Prophylactic Antibiotic Treatment During Vaginal Repair

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00162604

Collaborator

(none)

200

Enrollment

Location

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

Antibiotikaprofylakse Ved Vaginalplastik

Study Start Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.