None listed
Conditions
Brief summary
Current guidelines indicate that after major surgeries for gynaecology cancers, 28 days of blood thinning medication injected under the skin is recommended to reduce the risk of blood clots in the lungs and legs. This can cause bruising and localised pain and impacts whether patients continue taking the medication or not. One study in orthopaedic patients has shown that an oral medication may be effective as an alternative in preventing blood clots instead and because orthopaedic patients and gynae-oncology patients have similar patient characteristics, we believe that this oral medication called rivaroxaban could be suitable for our patients. This study wants to see how the current different treatment options impact patient’s quality of life and how closely they stick with taking the medication. The expected outcome is that patients will prefer the oral medication as this is less likely to produce side effects and so patients will be more likely to continue to take the medication also. We hope that this will have a positive impact on patient's recovery from surgery in the future and if more patients take the medication, an overall lower risk of blood clots.
Interventions
Rivaroxaban 10mg oral once daily. This will be initiated at the treating doctor’s discretion on day 1-3 post-operatively and continued until day 28 post op
Patients will complete a medication adherence diary
Sponsors
Health NZ Waitaha
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Suspected or known diagnosis of an abdominal or pelvic malignancy (regardless of stage) Scheduled for elective abdominal surgery (either laparotomy or laparoscopy) and who would routinely be discharged with prophylactic dose enoxaparin for 28 days.
Exclusion criteria
- Elective surgery for known benign disease - Surgery for vulvar malignancies - High risk for bleeding (not limited to thrombocytopenia, hemophilia’s, potential bleeding lesions, recent trauma, recent stroke, confirmed intracranial or intraspinal bleeding) - Contraindications for anticoagulant treatment, renal disease (Crcl< 50mls/min) - Liver disease i.e. AST and ALT twice the normal, liver failure, chronic active hepatitis, liver cirrhosis - Known history of VTE - Patients already on anti-coagulation preoperatively - History of disorders that predispose to hypercoagulability i.e. Factor V Leiden homozygotes or antithrombin deficiency - History of heparin induced thrombocytopenia - Concomitant use of other anti-coagulants or antiplatelet therapy - With prosthetic heart valves - Uncontrolled severe hypertension (systolic >200mmHg or diastolic >120 mmHg) - <18 years old - Pregnancy or lactation - Unable to provide informed consent - Documented allergy to rivaroxaban or LMWH. - Patients deemed otherwise clinically unfit for clinical trial per investigator’s discretion - Concomitant use of any of the following medications: ketoconazole, rifampicin, carbamazepine and phenytoin, itraconazole, erythromycin, azithromycin, St John’s Wort
Outcome results
None listed