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

a Prospective, Randomized, Double-blind Study. comparıson of Karydakis Flap and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Pilonidal Sinus
• Intervention / Treatment: Procedure: pilonidal sinus excision

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Onikisubat
    • Kahramanmaras, Onikisubat, Turkey, 46050
      • Recruiting
      • Kahramanmaraş Sütçü İmam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pilonidal sinus disease

Exclusion Criteria:

• Other disease than pilonidal sinus disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: karydakis flap; 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.	Procedure: pilonidal sinus excision; Closure of the defect in pilonidal sinus excision with one of the randomly selected flap methods.
ACTIVE_COMPARATOR: limberg flap; 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.	Procedure: pilonidal sinus excision; Closure of the defect in pilonidal sinus excision with one of the randomly selected flap methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative recurrence	pain, swelling and redness in examination	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative infection	purulent drainage	1 week
Postoperative wound dehiscence	wound separation	1 week

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University
• Investigators: Principal Investigator: ahmet gökhan güler, kahramanmarasSUI

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2019
• Primary Completion (ANTICIPATED): May 22, 2021
• Study Completion (ANTICIPATED): May 22, 2021

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (ACTUAL): January 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pilonidal sinus; presakral apse; limberg flap; karydakis flap
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Cysts; Postoperative Complications; Pilonidal Sinus
• Other Study ID Numbers: 2019/04-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No