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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fadoi Foundation, Italy
• Collaborator: University Of Perugia
• Treatments: Rivaroxaban

Criteria

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.