Bartholin AbscessNCT03328429
Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
A study testing Excision and Marsupialization in people with Bartholin Abscess, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bartholin Abscess
- What is being tested?
- Excision and Marsupialization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 May 2018
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40, Bartholin cyst/abscess
Who cannot join
- patients with systemical diseases, patients with recurrent Bartholin abscess
Trial locations and contacts
1 site in 1 country.
About this study
To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision
Read the detailed description
Bartholin cysts and abscess are commonly seen. Different surgical procedures are done for therapy. Our aim is to compare intraoperative results and postoperative healing of patients undergoing marsupialisation versus excision.
- Conditions
- Bartholin Abscess
- Being tested
- Excision, Marsupialization
- Keywords
- bartholin, marsupialisation, abscess
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExcisionOther
Bartholin gland will be excised
MarsupializationOther
Bartholin gland will be marsupialised
| Study group | Role | What they receive |
|---|---|---|
| Marsupialization | Other | Bartholin gland marsupialization will be done to all patients with Bartholin abscess. Receives: Other: Marsupialization |
| Excision | Other | Bartholin gland excision will be done to all patients with Bartholin abscess. Receives: Other: Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative
Patients will be followed up for three months. 3 months after the surgery, all patients will be asked to complete the Female Sexual Function Index (FSFI) questionnaire alone in a hospital room. The FSFI includes a total of 19-item validated questionnaire which was used for the evaluation of sexual desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual intercourse. Scores range from 2 to 36, higher scores indicate better sexual function. Sexual dysfunction is described as having a total FSFI score of 26.55 or less.
Measured: 3 months
Secondary outcomes (1)
operation time
operation time during the procedure will be recorded.
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Jan 2017
- Primary completion15 Dec 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bartholin AbscessStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Berna Aslan Çein, Principal investigator, KSSTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328429
- Sponsor's protocol ID
- 2017/220
- Status last verified
- Jun 2018
- First submitted
- 22 Oct 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozdegirmenci O, Kayikcioglu F, Haberal A. Prospective Randomized Study of Marsupialization versus Silver Nitrate Application in the Management of Bartholin Gland Cysts and Abscesses. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):149-52. doi: 10.1016/j.jmig.2008.10.006.
PubMed 19598336
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
- ClinicalTrials.gov ID
- NCT03328429
- Acronym / sponsor ID
- 2017/220
- Conditions
- Bartholin Abscess
- Keywords
- bartholin, marsupialisation, abscess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- 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.
To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision
Detailed description
Bartholin cysts and abscess are commonly seen. Different surgical procedures are done for therapy. Our aim is to compare intraoperative results and postoperative healing of patients undergoing marsupialisation versus excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marsupialization | Other | Other: MarsupializationBartholin gland marsupialization will be done to all patients with Bartholin abscess. |
| Excision | Other | Other: ExcisionBartholin gland excision will be done to all patients with Bartholin abscess. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-40, Bartholin cyst/abscess
Key exclusion criteria (1 listed)
- patients with systemical diseases, patients with recurrent Bartholin abscess
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 |
|---|---|---|
| ExcisionBartholin gland will be excised | Other | Excision |
| MarsupializationBartholin gland will be marsupialised | Other | Marsupialization |
Primary outcome
postoperative
Time frame: 3 months
Patients will be followed up for three months. 3 months after the surgery, all patients will be asked to complete the Female Sexual Function Index (FSFI) questionnaire alone in a hospital room. The FSFI includes a total of 19-item validated questionnaire which was used for the evaluation of sexual desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual intercourse. Scores range from 2 to 36, higher scores indicate better sexual function. Sexual dysfunction is described as having a total FSFI score of 26.55 or less.
1 secondary outcome
operation time
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Background: PubMed 19598336Ozdegirmenci O, Kayikcioglu F, Haberal A. Prospective Randomized Study of Marsupialization versus Silver Nitrate Application in the Management of Bartholin Gland Cysts and Abscesses. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):149-52. doi: 10.1016/j.jmig.2008.10.006.
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.
Berna Aslan Çein principal investigator
KSSTRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision and Marsupialization in people with Bartholin Abscess, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 27 Jun 2018. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328429, which also lists 1 linked publication.
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 27 Jun 2018.