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Prophylactic Antibiotic Treatment During Vaginal Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162604
Recruitment Status : Unknown
Verified February 2005 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : September 13, 2005
Last Update Posted : September 11, 2006
Information provided by:
Hvidovre University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Uterine Prolapse Cystocele Rectocele Enterocele Drug: Cefuroxime Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Antibiotikaprofylakse Ved Vaginalplastik
Study Start Date : May 2005

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162604

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

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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
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Study Director: Marianne Ottesen, M.D, Ph.D Hvidovre University Hospital

Layout table for additonal information Identifier: NCT00162604     History of Changes
Other Study ID Numbers: 2602-415
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: February 2005
Keywords provided by Hvidovre University Hospital:
Prophylactic antibiotic
Postoperative infections
Uterine prolapse grade I - II
defects of the perineal body
Additional relevant MeSH terms:
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Uterine Prolapse
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Uterine Diseases
Genital Diseases, Female
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents