Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease

Study Overview
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Brief Summary
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In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.

Detailed Description
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Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally. PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet. In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.

Official Title
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Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease

Conditions
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Pilonidal Sinus, Sacrococcygeal Pilonidal Disease

Intervention / Treatment
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* Procedure: Karydakis Flap Procedure
* Procedure: Burow's Triangle Advancement Flap Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18-65 Primary pilonidal sinus disease No abscess and absence of active infection during the operation Exclusion Criteria: Patients under the age of 18 and over the age of 65 Recurrent pilonidal sinus cases Patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease Patients with an ASA score of 3-4 Patients with a body mass index greater than 35 kg/m2 Patients with drug and alcohol addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Karydakis Flap Procedure<br>Vertical eccentric elliptical incision down to the post-sacral fascia, complete removal of unhealthy tissue, and normal tissue around the cyst and sinus tracts. Mobilization of the medial wound edge and advancement of the skin. Flap along the midline to the post-sacral fascia and suturing its margin to the lateral wound margin. | Procedure: Karydakis Flap Procedure<br>* Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.<br>|
| Active Comparator: Burow's Triangle Advancement Flap Procedure<br>The flap is incised along the base of the wedge-shaped defect, and a small Burow's triangle is excised on the opposite side. The skin is mobilized and shifted in the direction of the arrow to close the defect. Excising the small Burow's triangle eliminates a dog ear at the base of the flap. | Procedure: Burow's Triangle Advancement Flap Procedure<br>* Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score according to the visual analogue scale | Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score) | 1-3 days | 
| Postoperative wound healing time | Number of weeks of complete duration epithelialization of the wound | 4 to 6 weeks | 
| Procedure-related complications | Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection) | 1 to 6 weeks | 
| Time to return to normal activity | The number of weeks it passes the patient to return to normal activity. | 4 to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Pilonidal Sinus | Number of patients with recurrence pilonidal disease | 6 - 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Karydakis Flap, Pilonidal Cyst