Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

Federico II University

Status: Completed

Conditions: Chronic Sacrococcygeal Pilonidal Sinus

Treatments: Procedure: Video assisted ablation of pilonidal sinus; Procedure: Bascom Cleft lift procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02222298

framar

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic sacrococcygeal pilonidal sinus

Exclusion criteria

• Absence of consent to the study
• Acute abscess

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

VAAPS group

Experimental group

Description:

patients undergoing video assisted ablation of pilonidal sinus

Treatment:

Procedure: Video assisted ablation of pilonidal sinus

conventional treatment group

Active Comparator group

Description:

patients undergoing conventional off-midline Bascom cleft lift procedure

Treatment:

Procedure: Bascom Cleft lift procedure