Antibiotikaprofylakse ved vaginalplastik
- Conditions
- terine prolapse grade I-II, cystocele and/or rectocele and/or enterocele grade I - IV and/or defects of the perineal body where there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy.ICD10 codes: N81.1 - N81.8
- Registration Number
- EUCTR2004-005138-38-DK
- Lead Sponsor
- Hvidovre Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
Women age +18 with uterine prolapse grade I-II and/or cystocele and/or rectocele and/or enterocele grade I - IV and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients allergic to Cefuroxim.
Patients in whom a vaginal hysterectomy or a transvaginal suspension of the vaginal vault or other major surgery is planned, where prophylactic antibiotic treatment is standard.
Patients suffering from physical or mental disorders that will not allow them to give informed consent.
Pregnant and nursing women.
Drop outs are defined as:
Patients where the surgeon find it indicated to perform a VH or VV-suspension, or laparotomy, where prophylactic antibiotic treatment is standard.
Patients with adverse events. I.e. intraoperative bladder, ureter or bowl injury where antibiotics are obligatory.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary endpoint is : no infections (urinary tract infections, pneumonia, wound infections, infected haematomas etc) within 30 days postoperatively.;Secondary Objective: ;Primary end point(s): No diagnosed infections (urinary tract infections, pneumonia, wound infections, infected haematomas etc) 30 days postoperatively.
- Secondary Outcome Measures
Name Time Method