Cystocele, Enterocele, Rectocele, Uterine Prolapse
Conditions
Keywords
Prophylactic antibiotic, Postoperative infections, Uterine prolapse grade I - II, cystocele, rectocele, enterocele, defects of the perineal body
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.
Interventions
DRUGCefuroxime
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively | — |
Countries
Denmark
Contacts
Primary ContactMarianne Ottesen, M.D
Outcome results
None listed