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

Bartholin Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328429
• Other study ID #: 2017/220
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: June 2018
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 1, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age 18-40, Bartholin cyst/abscess

Exclusion Criteria:

• patients with systemical diseases, patients with recurrent Bartholin abscess

Related Conditions & MeSH terms

• Abscess
• Bartholin Abscess

Intervention

Other:
• Excision
Bartholin gland will be excised
• Marsupialization
Bartholin gland will be marsupialised

Locations

Country	Name	City	State
Turkey	Kanuni SSTRH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	operation time	operation time during the procedure will be recorded.	during procedure