Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.

Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.

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Key information

Conditions

Prevention of Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedale Santa Maria delle Grazie, Pozzuoli, Napoli, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Objective diagnosis of colorectal cancer;
Elective laparoscopic surgery for colorectal cancer
Whatever the stage of cancer
Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery

Exclusion criteria

Age < 18 years
Surgery for non-cancer disease
Duration of surgery < 45 min
Conversion to open surgery
Other indication for anticoagulant therapy
Known cerebral metastases
Kidney or liver failure
Known hemorrhagic diathesis or high risk for bleeding
History of intracerebral bleeding or neurosurgery within 6 months
History of heparin induced thrombocytopenia
Pregnancy or lactation
Refusal of informed consent.

Treatment and study plan

Rivaroxaban

Drug

Tablets

Placebo

Drug

Tablets

Primary outcomes

Venous thromboembolism

Time frame: 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.

The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death.

Sponsors and collaborators

Lead sponsor

Fadoi Foundation, Italy

Other

Collaborators

University Of Perugia

Registry information

Official study title

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

Acronym: PRO-LAPSII

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Feb 16, 2017
Registry last updated: Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed