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Prophylactic Antibiotic Treatment During Vaginal Repair

H

Hvidovre University Hospital

Status

Unknown

Conditions

Enterocele
Uterine Prolapse
Cystocele
Rectocele

Treatments

Drug: Cefuroxime

Study type

Interventional

Funder types

Other

Identifiers

NCT00162604
2602-415

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Marianne Ottesen, M.D

Data sourced from clinicaltrials.gov

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