The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00786461|
Recruitment Status : Unknown
Verified November 2008 by University of Aarhus.
Recruitment status was: Recruiting
First Posted : November 6, 2008
Last Update Posted : November 6, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Bartholin´s Cyst||Procedure: silver nitrate application to the Bartholin´s cyst Procedure: silver nitrat stick||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||December 2009|
- 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.
- Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment [ Time Frame: up to one year after treatment ]
- Wound healing, local burning, sequelae, hospitalisation time [ Time Frame: 3-4 weeks after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786461
|Contact: Pinar Bor, MD, Ph.d||+45 firstname.lastname@example.org|
|Randers Central Hospital||Recruiting|
|Randers, Denmark, 8900|
|Contact: Pinar Bor, MD, PhD 004589102503 email@example.com|