Uterine 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
Conditions
Interventions
Product Name: cefuroxim
Product Code: 436485
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: cefuroxim
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark
Outcome results
None listed