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Mechanical bowel preparation in elective colorectal surgery: a propensity score-matched analysis of the Italian colorectal anastomotic leakage (iCral) study group prospective cohorts

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Abstract

Retrospective evaluation of the effects of mechanical bowel preparation (MBP) on data derived from two prospective open-label observational multicenter studies in Italy regarding elective colorectal surgery. MBP for elective colorectal surgery remains a controversial issue with contrasting recommendations in current guidelines. The Italian ColoRectal Anastomotic Leakage (iCral) study group, therefore, decided to estimate the effects of no MBP (treatment variable) versus MBP for elective colorectal surgery. A total of 8359 patients who underwent colorectal resection with anastomosis were enrolled in two consecutive prospective studies in 78 surgical centers in Italy from January 2019 to September 2021. A retrospective PSMA was performed on 5455 (65.3%) cases after the application of explicit exclusion criteria to eliminate confounders. The primary endpoints were anastomotic leakage (AL) and surgical site infections (SSI) rates; the secondary endpoints included SSI subgroups, overall and major morbidity, reoperation, and mortality rates. Overall length of postoperative hospital stay (LOS) was also considered. Two well-balanced groups of 1125 patients each were generated: group A (No MBP, true population of interest), and group B (MBP, control population), performing a PSMA considering 21 covariates. Group A vs. group B resulted significantly associated with a lower risk of AL [42 (3.5%) vs. 73 (6.0%) events; OR 0.57; 95% CI 0.38–0.84; p = 0.005]. No difference was recorded between the two groups for SSI [73 (6.0%) vs. 85 (7.0%) events; OR 0.88; 95% CI 0.63–1.22; p = 0.441]. Regarding the secondary endpoints, no MBP resulted significantly associated with a lower risk of reoperation and LOS > 6 days. This study confirms that no MBP before elective colorectal surgery is significantly associated with a lower risk of AL, reoperation rate, and LOS < 6 days when compared with MBP.

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Data availability

Data are available upon reasonable request from Marco Catarci, iCral Study Group coordinator (email: marco.catarci@aslroma2.it).

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Acknowledgements

Assistance with the study: † iCral study group co-investigators are

Raffaele De Luca, Ferdinando Ficari, Stefano Scabini, Andrea Liverani, Stefano Mancini, Gian Luca Baiocchi, Roberto Santoro, Walter Siquini, Gianluca Guercioni, Massimo Basti, Corrado Pedrazzani, Mauro Totis, Alessandro Carrara, Andrea Lucchi, Maurizio Pavanello, Andrea Muratore, Stefano D’Ugo, Alberto Di Leo, Giusto Pignata, Ugo Elmore, Gabriele Anania, Massimo Carlini, Francesco Corcione, Nereo Vettoretto, Graziano Longo, Mario Sorrentino, Antonio Giuliani, Giovanni Ferrari, Lucio Taglietti, Augusto Verzelli, Mariantonietta Di Cosmo, Davide Cavaliere, Marco Milone, Stefano Rausei, Giovanni Ciaccio, Giovanni Tebala, Giuseppe Brisinda, Stefano Berti, Paolo Millo, Luigi Boni, Mario Guerrieri, Roberto Persiani, Dario Parini, Antonino Spinelli, Michele Genna, Vincenzo Bottino, Andrea Coratti, Dario Scala, Umberto Rivolta, Micaela Piccoli, Carlo Talarico, Franco Roviello, Alessandro Anastasi, Giuseppe Maria Ettorre, Mauro Montuori, Pierpaolo Mariani, Nicolò de Manzini, Annibale Donini, Mariano Fortunato Armellino, Carlo Feo, Silvio Guerriero, Andrea Costanzi, Federico Marchesi, Moreno Cicetti, Maria Sole Mattei, Elena Belloni, Daniela Apa, Matteo Di Carlo, Simone Cicconi, Irene Marziali, Marco Clementi, Elisa Bertocchi, Gaia Masini, Amedeo Altamura, Francesco Rubichi, Desirée Cianflocca, Marco Migliore, Diletta Cassini, Antonio Sciuto, Ugo Pace, Andrea Fares Bucci, Francesco Monari, Grazia Maria Attinà, Valerio Sisti, Marcella Lodovica Ricci, Angela Maurizi, Bruno Sensi, Gabriella Teresa Capolupo, Lorenzo Pandolfini, Alessandro Falsetto, Michele Simone, Francesco Giudici, Fabio Cianchi, Gabriele Baldini, Alessandra Aprile, Domenico Soriero, Andrea Scarinci, Andrea Sagnotta, Sarah Molfino, Pietro Amodio, Alessandro Cardinali, Diletta Frazzini, Cristian Conti, Nicolò Tamini, Marco Braga, Michele Motter, Giuseppe Tirone, Giacomo Martorelli, Alban Cacurri, Carlo Di Marco, Patrizia Marsanic, Nicoletta Sveva Pipitone Federico, Marcello Spampinato, Lorenzo Crepaz, Jacopo Andreuccetti, Ilaria Canfora, Giulia Maggi, Matteo Chiozza, Domenico Spoletini, Rosa Marcellinaro, Giorgio Lisi, Umberto Bracale, Roberto Peltrini, Maria Michela Di Nuzzo, Emanuele Botteri, Simone Santoni, Massimo Stefanoni, Giovanni Del Vecchio, Carmelo Magistro, Silvia Ruggiero, Arianna Birindelli, Andrea Budassi, Daniele Zigiotto, Leonardo Solaini, Giorgio Ercolani, Giovanni Domenico De Palma, Silvia Tenconi, Paolo Locurto, Antonio Di Cintio, Maria Michela Chiarello, Maria Cariati, Andrea Gennai, Manuela Grivon, Elisa Cassinotti, Monica Ortenzi, Alberto Biondi, Maurizio De Luca, Francesco Carrano, Francesca Fior, Antonio Ferronetti, Giuseppe Giuliani, Graziella Marino, Camillo Leonardo Bertoglio, Francesca Pecchini, Vincenzo Greco, Roberto Piagnerelli, Giuseppe Canonico, Marco Colasanti, Enrico Pinotti, Roberta Carminati, Edoardo Osenda, Luigina Graziosi, Ciro De Martino, Giovanna Ioia, Fioralba Pindozzi, Lorenzo Organetti, Michela Monteleone, Giorgio Dalmonte, Gabriele La Gioia.

From the 20Department of Surgical Oncology, IRCCS Istituto Tumori “Giovanni Paolo II”, Bari; 21General Surgery and IBD Unit, Careggi University Hospital, Firenze; 22General & Oncologic Surgery Unit, IRCCS “San Martino” National Cancer Center, Genova; 23General Surgery Unit, Regina Apostolorum Hospital, Albano Laziale (RM); 24General & Oncologic Surgery Unit, San Filippo Neri Hospital, ASL Roma 1; 25General Surgery Unit 3, Department of Clinical and Experimental Sciences, University of Brescia; 26General Oncologic Surgery Unit, Belcolle Hospital, Viterbo; 27General Surgery Unit, S. Lucia Hospital, Macerata; 28General Surgery Unit, Spirito Santo Hospital, Pescara; 29General & HPB Surgery Unit, University Hospital, Verona; 30Colorectal Surgery Unit, San Gerardo Hospital, ASST Monza; 311st General Surgery Unit, S. Chiara Hospital, Trento; 32General Surgery Unit, “Ceccarini” Hospital, Riccione (RN); 33General Surgery Unit, AULSS2 Marca Trevigiana, Conegliano Veneto (TV); 34General Surgery Unit, “E. Agnelli” Hospital, Pinerolo (TO); 35General Surgery Unit, “V. Fazzi” Hospital, Lecce; 36General and Minimally Invasive Surgery Unit, San Camillo Hospital, Trento; 372nd General Surgery Unit 2, Spedali Civili di Brescia; 38Gastroenterologic Surgery Unit, IRCCS S. Raffaele Hospital, Milano; 39General & Laparoscopic Surgery Unit, University Hospital, Ferrara; 40General Surgery Unit, S. Eugenio Hospital, ASL Roma 2; 41General Oncologic and Mininvasive Surgery Unit, “Federico II” University, Napoli; 42General Surgery Unit, Spedali Civili of Brescia, Montichiari (BS); 43General Surgery Unit, Policlinico Casilino, Roma; 44General Surgery Unit, Latisana-Palmanova Hospital, Friuli Centrale University (UD); 45General Surgery Unit, S. Carlo Hospital, Potenza; 46General Oncologic and Mininvasive Surgery Unit, Great Metropolitan Niguarda Hospital, Milano; 47General Surgery Unit, ASST Valcamonica, Esine (BS); 48General Surgery Unit, Profili Hospital, Fabriano (AN); 49General & Upper GI Surgery Unit, University Hospital, Verona; 50General & Oncologic Surgery Unit, AUSL Romagna, Forlì (FC); 51General & Endoscopic Surgery Unit, “Federico II” University, Napoli; 52General Surgery Unit, Gallarate Hospital (VA); 53General Surgery Unit, S. Elia Hospital, Caltanissetta; 54General Surgery Unit, S. Maria Hospital, Terni; 55General Surgery Unit, San Giovanni di Dio Hospital, Crotone; 56General Surgery Unit, ASL 5 Liguria POLL, La Spezia; 57General Surgery Unit, “U. Parini” Regional Hospital, Aosta; 58General Surgery Unit, Fondazione IRCCS Ca’ Granda, Policlinico Maggiore Hospital, Milano; 59Surgical Clinic, Torrette Hospital, University of Ancona; 60General Surgery Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma; 61General Surgery Unit, S. Maria della Misericordia Hospital, Rovigo; 62Colorectal Surgery Unit, Humanitas University, Rozzano (MI); 63General & Bariatric Surgery Unit, University Hospital, Verona; 64General & Oncologic Surgery Unit, Evangelico Betania Hospital, Napoli; 65General Surgery Unit, Misericordia Hospital, Grosseto; 66Abdominal Oncologic Surgery Unit, Basilicata Oncologic Hospital, Rionero in Vulture (PZ); 67General Surgery Unit, Fornaroli Hospital, ASST Ovest Milanese, Magenta (MI); 68General Surgery Unit, Civil Hospital, Baggiovara (MO); 69General Surgery Unit, Villa dei Gerani Hospital, Vibo Valentia (VV); 70Surgical Clinic, University of Siena; 71General Surgery Unit, San Giovanni di Dio Hospital, Firenze; 72General & Transplant Surgery Unit, San Camillo-Forlanini Hospital, Roma; 73General & Mininvasive Surgery Unit, S. Pietro Hospital, Ponte San Pietro (BG); 74General Surgery Unit, Pesenti Fenaroli Hospital, Alzano Lombardo (BG); 75Surgical Clinic, University of Trieste; 76General & Emergency Surgery Unit, University of Perugia; 77General & Emergency Surgery Unit, S. Giovanni di Dio e Ruggi d’Aragona Hospital, Salerno; 78General Surgery Unit, Delta Hospital, Lagosanto (FE); 79General Surgery Unit, “F. Murri” Hospital, Fermo; 80General Surgery Unit, S. Leopoldo Hospital, Merate (LC); 81Surgical Clinic, University of Parma; 82General Surgery Unit, S. Maria della Misericordia Hospital, Urbino (PU); Italy.

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Medtronic SI® Italy provided unconditioned support to the organization of three iCral2 study investigator meetings, held in Rome, Italy—October 2018, Matera, Italy—June 2019 and Bologna, Italy—October 2019.

Author information

Authors and Affiliations

  1. General Surgery Unit, Sandro Pertini Hospital, ASL Rome 2, Via Dei Monti Tiburtini, 385, 00157, Rome, Italy

    Marco Catarci, Leonardo Antonio Montemurro, Paolo Ciano & Michele Benedetti

  2. General Surgery Unit, “C.&G. Mazzoni” Hospital, Ascoli Piceno, Italy

    Marco Catarci & Gianluca Guercioni

  3. General Surgery Unit, University of L’Aquila, L’Aquila, Italy

    Stefano Guadagni

  4. Department of Applied Clinical Sciences and Biotechnology, University of L’Aquila, L’Aquila, Italy

    Francesco Masedu

  5. General Surgery Unit, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, VR, Italy

    Giacomo Ruffo

  6. General Surgery Unit, Cardinale G. Panico Hospital, Tricase, LE, Italy

    Massimo Giuseppe Viola

  7. Oncologic Surgery Unit, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, TO, Italy

    Felice Borghi

  8. General and Oncologic Surgery Unit, Department of Surgery, Santa Croce e Carle Hospital, Cuneo, Italy

    Felice Borghi

  9. General Surgery Unit, ASST Ovest Milanese, Legnano, MI, Italy

    Gianandrea Baldazzi

  10. General Surgery Unit, ASST Nord Milano, Sesto San Giovanni, MI, Italy

    Gianandrea Baldazzi

  11. General Surgery Unit, ASL Napoli 2 Nord, Pozzuoli, NA, Italy

    Felice Pirozzi

  12. Colorectal Surgical Oncology, Istituto Nazionale Per Lo Studio E La Cura Dei Tumori, Fondazione Giovanni Pascale IRCCS”, Naples, Italy

    Paolo Delrio

  13. General Surgery Unit, Infermi Hospital, Rimini, Italy

    Gianluca Garulli

  14. General and Emergency Surgery Unit, San Camillo-Forlanini Hospital, Rome, Italy

    Pierluigi Marini

  15. Department of Surgery, Marche Nord Hospital, Pesaro e Fano, PU, Italy

    Alberto Patriti

  16. General Surgery Unit, “C. Urbani” Hospital, Jesi, AN, Italy

    Roberto Campagnacci

  17. Minimally Invasive Surgery Unit, Policlinico Tor Vergata University Hospital, Rome, Italy

    Giuseppe Sica

  18. Colorectal Surgery Unit, Policlinico Campus BioMedico, Rome, Italy

    Marco Caricato

  19. General Surgery Unit, Santa Maria Annunziata & Serristori Hospital, Florence, Italy

    Marco Scatizzi

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  1. Marco Catarci
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  2. Stefano Guadagni
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  3. Francesco Masedu
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  4. Giacomo Ruffo
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  5. Massimo Giuseppe Viola
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  6. Felice Borghi
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  7. Gianandrea Baldazzi
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  8. Felice Pirozzi
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  9. Paolo Delrio
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  10. Gianluca Garulli
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  11. Pierluigi Marini
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  12. Alberto Patriti
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  13. Roberto Campagnacci
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  14. Giuseppe Sica
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  15. Marco Caricato
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  16. Leonardo Antonio Montemurro
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  17. Paolo Ciano
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  18. Michele Benedetti
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  19. Gianluca Guercioni
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  20. Marco Scatizzi
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Consortia

the Italian ColoRectal Anastomotic Leakage (iCral) study group

  • Raffaele De Luca
  • , Ferdinando Ficari
  • , Stefano Scabini
  • , Andrea Liverani
  • , Stefano Mancini
  • , Gian Luca Baiocchi
  • , Roberto Santoro
  • , Walter Siquini
  • , Gianluca Guercioni
  • , Massimo Basti
  • , Corrado Pedrazzani
  • , Mauro Totis
  • , Alessandro Carrara
  • , Andrea Lucchi
  • , Maurizio Pavanello
  • , Andrea Muratore
  • , Stefano D’Ugo
  • , Alberto Di Leo
  • , Giusto Pignata
  • , Ugo Elmore
  • , Gabriele Anania
  • , Massimo Carlini
  • , Francesco Corcione
  • , Nereo Vettoretto
  • , Graziano Longo
  • , Mario Sorrentino
  • , Antonio Giuliani
  • , Giovanni Ferrari
  • , Lucio Taglietti
  • , Augusto Verzelli
  • , Mariantonietta Di Cosmo
  • , Davide Cavaliere
  • , Marco Milone
  • , Stefano Rausei
  • , Giovanni Ciaccio
  • , Giovanni Tebala
  • , Giuseppe Brisinda
  • , Stefano Berti
  • , Paolo Millo
  • , Luigi Boni
  • , Mario Guerrieri
  • , Roberto Persiani
  • , Dario Parini
  • , Antonino Spinelli
  • , Michele Genna
  • , Vincenzo Bottino
  • , Andrea Coratti
  • , Dario Scala
  • , Umberto Rivolta
  • , Micaela Piccoli
  • , Carlo Talarico
  • , Franco Roviello
  • , Alessandro Anastasi
  • , Giuseppe Maria Ettorre
  • , Mauro Montuori
  • , Pierpaolo Mariani
  • , Nicolò de Manzini
  • , Annibale Donini
  • , Mariano Fortunato Armellino
  • , Carlo Feo
  • , Silvio Guerriero
  • , Andrea Costanzi
  • , Federico Marchesi
  • , Moreno Cicetti
  • , Maria Sole Mattei
  • , Elena Belloni
  • , Daniela Apa
  • , Matteo Di Carlo
  • , Simone Cicconi
  • , Irene Marziali
  • , Marco Clementi
  • , Elisa Bertocchi
  • , Gaia Masini
  • , Amedeo Altamura
  • , Francesco Rubichi
  • , Desirée Cianflocca
  • , Marco Migliore
  • , Diletta Cassini
  • , Antonio Sciuto
  • , Ugo Pace
  • , Andrea Fares Bucci
  • , Francesco Monari
  • , Grazia Maria Attinà
  • , Valerio Sisti
  • , Marcella Lodovica Ricci
  • , Angela Maurizi
  • , Bruno Sensi
  • , Gabriella Teresa Capolupo
  • , Lorenzo Pandolfini
  • , Alessandro Falsetto
  • , Michele Simone
  • , Francesco Giudici
  • , Fabio Cianchi
  • , Gabriele Baldini
  • , Alessandra Aprile
  • , Domenico Soriero
  • , Andrea Scarinci
  • , Andrea Sagnotta
  • , Sarah Molfino
  • , Pietro Amodio
  • , Alessandro Cardinali
  • , Diletta Frazzini
  • , Cristian Conti
  • , Nicolò Tamini
  • , Marco Braga
  • , Michele Motter
  • , Giuseppe Tirone
  • , Giacomo Martorelli
  • , Alban Cacurri
  • , Carlo Di Marco
  • , Patrizia Marsanic
  • , Nicoletta Sveva Pipitone Federico
  • , Marcello Spampinato
  • , Lorenzo Crepaz
  • , Jacopo Andreuccetti
  • , Ilaria Canfora
  • , Giulia Maggi
  • , Matteo Chiozza
  • , Domenico Spoletini
  • , Rosa Marcellinaro
  • , Giorgio Lisi
  • , Umberto Bracale
  • , Roberto Peltrini
  • , Maria Michela Di Nuzzo
  • , Emanuele Botteri
  • , Simone Santoni
  • , Massimo Stefanoni
  • , Giovanni Del Vecchio
  • , Carmelo Magistro
  • , Silvia Ruggiero
  • , Arianna Birindelli
  • , Andrea Budassi
  • , Daniele Zigiotto
  • , Leonardo Solaini
  • , Giorgio Ercolani
  • , Giovanni Domenico De Palma
  • , Silvia Tenconi
  • , Paolo Locurto
  • , Antonio Di Cintio
  • , Maria Michela Chiarello
  • , Maria Cariati
  • , Andrea Gennai
  • , Manuela Grivon
  • , Elisa Cassinotti
  • , Monica Ortenzi
  • , Alberto Biondi
  • , Maurizio De Luca
  • , Francesco Carrano
  • , Francesca Fior
  • , Antonio Ferronetti
  • , Giuseppe Giuliani
  • , Graziella Marino
  • , Camillo Leonardo Bertoglio
  • , Francesca Pecchini
  • , Vincenzo Greco
  • , Roberto Piagnerelli
  • , Giuseppe Canonico
  • , Marco Colasanti
  • , Enrico Pinotti
  • , Roberta Carminati
  • , Edoardo Osenda
  • , Luigina Graziosi
  • , Ciro De Martino
  • , Giovanna Ioia
  • , Fioralba Pindozzi
  • , Lorenzo Organetti
  • , Michela Monteleone
  • , Giorgio Dalmonte
  •  & Gabriele La Gioia

Contributions

MC: iCral Study Group coordinator, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: MC, SG, GR, GV, FB, GB, FP, PD, GG, PM, AP, RC, AM, PC, MB, GG, GS, MC, and MS. Acquisition, analysis, or interpretation of data: MC, SG, GR, MSV, FB, GB, FP, PD, GG, PM, AP, RC, AM, PC, MB, GG, MS, and MS. Drafting of the manuscript: MC, SG, and FM. Critical revision of the manuscript for important intellectual content: MC, SG, GR, MGV, FB, GB, FP, PD, GG, PM, AP, RC, AM, PC, MB, GG, GS, MC, and MS. Statistical analysis: FM and SG.

Corresponding author

Correspondence to Marco Catarci.

Ethics declarations

Conflict of interest

Dr. Catarci reports personal fees from Baxter Spa outside the submitted work. Dr. Guadagni, Ruffo, Viola, Borghi, Baldazzi, Pirozzi, Delrio, Garulli, Marini, Patriti, Campagnacci, Montemurro, Ciano, Benedetti, Guercioni, Sica, Caricato, and Scatizzi have no competing interests.

Ethical approval

Both studies were conducted in accordance with the Declaration of Helsinki and the guidelines for good clinical practice E6 (R2). The study protocols were approved by the ethics committee of the coordinating center (Marche Regional Ethics Committee—CERM—2018/334 released on 11/28/2018 for iCral2; CERM—2020/192 released on 07/30/2020 for iCral3) and registered at ClinicalTrials.gov (NCT03771456 for iCral2 and NCT04397627 for iCral3).

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The members of the Study group coordinator and iCral study group co-investigators are listed in the Acknowledgments section.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 42 KB)

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Catarci, M., Guadagni, S., Masedu, F. et al. Mechanical bowel preparation in elective colorectal surgery: a propensity score-matched analysis of the Italian colorectal anastomotic leakage (iCral) study group prospective cohorts. Updates Surg 76, 107–117 (2024). https://doi.org/10.1007/s13304-023-01670-w

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