EUCTR2004-005138-38-DK进行中(未招募)不适用
Antibiotikaprofylakse ved vaginalplastik
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
研究者
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