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NCT00162604 Clinical Trial

Prophylactic Antibiotic Treatment During Vaginal Repair

Cystocele Clinical Trial

Official title:
Antibiotikaprofylakse Ved Vaginalplastik

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00162604
Other study ID # 2602-415
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2005
Last updated September 8, 2006
Start date May 2005

Study information
Verified date February 2005
Source Hvidovre University Hospital
Contact Marianne Ottesen, M.D
Phone 0045 36323632
Email marianne.8sen@dadlnet.dk
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Cefuroxime

Locations
Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively
See also
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Active, not recruiting NCT02272322 - Transvaginal Treatment of Symptomatic Cystocele Grade II-III N/A
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Completed NCT04175782 - Enhanced Recovery Protocol in Urogynecologic Surgery N/A
Recruiting NCT05449054 - Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy N/A
Recruiting NCT05688059 - Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension N/A