Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

Not Applicable

Completed

• Conditions: Chronic Sacrococcygeal Pilonidal Sinus
• Interventions: Procedure: Bascom Cleft lift procedure; Procedure: Video assisted ablation of 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

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-21
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Chronic sacrococcygeal pilonidal sinus

Exclusion Criteria

• Absence of consent to the study
• Acute abscess

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
conventional treatment group	Bascom Cleft lift procedure	patients undergoing conventional off-midline Bascom cleft lift procedure
VAAPS group	Video assisted ablation of pilonidal sinus	patients undergoing video assisted ablation of pilonidal sinus

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