Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein

study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC

M. Benedetti, P. Ciano, I. Pergolini, S. Ciotti, G. Guercioni, G. Ruffo, F. Borghi, A. Patriti, P. Del Rio, M. Scatizzi, S. Mancini, G. Garulli, A. Carrara, F. Pirozzi, S. Scabini, A. Liverani, G. Baiocchi, R. Campagnacci, A. Muratore, G. Longo & 31 others M. Caricato, R. Macarone Palmieri, N. Vettoretto, M. Ceccaroni, S. Guadagni, E. Bertocchi, D. Cianflocca, M. Lambertini, U. Pace, M. Baraghini, L. Pandolfini, R. Angeloni, A. Lucchi, G. Martorelli, G. Tirone, M. Motter, A. Sciuto, A. Martino, A. P. Luzzi, T. Di Cesare, S. Molfino, A. Maurizi, P. Marsanic, F. Tomassini, S. Santoni, G. T. Capolupo, P. Amodio, E. Arici, M. Clementi, B. Ruggeri, M. Catarci

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

BACKGROUND: Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. There is no uniform definition of anastomotic dehiscence and leak. Over the years many risk factors have been identified (distance of anastomosis from anal verge, gender, BMI, ASA score) but none of these allows an early diagnosis of AL. The DUtch LeaKage (DULK) score, C reactive protein (CRP) and procalcitonin (PCT) have been identified as early predictors for anastomotic leakage starting from postoperative day (POD) 2-3. The study was designed to prospectively evaluate AL rates after colorectal resections, in order to give a definite answer to the need for clear risk factors, and testing the diagnostic yeld of DULK score and of laboratory markers. Methods and analysis. A prospective enrollment for all patients undergoing elective colorectal surgery with anastomosis carried out from September 2017 to September 2018 in 19 Italian surgical centers. OUTCOME MEASURES: preoperative risk factors of anastomotic leakage; operative parameters; leukocyte count, serum CRP, serum PCT and DULK score assessment on POD 2 and 3. Primary endpoint is AL; secondary endpoints are minor and major complications according to Clavien-Dindo classification; morbidity and mortality rates; readmission and reoperation rates, length of postoperative hospital stay (Retrospectively registered at ClinicalTrials.gov Identifier: NCT03560180, on June 18, 2018). Ethics. 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.

Original languageEnglish
Pages (from-to)20-25
Number of pages6
JournalIl Giornale di chirurgia
Volume40
Issue number1
Publication statusPublished - Jan 1 2019

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Colorectal Surgery
Anastomotic Leak
Calcitonin
C-Reactive Protein
Multicenter Studies
Observational Studies
Blood Proteins
Early Diagnosis
Serum
Ethics Committees
Research Ethics Committees
Leukocyte Count
Reoperation
Ethics
Length of Stay
Biomarkers
Morbidity
Mortality

ASJC Scopus subject areas

  • Surgery

Cite this

Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein : study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC. / Benedetti, M.; Ciano, P.; Pergolini, I.; Ciotti, S.; Guercioni, G.; Ruffo, G.; Borghi, F.; Patriti, A.; Del Rio, P.; Scatizzi, M.; Mancini, S.; Garulli, G.; Carrara, A.; Pirozzi, F.; Scabini, S.; Liverani, A.; Baiocchi, G.; Campagnacci, R.; Muratore, A.; Longo, G.; Caricato, M.; Macarone Palmieri, R.; Vettoretto, N.; Ceccaroni, M.; Guadagni, S.; Bertocchi, E.; Cianflocca, D.; Lambertini, M.; Pace, U.; Baraghini, M.; Pandolfini, L.; Angeloni, R.; Lucchi, A.; Martorelli, G.; Tirone, G.; Motter, M.; Sciuto, A.; Martino, A.; Luzzi, A. P.; Di Cesare, T.; Molfino, S.; Maurizi, A.; Marsanic, P.; Tomassini, F.; Santoni, S.; Capolupo, G. T.; Amodio, P.; Arici, E.; Clementi, M.; Ruggeri, B.; Catarci, M.

In: Il Giornale di chirurgia, Vol. 40, No. 1, 01.01.2019, p. 20-25.

Research output: Contribution to journalArticle

Benedetti, M, Ciano, P, Pergolini, I, Ciotti, S, Guercioni, G, Ruffo, G, Borghi, F, Patriti, A, Del Rio, P, Scatizzi, M, Mancini, S, Garulli, G, Carrara, A, Pirozzi, F, Scabini, S, Liverani, A, Baiocchi, G, Campagnacci, R, Muratore, A, Longo, G, Caricato, M, Macarone Palmieri, R, Vettoretto, N, Ceccaroni, M, Guadagni, S, Bertocchi, E, Cianflocca, D, Lambertini, M, Pace, U, Baraghini, M, Pandolfini, L, Angeloni, R, Lucchi, A, Martorelli, G, Tirone, G, Motter, M, Sciuto, A, Martino, A, Luzzi, AP, Di Cesare, T, Molfino, S, Maurizi, A, Marsanic, P, Tomassini, F, Santoni, S, Capolupo, GT, Amodio, P, Arici, E, Clementi, M, Ruggeri, B & Catarci, M 2019, 'Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein: study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC', Il Giornale di chirurgia, vol. 40, no. 1, pp. 20-25.
Benedetti, M. ; Ciano, P. ; Pergolini, I. ; Ciotti, S. ; Guercioni, G. ; Ruffo, G. ; Borghi, F. ; Patriti, A. ; Del Rio, P. ; Scatizzi, M. ; Mancini, S. ; Garulli, G. ; Carrara, A. ; Pirozzi, F. ; Scabini, S. ; Liverani, A. ; Baiocchi, G. ; Campagnacci, R. ; Muratore, A. ; Longo, G. ; Caricato, M. ; Macarone Palmieri, R. ; Vettoretto, N. ; Ceccaroni, M. ; Guadagni, S. ; Bertocchi, E. ; Cianflocca, D. ; Lambertini, M. ; Pace, U. ; Baraghini, M. ; Pandolfini, L. ; Angeloni, R. ; Lucchi, A. ; Martorelli, G. ; Tirone, G. ; Motter, M. ; Sciuto, A. ; Martino, A. ; Luzzi, A. P. ; Di Cesare, T. ; Molfino, S. ; Maurizi, A. ; Marsanic, P. ; Tomassini, F. ; Santoni, S. ; Capolupo, G. T. ; Amodio, P. ; Arici, E. ; Clementi, M. ; Ruggeri, B. ; Catarci, M. / Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein : study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC. In: Il Giornale di chirurgia. 2019 ; Vol. 40, No. 1. pp. 20-25.
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title = "Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein: study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC",
abstract = "BACKGROUND: Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. There is no uniform definition of anastomotic dehiscence and leak. Over the years many risk factors have been identified (distance of anastomosis from anal verge, gender, BMI, ASA score) but none of these allows an early diagnosis of AL. The DUtch LeaKage (DULK) score, C reactive protein (CRP) and procalcitonin (PCT) have been identified as early predictors for anastomotic leakage starting from postoperative day (POD) 2-3. The study was designed to prospectively evaluate AL rates after colorectal resections, in order to give a definite answer to the need for clear risk factors, and testing the diagnostic yeld of DULK score and of laboratory markers. Methods and analysis. A prospective enrollment for all patients undergoing elective colorectal surgery with anastomosis carried out from September 2017 to September 2018 in 19 Italian surgical centers. OUTCOME MEASURES: preoperative risk factors of anastomotic leakage; operative parameters; leukocyte count, serum CRP, serum PCT and DULK score assessment on POD 2 and 3. Primary endpoint is AL; secondary endpoints are minor and major complications according to Clavien-Dindo classification; morbidity and mortality rates; readmission and reoperation rates, length of postoperative hospital stay (Retrospectively registered at ClinicalTrials.gov Identifier: NCT03560180, on June 18, 2018). Ethics. 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.",
author = "M. Benedetti and P. Ciano and I. Pergolini and S. Ciotti and G. Guercioni and G. Ruffo and F. Borghi and A. Patriti and {Del Rio}, P. and M. Scatizzi and S. Mancini and G. Garulli and A. Carrara and F. Pirozzi and S. Scabini and A. Liverani and G. Baiocchi and R. Campagnacci and A. Muratore and G. Longo and M. Caricato and {Macarone Palmieri}, R. and N. Vettoretto and M. Ceccaroni and S. Guadagni and E. Bertocchi and D. Cianflocca and M. Lambertini and U. Pace and M. Baraghini and L. Pandolfini and R. Angeloni and A. Lucchi and G. Martorelli and G. Tirone and M. Motter and A. Sciuto and A. Martino and Luzzi, {A. P.} and {Di Cesare}, T. and S. Molfino and A. Maurizi and P. Marsanic and F. Tomassini and S. Santoni and Capolupo, {G. T.} and P. Amodio and E. Arici and M. Clementi and B. Ruggeri and M. Catarci",
year = "2019",
month = "1",
day = "1",
language = "English",
volume = "40",
pages = "20--25",
journal = "Giornale di Chirurgia",
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TY - JOUR

T1 - Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein

T2 - study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC

AU - Benedetti, M.

AU - Ciano, P.

AU - Pergolini, I.

AU - Ciotti, S.

AU - Guercioni, G.

AU - Ruffo, G.

AU - Borghi, F.

AU - Patriti, A.

AU - Del Rio, P.

AU - Scatizzi, M.

AU - Mancini, S.

AU - Garulli, G.

AU - Carrara, A.

AU - Pirozzi, F.

AU - Scabini, S.

AU - Liverani, A.

AU - Baiocchi, G.

AU - Campagnacci, R.

AU - Muratore, A.

AU - Longo, G.

AU - Caricato, M.

AU - Macarone Palmieri, R.

AU - Vettoretto, N.

AU - Ceccaroni, M.

AU - Guadagni, S.

AU - Bertocchi, E.

AU - Cianflocca, D.

AU - Lambertini, M.

AU - Pace, U.

AU - Baraghini, M.

AU - Pandolfini, L.

AU - Angeloni, R.

AU - Lucchi, A.

AU - Martorelli, G.

AU - Tirone, G.

AU - Motter, M.

AU - Sciuto, A.

AU - Martino, A.

AU - Luzzi, A. P.

AU - Di Cesare, T.

AU - Molfino, S.

AU - Maurizi, A.

AU - Marsanic, P.

AU - Tomassini, F.

AU - Santoni, S.

AU - Capolupo, G. T.

AU - Amodio, P.

AU - Arici, E.

AU - Clementi, M.

AU - Ruggeri, B.

AU - Catarci, M.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - BACKGROUND: Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. There is no uniform definition of anastomotic dehiscence and leak. Over the years many risk factors have been identified (distance of anastomosis from anal verge, gender, BMI, ASA score) but none of these allows an early diagnosis of AL. The DUtch LeaKage (DULK) score, C reactive protein (CRP) and procalcitonin (PCT) have been identified as early predictors for anastomotic leakage starting from postoperative day (POD) 2-3. The study was designed to prospectively evaluate AL rates after colorectal resections, in order to give a definite answer to the need for clear risk factors, and testing the diagnostic yeld of DULK score and of laboratory markers. Methods and analysis. A prospective enrollment for all patients undergoing elective colorectal surgery with anastomosis carried out from September 2017 to September 2018 in 19 Italian surgical centers. OUTCOME MEASURES: preoperative risk factors of anastomotic leakage; operative parameters; leukocyte count, serum CRP, serum PCT and DULK score assessment on POD 2 and 3. Primary endpoint is AL; secondary endpoints are minor and major complications according to Clavien-Dindo classification; morbidity and mortality rates; readmission and reoperation rates, length of postoperative hospital stay (Retrospectively registered at ClinicalTrials.gov Identifier: NCT03560180, on June 18, 2018). Ethics. 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.

AB - BACKGROUND: Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. There is no uniform definition of anastomotic dehiscence and leak. Over the years many risk factors have been identified (distance of anastomosis from anal verge, gender, BMI, ASA score) but none of these allows an early diagnosis of AL. The DUtch LeaKage (DULK) score, C reactive protein (CRP) and procalcitonin (PCT) have been identified as early predictors for anastomotic leakage starting from postoperative day (POD) 2-3. The study was designed to prospectively evaluate AL rates after colorectal resections, in order to give a definite answer to the need for clear risk factors, and testing the diagnostic yeld of DULK score and of laboratory markers. Methods and analysis. A prospective enrollment for all patients undergoing elective colorectal surgery with anastomosis carried out from September 2017 to September 2018 in 19 Italian surgical centers. OUTCOME MEASURES: preoperative risk factors of anastomotic leakage; operative parameters; leukocyte count, serum CRP, serum PCT and DULK score assessment on POD 2 and 3. Primary endpoint is AL; secondary endpoints are minor and major complications according to Clavien-Dindo classification; morbidity and mortality rates; readmission and reoperation rates, length of postoperative hospital stay (Retrospectively registered at ClinicalTrials.gov Identifier: NCT03560180, on June 18, 2018). Ethics. 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.

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M3 - Article

VL - 40

SP - 20

EP - 25

JO - Giornale di Chirurgia

JF - Giornale di Chirurgia

SN - 0391-9005

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