Back to resultsVideo Assisted Ablation of Pilonidal Sinus
Primary Purpose
Pilonidal Sinus
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Video Assisted Ablation of Pilonidal Sinus
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic pilonidal sinus
Exclusion Criteria:
Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique
Sites / Locations
- Milone Francesco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pilonidal sinuses
Arm Description
All consecutive patients with diagnosis of chronic sacrococcygeal pilonidal sinus will be screened for the enrollment in our study.
Outcomes
Primary Outcome Measures
Infection
Wound infection was defined as redness and/or oedema of the skin and/or discharge
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01963273
First Posted
October 10, 2013
Last Updated
October 15, 2013
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT01963273
Brief Title
Video Assisted Ablation of Pilonidal Sinus
Official Title
Video Assisted Ablation of Pilonidal Sinus. Evaluation of Safety and Efficacy of a New Minimally Invasive Technique
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pilonidal sinuses
Arm Type
Experimental
Arm Description
All consecutive patients with diagnosis of chronic sacrococcygeal pilonidal sinus will be screened for the enrollment in our study.
Intervention Type
Procedure
Intervention Name(s)
Video Assisted Ablation of Pilonidal Sinus
Primary Outcome Measure Information:
Title
Infection
Description
Wound infection was defined as redness and/or oedema of the skin and/or discharge
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Recurrence
Description
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
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
time off work
Time Frame
1 month
Title
Time to sitting on toilet without pain
Time Frame
1 month
Title
satisfaction
Description
Satisfaction Scores on the Visual Analog Scale
Time Frame
6 months
Title
Aesthetic appearance
Description
Aesthetic appearance on a 3 points scale of good fair and bad
Time Frame
6 months
Title
Pain
Description
Pain Scores on the Visual Analog Scale
Time Frame
1 day, 1 week and 1 month
Title
time to walk without pain
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic pilonidal sinus
Exclusion Criteria:
Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique
Facility Information:
Facility Name
Milone Francesco
City
Naples
State/Province
Italiy
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
26819186
Citation
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.
Results Reference
derived
Learn more about this trial
Video Assisted Ablation of Pilonidal Sinus
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