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

Phase 3

Completed

• Conditions: Prevention of Venous Thromboembolism
• Interventions: Drug: Placebo; Drug: Rivaroxaban

• Registration Number: NCT03055026
• Lead Sponsor: Fadoi Foundation, Italy

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Start: 2017-05-03
• Primary Completion: 2021-07-09
• Study Completion: 2021-09-06
• Status Verified: 2022-02
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Orally administered, OD for 3 weeks (extended prophylaxis)
Rivaroxaban	Rivaroxaban	Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)

Primary Outcome Measures

Name	Time	Method
Venous thromboembolism	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.

Trial Locations

Locations (17)

Ospedale San Donato; 🇮🇹 Arezzo, Italy

AOU Careggi; 🇮🇹 Firenze, Italy

Ospedale San Matteo degli Infermi; 🇮🇹 Spoleto, Perugia, Italy

Ospedale E. Agnelli; 🇮🇹 Pinerolo, Torino, Italy

Nuovo Ospedale "San Giovanni Battista"; 🇮🇹 Foligno, Italy

Ospedale San Giacomo Apostolo; 🇮🇹 Castelfranco Veneto, Treviso, Italy

Policlinico Gemelli; 🇮🇹 Roma, Italy

Ospedale Santa Maria delle Grazie; 🇮🇹 Pozzuoli, Napoli, Italy

Ospedale Santa Maria; 🇮🇹 Terni, Italy

IRCCS Fondazione Pascale; 🇮🇹 Napoli, Italy

Istituto Clinico Humanitas Mater Domini; 🇮🇹 Castellanza, Varese, Italy

Ospedale di Piacenza; 🇮🇹 Piacenza, Italy

AOU Federico II; 🇮🇹 Napoli, Italy

Policlinico di Padova; 🇮🇹 Padova, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Perugia, Italy

Ospedale San Salvatore; 🇮🇹 Pesaro, Italy

Ospedale di Cittadella; 🇮🇹 Cittadella, Padova, Italy