Evidence map›Paper›PMID 35580191›Full record

Trial reportBlood2022

Rivaroxaban vs placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer.

Cecilia Becattini, Ugo Pace, Felice Pirozzi, Annibale Donini, Giampiero Avruscio, Fabio Rondelli, Michela Boncompagni, Damiano Chiari, Marco De Prizio, Adriana Visonà and 16 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Blood, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03055026 (Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer), which is not on this map. Cited by 29 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 7 pooled it
10.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03055026 phase3completednot on this map

Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.

TypeinterventionalSponsorFadoi Foundation, ItalyRan2017 to 2021Enrolled582ConditionsPrevention of Venous ThromboembolismArmsRivaroxaban, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 7 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
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  5. SEOM clinical guidelines on venous thromboembolism (VTE) and cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  6. Pooled it
  7. Efficacy of Factor Xa Inhibitors Versus Placebo in Thromboprophylaxis for Cancer-Associated Thromboembolism: A Systematic Review and Meta-analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  8. Article
  9. Article
  10. Review
  11. Unmet Needs and Challenges in Cancer-Associated Venous Thromboembolism.International journal of molecular sciences · 2026
    Review
  12. Review
  13. Article
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  15. Article
  16. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 2 countries.

Cecilia BecattiniDepartment of Internal and Cardiovascular Medicine and Stroke Unit, University of Perugia, Perugia, Italy.ORCID 0000-0002-8343-4888
Ugo PaceNational Cancer Institute, "G. Pascale" Foundation, Napoli, Italy.ORCID 0000-0003-1367-1500
Felice PirozziLaparoscopic and Robotic Surgery, Department of General Surgery, Santa Maria delle Grazie Hospital, Pozzuoli, Italy.
Annibale DoniniDepartment of Oncology Surgery, University of Perugia, Perugia, Italy.
Giampiero AvruscioDepartment of Cardiac, Thoracic, and Vascular Sciences, Unit of Angiology, University Hospital of Padua, Padua, Italy.ORCID 0000-0002-2344-0637
Fabio RondelliDepartment of General Surgery, S. Giovanni Battista Hospital, Foligno, Italy.
Michela BoncompagniDepartment of General Surgery, S. Maria della Misericordia Hospital, Perugia, Italy.
Damiano ChiariDepartment of General Surgery, Istituto Clinico Humanitas Mater Domini, Varese, Italy.ORCID 0000-0003-3623-686X
Marco De PrizioDepartment of General Surgery, S. Donato Hospital, Arezzo, Italy.
Adriana VisonàDepartment of Vascular Medicine, S. Giacomo Apostolo Hospital, Catelfranco Veneto, Treviso, Italy.
Raffaele De LucaDepartment of Surgical Oncology Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Tumori "Giovanni Paolo II," Bari, Italy.ORCID 0000-0002-9337-0769
Francesco GuerraDepartment of General Surgery, Ospedali Riuniti Marche Nord, Pesaro, Italy.ORCID 0000-0003-2891-4659
Andrea MuratoreDepartment of General Surgery, E. Agnelli Hospital, Pinerolo, Italy.ORCID 0000-0002-8049-6549
Giuseppe PortaleDepartment of General Surgery, Cittadella Hospital, Azienda Unità Sanitaria Locale Socio Sanitaria 6 Euganea, Cittadella, Italy.
Marco MiloneDepartment of General and Emergency Surgery, Azienda Ospedaliera Universitaria "Federico II," Napoli, Italy.ORCID 0000-0001-5612-1926
Giampaolo CastagnoliDepartment of General Surgey, San Matteo degli Infermi Hospital, Spoleto, Italy.
Marc RighiniDivision of Angiology and Hemostasis, Department of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
Jacopo MartellucciEmergency Surgery, Careggi University Hospital, Florence, Italy.ORCID 0000-0002-7437-9098
Roberto PersianiDepartment of General Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Catholic University of the Sacred Heart, Roma, Italy.
Stefania FrassonResearch Department, FADOI Foundation, Milan, Italy.
Francesco DentaliDepartment of Emergencies and Medical Center, Azienda Socio Sanitaria Territoriale "Sette Laghi," Insubria University, Varese, Italy; and.
Paolo DelrioNational Cancer Institute, "G. Pascale" Foundation, Napoli, Italy.ORCID 0000-0002-4271-4939
Mauro CampaniniDepartment of Internal Medicine, Hospital "Maggiore della Carità", Novara, Italy.
Gualberto GussoniResearch Department, FADOI Foundation, Milan, Italy.ORCID 0000-0003-3573-5069
Maria Cristina VedovatiDepartment of Internal and Cardiovascular Medicine and Stroke Unit, University of Perugia, Perugia, Italy.ORCID 0000-0002-2268-9983
Giancarlo AgnelliDepartment of Internal and Cardiovascular Medicine and Stroke Unit, University of Perugia, Perugia, Italy.
University of Perugia · ITFondazione FADOI · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITASL Roma · ITAzienda Ospedaliera di Perugia · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Ospedaliero Universitaria San Giovanni Battista · ITAzienda Socio Sanitaria Territoriale Lariana · ITFederico II University Hospital · ITHumanitas Mater Domini · ITIstituto Tumori Bari · ITOspedale Civile Edoardo Agnelli · ITOspedale di Spoleto · ITOspedale San Donato · ITOspedale San Giacomo Apostolo · ITOspedale Santa Maria · ITOspedali Riuniti Marche Nord · ITUniversità Cattolica del Sacro Cuore · ITUniversity Hospital of Geneva · CHUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The clinical benefit of extended prophylaxis for venous thromboembolism (VTE) after laparoscopic surgery for cancer is unclear. The efficacy and safety of direct oral anticoagulants for this indication are unexplored. PROphylaxis of venous thromboembolism after LAParoscopic Surgery for colorectal cancer Study II (PROLAPS II) was a randomized, double-blind, placebo-controlled, investigator-initiated, superiority study aimed at assessing the efficacy and safety of extended prophylaxis with rivaroxaban after laparoscopic surgery for colorectal cancer. Consecutive patients who had laparoscopic surgery for colorectal cancer were randomized to receive rivaroxaban (10 mg once daily) or a placebo to be started at 7 ± 2 days after surgery and given for the subsequent 3 weeks. All patients received antithrombotic prophylaxis with low-molecular-weight heparin from surgery to randomization. The primary study outcome was the composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected deep vein thrombosis (DVT), or VTE-related death at 28 ± 2 days after surgery. The primary safety outcome was major bleeding. Patient recruitment was prematurely closed due to study drug expiry after the inclusion of 582 of the 646 planned patients. A primary study outcome event occurred in 11 of 282 patients in the placebo group compared with 3 of 287 in the rivaroxaban group (3.9 vs 1.0%; odds ratio, 0.26; 95% confidence interval [CI], 0.07-0.94; log-rank P = .032). Major bleeding occurred in none of the patients in the placebo group and 2 patients in the rivaroxaban group (incidence rate 0.7%; 95% CI, 0-1.0). Oral rivaroxaban was more effective than placebo for extended prevention of VTE after laparoscopic surgery for colorectal cancer without an increase in major bleeding. This trial was registered at www.clinicaltrials.gov as #NCT03055026.

Indexed as

Colorectal NeoplasmsLaparoscopyVenous ThromboembolismAnticoagulantsFibrinolytic AgentsHemorrhageHumansRivaroxabanAnticoagulantsFibrinolytic AgentsRivaroxaban

Identifiers

PMID35580191
PMCPMC9412006
OpenAlexW4280552975

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.