A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: The @RISTOS Project

Giancarlo Agnelli, Giorgio Bolis, Lorenzo Capussotti, Roberto Mario Scarpa, Francesco Tonelli, Erminio Bonizzoni, Marco Moia, Fabio Parazzini, Romina Rossi, Francesco Sonaglia, Bettina Valarani, Carlo Bianchini, Gualberto Gussoni, F. Tonelli, I. Martinelli, B. Andreoni, R. Biffi, S. Cenciarelli, M. Calgaro, R. PolastriD. Zorzi, A. Tubaro, R. Perna, C. Vicentini, S. Montemurro, C. Caliandro, E. Ruggeri, L. Gennari, A. Brocchi, V. Quagliuolo, F. Ragni, G. Conti, E. Cretarola, A. Pagliarulo, G. D'Achille, A. Bartoli, C. Bussotti, E. Ricci, A. Servoli, G. Carrieri, T. Corvasce, G. Disabato, R. Moretti, L. Bencini, S. Cantafio, M. Scatizzi, G. Scambia, E. Foti, L. Frigerio, L. Carlini, A. Gallo, V. Mirone, F. Mangiapia, A. Palmieri, V. Mazzaferro, F. Ravagnani, R. Romito, A. Ferrari, G. Mangili, P. Carnelli, R. Viganò, R. Dionigi, P. Castelli, R. Caronno, G. Piffaretti, L. Uccella, V. Parisi, F. Ruffolo, C. Verrusio, S. Tateo, L. Mereu, S. Salamano, R. Valanzano, M. Lise, D. Nitti, C. Belluco, M. Forlin, R. Massarut, E. Usai, A. De Lisa, P. Cirillo, G. Mosella, G. Quarto, A. Cappiello, F. Mosella, M. Pastore, C. Mangioni, A. Pellegrino, A. Villa, G. Daddi, L. Cagini, F. Calzolari, R. Nigro, G. Confuorto, S. Pecorelli, F. Odicino, T. Sacconi, P. Scollo, G. Scibilia, A. Del Gaudio, D. Accorsi, G. Fiaccavento, F. Plaino

Research output: Contribution to journalArticle

409 Citations (Scopus)

Abstract

Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21-5.71), previous VTE (5.98, 2.13-16.80), advanced cancer (2.68, 1.37-5.24), anesthesia lasting more than 2 hours (4.50, 1.06-19.04), and bed rest longer than 3 days (4.37, 2.45-7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion of events occurring late after surgery. In patients undergoing cancer surgery, VTE is the most common cause of death at 30 days after surgery.

Original languageEnglish
Pages (from-to)89-95
Number of pages7
JournalAnnals of Surgery
Volume243
Issue number1
DOIs
Publication statusPublished - Jan 2006

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Venous Thromboembolism
Prospective Studies
Neoplasms
Gynecologic Surgical Procedures
Ambulatory Surgical Procedures
Venous Thrombosis
Phlebography
Clinical Trials
Bed Rest
Incidence
Pulmonary Embolism
Population
Observational Studies
Cause of Death
Length of Stay
Epidemiology
Anesthesia
Confidence Intervals

ASJC Scopus subject areas

  • Surgery

Cite this

Agnelli, G., Bolis, G., Capussotti, L., Scarpa, R. M., Tonelli, F., Bonizzoni, E., ... Plaino, F. (2006). A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: The @RISTOS Project. Annals of Surgery, 243(1), 89-95. https://doi.org/10.1097/01.sla.0000193959.44677.48

A clinical outcome-based prospective study on venous thromboembolism after cancer surgery : The @RISTOS Project. / Agnelli, Giancarlo; Bolis, Giorgio; Capussotti, Lorenzo; Scarpa, Roberto Mario; Tonelli, Francesco; Bonizzoni, Erminio; Moia, Marco; Parazzini, Fabio; Rossi, Romina; Sonaglia, Francesco; Valarani, Bettina; Bianchini, Carlo; Gussoni, Gualberto; Tonelli, F.; Martinelli, I.; Andreoni, B.; Biffi, R.; Cenciarelli, S.; Calgaro, M.; Polastri, R.; Zorzi, D.; Tubaro, A.; Perna, R.; Vicentini, C.; Montemurro, S.; Caliandro, C.; Ruggeri, E.; Gennari, L.; Brocchi, A.; Quagliuolo, V.; Ragni, F.; Conti, G.; Cretarola, E.; Pagliarulo, A.; D'Achille, G.; Bartoli, A.; Bussotti, C.; Ricci, E.; Servoli, A.; Carrieri, G.; Corvasce, T.; Disabato, G.; Moretti, R.; Bencini, L.; Cantafio, S.; Scatizzi, M.; Scambia, G.; Foti, E.; Frigerio, L.; Carlini, L.; Gallo, A.; Mirone, V.; Mangiapia, F.; Palmieri, A.; Mazzaferro, V.; Ravagnani, F.; Romito, R.; Ferrari, A.; Mangili, G.; Carnelli, P.; Viganò, R.; Dionigi, R.; Castelli, P.; Caronno, R.; Piffaretti, G.; Uccella, L.; Parisi, V.; Ruffolo, F.; Verrusio, C.; Tateo, S.; Mereu, L.; Salamano, S.; Valanzano, R.; Lise, M.; Nitti, D.; Belluco, C.; Forlin, M.; Massarut, R.; Usai, E.; De Lisa, A.; Cirillo, P.; Mosella, G.; Quarto, G.; Cappiello, A.; Mosella, F.; Pastore, M.; Mangioni, C.; Pellegrino, A.; Villa, A.; Daddi, G.; Cagini, L.; Calzolari, F.; Nigro, R.; Confuorto, G.; Pecorelli, S.; Odicino, F.; Sacconi, T.; Scollo, P.; Scibilia, G.; Del Gaudio, A.; Accorsi, D.; Fiaccavento, G.; Plaino, F.

In: Annals of Surgery, Vol. 243, No. 1, 01.2006, p. 89-95.

Research output: Contribution to journalArticle

Agnelli, G, Bolis, G, Capussotti, L, Scarpa, RM, Tonelli, F, Bonizzoni, E, Moia, M, Parazzini, F, Rossi, R, Sonaglia, F, Valarani, B, Bianchini, C, Gussoni, G, Tonelli, F, Martinelli, I, Andreoni, B, Biffi, R, Cenciarelli, S, Calgaro, M, Polastri, R, Zorzi, D, Tubaro, A, Perna, R, Vicentini, C, Montemurro, S, Caliandro, C, Ruggeri, E, Gennari, L, Brocchi, A, Quagliuolo, V, Ragni, F, Conti, G, Cretarola, E, Pagliarulo, A, D'Achille, G, Bartoli, A, Bussotti, C, Ricci, E, Servoli, A, Carrieri, G, Corvasce, T, Disabato, G, Moretti, R, Bencini, L, Cantafio, S, Scatizzi, M, Scambia, G, Foti, E, Frigerio, L, Carlini, L, Gallo, A, Mirone, V, Mangiapia, F, Palmieri, A, Mazzaferro, V, Ravagnani, F, Romito, R, Ferrari, A, Mangili, G, Carnelli, P, Viganò, R, Dionigi, R, Castelli, P, Caronno, R, Piffaretti, G, Uccella, L, Parisi, V, Ruffolo, F, Verrusio, C, Tateo, S, Mereu, L, Salamano, S, Valanzano, R, Lise, M, Nitti, D, Belluco, C, Forlin, M, Massarut, R, Usai, E, De Lisa, A, Cirillo, P, Mosella, G, Quarto, G, Cappiello, A, Mosella, F, Pastore, M, Mangioni, C, Pellegrino, A, Villa, A, Daddi, G, Cagini, L, Calzolari, F, Nigro, R, Confuorto, G, Pecorelli, S, Odicino, F, Sacconi, T, Scollo, P, Scibilia, G, Del Gaudio, A, Accorsi, D, Fiaccavento, G & Plaino, F 2006, 'A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: The @RISTOS Project', Annals of Surgery, vol. 243, no. 1, pp. 89-95. https://doi.org/10.1097/01.sla.0000193959.44677.48
Agnelli, Giancarlo ; Bolis, Giorgio ; Capussotti, Lorenzo ; Scarpa, Roberto Mario ; Tonelli, Francesco ; Bonizzoni, Erminio ; Moia, Marco ; Parazzini, Fabio ; Rossi, Romina ; Sonaglia, Francesco ; Valarani, Bettina ; Bianchini, Carlo ; Gussoni, Gualberto ; Tonelli, F. ; Martinelli, I. ; Andreoni, B. ; Biffi, R. ; Cenciarelli, S. ; Calgaro, M. ; Polastri, R. ; Zorzi, D. ; Tubaro, A. ; Perna, R. ; Vicentini, C. ; Montemurro, S. ; Caliandro, C. ; Ruggeri, E. ; Gennari, L. ; Brocchi, A. ; Quagliuolo, V. ; Ragni, F. ; Conti, G. ; Cretarola, E. ; Pagliarulo, A. ; D'Achille, G. ; Bartoli, A. ; Bussotti, C. ; Ricci, E. ; Servoli, A. ; Carrieri, G. ; Corvasce, T. ; Disabato, G. ; Moretti, R. ; Bencini, L. ; Cantafio, S. ; Scatizzi, M. ; Scambia, G. ; Foti, E. ; Frigerio, L. ; Carlini, L. ; Gallo, A. ; Mirone, V. ; Mangiapia, F. ; Palmieri, A. ; Mazzaferro, V. ; Ravagnani, F. ; Romito, R. ; Ferrari, A. ; Mangili, G. ; Carnelli, P. ; Viganò, R. ; Dionigi, R. ; Castelli, P. ; Caronno, R. ; Piffaretti, G. ; Uccella, L. ; Parisi, V. ; Ruffolo, F. ; Verrusio, C. ; Tateo, S. ; Mereu, L. ; Salamano, S. ; Valanzano, R. ; Lise, M. ; Nitti, D. ; Belluco, C. ; Forlin, M. ; Massarut, R. ; Usai, E. ; De Lisa, A. ; Cirillo, P. ; Mosella, G. ; Quarto, G. ; Cappiello, A. ; Mosella, F. ; Pastore, M. ; Mangioni, C. ; Pellegrino, A. ; Villa, A. ; Daddi, G. ; Cagini, L. ; Calzolari, F. ; Nigro, R. ; Confuorto, G. ; Pecorelli, S. ; Odicino, F. ; Sacconi, T. ; Scollo, P. ; Scibilia, G. ; Del Gaudio, A. ; Accorsi, D. ; Fiaccavento, G. ; Plaino, F. / A clinical outcome-based prospective study on venous thromboembolism after cancer surgery : The @RISTOS Project. In: Annals of Surgery. 2006 ; Vol. 243, No. 1. pp. 89-95.
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title = "A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: The @RISTOS Project",
abstract = "Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52{\%}) undergoing general, 685 (29{\%}) urologic, and 450 (19{\%}) gynecologic surgery. In-hospital prophylaxis was given in 81.6{\%} and postdischarge prophylaxis in 30.7{\%} of the patients. Fifty patients (2.1{\%}) were adjudicated as affected by clinically overt VTE (DVT, 0.42{\%}; nonfatal pulmonary embolism, 0.88{\%}; death 0.80{\%}). The incidence of VTE was 2.83{\%} in general surgery, 2.0{\%} in gynecologic surgery, and 0.87{\%} in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72{\%}; in 46.3{\%} of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95{\%} confidence interval, 1.21-5.71), previous VTE (5.98, 2.13-16.80), advanced cancer (2.68, 1.37-5.24), anesthesia lasting more than 2 hours (4.50, 1.06-19.04), and bed rest longer than 3 days (4.37, 2.45-7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion of events occurring late after surgery. In patients undergoing cancer surgery, VTE is the most common cause of death at 30 days after surgery.",
author = "Giancarlo Agnelli and Giorgio Bolis and Lorenzo Capussotti and Scarpa, {Roberto Mario} and Francesco Tonelli and Erminio Bonizzoni and Marco Moia and Fabio Parazzini and Romina Rossi and Francesco Sonaglia and Bettina Valarani and Carlo Bianchini and Gualberto Gussoni and F. Tonelli and I. Martinelli and B. Andreoni and R. Biffi and S. Cenciarelli and M. Calgaro and R. Polastri and D. Zorzi and A. Tubaro and R. Perna and C. Vicentini and S. Montemurro and C. Caliandro and E. Ruggeri and L. Gennari and A. Brocchi and V. Quagliuolo and F. Ragni and G. Conti and E. Cretarola and A. Pagliarulo and G. D'Achille and A. Bartoli and C. Bussotti and E. Ricci and A. Servoli and G. Carrieri and T. Corvasce and G. Disabato and R. Moretti and L. Bencini and S. Cantafio and M. Scatizzi and G. Scambia and E. Foti and L. Frigerio and L. Carlini and A. Gallo and V. Mirone and F. Mangiapia and A. Palmieri and V. Mazzaferro and F. Ravagnani and R. Romito and A. Ferrari and G. Mangili and P. Carnelli and R. Vigan{\`o} and R. Dionigi and P. Castelli and R. Caronno and G. Piffaretti and L. Uccella and V. Parisi and F. Ruffolo and C. Verrusio and S. Tateo and L. Mereu and S. Salamano and R. Valanzano and M. Lise and D. Nitti and C. Belluco and M. Forlin and R. Massarut and E. Usai and {De Lisa}, A. and P. Cirillo and G. Mosella and G. Quarto and A. Cappiello and F. Mosella and M. Pastore and C. Mangioni and A. Pellegrino and A. Villa and G. Daddi and L. Cagini and F. Calzolari and R. Nigro and G. Confuorto and S. Pecorelli and F. Odicino and T. Sacconi and P. Scollo and G. Scibilia and {Del Gaudio}, A. and D. Accorsi and G. Fiaccavento and F. Plaino",
year = "2006",
month = "1",
doi = "10.1097/01.sla.0000193959.44677.48",
language = "English",
volume = "243",
pages = "89--95",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - A clinical outcome-based prospective study on venous thromboembolism after cancer surgery

T2 - The @RISTOS Project

AU - Agnelli, Giancarlo

AU - Bolis, Giorgio

AU - Capussotti, Lorenzo

AU - Scarpa, Roberto Mario

AU - Tonelli, Francesco

AU - Bonizzoni, Erminio

AU - Moia, Marco

AU - Parazzini, Fabio

AU - Rossi, Romina

AU - Sonaglia, Francesco

AU - Valarani, Bettina

AU - Bianchini, Carlo

AU - Gussoni, Gualberto

AU - Tonelli, F.

AU - Martinelli, I.

AU - Andreoni, B.

AU - Biffi, R.

AU - Cenciarelli, S.

AU - Calgaro, M.

AU - Polastri, R.

AU - Zorzi, D.

AU - Tubaro, A.

AU - Perna, R.

AU - Vicentini, C.

AU - Montemurro, S.

AU - Caliandro, C.

AU - Ruggeri, E.

AU - Gennari, L.

AU - Brocchi, A.

AU - Quagliuolo, V.

AU - Ragni, F.

AU - Conti, G.

AU - Cretarola, E.

AU - Pagliarulo, A.

AU - D'Achille, G.

AU - Bartoli, A.

AU - Bussotti, C.

AU - Ricci, E.

AU - Servoli, A.

AU - Carrieri, G.

AU - Corvasce, T.

AU - Disabato, G.

AU - Moretti, R.

AU - Bencini, L.

AU - Cantafio, S.

AU - Scatizzi, M.

AU - Scambia, G.

AU - Foti, E.

AU - Frigerio, L.

AU - Carlini, L.

AU - Gallo, A.

AU - Mirone, V.

AU - Mangiapia, F.

AU - Palmieri, A.

AU - Mazzaferro, V.

AU - Ravagnani, F.

AU - Romito, R.

AU - Ferrari, A.

AU - Mangili, G.

AU - Carnelli, P.

AU - Viganò, R.

AU - Dionigi, R.

AU - Castelli, P.

AU - Caronno, R.

AU - Piffaretti, G.

AU - Uccella, L.

AU - Parisi, V.

AU - Ruffolo, F.

AU - Verrusio, C.

AU - Tateo, S.

AU - Mereu, L.

AU - Salamano, S.

AU - Valanzano, R.

AU - Lise, M.

AU - Nitti, D.

AU - Belluco, C.

AU - Forlin, M.

AU - Massarut, R.

AU - Usai, E.

AU - De Lisa, A.

AU - Cirillo, P.

AU - Mosella, G.

AU - Quarto, G.

AU - Cappiello, A.

AU - Mosella, F.

AU - Pastore, M.

AU - Mangioni, C.

AU - Pellegrino, A.

AU - Villa, A.

AU - Daddi, G.

AU - Cagini, L.

AU - Calzolari, F.

AU - Nigro, R.

AU - Confuorto, G.

AU - Pecorelli, S.

AU - Odicino, F.

AU - Sacconi, T.

AU - Scollo, P.

AU - Scibilia, G.

AU - Del Gaudio, A.

AU - Accorsi, D.

AU - Fiaccavento, G.

AU - Plaino, F.

PY - 2006/1

Y1 - 2006/1

N2 - Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21-5.71), previous VTE (5.98, 2.13-16.80), advanced cancer (2.68, 1.37-5.24), anesthesia lasting more than 2 hours (4.50, 1.06-19.04), and bed rest longer than 3 days (4.37, 2.45-7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion of events occurring late after surgery. In patients undergoing cancer surgery, VTE is the most common cause of death at 30 days after surgery.

AB - Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21-5.71), previous VTE (5.98, 2.13-16.80), advanced cancer (2.68, 1.37-5.24), anesthesia lasting more than 2 hours (4.50, 1.06-19.04), and bed rest longer than 3 days (4.37, 2.45-7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion of events occurring late after surgery. In patients undergoing cancer surgery, VTE is the most common cause of death at 30 days after surgery.

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