Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus

April 15, 2014 updated by: MD. Mehmet SAYDAM (General Surgeon), Ankara Mevki Military Hospital

Interventional Study of the Relatively New Surgical Techniques on the Treatment of Pilonidal Sinus Disease

The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.

Study Type

Interventional

Enrollment (Actual)

1

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
      • Ankara, Turkey, 06110
        • Ankara Mevki Military Hospital : General Surgery Department

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

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Pilonidal Sinus Disease
  • Must be able to suitable for the surgery

Exclusion Criteria:

  • Patients with Recurrent Pilonidal Sinus disease
  • Patient whom is not suitable for surgery

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flap Transposition Technique
Procedure: Flap Transposition Procedures
Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)
Time Frame: 12 hours
12 hours

Collaborators and Investigators

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

Sponsor

Ankara Mevki Military 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

Helpful Links

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

June 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 17, 2014

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMMA-LEC-001642

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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