Pilonidal SinusNCT01963273
Video Assisted Ablation of Pilonidal Sinus
A study testing Video Assisted Ablation of Pilonidal Sinus in people with Pilonidal Sinus, run by Federico II University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Video Assisted Ablation of Pilonidal Sinus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of chronic pilonidal sinus
Who cannot join
- Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Assisted Ablation of Pilonidal Sinus. Evaluation of Safety and Efficacy of a New Minimally Invasive Technique
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.
- Conditions
- Pilonidal Sinus
- Being tested
- Video Assisted Ablation of Pilonidal Sinus
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Assisted Ablation of Pilonidal SinusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pilonidal sinuses | Experimental | All consecutive patients with diagnosis of chronic sacrococcygeal pilonidal sinus will be screened for the enrollment in our study. Receives: Procedure: Video Assisted Ablation of Pilonidal Sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Wound infection was defined as redness and/or oedema of the skin and/or discharge
Measured: 1 month
Secondary outcomes (1)
Recurrence
Recurrence can be divided into two groups: early and late. Early recurrence is usually due to failure to identify one or more sinuses. Late recurrence is usually due to secondary infection caused by residual hair or debris that was not removed at operation, inadequate wound care or insufficient attention to depilation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Milone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963273
- Sponsor's protocol ID
- 5082
- Other IDs
- Surgery
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
Publications
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.
PubMed 26819186
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Ablation of Pilonidal Sinus. Evaluation of Safety and Efficacy of a New Minimally Invasive Technique
- ClinicalTrials.gov ID
- NCT01963273
- Acronym / sponsor ID
- 5082
- Conditions
- Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pilonidal sinuses | Experimental | Procedure: Video Assisted Ablation of Pilonidal SinusAll consecutive patients with diagnosis of chronic sacrococcygeal pilonidal sinus will be screened for the enrollment in our study. |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic pilonidal sinus
Key exclusion criteria (1 listed)
- Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Assisted Ablation of Pilonidal Sinus | Procedure or surgery | pilonidal sinuses |
Primary outcome
Infection
Time frame: 1 month
Wound infection was defined as redness and/or oedema of the skin and/or discharge
1 secondary outcome
Recurrence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 26819186Milone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Assisted Ablation of Pilonidal Sinus in people with Pilonidal Sinus, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.