al (2023) Validation of an endoscopic anastomotic grading score as an intraoperative method for assessing stapled rectal anastomoses. Tech Coloproctol 27:1235–1242
pubmed: 37184769
doi: 10.1007/s10151-023-02797-z
Rausa E, Zappa MA, Kelly ME et al (2019) A standardized use of intraoperative anastomotic testing in colorectal surgery in the new millennium: is technology taking over? A systematic review and network meta-analysis. Tech Coloproctol 23(7):625–631
pubmed: 31302816
doi: 10.1007/s10151-019-02034-6
Emile SH, Gilshtein H, Wexner SD (2020) Quadruple assessment of colorectal anastomoses: a technique to reduce the incidence of anastomotic leakage. Colorectal Dis 22(1):102–103
pubmed: 31487087
doi: 10.1111/codi.14844