Prophylactic Antibiotic Treatment During Vaginal Repair
Not Applicable
- Conditions
- Uterine ProlapseCystoceleRectoceleEnterocele
- Registration Number
- NCT00162604
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections.
The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
- Women ages 18+ with uterine prolapse grade I - II and/or cystocele and/or rectocele and/or enterocele grade I - II 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.
Exclusion Criteria
- Patients allergic to cefuroxime.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hvidovre University Hospital
🇩🇰Hvidovre, Denmark