Overview

This trial is active, not recruiting.

Condition pilonidal sinus
Treatment video assisted ablation of pilonidal sinus
Sponsor Federico II University
Start date September 2013
End date December 2015
Trial size 200 participants
Trial identifier NCT01963273, 5082, Surgery

Summary

The investigators supposed that the complete video assisted ablation of pilonidal sinus (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new minimally invasive treatment allows the identification of the sinus cavity with its lateral tracks, the destruction and the removal of all infected tissue and the removing of any hair.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All consecutive patients with diagnosis of chronic sacrococcygeal pilonidal sinus will be screened for the enrollment in our study.
video assisted ablation of pilonidal sinus

Primary Outcomes

Measure
Infection
time frame: 1 month

Secondary Outcomes

Measure
Recurrence
time frame: 1 year

Eligibility Criteria

Male or female participants from 15 years up to 90 years old.

Inclusion Criteria: Diagnosis of chronic pilonidal sinus Exclusion Criteria: Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique

Additional Information

Official title Video Assisted Ablation of Pilonidal Sinus. Evaluation of Safety and Efficacy of a New Minimally Invasive Technique
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Federico II University.