Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

NCT02222298 | Completed

• 1 other identifier: framar
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Sacrococcygeal Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

• Infection

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

  at 30 days after surgery

Secondary Outcomes (4)

• recurrence

  at 1 year after surgery

• return at work

  up to 30 days after surgery

• Pain

  up to 30 days after surgery

• satisfaction

  up to six months after surgery

Study Arms (2)

VAAPS group

EXPERIMENTAL

patients undergoing video assisted ablation of pilonidal sinus

Procedure: Video assisted ablation of pilonidal sinus

conventional treatment group

ACTIVE COMPARATOR

patients undergoing conventional off-midline Bascom cleft lift procedure

Procedure: Bascom Cleft lift procedure

Interventions

Video assisted ablation of pilonidal sinus PROCEDURE

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.

VAAPS group

Bascom Cleft lift procedure PROCEDURE

conventional treatment group

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic sacrococcygeal pilonidal sinus

You may not qualify if:

• Absence of consent to the study
• Acute abscess

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, Italy, 80131, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: April 1, 2012
• Primary Completion: November 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

IT (1)