The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate

Brief Summary

Official Title: “The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate”

Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization treatment.

It is expected that silver nitrate treatment is effective, simple, inexpensive and the least anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2008

Detailed Clinical Trial Description

Background and objective:

Bartholin gland cysts and abscesses are common problems in women of reproductive age. The traditional treatment of Bartholin´s cyst or abscess is marsupialization, which has disadvantages, such as pain of long duration, scarring, risk of general anaesthesia and risk of recurrence. In the present study we use silver nitrate in the treatment of Bartholin's cyst or abscess and compare to marsupialization. We expect lower healing time, lower recurrence rate and less pain with the silver nitrate treatment.

Methods and materials:

30 patients with Bartholin´s cyst or abscess will be investigated. It is prospective randomized study. The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.

The standard marsupialization treatment is performed under general anaesthesia.

Interventions Used in this Clinical Trial

  • Procedure: silver nitrate application to the Bartholin´s cyst
    • 5 mm in diameter and 5 mm in length crystalloid silver nitrate stick is inserted into the cyst or abscess cavity.
  • Procedure: silver nitrat stick
    • The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.

Outcome Measures for this Clinical Trial

Primary Measures

  • Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment
    • Time Frame: up to one year after treatment
      Safety Issue?: No

Secondary Measures

  • Wound healing, local burning, sequelae, hospitalisation time
    • Time Frame: 3-4 weeks after treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Women with a age of 18-60 years
  • Should read and understand Danish
  • All women inclusive pregnant should have a Bartholins cyst or abscess

Exclusion Criteria

  • Subject who cannot give written informed consent

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of Aarhus
  • Collaborator
    • Department of Gynaecology and Obstetrics, Randers Hospital
  • Provider of Information About this Clinical Study
    • Pinar Bor, M.D, Randers Hospital
  • Overall Contact(s)
    • Pinar Bor, MD, Ph.d, +45 89102503, pinarbor@yahoo.com

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00786461