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Colorectal surgery in Italy: a snapshot from the iCral study group

  • The Italian ColoRectal Anastomotic Leakage (iCral) study groupEmail author
Original Article

Abstract

During a recent prospective trial on early diagnosis of anastomotic leakage (AL) after colorectal surgery, we gathered a large database on more than 1500 procedures performed in 19 surgical centers in Italy over a 12-month period. Main purpose of the present paper is to show the epidemiological data about colorectal procedures and anastomotic leakage. Prospective enrollment for all elective colorectal resections with anastomosis (September 2017–September 2018). Primary endpoint was AL; secondary endpoints were morbidity and mortality rates, readmission and reoperation rates, and length of post-operative hospital stay (ClinicalTrials.gov; Identifier: NCT03560180). There were 1546 enrolled cases (56.9% of 2717 total resected cases). The rate of minimally invasive resections was 83.5%. Overall AL rate was 4.92% (76 cases; range per center 0-12.12%). Mean ± SD time to AL diagnosis was 5.95 ± 4.78 days (median 5, range 1-31). Overall morbidity rate was 30.20%, mortality 1.29% (20 cases; range per center 0-3.27), readmission 0.90%, and reoperation 6.92%. Mean ± SD post-operative LOS was 7.89 ± 5.97 days (median 6; range 1-120). AL significantly influenced all other secondary endpoints. This study offers a good snapshot of colorectal resections in Italy. There was a high rate of laparoscopic resections, reflecting the special interest in this kind of surgery by the participating centers. AL, morbidity, mortality, readmission and reoperation rates are compared to those reported in previous population-based studies. Compared to series dealing with open colorectal resections, the time to diagnosis of AL was shortened by several days.

Keywords

Anastomotic leakage Colorectal surgery Multicenter study Prospective observational study 

Notes

Acknolwedgements

Members of The Italian ColoRectal Anastomotic Leakage (iCral) study group and authors are: Marco Catarci Principal investigator and promoter (General Surgery Unit, Ospedale “C. e G. Mazzoni”, ASUR Marche AV5 Via degli Iris snc, 63100 Ascoli Piceno, Italy), Giacomo Ruffo (General Surgery Unit, Sacro Cuore Hospital, Negrar, VR, Italy), Felice Borghi (Department of Surgery, Santa Croce e Carle Hospital, Cuneo, Italy), Alberto Patriti (Department of Surgery, Marche Nord Hospital, Pesaro e Fano, PU, Italy), Paolo Delrio (Colorectal Surgical Oncology, National Cancer Institute - IRCCS - G. Pascale Foundation, Naples, Italy), Marco Scatizzi (General and Oncologic Surgery Unit, Santo Stefano Hospital, Prato, FI, Italy), Stefano Mancini (General and Oncologic Surgery Unit, San Filippo Neri Hospital, Rome, Italy), Gianluca Garulli (General Surgery Unit, “Ceccarini” Hospital, Riccione, RN, Italy), Alessandro Carrara (Department of Surgery, Santa Chiara Hospital, Trento, Italy), Felice Pirozzi (Abdominal Surgery Unit, Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, FG, Italy), Stefano Scabini (General and Oncologic Surgery Unit, National Cancer Center “San Martino”, Genoa, Italy), Andrea Liverani (General Surgery Unit, Regina Apostolorum Hospital, Albano Laziale, RM, Italy), Gianluca Baiocchi (General Surgery Unit 3, University and Spedali Civili of Brescia, Brescia, Italy), Roberto Campagnacci (Department of Surgery, “C. Urbani” Hospital, Jesi, AN, Italy), Andrea Muratore (General Surgery Unit, “E. Agnelli” Hospital, Pinerolo, TO, Italy), Graziano Longo (General Surgery Unit, Policlinico Casilino, Rome, Italy), Marco Caricato (Geriatric Surgery Unit, Policlinico Campus BioMedico, Rome, Italy), Raffaele Macarone Palmieri (General and Oncologic Surgery Unit, Belcolle Hospital, Viterbo, Italy), Nereo Vettoretto (General Surgery Unit, Spedali Civili of Brescia, Montichiari, BS, Italy), Marcello Ceccaroni (Gynecology Unit, Sacro Cuore Hospital, Negrar, VR, Italy), Paolo Ciano (General Surgery Unit, Ospedale “C. e G. Mazzoni”, ASUR Marche AV5 Via degli Iris snc, 63100 Ascoli Piceno, Italy), Elisa Bertocchi (General Surgery and Gynecology Units, Sacro Cuore Hospital, Negrar, VR, Italy), Desirée Cianflocca (Department of Surgery, Santa Croce e Carle Hospital, Cuneo, Italy), Margherita Lambertini (Department of Surgery, Marche Nord Hospital, Pesaro e Fano, PU, Italy), Ugo Pace (Colorectal Surgical Oncology, National Cancer Institute - IRCCS - G. Pascale Foundation, Naples, Italy), Maddalena Baraghini (General and Oncologic Surgery Unit, Santo Stefano Hospital, Prato, FI, Italy), Lorenzo Pandolfini (General and Oncologic Surgery Unit, Santo Stefano Hospital, Prato, FI, Italy), Riccardo Angeloni (General and Oncologic Surgery Unit, San Filippo Neri Hospital, Rome, Italy), Andrea Lucchi (General Surgery Unit, “Ceccarini” Hospital, Riccione, RN, Italy), Giacomo Martorelli (General Surgery Unit, “Ceccarini” Hospital, Riccione, RN, Italy), Giuseppe Tirone (Department of Surgery, Santa Chiara Hospital, Trento, Italy), Michele Motter (Department of Surgery, Santa Chiara Hospital, Trento, Italy), Antonio Sciuto (Abdominal Surgery Unit, Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, FG, Italy), Antonio Martino (General and Oncologic Surgery Unit, National Cancer Center “San Martino”, Genoa, Italy), Andrea Pierre Luzzi (General and Oncologic Surgery Unit, National Cancer Center “San Martino”, Genoa, Italy), Tatiana di Cesare (General Surgery Unit, Regina Apostolorum Hospital, Albano Laziale, RM, Italy), Sarah Molfino (General Surgery Unit 3, University and Spedali Civili of Brescia, Brescia, Italy), Angela Maurizi (Department of Surgery, “C. Urbani” Hospital, Jesi, AN, Italy), Patrizia Marsanic (General Surgery Unit, “E. Agnelli” Hospital, Pinerolo, TO, Italy), Federico Tomassini (General Surgery Unit, Policlinico Casilino, Rome, Italy), Simone Santoni (General Surgery Unit, Policlinico Casilino, Rome, Italy), Gabriella Teresa Capolupo (Geriatric Surgery Unit, Policlinico Campus BioMedico, Rome, Italy), Pietro Amodio (General and Oncologic Surgery Unit, Belcolle Hospital, Viterbo, Italy), Elisa Arici (General Surgery Unit, Spedali Civili of Brescia, Montichiari, BS, Italy), Benedetta Ruggeri (Clinical Governance Unit, “C. e G. Mazzoni” Hospital, Ascoli Piceno, Italy), Gianluca Guercioni (General Surgery Unit, Ospedale “C. e G. Mazzoni”, ASUR Marche AV5 Via degli Iris snc, 63100 Ascoli Piceno, Italy).

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Medtronic SI® Italy gave liberal and unconditioned economic support for the organization of the first, second and third investigator meetings, held in Milan, Italy, on September 2017 and June 2018, and in Rome on October 2018, respectively.

Compliance with ethical standards

Conflicts of interest

The authors have no competing interests to declare.

Ethical approval

The ethics committee of the “Comitato Etico Regionale delle Marche—C.E.R.M.” reviewed and approved this study protocol on September 7, 2017 (protocol no. 2017-0244-AS). All the participating centers submitted the protocol and obtained authorization from the local institutional review board. After completion of the full study report, anonymized participant-level datasets will be available upon reasonable request by contacting the principal investigator.

Informed consent

Informed consent was obtained (in written form) by all the participants in the study.

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Copyright information

© Italian Society of Surgery (SIC) 2019

Authors and Affiliations

  • The Italian ColoRectal Anastomotic Leakage (iCral) study group
    • 1
    Email author
  1. 1.UOC Chirurgia GeneraleAscoli PicenoItaly

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