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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00162604 |
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Date of registration:
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09/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prophylactic Antibiotic Treatment During Vaginal Repair
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Scientific title:
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Antibiotikaprofylakse Ved Vaginalplastik |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00162604 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Marianne Ottesen, M.D, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hvidovre University Hospital |
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Name:
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Marianne Ottesen, M.D |
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Address:
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Telephone:
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0045 36323632 |
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Email:
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marianne.8sen@dadlnet.dk |
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Affiliation:
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Name:
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Marianne Ottesen, M.D |
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Address:
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Telephone:
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0045 36323632 |
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Email:
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marianne.8sen@dadlnet.dk |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Uterine Prolapse
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Enterocele
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Cystocele
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Rectocele
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Intervention(s)
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Drug: Cefuroxime
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Primary Outcome(s)
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primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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