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

Primary Purpose

Bartholin Abscess

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Excision
Marsupialization
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bartholin Abscess focused on measuring bartholin, marsupialisation, abscess

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-40, Bartholin cyst/abscess

Exclusion Criteria:

  • patients with systemical diseases, patients with recurrent Bartholin abscess

Sites / Locations

  • Kanuni SSTRH

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Marsupialization

Excision

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

operation time
operation time during the procedure will be recorded.

Full Information

First Posted
October 22, 2017
Last Updated
June 25, 2018
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03328429
Brief Title
Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
Official Title
Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bartholin Abscess
Keywords
bartholin, marsupialisation, abscess

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marsupialization
Arm Type
Other
Arm Description
Bartholin gland marsupialization will be done to all patients with Bartholin abscess.
Arm Title
Excision
Arm Type
Other
Arm Description
Bartholin gland excision will be done to all patients with Bartholin abscess.
Intervention Type
Other
Intervention Name(s)
Excision
Intervention Description
Bartholin gland will be excised
Intervention Type
Other
Intervention Name(s)
Marsupialization
Intervention Description
Bartholin gland will be marsupialised
Primary Outcome Measure Information:
Title
postoperative
Description
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 Outcome Measure Information:
Title
operation time
Description
operation time during the procedure will be recorded.
Time Frame
during procedure

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients with Bartholin cyst/abscess
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-40, Bartholin cyst/abscess Exclusion Criteria: patients with systemical diseases, patients with recurrent Bartholin abscess
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berna Aslan Çein
Organizational Affiliation
KSSTRH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni SSTRH
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19598336
Citation
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.
Results Reference
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Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy

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