Clinical Trial: Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Federico II University

Current Primary Outcome: Infection [ Time Frame: at 30 days after surgery ]

Wound infection was defined as redness and/or oedema of the skin and/or discharge.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Federico II University

Dates:
Date Received: August 19, 2014
Date Started: April 2012
Date Completion:
Last Updated: November 2, 2015
Last Verified: November 2015