Evidence map›Paper›PMID 36100263›Full record

Trial reportBMJ (Clinical research ed.)2022

Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial.

Rebecca C Auer, Michael Ott, Paul Karanicolas, Muriel Rebecca Brackstone, Shady Ashamalla, Joel Weaver, Vicky Tagalakis, Marylise Boutros, Peter Stotland, Antonio Caycedo Marulanda and 14 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01455831 (A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colorectal Cancer), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01455831 phase3completednot on this map

A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colorectal Cancer

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2011 to 2021Enrolled616ConditionsAdenocarcinoma of the ColonArmsTinzaparin
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Observational
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  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Rebecca C AuerDepartment of Surgery, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Michael OttDepartment of Surgery, London Health Sciences Centre, London, ON, Canada.
Paul KaranicolasDepartment of Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Muriel Rebecca BrackstoneDepartment of Surgery, London Health Sciences Centre, London, ON, Canada.
Shady AshamallaDepartment of Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Joel WeaverDepartment of Surgery, Queensway Carleton Hospital, Ottawa, ON, Canada.
Vicky TagalakisJewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal, QC, Canada.
Marylise BoutrosJewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal, QC, Canada.
Peter StotlandDepartment of Surgery, North York General Hospital, North York, ON, Canada.
Antonio Caycedo MarulandaDepartment of Surgery, Health Science North, Sudbury, ON, Canada.
Husein MolooDepartment of Surgery, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Shiva JayaramanDepartment of Surgery, St Joseph's Health Centre, Toronto, ON, Canada.
Suni PatelDepartment of Surgery, Kingston Health Sciences Centre, Kingston, ON, Canada.
Grégoire Le GalDepartment of Medicine, Institut du Savoir Montfort, Ottawa, ON, Canada.
Silvana SpadaforaAlgoma District Cancer Program, Sault Area Hospital, Sault Ste Marie, ON, Canada.
Steven MacLellanDepartment of Surgery, Humber River Hospital, Toronto, ON, Canada.
Daniel TrottierDepartment of Surgery, Montfort Hospital, Ottawa, ON, Canada.
Derek JonkerDepartment of Medicine University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Timothy AsmisDepartment of Medicine University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Ranjeeta MallickClinical Epidemiology Program, Method Centre, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Amanda PecarskieDepartment of Medicine University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Tim RamsayDepartment of Surgery, Montfort Hospital, Ottawa, ON, Canada.
Marc CarrierDepartment of Medicine University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada mcarrier@toh.ca.ORCID 0000-0001-8296-2972
PERIOP-01 investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the efficacy and safety of extended duration perioperative thromboprophylaxis by low molecular weight heparin when assessing disease-free survival in patients undergoing resection for colorectal cancer.

designMulticentre, open label, randomised controlled trial. SETTINGS: 12 hospitals in Quebec and Ontario, Canada, between 25 October 2011 and 31 December 2020.

participants614 adults (age ≥18 years) were eligible with pathologically confirmed invasive adenocarcinoma of the colon or rectum, no evidence of metastatic disease, a haemoglobin concentration of ≥8 g/dL, and were scheduled to undergo surgical resection.

interventionsRandom assignment to extended duration thromboprophylaxis using daily subcutaneous tinzaparin at 4500 IU, beginning at decision to operate and continuing for 56 days postoperatively, compared with in-patient postoperative thromboprophylaxis only.

main outcome measuresPrimary outcome was disease-free survival at three years, defined as survival without locoregional recurrence, distant metastases, second primary (same cancer), second primary (other cancer), or death. Secondary outcomes included venous thromboembolism, postoperative major bleeding complications, and five year overall survival. Analyses were done in the intention-to-treat population.

resultsThe trial stopped recruitment prematurely after the interim analysis for futility. The primary outcome occurred in 235 (77%) of 307 patients in the extended duration group and in 243 (79%) of 307 patients in the in-hospital thromboprophylaxis group (hazard ratio 1.1, 95% confidence interval 0.90 to 1.33; P=0.4). Postoperative venous thromboembolism occurred in five patients (2%) in the extended duration group and in four patients (1%) in the in-hospital thromboprophylaxis group (P=0.8). Major surgery related bleeding in the first postoperative week was reported in one person (<1%) in the extended duration and in six people (2%) in the in-hospital thromboprophylaxis group (P=0.1). No difference was noted for overall survival at five years in 272 (89%) patients in the extended duration group and 280 (91%) patients in the in-hospital thromboprophylaxis group (hazard ratio 1.12; 95% confidence interval 0.72 to 1.76; P=0.1).

conclusionsExtended duration to perioperative anticoagulation with tinzaparin did not improve disease-free survival or overall survival in patients with colorectal cancer undergoing surgical resection compared with in-patient postoperative thromboprophylaxis alone. The incidences of venous thromboembolism and postoperative major bleeding were low and similar between groups.

trial registrationClinicalTrials.gov NCT01455831.

Indexed as

Colorectal NeoplasmsVenous ThromboembolismAdolescentAdultAnticoagulantsDisease-Free SurvivalHeparin, Low-Molecular-WeightHumansNeoplasm Recurrence, LocalOntarioPostoperative ComplicationsPostoperative HemorrhageTinzaparinAnticoagulantsHeparin, Low-Molecular-WeightTinzaparin

Identifiers

PMID36100263
PMCPMC9468899

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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.