Patients needing operative hysteroscopy
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Cefazolin
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
UNIVERSITA` CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients needing operative hysteroscopy ( endometrial polyps, sub mucosal myoma, endometrial ablation, uterine sinechia, uterine septum) 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 undergoing antibiotic therapy for other indications. Patients with infectious disease ( WBC > 11.000\mm3 , Temperature >38 C, muco-purulent leucorrhea)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and feasibility of antibiotic prophylaxis in patients undergoing operative hysteroscopy;Secondary Objective: ;Primary end point(s): Postoperative fever (defined as increase in internal body temperature > 38C starting from 24h and within 10 days after surgical procedure) 2. Postoperative infections (defined as any infection confirmed by positive results of microbiological culture or symptoms of infection) such as: Endometritis PID (pelvic inflammatory disease) Pelvic abscess cervicities-vaginitis | — |
Countries
Italy
Outcome results
None listed