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 Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Randers, Denmark, 8900
- Recruiting
- Randers Central Hospital
-
Contact:
- Pinar Bor, MD, PhD
- Phone Number: 004589102503
- Email: pinarbor@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment
Time Frame: up to one year after treatment
|
up to one year after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Wound healing, local burning, sequelae, hospitalisation time
Time Frame: 3-4 weeks after treatment
|
3-4 weeks after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-000494-22
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