NCT02222298

Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Sacrococcygeal Pilonidal Sinus

Interventions

Type	Name	Description
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.
PROCEDURE	Bascom Cleft lift procedure

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-11-01
• First posted: 2014-08-21
• Last updated: 2015-11-03

Locations

1 site across 1 country: Italy