NCT01963273

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

2.2 years

First QC Date

October 10, 2013

Last Update Submit

October 15, 2013

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • Infection

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

    1 month

Secondary Outcomes (1)

  • Recurrence

    1 year

Other Outcomes (6)

  • time off work

    1 month

  • Time to sitting on toilet without pain

    1 month

  • satisfaction

    6 months

  • +3 more other outcomes

Study Arms (1)

pilonidal sinuses

EXPERIMENTAL

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

Procedure: Video Assisted Ablation of Pilonidal Sinus

Interventions

Video Assisted Ablation of Pilonidal SinusPROCEDURE
pilonidal sinuses

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic pilonidal sinus

You may not qualify if:

  • Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milone Francesco

Naples, Italiy, 80131, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26819186DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

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

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 16, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

IT(1)