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Prophylactic Antibiotic Treatment During Vaginal Repair

NCT ID: NCT00162604

Last Updated: 2006-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Prolapse Cystocele Rectocele Enterocele

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Cefuroxime

Intervention Type DRUG

Eligibility 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Marianne Ottesen, M.D, Ph.D

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Marianne Ottesen, M.D

Role: CONTACT

Phone: 0045 36323632

Email: [email protected]

Facility Contacts

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Marianne Ottesen, M.D

Role: primary

Other Identifiers

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2602-415

Identifier Type: -

Identifier Source: org_study_id