Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment
- Conditions
- Chronic Sacrococcygeal Pilonidal Sinus
- Registration Number
- NCT02222298
- Lead Sponsor
- Federico II University
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Chronic sacrococcygeal pilonidal sinus
- Absence of consent to the study
- Acute abscess
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Infection at 30 days after surgery Wound infection was defined as redness and/or oedema of the skin and/or discharge.
- Secondary Outcome Measures
Name Time Method Pain up to 30 days after surgery A vas-score scale (0-10) will be used
satisfaction up to six months after surgery a Vas-score scale (0-10) and a SF_36 model will be used
return at work up to 30 days after surgery recurrence at 1 year after surgery recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.
Trial Locations
- Locations (1)
University of Naples "Federico II"
🇮🇹Naples, Italy
University of Naples "Federico II"🇮🇹Naples, Italy