Back to resultsVideo Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment
Primary Purpose
Chronic Sacrococcygeal Pilonidal Sinus
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Video assisted ablation of pilonidal sinus
Bascom Cleft lift procedure
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sacrococcygeal Pilonidal Sinus
Eligibility Criteria
Inclusion Criteria:
- Chronic sacrococcygeal pilonidal sinus
Exclusion Criteria:
- Absence of consent to the study
- Acute abscess
Sites / Locations
- University of Naples "Federico II"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VAAPS group
conventional treatment group
Arm Description
patients undergoing video assisted ablation of pilonidal sinus
patients undergoing conventional off-midline Bascom cleft lift procedure
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 was defined when symptoms of the disease recurred after an interval following complete wound healing.
return at work
Pain
A vas-score scale (0-10) will be used
satisfaction
a Vas-score scale (0-10) and a SF_36 model will be used
Full Information
NCT ID
NCT02222298
First Posted
August 19, 2014
Last Updated
November 2, 2015
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02222298
Brief Title
Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment
Official Title
Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sacrococcygeal Pilonidal Sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VAAPS group
Arm Type
Experimental
Arm Description
patients undergoing video assisted ablation of pilonidal sinus
Arm Title
conventional treatment group
Arm Type
Active Comparator
Arm Description
patients undergoing conventional off-midline Bascom cleft lift procedure
Intervention Type
Procedure
Intervention Name(s)
Video assisted ablation of pilonidal sinus
Intervention Description
A 5-phases' technique. The 1st phase is to insert the endoscope through the external opening (orifice). In the patients that had more than one opening the lower pit is used for access. The 2nd phase is to identify the sinus cavity and its lateral tracks. The endoscope is advanced along the pathway using slow movements, left/right and up/down. These manoeuvres and the saline solution, used as distension medium, allow the sinus cavity to accommodate the endoscope. Additionally mechanical adhesiolysis with the forceps grasping could be useful. The 3rd phase is to identify the presence of hair and its removal. The 4th phase phase is to obtain complete ablation of sinus cavity. The sinus cavity and its lateral tracks are destroyed with the electrode under continuous direct vision. The 5th phase is to obtain the accurate cleaning of sinus cavity. The saline solution flow allows the elimination of any necrotic material. A Volkmann spoon could be useful to complete the cleaning.
Intervention Type
Procedure
Intervention Name(s)
Bascom Cleft lift procedure
Primary Outcome Measure Information:
Title
Infection
Description
Wound infection was defined as redness and/or oedema of the skin and/or discharge.
Time Frame
at 30 days after surgery
Secondary Outcome Measure Information:
Title
recurrence
Description
recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.
Time Frame
at 1 year after surgery
Title
return at work
Time Frame
up to 30 days after surgery
Title
Pain
Description
A vas-score scale (0-10) will be used
Time Frame
up to 30 days after surgery
Title
satisfaction
Description
a Vas-score scale (0-10) and a SF_36 model will be used
Time Frame
up to six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic sacrococcygeal pilonidal sinus
Exclusion Criteria:
Absence of consent to the study
Acute abscess
Facility Information:
Facility Name
University of Naples "Federico II"
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
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Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment
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