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Prophylactic Antibiotic Treatment During Vaginal Repair - Article


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Birth Defects

Abnormalities


Clinical Trial: Prophylactic Antibiotic Treatment During Vaginal Repair

This study is currently recruiting patients.
Verified by Hvidovre University Hospital February 2005

Sponsored by: Hvidovre University Hospital
Information provided by: Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00162604

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

Further Study Details: 
Primary Outcomes: primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas ect) within 30 days postoperatively
Expected Total Enrollment:  200

Study start: May 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00162604

Tina Olsen, M.D      0045 36323632  Ext. 5372    tinao@get2net

Denmark
      Hvidovre University Hospital, Hvidovre,  2650,  Denmark; Recruiting
Tina Olsen, M.D  0045 36323632  Ext. 5372    tinao@get2net.dk 
Tina Olsen, M.D,  Principal Investigator

Study chairs or principal investigators

Marianne Ottesen, M.D, ph.D,  Study Director,  Hvidovre University Hospital   

More Information

Study ID Numbers:  2602-415
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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Page Updated: October 3, 2005
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