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...
Date First Received: September 9, 2005
Last Updated: September 8, 2006
Verified by: Hvidovre University Hospital, February 2005
Clinical Trial Phase: N/A | Start Date: May 2005
Overall Status: Recruiting
Estimated Enrollment: 200
Brief Summary
Official Title: “Antibiotikaprofylakse Ved Vaginalplastik”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Intervention(s) in this Clinical Trial
- Drug: Cefuroxime
Outcome Measures for this Clinical Trial
Primary Measures
- primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hvidovre University Hospital
Overall Clinical Trial Officials and Contacts
Marianne Ottesen, M.D, Ph.D Study Director Hvidovre University Hospital
Overall Contact: Marianne Ottesen, M.D 0045 36323632 marianne.8sen@dadlnet.dk
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162604
Study ID Number: 2602-415
ClinicalTrials.gov Identifier: NCT00162604
Health Authority: Denmark: Danish Medicines Agency
Clinical Trials Authorship and Review
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