Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery
iCral2
1 other identifier
observational
1,748
1 country
41
Brief Summary
Prospective observational multicenter study on the influence of adherence to enhanced recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission, reoperation rates and length of postoperative stay) after elective colorectal surgery in Italy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Shorter than P25 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedStudy Start
First participant enrolled
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedDecember 11, 2018
December 1, 2018
12 months
December 6, 2018
December 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Anastomotic Leakage rate
Rate of any complication related to the anastomosis after colorectal resection
up to 45 days
Secondary Outcomes (5)
Morbidity rate
up to 45 days
Mortality rate
up to 45 days
Reoperation rate
up to 45 days
Readmission rate
up to 45 days
Length of postoperative hospital stay
up to 45 days
Interventions
Colorectal resections
Eligibility Criteria
Any patient submitted to elective colorectal resection with anastomosis
You may qualify if:
- Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra- and extra-corporeal), including planned Hartmann's reversals.
- American Society of Anesthesiologists' (ASA) class I, II or III
- Elective or delayed urgency surgery
- Patients' written acceptance to be included in the study.
You may not qualify if:
- American Society of Anesthesiologists' (ASA) class IV-V
- Patients with stoma before or at operation
- Simple stoma closure
- Transanal procedure
- Pregnancy
- Hyperthermic intraperitoneal chemotherapy for carcinomatosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
UOC Chirurgia Generale - Ospedale Profili - Fabriano (AN) - ASUR MARCHE AV2
Fabriano, AN, Italy
UOC Chirurgia Generale - Ospedale "C. Urbani" Jesi - AV2 - ASUR Marche
Iesi, AN, Italy
UOC Chirurgia Generale e d'Urgenza - Ospedale Regionale "U. Parini" - Aosta
Aosta, AO, Italy
UOC Chirurgia Generale - Ascoli Piceno - AV5 - ASUR Marche
Ascoli Piceno, AP, Italy
UOC Chirurgia Generale - San Benedetto del Tronto (AP) - AV5 - ASUR Marche
San Benedetto del Tronto, AP, Italy
UOC Chirurgia Generale Universitaria - Ospedale San Salvatore - L'Aquila
L’Aquila, AQ, Italy
UOC Chirurgia Oncologica - AORN San Giuseppe Moscati - Avellino
Avellino, AV, Italy
Clinica Chirurgica, Università di Brescia - UOC Chirurgia Generale 3, ASST Spedali Civili di Brescia - Brescia
Brescia, BS, Italy
UOC Chirurgia Generale - Ospedale Montichiari (BS) - ASST Spedali Civili di Brescia
Montichiari, BS, Italy
S.C. Chirurgia Generale e Oncologica - Azienda Ospedaliera S. Croce e Carle - Cuneo, Italia
Cuneo, CN, 12100, Italy
UOC Chirurgia Generale 1 - Chirurgia laparoscopica - Università di Ferrara
Ferrara, FE, Italy
UOC di Chirurgia Addominale IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo - Foggia
San Giovanni Rotondo, FG, 71013, Italy
UOC Chirurgia Generale - Ospedale S. Maria Annunziata - Firenze - ASL Toscana Centro
Florence, FI, Italy
UOC Chirurgia Generale ad Indirizzo Oncologico - IRCCS San Martino IST - Genova
Genova, GE, 16121, Italy
UOC Chirurgia Generale - Ospedale"San Giovanni di Dio", ASP di Crotone (KR)
Crotone, KR, Italy
UOC Chirurgia Generale e d'Urgenza - Ospedale Cardinale Panico - Tricase (LE)
Tricase, LE, Italy
UOC Chirurgia Generale - ASST Nord - Sesto San Giovanni (MI)
Sesto San Giovanni, MI, Italy
UOC Chirurgia Generale - Ospedale di Esine (BS) - ASST Valcamonica
Esine, NS, Italy
UOC Chirurgia Generale e D'Urgenza - Pescara
Pescara, PE, Italy
UOC Chirurgia Generale - Foligno (PG) - USL UMBRIA 2
Foligno, PG, Italy
SC Chirurgia Generale e Oncologica - AO Marche Nord - Pesaro
Pesaro, PU, Italy
UOC Chirurgia Generale - Ragusa
Ragusa, RG, Italy
UOC Chirurgia Generale - Ospedale "Regina Apostolorum" Albano Laziale (RM)
Albano Laziale, RM, Italy
UOC Chirurgia Generale e d'Urgenza - Policlinico Casilino - Roma
Roma, RM, Italy
UOC Chirurgia Generale e D'Urgenza . Azienda Ospedaliera San Camillo Forlanini Roma
Roma, RM, Italy
UOC Chirurgia Generale e Oncologica - Ospedale San Filippo Neri - ASL Roma1
Roma, RM, Italy
UOS Chirurgia Geriatrica - Università Campus BioMedico - Roma
Roma, RM, Italy
UOSD Chirurgia Mininvasiva e dell'Apparato Digerente - Università Tor Vergata - Roma
Roma, RM, Italy
UOC Chirurgia Generale, Ospedale "Ceccarini" di Riccione (RN)
Riccione, RN, Italy
UOC Chirurgia Generale e d'urgenza, Rimini, Novafeltria, Santarcangelo
Rimini, RN, Italy
UOC Chirurgia Generale I - Ospedale di La Spezia - ASL5 Spezzino
La Spezia, SP, Italy
UOC Chirurgia Generale 1 - Ospedale S. Chiara - APSS Trento
Trento, TN, Italy
UOC Chirurgia Generale e Mininvasiva, Ospedale San Camillo di Trento
Trento, TN, Italy
UOC Chirurgia Generale - Ospedale "E. Agnelli" di Pinerolo (TO) - ASL TO3
Pinerolo, TO, Italy
UOC Chirurgia Generale - Conegliano Veneto (TV) AULSS2 Marca trevigiana
Conegliano, TV, Italy
UOC Chirurgia Generale - Ospedale Sacro Cuore Don Calabria Negrar Verona
Negrar, VR, 37024, Italy
U.O.C. di Chirurgia Generale e dell'Esofago e Stomaco - AOUI di Verona
Verona, VR, Italy
UOC Chirurgia Generale Epatobiliare - AOUI Verona
Verona, VR, Italy
UOC Chirurgia Generale Oncologica - Azienda Ospedaliera Belcolle - Viterbo
Viterbo, VT, Italy
SOC Chirurgia Colorettale - Istituto Nazionale dei Tumori - IRCCS Fondazione "G.Pascale" - Napoli
Napoli, 80100, Italy
UOC Chirurgia Generale - Pozzuoli (NA) - ASL Napoli2 nord
Pozzuoli, Italy
Related Publications (22)
Boushey R, Williams LJ. Management of anastomotic complications of colorectal surgery. Uptodate 2017.
BACKGROUNDSlieker JC, Komen N, Mannaerts GH, Karsten TM, Willemsen P, Murawska M, Jeekel J, Lange JF. Long-term and perioperative corticosteroids in anastomotic leakage: a prospective study of 259 left-sided colorectal anastomoses. Arch Surg. 2012 May;147(5):447-52. doi: 10.1001/archsurg.2011.1690.
PMID: 22249852BACKGROUNDKingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg. 2009 Feb;208(2):269-78. doi: 10.1016/j.jamcollsurg.2008.10.015. Epub 2008 Dec 4. No abstract available.
PMID: 19228539BACKGROUNDHyman N, Manchester TL, Osler T, Burns B, Cataldo PA. Anastomotic leaks after intestinal anastomosis: it's later than you think. Ann Surg. 2007 Feb;245(2):254-8. doi: 10.1097/01.sla.0000225083.27182.85.
PMID: 17245179BACKGROUNDPark JS, Choi GS, Kim SH, Kim HR, Kim NK, Lee KY, Kang SB, Kim JY, Lee KY, Kim BC, Bae BN, Son GM, Lee SI, Kang H. Multicenter analysis of risk factors for anastomotic leakage after laparoscopic rectal cancer excision: the Korean laparoscopic colorectal surgery study group. Ann Surg. 2013 Apr;257(4):665-71. doi: 10.1097/SLA.0b013e31827b8ed9.
PMID: 23333881BACKGROUNDDietz, DW, Bailey, HR. Postoperative complications. In: ASCRS Textbook of Colon and Rectal Surgery, Church, JM, Beck, DE, Wolff, BG, Fleshman, JW, Pemberton, JH, (Eds), Springer-Verlag New York, LLC, New York 2006. p.141.
BACKGROUNDBruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. doi: 10.1046/j.0007-1323.2001.01829.x.
PMID: 11531861BACKGROUNDLaw WI, Chu KW, Ho JW, Chan CW. Risk factors for anastomotic leakage after low anterior resection with total mesorectal excision. Am J Surg. 2000 Feb;179(2):92-6. doi: 10.1016/s0002-9610(00)00252-x.
PMID: 10773140BACKGROUNDLipska MA, Bissett IP, Parry BR, Merrie AE. Anastomotic leakage after lower gastrointestinal anastomosis: men are at a higher risk. ANZ J Surg. 2006 Jul;76(7):579-85. doi: 10.1111/j.1445-2197.2006.03780.x.
PMID: 16813622BACKGROUNDPlatell C, Barwood N, Dorfmann G, Makin G. The incidence of anastomotic leaks in patients undergoing colorectal surgery. Colorectal Dis. 2007 Jan;9(1):71-9. doi: 10.1111/j.1463-1318.2006.01002.x.
PMID: 17181849BACKGROUNDLjungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PMID: 28097305BACKGROUNDLjungqvist O, Thanh NX, Nelson G. ERAS-Value based surgery. J Surg Oncol. 2017 Oct;116(5):608-612. doi: 10.1002/jso.24820. Epub 2017 Sep 5.
PMID: 28873501BACKGROUNDNelson G, Kiyang LN, Crumley ET, Chuck A, Nguyen T, Faris P, Wasylak T, Basualdo-Hammond C, McKay S, Ljungqvist O, Gramlich LM. Implementation of Enhanced Recovery After Surgery (ERAS) Across a Provincial Healthcare System: The ERAS Alberta Colorectal Surgery Experience. World J Surg. 2016 May;40(5):1092-103. doi: 10.1007/s00268-016-3472-7.
PMID: 26928854BACKGROUNDNeville A, Lee L, Antonescu I, Mayo NE, Vassiliou MC, Fried GM, Feldman LS. Systematic review of outcomes used to evaluate enhanced recovery after surgery. Br J Surg. 2014 Feb;101(3):159-70. doi: 10.1002/bjs.9324.
PMID: 24469616BACKGROUNDERAS Compliance Group. The Impact of Enhanced Recovery Protocol Compliance on Elective Colorectal Cancer Resection: Results From an International Registry. Ann Surg. 2015 Jun;261(6):1153-9. doi: 10.1097/SLA.0000000000001029.
PMID: 25671587BACKGROUNDGustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
PMID: 23052794BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PMID: 15273542BACKGROUNDClavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PMID: 19638912BACKGROUNDKaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. doi: 10.1007/s12603-009-0214-7.
PMID: 19812868BACKGROUNDSkipper A, Ferguson M, Thompson K, Castellanos VH, Porcari J. Nutrition screening tools: an analysis of the evidence. JPEN J Parenter Enteral Nutr. 2012 May;36(3):292-8. doi: 10.1177/0148607111414023. Epub 2011 Nov 1.
PMID: 22045723BACKGROUNDHoran TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.
PMID: 1334988BACKGROUNDCatarci M, Ruffo G, Viola MG, Garulli G, Pavanello M, Scatizzi M, Bottino V, Guadagni S; Italian ColoRectal Anastomotic Leakage (iCral) study group. Enhanced Recovery Independently Lowers Failure to Rescue After Colorectal Surgery. Dis Colon Rectum. 2025 May 1;68(5):616-626. doi: 10.1097/DCR.0000000000003655. Epub 2025 Feb 11.
PMID: 39932201DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marco Catarci, MD FACS
Ospedale C & G Mazzoni - Ascoli Piceno
- PRINCIPAL INVESTIGATOR
Gianluca Guercioni, MD
Ospedale C & G Mazzoni - Ascoli Piceno
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, General Surgery Unit
Study Record Dates
First Submitted
December 6, 2018
First Posted
December 11, 2018
Study Start
January 7, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
December 11, 2018
Record last verified: 2018-12