Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

November 2, 2015 updated by: Francesco Milone, Federico II University

Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic sacrococcygeal pilonidal sinus

Exclusion Criteria:

  • Absence of consent to the study
  • Acute abscess

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VAAPS group
patients undergoing video assisted ablation of pilonidal sinus
Procedure: Video assisted ablation of pilonidal sinus
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.
Active Comparator: conventional treatment group
patients undergoing conventional off-midline Bascom cleft lift procedure
Procedure: Bascom Cleft lift procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection
Time Frame: at 30 days after surgery
Wound infection was defined as redness and/or oedema of the skin and/or discharge.
at 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: at 1 year after surgery
recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.
at 1 year after surgery
return at work
Time Frame: up to 30 days after surgery
up to 30 days after surgery
Pain
Time Frame: up to 30 days after surgery
A vas-score scale (0-10) will be used
up to 30 days after surgery
satisfaction
Time Frame: up to six months after surgery
a Vas-score scale (0-10) and a SF_36 model will be used
up to six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • framar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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