Back to resultsThe Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
Primary Purpose
Bartholin´s Cyst
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
silver nitrate application to the Bartholin´s cyst
silver nitrat stick
Sponsored by
About this trial
This is an interventional treatment trial for Bartholin´s Cyst focused on measuring silver nitrate, marsupialisation
Eligibility Criteria
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
Sites / Locations
- Randers Central HospitalRecruiting
Outcomes
Primary Outcome Measures
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment
Secondary Outcome Measures
Wound healing, local burning, sequelae, hospitalisation time
Full Information
NCT ID
NCT00786461
First Posted
November 5, 2008
Last Updated
November 5, 2008
Sponsor
University of Aarhus
Collaborators
Randers Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00786461
Brief Title
The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
Official Title
The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Randers Regional Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bartholin´s Cyst
Keywords
silver nitrate, marsupialisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
silver nitrate application to the Bartholin´s cyst
Intervention Description
5 mm in diameter and 5 mm in length crystalloid silver nitrate stick is inserted into the cyst or abscess cavity.
Intervention Type
Procedure
Intervention Name(s)
silver nitrat stick
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment
Time Frame
up to one year after treatment
Secondary Outcome Measure Information:
Title
Wound healing, local burning, sequelae, hospitalisation time
Time Frame
3-4 weeks after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pinar Bor, MD, Ph.d
Phone
+45 89102503
Email
pinarbor@yahoo.com
Facility Information:
Facility Name
Randers Central Hospital
City
Randers
ZIP/Postal Code
8900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinar Bor, MD, PhD
Phone
004589102503
Email
pinarbor@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
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