hysterectomy with or without a unilateral or bilateral salpingooophorectomy per laparotomy for benigne pathology.
Conditions
Interventions
Intervention: Simvastatine tablets, 80mg simvastatine a day, 3 weeks before and 1 week after surgery
Control: Placebo.
Sponsors
BWJ Hellebrekers
Haga Teaching Hospital, Department of Gynecology
Leyweg 275
2545 CH The Hague
0702100000
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years or older; 2. Scheduled for hysterectomy with or without a unilateral or bilateral salpingooophorectomy per laparotomy for benigne pathology; 3. Good general health with no significant systemic condition at baseline evaluation that would hinder proper outcome assessment.
Exclusion criteria
Exclusion criteria: 1. Non compliance with one or several inclusion criteria; 2. Pregnant women; 3. Haematologic or coagulation disorders; 4. Patient has been diagnosed with a carcinoma or is receiving cancer therapy, including anti-neoplastic drugs and radiation; 5. Patient is already on statin therapy; 6. Patients unavailible for the duration of the study; 7. Presence of ongoing pelvic infection, as for example, ovarian or tubal abscess; 8. Patients participating in another clinical trial side effects on previous statin treatment; 9. CPK levels >1,5 times ULN at baseline assessment; 10. ALAT levels >1,5 times ULN at baseline assessment; 11. Concomitant liver disease; 12. Renal insufficiency >KDOKI stage III (cockroft formula); 13. Concomitant muscle disease; 14. Reumatological disorders; 15. Medication: CYP3A4-inhibitors as Ciclosporine, Itraconazol, Ketoconazol, Erytromycin, Claritromycin, HIV-protease inhibitors of grapefruit juice. Antimycotic azoolderivates or macrolide antibiotics and Gemfibrozil. Also other fibrates (PPAR-alpha), nicotine acid and fucidin acid, use of Gamma activators (Rosiglitazone, Pioglitazone, etc.) and use of anti-inflammatory agents in general.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in CRP plasma level from study entry to surgery; 2. Peak plasma level of CRP after surgery; 3. Area under curve of postoperative CRP levels in plasma; 4. tPA concentration in plasma at surgery; 5. tPA activity in plasma at surgery; 6. tPA concentration in peritoneal fluid at surgery; 7. tPA activity in peritoneal fluid at surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peak level in plasma of distribution FM/FbDP's; 2. Area under curve of postoperative distribution FM/FbDP's in plasma. | — |
Contacts
Public ContactMarianne Hel, van der
Research nurse gynecology Haga Teaching Hospital, Department of Gynecology Leyweg 275
Outcome results
None listed