Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: Italian ColoRectal Anastomotic Leakage Study Group.

NCT03560180 | Unknown DMC

• 1 other identifier: 01/2017
• Study Type: observational
• Target: 1,131
• Locations: 1 country
• Sites: 18

Brief Summary

Prospective evaluation of early diagnosis of anastomotic leak after colorectal resection through evaluation of Dutch leakage score, serum C-reactive protein and serum Procalcitonin

Conditions

Anastomotic Leak; Colorectal Surgery

Keywords

Anastomotic Leak; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Anastomotic Leakage

  Main outcome is anastomotic dehiscence (intended as any deviation from the planned postoperative course related to the anastomosis, or presence of pus or enteric contents within the drains, presence of abdominal or pelvic collection in the area of the anastomosis on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of contrast through the anastomosis during enema or evident anastomotic dehiscence at reoperation for postoperative peritonitis). Thus, all detected leaks will be considered independently of clinical significance. No imaging will be performed routinely in order to search for leakage.

  60 days after operation

Secondary Outcomes (3)

• Operative mortality rates

  60 days after operation

• Operative morbidity rates

  60 days after operation

• Postoperative length of stay

  60 days after operation

Interventions

Dutch score DIAGNOSTIC_TEST

leakage score (DUtch LeaKage, DULK), that consider several items (fever, heart rate, respiratory rate, urinary production, mental status, clinical conditions, signs of ileus, gastric retention, fascial dehiscence, abdominal pain, wound pain, leukocytosis, CRP, increase of urea or creatinine and nutrition status), to give a score

Also known as: Dulk score, Anastomotic Leakage Clinical score

Serum C-reactive Protein DIAGNOSTIC_TEST

see study protocol

serum Procalcitonin DIAGNOSTIC_TEST

see study protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective enrollment from September 2017 to September 2018 in 19 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after having provided a written informed consent.

You may qualify if:

• Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra- and/or extra-corporeal), including planned Hartmann's reversals.
• American Society of Anesthesiologists' (ASA) class I, II or III
• Elective 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
• Ongoing infection prior to surgery
• Hyperthermic intraperitoneal chemotherapy for carcinomatosis

Sponsors & Collaborators

• Ospedale C & G Mazzoni: lead

Study Sites (18)

UOC Chirurgia Generale - Jesi - AV5 - ASUR Marche

Iesi, AN, 60035, Italy

RECRUITING

UOC Chirurgia Generale - Ospedale Montichiari (BS) - ASST Spedali Civili di Brescia

Brescia, BS, 25018, Italy

RECRUITING

Clinica Chirurgica, Università di Brescia - UOC Chirurgia Generale 3, ASST Spedali Civili di Brescia - Brescia

Brescia, BS, 25121, Italy

RECRUITING

S.C. Chirurgia Generale e Oncologica - Azienda Ospedaliera S. Croce e Carle - Cuneo, Italia

Cuneo, CN, 12100, Italy

RECRUITING

UOC di Chirurgia Addominale IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo - Foggia

San Giovanni Rotondo, FG, 71013, Italy

RECRUITING

UOC Chirurgia Generale e Oncologica - Ospedale S. Stefano - Prato (FI) - ASL Toscana Centro

Prato, FI, 59100, Italy

RECRUITING

UOC Chirurgia Generale ad Indirizzo Oncologico - IRCCS San Martino IST - Genova

Genova, GE, 16121, Italy

RECRUITING

SOC Chirurgia Generale, Oncologica e Vascolare - Azienda Ospedaliera Marche Nord - Pesaro

Pesaro, PU, 61121, Italy

RECRUITING

UOC Chirurgia Generale - Ospedale "Regina Apostolorum" Albano Laziale (RM)

Albano Laziale, RM, 00041, Italy

RECRUITING

U.O. di Chirurgia Generale e d'Urgenza - Policlinico Casilino - Roma

Roma, RM, 00100, Italy

RECRUITING

UOC Chirurgia Generale e Oncologica - Ospedale San Filippo Neri - ASL Roma1

Roma, RM, 00100, Italy

RECRUITING

UOS Chirurgia Geriatrica - Policlinico Campus BioMedico - Roma

Roma, RM, 00100, Italy

RECRUITING

UOC Chirurgia Generale, Laparoscopica, Toracica -Ospedale "Ceccarini" di Riccione - Area Vasta Romagna

Riccione, RN, 47921, Italy

RECRUITING

UOC Chirurgia Generale 1 - Ospedale S. Chiara - APSS Trento

Trento, TN, 38121, Italy

RECRUITING

UOC Chirurgia Generale - Ospedale "E. Agnelli" di Pinerolo (TO) - ASL TO3

Pinerolo, TO, 10064, Italy

RECRUITING

UOC Chirurgia Generale - Ospedale Sacro Cuore Don Calabria Negrar Verona

Negrar, VR, 37024, Italy

RECRUITING

UOC Chirurgia Generale Oncologica - Azienda Ospedaliera Belcolle - Viterbo

Viterbo, VT, 01100, Italy

RECRUITING

SOC Chirurgia Colorettale - Istituto Nazionale dei Tumori - IRCCS Fondazione "G.Pascale" - Napoli

Napoli, 80100, Italy

RECRUITING

Related Publications (21)

• Slieker 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: 22249852 BACKGROUND

• Kingham 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: 19228539 BACKGROUND

• Hyman 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: 17245179 BACKGROUND

• Park 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: 23333881 BACKGROUND

• Bruce 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: 11531861 BACKGROUND

• Lipska 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: 16813622 BACKGROUND

• Platell 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: 17181849 BACKGROUND

• Giaccaglia V, Salvi PF, Cunsolo GV, Sparagna A, Antonelli MS, Nigri G, Balducci G, Ziparo V. Procalcitonin, as an early biomarker of colorectal anastomotic leak, facilitates enhanced recovery after surgery. J Crit Care. 2014 Aug;29(4):528-32. doi: 10.1016/j.jcrc.2014.03.036. Epub 2014 Apr 5.

  PMID: 24798346 BACKGROUND

• Ortega-Deballon P, Radais F, Facy O, d'Athis P, Masson D, Charles PE, Cheynel N, Favre JP, Rat P. C-reactive protein is an early predictor of septic complications after elective colorectal surgery. World J Surg. 2010 Apr;34(4):808-14. doi: 10.1007/s00268-009-0367-x.

  PMID: 20049435 BACKGROUND

• Oberhofer D, Juras J, Pavicic AM, Rancic Zuric I, Rumenjak V. Comparison of C-reactive protein and procalcitonin as predictors of postoperative infectious complications after elective colorectal surgery. Croat Med J. 2012 Dec;53(6):612-9. doi: 10.3325/cmj.2012.53.612.

  PMID: 23275327 BACKGROUND

• den Dulk M, Noter SL, Hendriks ER, Brouwers MA, van der Vlies CH, Oostenbroek RJ, Menon AG, Steup WH, van de Velde CJ. Improved diagnosis and treatment of anastomotic leakage after colorectal surgery. Eur J Surg Oncol. 2009 Apr;35(4):420-6. doi: 10.1016/j.ejso.2008.04.009. Epub 2008 Jun 27.

  PMID: 18585889 BACKGROUND

• Dindo 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: 15273542 BACKGROUND

• Clavien 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: 19638912 BACKGROUND

• Kaiser 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: 19812868 BACKGROUND

• Skipper 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: 22045723 BACKGROUND

• Horan 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: 1334988 BACKGROUND

• Italian ColoRectal Anastomotic Leakage (iCral) study group; Borghi F, Migliore M, Cianflocca D, Ruffo G, Patriti A, Delrio P, Scatizzi M, Mancini S, Garulli G, Lucchi A, Carrara A, Pirozzi F, Scabini S, Liverani A, Baiocchi G, Campagnacci R, Muratore A, Longo G, Caricato M, Macarone Palmieri R, Vettoretto N, Ciano P, Benedetti M, Bertocchi E, Ceccaroni M, Pace U, Pandolfini L, Sagnotta A, Pirrera B, Alagna V, Martorelli G, Tirone G, Motter M, Sciuto A, Martino A, Scarinci A, Molfino S, Maurizi A, Marsanic P, Tomassini F, Santoni S, Capolupo GT, Amodio P, Arici E, Cicconi S, Marziali I, Guercioni G, Catarci M. Management and 1-year outcomes of anastomotic leakage after elective colorectal surgery. Int J Colorectal Dis. 2021 May;36(5):929-939. doi: 10.1007/s00384-020-03777-7. Epub 2020 Oct 29.

  PMID: 33118101 DERIVED

• Italian ColoRectal Anastomotic Leakage (iCral) study group. Risk factors for adverse events after elective colorectal surgery: beware of blood transfusions. Updates Surg. 2020 Sep;72(3):811-819. doi: 10.1007/s13304-020-00753-2. Epub 2020 May 12.

  PMID: 32399595 DERIVED

• Italian ColoRectal Anastomotic Leakage (iCral) Study Group. Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis. BJS Open. 2020 Jun;4(3):499-507. doi: 10.1002/bjs5.50269. Epub 2020 Mar 5.

  PMID: 32134216 DERIVED

• 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. 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. G Chir. 2019 Jan-Feb;40(1):20-25.

  PMID: 30771794 DERIVED

• Italian ColoRectal Anastomotic Leakage (iCral) study group. Colorectal surgery in Italy: a snapshot from the iCral study group. Updates Surg. 2019 Jun;71(2):339-347. doi: 10.1007/s13304-018-00612-1. Epub 2019 Feb 11.

  PMID: 30747374 DERIVED

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Catarci, MD

  ASUR Marche

  STUDY DIRECTOR

Central Study Contacts

Marco Catarci, MD

CONTACT

+39 329 8610040; marco.catarci@sanita.marche.it

Benedetta Ruggeri, MD

CONTACT

+39 0736 358254; benedetta.ruggeri@sanita.marche.it

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: June 4, 2018
• First Posted: June 18, 2018
• Study Start: September 4, 2017
• Primary Completion: August 31, 2018
• Study Completion: September 30, 2018
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

IT (18)