MedDataX Logo

Video Assisted Ablation of Pilonidal Sinus

NCT ID: NCT01963273

Last Updated: 2013-10-16

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators supposed that the complete video assisted ablation of pilonidal sinus (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new minimally invasive treatment allows the identification of the sinus cavity with its lateral tracks, the destruction and the removal of all infected tissue and the removing of any hair.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pilonidal Sinus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pilonidal sinuses

All consecutive patients with diagnosis of chronic sacrococcygeal pilonidal sinus will be screened for the enrollment in our study.

Group Type EXPERIMENTAL

Video Assisted Ablation of Pilonidal Sinus

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Video Assisted Ablation of Pilonidal Sinus

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Diagnosis of chronic pilonidal sinus

Exclusion Criteria

Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique
Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federico II University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Francesco Milone

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Milone Francesco

Naples, Italiy, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Milone M, Fernandez LM, Musella M, Milone F. Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial. JAMA Surg. 2016 Jun 1;151(6):547-53. doi: 10.1001/jamasurg.2015.5233.

Reference Type DERIVED
PMID: 26819186 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Surgery

Identifier Type: -

Identifier Source: secondary_id

5082

Identifier Type: -

Identifier Source: org_study_id