Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Study Overview
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Brief Summary
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This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.

Detailed Description
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This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy) Group A: excision and paramedian closure according to modified Karydakis technique Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention

Official Title
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Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial

Conditions
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Pilonidal Sinus

Intervention / Treatment
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* Procedure: Primary closure
* Procedure: Fistulectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pilonidal cyst requiring surgery Signed Informed Consent Form Exclusion Criteria: Abnormal lesions Injuries requiring a closing with rotation flap

Ages Eligible for Study
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Minimum Age: 16 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
Interventional Model Description: Randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary closure<br>Excision of sinus and paramedian closure according to modified Karydakis technique | Procedure: Primary closure<br>* Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.<br>|
| Experimental: Fistulectomy<br>Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention | Procedure: Fistulectomy<br>* Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete healing | percentage of complete healing | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Time to completely recovery | 12 months | 
| percentage of relapse | percentage of relapse after surgery | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilonidal sinus, Bascom, Cleft lift, Fistulectomy, Karydakis