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Prophylactic Antibiotic Treatment During Vaginal Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2005 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Information provided by:
Hvidovre University Hospital Identifier:
First received: September 9, 2005
Last updated: September 8, 2006
Last verified: February 2005

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.

Condition Intervention
Uterine Prolapse
Drug: Cefuroxime

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Antibiotikaprofylakse Ved Vaginalplastik

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively

Estimated Enrollment: 200
Study Start Date: May 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00162604

Contact: Marianne Ottesen, M.D 0045 36323632 ext 3540

Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Marianne Ottesen, M.D    0045 36323632 ext 3540   
Sub-Investigator: Tina Olsen, M.D         
Sub-Investigator: Abelone Elisabeth Sakse, M.D         
Principal Investigator: Marianne Ottesen, M.D, PhD         
Sponsors and Collaborators
Hvidovre University Hospital
Study Director: Marianne Ottesen, M.D, Ph.D Hvidovre University Hospital
  More Information Identifier: NCT00162604     History of Changes
Other Study ID Numbers: 2602-415 
Study First Received: September 9, 2005
Last Updated: September 8, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:
Prophylactic antibiotic
Postoperative infections
Uterine prolapse grade I - II
defects of the perineal body

Additional relevant MeSH terms:
Uterine Diseases
Uterine Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Genital Diseases, Female
Anti-Bacterial Agents
Cefuroxime axetil
Anti-Infective Agents processed this record on October 25, 2016