Video Assisted Ablation of Pilonidal Sinus

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

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.

Study Overview

• Status: Unknown
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: Video Assisted Ablation of Pilonidal Sinus

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italiy
    • Naples, Italiy, Italy, 80131
      • Milone Francesco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Diagnosis of chronic pilonidal sinus

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pilonidal sinuses; All consecutive patients with diagnosis of chronic sacrococcygeal pilonidal sinus will be screened for the enrollment in our study.	Procedure: Video Assisted Ablation of Pilonidal Sinus

What is the study measuring?

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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
time off work		1 month
Time to sitting on toilet without pain		1 month
satisfaction	Satisfaction Scores on the Visual Analog Scale	6 months
Aesthetic appearance	Aesthetic appearance on a 3 points scale of good fair and bad	6 months
Pain	Pain Scores on the Visual Analog Scale	1 day, 1 week and 1 month
time to walk without pain		1 month

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Milone M, Fernandez LM, Musella M, Milone F. Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial. JAMA Surg. 2016 Jun 1;151(6):547-53. doi: 10.1001/jamasurg.2015.5233.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: 5082; Surgery