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. LongoM. 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

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

    Fingerprint

ASJC Scopus subject areas

  • Surgery

Cite this

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., ... 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, 40(1), 20-25.