search
Back to results

Comparison of Karydakis and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study

Primary Purpose

Pilonidal Sinus, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pilonidal sinus excision
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pilonidal Sinus focused on measuring pilonidal sinus, presakral apse, limberg flap, karydakis flap

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pilonidal sinus disease

Exclusion Criteria:

  • Other disease than pilonidal sinus disease.

Sites / Locations

  • Kahramanmaras Sutcu Imam UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

karydakis flap

limberg flap

Arm Description

An asymmetric elliptical excision is performed, defective tissues between the lower and upper ends are removed until they reach healthy borders. The wound edge is then mobilized and the flap is slid over the corresponding wound edge by suturing to the fascia and the skin to the appropriate wound layers. Thus, the gluteal groove is lateralized. Subcutaneous tissue and skin are closed.

Rhomboid excision and pilonidal sinuses together with damaged tissue. On the right side of the patient, the intact skin is shifted to the medial area where the tissues are removed without tension. Thus, the defective part and gluteal groove are corrected.

Outcomes

Primary Outcome Measures

Postoperative recurrence
pain, swelling and redness in examination

Secondary Outcome Measures

Postoperative infection
purulent drainage
Postoperative wound dehiscence
wound separation

Full Information

First Posted
January 2, 2020
Last Updated
July 8, 2020
Sponsor
Kahramanmaras Sutcu Imam University
search

1. Study Identification

Unique Protocol Identification Number
NCT04217824
Brief Title
Comparison of Karydakis and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study
Official Title
a Prospective, Randomized, Double-blind Study. comparıson of Karydakis Flap and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
May 22, 2021 (Anticipated)
Study Completion Date
May 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

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
Pilonidal sinus disease (PSD) is a chronic inflammation and infection of the sacrococcygeal region. Produces clinic findings with abscess and discharge in the sacrococcygeal region or painful sinus tract in the natal cleft. Its incidence rate among Turkish servicemen is reported to be 8.8% in a study. Although pilonidal sinus disease is common in men, this is the opposite in adolescence. Because adolescent girls are 2 or 3 times more. Karydakis flap and Limberg flap operations widely preferred in recent years in the surgical treatment of PSD. In our study, we aim to compare these two techniques prospectively and randomly.
Detailed Description
The best treatment technique for pilonidal sinus disease (PSD) is still controversial. While some researchers prefer minimally invasive methods, some researchers prefer surgical treatment. The most important concern in surgical treatment options is the prolongation of the disease recovery time and recurrence of the disease. Complications that may develop after treatment prolong the treatment period. The aim of this prospective, randomized study was to compare the results of the widely used Limberg and Karydakis flap operations in recent years. The parameters that will be used in the comparison will be an infection, recurrence and wound decomposition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus, Postoperative Complications
Keywords
pilonidal sinus, presakral apse, limberg flap, karydakis flap

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
karydakis flap
Arm Type
Active Comparator
Arm Description
An asymmetric elliptical excision is performed, defective tissues between the lower and upper ends are removed until they reach healthy borders. The wound edge is then mobilized and the flap is slid over the corresponding wound edge by suturing to the fascia and the skin to the appropriate wound layers. Thus, the gluteal groove is lateralized. Subcutaneous tissue and skin are closed.
Arm Title
limberg flap
Arm Type
Active Comparator
Arm Description
Rhomboid excision and pilonidal sinuses together with damaged tissue. On the right side of the patient, the intact skin is shifted to the medial area where the tissues are removed without tension. Thus, the defective part and gluteal groove are corrected.
Intervention Type
Procedure
Intervention Name(s)
pilonidal sinus excision
Intervention Description
Closure of the defect in pilonidal sinus excision with one of the randomly selected flap methods.
Primary Outcome Measure Information:
Title
Postoperative recurrence
Description
pain, swelling and redness in examination
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Postoperative infection
Description
purulent drainage
Time Frame
1 week
Title
Postoperative wound dehiscence
Description
wound separation
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pilonidal sinus disease Exclusion Criteria: Other disease than pilonidal sinus disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmet gokhan guler
Phone
+905057702633
Email
drgokhanguler@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ali erdal karakaya
Phone
+905326313017
Email
dralierdal@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmet gökhan güler
Organizational Affiliation
kahramanmarasSUI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaras
State/Province
Onikisubat
ZIP/Postal Code
46050
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmet gökhan güler
Phone
+905057702633
Email
drgokhanguler@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Karydakis and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study

We'll reach out to this number within 24 hrs