Abdominal Perineal Resection |
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Clinical Trial: Prophylactic Antibiotic Treatment During Vaginal Repair
This study is currently recruiting patients.
Verified by Hvidovre University Hospital February 2005
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Purpose
Prolapse of the uterus, bladder and rectum is a common condition i multiparous and/or elderly women. The number of operations of vaginal repair is increasing in Denmark, but there is no consensus or evidence found of the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections.
The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic in vaginal repair operations.
| Condition | Intervention |
|---|---|
| Uterine Prolapse Cystocele Rectocele Enterocele defects of the perineal body | Drug: Cefuroxime |
MedlinePlus related topics: Anal and Rectal Diseases; Bladder Diseases; Hernia; Pelvic Support Problems
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title: Antibiotikaprofylakse Ved Vaginalplastik
Expected Total Enrollment: 200
Study start: May 2005
Eligibility
Inclusion Criteria:
- Women age + 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 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 re mental disorders that will not allow them to give informed consent.
- Pregnant and nursing women.
Location and Contact Information
Denmark
Hvidovre University Hospital, Hvidovre, 2650, Denmark; Recruiting
Tina Olsen, M.D, Principal Investigator
Marianne Ottesen, M.D, ph.D, Study Director, Hvidovre University Hospital
More Information
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162604
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-13

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