Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

Chronic Sacrococcygeal Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222298
• Other study ID #: framar
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: November 2, 2015
• Start date: April 2012

Study information

• Verified date: November 2015
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: University of Naples "Federico II"
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic sacrococcygeal pilonidal sinus

Exclusion Criteria:

• Absence of consent to the study

• Acute abscess

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sacrococcygeal Pilonidal Sinus
• Pilonidal Sinus

Intervention

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.
• Bascom Cleft lift procedure

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection	Wound infection was defined as redness and/or oedema of the skin and/or discharge.	at 30 days after surgery	Yes
Secondary	recurrence	recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.	at 1 year after surgery	Yes
Secondary	return at work		up to 30 days after surgery	No
Secondary	Pain	A vas-score scale (0-10) will be used	up to 30 days after surgery	Yes
Secondary	satisfaction	a Vas-score scale (0-10) and a SF_36 model will be used	up to six months after surgery	Yes