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

June 25, 2018 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Kanuni SSTRH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18-40, Bartholin cyst/abscess

Exclusion Criteria:

  • patients with systemical diseases, patients with recurrent Bartholin abscess

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Marsupialization
Bartholin gland marsupialization will be done to all patients with Bartholin abscess.
Other: Marsupialization
Bartholin gland will be marsupialised
Other: Excision
Bartholin gland excision will be done to all patients with Bartholin abscess.
Other: Excision
Bartholin gland will be excised

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: during procedure
operation time during the procedure will be recorded.
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 22, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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