Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

Study Overview
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Brief Summary
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Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have designed a comparative study between the conventional and the minimally invasive treatment. Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision with a Bascom out-midline closure (Control group).

Official Title
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Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure

Conditions
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Chronic Sacrococcygeal Pilonidal Sinus

Intervention / Treatment
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* Procedure: Video assisted ablation of pilonidal sinus
* Procedure: Bascom Cleft lift procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic sacrococcygeal pilonidal sinus Exclusion Criteria: Absence of consent to the study Acute abscess

Ages Eligible for Study
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Minimum Age: 12 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAAPS group<br>patients undergoing video assisted ablation of pilonidal sinus | Procedure: Video assisted ablation of pilonidal sinus<br>* A 5-phases' technique. The 1st phase is to insert the endoscope through the external opening (orifice). In the patients that had more than one opening the lower pit is used for access. The 2nd phase is to identify the sinus cavity and its lateral tracks. The endoscope is advanced along the pathway using slow movements, left/right and up/down. These manoeuvres and the saline solution, used as distension medium, allow the sinus cavity to accommodate the endoscope. Additionally mechanical adhesiolysis with the forceps grasping could be useful. The 3rd phase is to identify the presence of hair and its removal. The 4th phase phase is to obtain complete ablation of sinus cavity. The sinus cavity and its lateral tracks are destroyed with the electrode under continuous direct vision. The 5th phase is to obtain the accurate cleaning of sinus cavity. The saline solution flow allows the elimination of any necrotic material. A Volkmann spoon could be useful to complete the cleaning.<br>|
| Active Comparator: conventional treatment group<br>patients undergoing conventional off-midline Bascom cleft lift procedure | Procedure: Bascom Cleft lift procedure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Wound infection was defined as redness and/or oedema of the skin and/or discharge. | at 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing. | at 1 year after surgery | 
| return at work |  | up to 30 days after surgery | 
| Pain | A vas-score scale (0-10) will be used | up to 30 days after surgery | 
| satisfaction | a Vas-score scale (0-10) and a SF_36 model will be used | up to six months after surgery |