Prophylactic Antibiotic Treatment During Vaginal Repair

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Cefuroxime

About this trial

This is an interventional prevention trial for Uterine Prolapse focused on measuring Prophylactic antibiotic, Postoperative infections, Uterine prolapse grade I - II, cystocele, rectocele, enterocele, defects of the perineal body

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Hvidovre University HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00162604

First Posted

September 9, 2005

Last Updated

September 8, 2006

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00162604

Brief Title

Prophylactic Antibiotic Treatment During Vaginal Repair

Official Title

Antibiotikaprofylakse Ved Vaginalplastik

Study Type

Interventional

2. Study Status

Record Verification Date

February 2005

Overall Recruitment Status

Unknown status

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Prolapse, Cystocele, Rectocele, Enterocele

Keywords

Prophylactic antibiotic, Postoperative infections, Uterine prolapse grade I - II, cystocele, rectocele, enterocele, defects of the perineal body

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cefuroxime

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marianne Ottesen, M.D

Phone

0045 36323632

Ext

3540

Email

marianne.8sen@dadlnet.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianne Ottesen, M.D, Ph.D

Organizational Affiliation

Hvidovre University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Hvidovre University Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marianne Ottesen, M.D

Phone

0045 36323632

Ext

3540

Email

marianne.8sen@dadlnet.dk

First Name & Middle Initial & Last Name & Degree

Tina Olsen, M.D

First Name & Middle Initial & Last Name & Degree

Abelone Elisabeth Sakse, M.D

First Name & Middle Initial & Last Name & Degree

Marianne Ottesen, M.D, PhD

Uterine Prolapse, Cystocele, Rectocele

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial