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Prophylactic Antibiotic Treatment During Vaginal Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2005 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162604
First Posted: September 13, 2005
Last Update Posted: September 11, 2006
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.
Information provided by:
Hvidovre University Hospital
  Purpose

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 Cystocele Rectocele Enterocele Drug: Cefuroxime

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00162604


Contacts
Contact: Marianne Ottesen, M.D 0045 36323632 ext 3540 marianne.8sen@dadlnet.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Marianne Ottesen, M.D    0045 36323632 ext 3540    marianne.8sen@dadlnet.dk   
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
Investigators
Study Director: Marianne Ottesen, M.D, Ph.D Hvidovre University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00162604     History of Changes
Other Study ID Numbers: 2602-415
First Submitted: September 9, 2005
First Posted: September 13, 2005
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
cystocele
rectocele
enterocele
defects of the perineal body

Additional relevant MeSH terms:
Prolapse
Cystocele
Uterine Prolapse
Rectocele
Hernia
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
Cefuroxime
Anti-Infective Agents