Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

Study Overview
=================
Brief Summary
-----------------
Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.

Official Title
-----------------
Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: Surgical treatment of pilonidal sinus disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Underwent surgery due to pilonidal sinus disease Exclusion Criteria: Patients with a history of previous pilonidal sinus surgery, An acute pilonidal abscess, immunodeficiency, using immunosuppressive drugs, refuse to participate in the study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral Parallel Elliptic Flap<br>Patients operated with the bilateral parallel elliptic flap technique. | Procedure: Surgical treatment of pilonidal sinus disease<br>* Advancement flap techniques in surgical treatment of pilonidal sinus disease.<br>|
| Active Comparator: Karydakis Flap<br>Patients operated with the karydakis flap technique. | Procedure: Surgical treatment of pilonidal sinus disease<br>* Advancement flap techniques in surgical treatment of pilonidal sinus disease.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to return to work/school | Time to return to work in daily life after surgery | The patients' return to work ranged from 11 to 49 days. | 
| Postoperative pain | The pain scores of the patients were determined on the first postoperative day. The Visual Analog Scale (VAS), scored from 1 to 10, was administered to the patients to evaluate their postoperative pain levels. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Time to discharge from hospital after surgery | The patients' length of hospital stay ranged from 1 to 4 days. | 
| Recurrence of the disease | Recurrence of the disease | 43 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pilonidal sinus disease, Flap, Karydakis, Bilaterally parallel elliptic