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CompletedNCT03328429Updated Jun 27, 2018

Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy

An interventional study of Excision and Marsupialization in Bartholin Abscess, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Bartholin Abscess

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Keywords

  • bartholin
  • marsupialisation
  • abscess
03

In context

Abscess

152 studies on the registry are indexed under Abscess; 22 are open to participants now.

This study's enrollment of 154 is above the median of 110 across 120 interventional studies indexed under Abscess.

Browse Abscess studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 225 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-40, Bartholin cyst/abscess

Exclusion criteria

Exclusion Criteria:

  • patients with systemical diseases, patients with recurrent Bartholin abscess
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
154 participants (actual)

Study arms

  • Other
    Marsupialization

    Bartholin gland marsupialization will be done to all patients with Bartholin abscess.

    Other: Marsupialization

  • Other
    Excision

    Bartholin gland excision will be done to all patients with Bartholin abscess.

    Other: Excision

Interventions

  • OtherExcision

    Bartholin gland will be excised

  • OtherMarsupialization

    Bartholin gland will be marsupialised

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. operation time

    operation time during the procedure will be recorded.

    Time frame: during procedure

07

Study locations

1 site
  • Kanuni SSTRH
    İstanbul, Turkey
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03328429
Responsible party
Berna Aslan Cetin (Attending physician,ObGyn, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Nov 1, 2017
Start date
Jan 1, 2017
Primary completion
Dec 15, 2017
Completion
May 1, 2018
Last update
Jun 27, 2018

Study contacts

Berna Aslan Çein
principal investigator · KSSTRH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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