Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

NCT ID: NCT02222298

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Brief Summary

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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 Description

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Conditions

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Chronic Sacrococcygeal Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VAAPS group

patients undergoing video assisted ablation of pilonidal sinus

Group Type EXPERIMENTAL

Video assisted ablation of pilonidal sinus

Intervention Type 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.

conventional treatment group

patients undergoing conventional off-midline Bascom cleft lift procedure

Group Type ACTIVE_COMPARATOR

Bascom Cleft lift procedure

Intervention Type PROCEDURE

Interventions

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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.

Intervention Type PROCEDURE

Bascom Cleft lift procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Chronic sacrococcygeal pilonidal sinus

Exclusion Criteria

* Absence of consent to the study
* Acute abscess
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Francesco Milone

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples "Federico II"

Naples, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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framar

Identifier Type: -

Identifier Source: org_study_id

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