Emergency Surgery in the Elderly: Comparison of Frailty Index and Surgical Risk Score

NCT02825082 | Completed

• 1 other identifier: 4252_2016 - 12/12/2016
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 43

Brief Summary

EMERGENCY GENERAL SURGERY IN GERIATRIC PATIENTS: EPIDEMIOLOGY, AND EVALUATION OF FACTORS AFFECTING MORBIDITY AND MORTALITY

Conditions

Surgery; Emergency

Keywords

Emergency general surgery; Geriatric; Outcomes; Frailty

Outcome Measures

Primary Outcomes (2)

• 30-day mortality rate

  18 months

• 30-day morbidity rate

  Morbidity defined by mean of the Clavien's Classification scoring system

  18 months

Secondary Outcomes (11)

• Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM)

  18 months

• Calculation of Charlson Age-Comorbidity Index (CACI)

  18 months

• Simplified Acute Physiology Score-II (SAPS-II)

  18 months

• American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator

  18 months

• Calculation of post-Operative Risk in Emergency Surgery (CORES)

  18 months

Interventions

Abdominal emergency surgery PROCEDURE

all abdominal emergency surgery procedures

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multicenter italian national survey cohort study

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (43)

Ospedale Civile Spirito Santo

Pescara, Abruzzo, Italy

Location

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, Apulia, Italy

Location

Presidio Ospedaliero Centrale SS Annunziata di Taranto

Taranto, Apulia, Italy

Location

Policlinico San Pietro

Ponte San Pietro, Bergamo, Italy

Location

Presidio Ospedaliero Duilio Casula

Monserrato, Cagliari, Sardegna, Italy

Location

Ospedale Convenzionato Villa dei Fiori

Acerra, Campania, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale e di alta Specialità

Avellino, Campania, Italy

Location

A.O.R.N Gaetano Rummo

Benevento, Campania, Italy

Location

Azienda Ospedaliera Cardarelli

Napoli, Campania, Italy

Location

Ospedale M. Bufalini Cesena

Cesena, Emilia-Romagna, 47521, Italy

Location

Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Emilia-Romagna, Italy

Location

Ospedale Maggiore di Parma

Parma, Emilia-Romagna, Italy

Location

Ospedale Infermi

Rimini, Emilia-Romagna, Italy

Location

Ospedale del Delta

Lagosanto, Ferrara, Italy

Location

AAS2 Bassa Friulana Isotina - Presidio Ospedaliero di Gorizia

Monfalcone, Gorizia, Italy

Location

Presidio Ospedaliero San Filippo Neri

Rome, Lazio, 00100, Italy

Location

Azienda Ospedaliera San Camillo Forlanini di Roma

Rome, Lazio, Italy

Location

Ospedale Cristo Re

Rome, Lazio, Italy

Location

Policlinico Umberto I

Rome, Lazio, Italy

Location

Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Location

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Ospedale Civile Sant'Agostino Estense

Baggiovara, Modena, Italy

Location

Ospedale Civile di Voghera

Voghera, Pavia, Italy

Location

Azienda Ospedaliero-Universitaria città della salute e della scienza di Torino, presidio Molinette

Turin, Piedmont, Italy

Location

Ospedale Civile di Adria

Adria, Rovigo, Italy

Location

Azienda Ospedaliera G. Brotzu

Cagliari, Sardinia, Italy

Location

P.O. Santissima Trinità ASL8

Cagliari, Sardinia, Italy

Location

Ospedale San Francesco

Nuoro, Sardinia, Italy

Location

Ospedale Santissima Annunziata A.O.U. Sassari

Sassari, Sardinia, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele

Catania, Sicily, Italy

Location

Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona

Ancona, The Marches, 60121, Italy

Location

Ospedale San Donato

Arezzo, Tuscany, 52100, Italy

Location

Ospedale della Misericordia Grosseto

Grosseto, Tuscany, 58100, Italy

Location

Azienda Ospedaliera Pisana Policlinico Universitario Cisanello

Pisa, Tuscany, 56121, Italy

Location

Ospedale San Jacopo di Pistoia

Pistoia, Tuscany, Italy

Location

Ospedale San Giovanni Battista

Foligno, Umbria, 06034, Italy

Location

Ospedale Santa Maria della Stella

Orvieto, Umbria, Italy

Location

Azienda Ospedaliera Santa Maria

Terni, Umbria, Italy

Location

Policlinico Abano Terme

Abano Terme, Veneto, 35031, Italy

Location

ULSS21 Legnago (Verona_ASL2)

Legnago, Verona, Italy

Location

Ospedale di Civita Castellana

Civita Castellana, Viterbo, Italy

Location

Ospedale di Macerata

Marche, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Location

Related Publications (15)

• A, Frezza B, Scandavini CM, Fransvea P, Costa G, Balducci Mortalità e morbilità per chirurgia colica in urgenza nel paziente anziano Lo Conte G Osp. Ital. Chirurgia 2012

  BACKGROUND

• Costa G, Nigri G, Tierno SM, Tomassini F, Varano GM, Venturini Emergency abdominal surgery in the elderly: a ten-year experience L BMC Geriatrics 2009, 9(Suppl 1):A53

  BACKGROUND

• Joseph B, Zangbar B, Pandit V, Fain M, Mohler MJ, Kulvatunyou N, Jokar TO, O'Keeffe T, Friese RS, Rhee P. Emergency General Surgery in the Elderly: Too Old or Too Frail? J Am Coll Surg. 2016 May;222(5):805-13. doi: 10.1016/j.jamcollsurg.2016.01.063. Epub 2016 Feb 26.

  PMID: 27113515 RESULT

• Shah AA, Zafar SN, Kodadek LM, Zogg CK, Chapital AB, Iqbal A, Greene WR, Cornwell EE 3rd, Havens J, Nitzschke S, Cooper Z, Salim A, Haider AH. Never giving up: outcomes and presentation of emergency general surgery in geriatric octogenarian and nonagenarian patients. Am J Surg. 2016 Aug;212(2):211-220.e3. doi: 10.1016/j.amjsurg.2016.01.021. Epub 2016 Mar 19.

  PMID: 27086200 RESULT

• Hewitt J, McCormack C, Tay HS, Greig M, Law J, Tay A, Asnan NH, Carter B, Myint PK, Pearce L, Moug SJ, McCarthy K, Stechman MJ. Prevalence of multimorbidity and its association with outcomes in older emergency general surgical patients: an observational study. BMJ Open. 2016 Mar 31;6(3):e010126. doi: 10.1136/bmjopen-2015-010126.

  PMID: 27033960 RESULT

• Poldermans D, Hoeks SE, Feringa HH. Pre-operative risk assessment and risk reduction before surgery. J Am Coll Cardiol. 2008 May 20;51(20):1913-24. doi: 10.1016/j.jacc.2008.03.005.

  PMID: 18482658 RESULT

• Vasivej T, Sathirapanya P, Kongkamol C. Incidence and Risk Factors of Perioperative Stroke in Noncardiac, and Nonaortic and Its Major Branches Surgery. J Stroke Cerebrovasc Dis. 2016 May;25(5):1172-1176. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.051. Epub 2016 Feb 24.

  PMID: 26922129 RESULT

• McLean RC, McCallum IJ, Dixon S, O'Loughlin P. A 15-year retrospective analysis of the epidemiology and outcomes for elderly emergency general surgical admissions in the North East of England: A case for multidisciplinary geriatric input. Int J Surg. 2016 Apr;28:13-21. doi: 10.1016/j.ijsu.2016.02.044. Epub 2016 Feb 23.

  PMID: 26892599 RESULT

• Merani S, Payne J, Padwal RS, Hudson D, Widder SL, Khadaroo RG. Predictors of in-hospital mortality and complications in very elderly patients undergoing emergency surgery. World J Emerg Surg. 2014 Jul 7;9:43. doi: 10.1186/1749-7922-9-43. eCollection 2014.

  PMID: 25050133 RESULT

• Desserud KF, Veen T, Soreide K. Emergency general surgery in the geriatric patient. Br J Surg. 2016 Jan;103(2):e52-61. doi: 10.1002/bjs.10044. Epub 2015 Dec 1.

  PMID: 26620724 RESULT

• St-Louis E, Sudarshan M, Al-Habboubi M, El-Husseini Hassan M, Deckelbaum DL, Razek TS, Feldman LS, Khwaja K. The outcomes of the elderly in acute care general surgery. Eur J Trauma Emerg Surg. 2016 Feb;42(1):107-13. doi: 10.1007/s00068-015-0517-9. Epub 2015 Apr 8.

  PMID: 26038035 RESULT

• Lorenzon L, Costa G, Massa G, Frezza B, Stella F, Balducci G. The impact of frailty syndrome and risk scores on emergency cholecystectomy patients. Surg Today. 2017 Jan;47(1):74-83. doi: 10.1007/s00595-016-1361-1. Epub 2016 May 30.

  PMID: 27241560 RESULT

• Costa G, La Torre M, Frezza B, Fransvea P, Tomassini F, Ziparo V, Balducci G. Changes in the surgical approach to colonic emergencies during a 15-year period. Dig Surg. 2014;31(3):197-203. doi: 10.1159/000365254. Epub 2014 Aug 28.

  PMID: 25170867 RESULT

• Costa G, Tomassini F, Tierno SM, Venturini L, Frezza B, Cancrini G, Mero A, Lepre L. [Emergency colonic surgery: analysis of risk factors predicting morbidity and mortality]. Chir Ital. 2009 Sep-Dec;61(5-6):565-71. Italian.

  PMID: 20380259 RESULT

• Costa G, Massa G; ERASO (Elderly Risk Assessment for Surgical Outcome) Collaborative Study Group. Frailty and emergency surgery in the elderly: protocol of a prospective, multicenter study in Italy for evaluating perioperative outcome (The FRAILESEL Study). Updates Surg. 2018 Mar;70(1):97-104. doi: 10.1007/s13304-018-0511-y. Epub 2018 Jan 30.

  PMID: 29383680 DERIVED

MeSH Terms

Conditions

Emergencies; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluca Costa, MD, PhD

  University of Roma La Sapienza, Sant' Andrea University Hospital

  STUDY DIRECTOR

• Giuseppe Nigri, MD, FACS

  University of Roma La Sapienza, Sant' Andrea University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD,

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 7, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

IT (43)