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

Phase 4

• Conditions: Bartholin´s Cyst

• Registration Number: NCT00786461
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2007-03
• Status Verified: 2008-11
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Last Update Submitted: 2008-11-05
• Study First Posted: 2008-11-06
• Last Update Posted: 2008-11-06
• Primary Completion: 2008-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment	up to one year after treatment

Secondary Outcome Measures

Name	Time	Method
Wound healing, local burning, sequelae, hospitalisation time	3-4 weeks after treatment

Trial Locations

Locations (1)

Randers Central Hospital; 🇩🇰 Randers, Denmark