NCT00162604

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

September 11, 2006

Status Verified

February 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 8, 2006

Conditions

Uterine ProlapseCystoceleRectoceleEnterocele

Keywords

Prophylactic antibioticPostoperative infectionsUterine prolapse grade I - IIcystocelerectoceleenteroceledefects of the perineal body

Outcome Measures

Primary Outcomes (1)

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

Interventions

CefuroximeDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Uterine ProlapseCystoceleRectoceleHernia

Interventions

Cefuroxime

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Marianne Ottesen, M.D, Ph.D

    Hvidovre University Hospital

    STUDY DIRECTOR

Central Study Contacts

Marianne Ottesen, M.D

CONTACT

0045 36323632marianne.8sen@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

May 1, 2005

Last Updated

September 11, 2006

Record last verified: 2005-02

Locations

DK(1)