Bartholin´s CystPhase 4NCT00786461
The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
A Phase 4 study testing silver nitrate application to the Bartholin´s cyst and silver nitrat stick in people with Bartholin´s Cyst, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bartholin´s Cyst
- What is being tested?
- silver nitrate application to the Bartholin´s cyst and silver nitrat stick
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a age of 18-60 years
- Should read and understand Danish
- All women inclusive pregnant should have a Bartholins cyst or abscess
Who cannot join
- Subject who cannot give written informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Randers Central Hospital
Randers, Randers, 8900
Pinar Bor, MD, PhD, 004589102503, pinarbor@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Bartholin´s Cyst
- Being tested
- silver nitrate application to the Bartholin´s cyst, silver nitrat stick
- Keywords
- silver nitrate, marsupialisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver nitrate application to the Bartholin´s cystProcedure or surgery
5 mm in diameter and 5 mm in length crystalloid silver nitrate stick is inserted into the cyst or abscess cavity.
silver nitrat stickProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment
Measured: up to one year after treatment
Secondary outcomes (1)
Wound healing, local burning, sequelae, hospitalisation time
Measured: 3-4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bartholin´s CystStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786461
- Sponsor's protocol ID
- 2005-000494-22
- Other IDs
- 2005
- Status last verified
- Nov 2008
- First submitted
- 5 Nov 2008
- Last updated
- 6 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
- ClinicalTrials.gov ID
- NCT00786461
- Acronym / sponsor ID
- 2005-000494-22
- Conditions
- Bartholin´s Cyst
- Keywords
- silver nitrate, marsupialisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with a age of 18-60 years
- Should read and understand Danish
- All women inclusive pregnant should have a Bartholins cyst or abscess
Key exclusion criteria (1 listed)
- Subject who cannot give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silver nitrate application to the Bartholin´s cyst5 mm in diameter and 5 mm in length crystalloid silver nitrate stick is inserted into the cyst or abscess cavity. | Procedure or surgery | – |
| silver nitrat stickThe 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. | Procedure or surgery | – |
Primary outcome
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment
Time frame: up to one year after treatment
1 secondary outcome
Wound healing, local burning, sequelae, hospitalisation time
Time frame: 3-4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing silver nitrate application to the Bartholin´s cyst and silver nitrat stick in people with Bartholin´s Cyst, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar Bor, MD, Ph.d (+45 89102503, pinarbor@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment (time frame: up to one year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2008.