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

Prevention of Venous Thromboembolism Clinical Trial

— PRO-LAPSII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055026
• Other study ID #: FADOI.01.2016
• Status: Completed
• Phase: Phase 3
• Start date: May 3, 2017
• Est. completion date: September 6, 2021

Study information

• Verified date: February 2022
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: September 6, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prevention of Venous Thromboembolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban
Tablets
• Placebo
Tablets

Locations

Country	Name	City	State
Italy	Ospedale San Donato	Arezzo
Italy	Ospedale San Giacomo Apostolo	Castelfranco Veneto	Treviso
Italy	Istituto Clinico Humanitas Mater Domini	Castellanza	Varese
Italy	Ospedale di Cittadella	Cittadella	Padova
Italy	AOU Careggi	Firenze
Italy	Nuovo Ospedale "San Giovanni Battista"	Foligno
Italy	AOU Federico II	Napoli
Italy	IRCCS Fondazione Pascale	Napoli
Italy	Policlinico di Padova	Padova
Italy	Ospedale Santa Maria della Misericordia	Perugia
Italy	Ospedale San Salvatore	Pesaro
Italy	Ospedale di Piacenza	Piacenza
Italy	Ospedale E. Agnelli	Pinerolo	Torino
Italy	Ospedale Santa Maria delle Grazie	Pozzuoli	Napoli
Italy	Policlinico Gemelli	Roma
Italy	Ospedale San Matteo degli Infermi	Spoleto	Perugia
Italy	Ospedale Santa Maria	Terni

Sponsors (2)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy	University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism	The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death.	28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.