No registrations found.
ID
Source
Health condition
hysterectomy with or without a unilateral or bilateral salpingooophorectomy per laparotomy for benigne pathology.
Sponsors and support
Haga Teaching Hospital, Department of Gynecology
Leyweg 275
2545 CH The Hague
0702100000
Haga Teaching Hospital, Department of Gynecology
Leyweg 275
2545 CH The Hague
0702100000
Intervention
Outcome measures
Primary outcome
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 outcome
1. Peak level in plasma of distribution FM/FbDP's;
2. Area under curve of postoperative distribution FM/FbDP's in plasma.
Background summary
Twenty patients, scheduled for an abdominal hysterectomy with or without a unilateral or bilateral salpingo-oophorectomy for benign pathology are included in this randomized clinical pilot study. Test patients will receive 80 mg Simvastatin per day, three weeks before surgery and one week thereafter, whereas the control patients will receive placebo before and after the surgical procedure. The ability to significantly increase peritoneal fibrinolytic activity will be assessed by comparing the fibrinolytic activity and concentrations of fibrinolytic parameters in peritoneal fluid and plasma in Simvastatin treated patients and controls.
Study objective
Statins are able to significantly increase peritoneal fibrinolytic activity.
Study design
Blood samples:
I: - 4-8 weeks;
II: -3 weeks;
III: day of surgery;
IV: during surgery;
V: +3 hours;
VI: +6 hours;
VII: +1 day;
VIII: + 2 days;
IX: +3 days;
X: +1 week.
Intervention
Intervention: Simvastatine tablets, 80mg simvastatine a day, 3 weeks before and 1 week after surgery;
Control: Placebo.
Haga Teaching Hospital, Department of Gynecology<br>
Leyweg 275
Marianne Hel, van der
Den Haag 2545 CH
The Netherlands
+31 (0)70 2106219
m.vanderhel@hagaziekenhuis.nl
Haga Teaching Hospital, Department of Gynecology<br>
Leyweg 275
Marianne Hel, van der
Den Haag 2545 CH
The Netherlands
+31 (0)70 2106219
m.vanderhel@hagaziekenhuis.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3309 |
| NTR-old | NTR3456 |
| Other | METC : 10-018 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |