Video Assisted Ablation of Pilonidal Sinus

Pilonidal Sinus Clinical Trial

Official title:

Video Assisted Ablation of Pilonidal Sinus. Evaluation of Safety and Efficacy of a New Minimally Invasive Technique

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01963273
• Other study ID #: 5082
• Secondary ID: Surgery
• Status: Active, not recruiting
• Phase: N/A
• First received: October 10, 2013
• Last updated: October 15, 2013
• Start date: September 2013

Study information

• Verified date: October 2013
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

Diagnosis of chronic pilonidal sinus

Exclusion Criteria:

Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• Video Assisted Ablation of Pilonidal Sinus

Locations

Country	Name	City	State
Italy	Milone Francesco	Naples	Italiy

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time off work		1 month	Yes
Other	Time to sitting on toilet without pain		1 month	Yes
Other	satisfaction	Satisfaction Scores on the Visual Analog Scale	6 months	Yes
Other	Aesthetic appearance	Aesthetic appearance on a 3 points scale of good fair and bad	6 months	Yes
Other	Pain	Pain Scores on the Visual Analog Scale	1 day, 1 week and 1 month	Yes
Other	time to walk without pain		1 month	Yes
Primary	Infection	Wound infection was defined as redness and/or oedema of the skin and/or discharge	1 month	Yes
Secondary	Recurrence	Recurrence can be divided into two groups: early and late. Early recurrence is usually due to failure to identify one or more sinuses. Late recurrence is usually due to secondary infection caused by residual hair or debris that was not removed at operation, inadequate wound care or insufficient attention to depilation	1 year	Yes