Chronic Sacrococcygeal Pilonidal SinusNCT02222298
Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment
A study testing Video assisted ablation of pilonidal sinus and Bascom Cleft lift procedure in people with Chronic Sacrococcygeal Pilonidal Sinus, run by Federico II University at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Chronic Sacrococcygeal Pilonidal Sinus
- What is being tested?
- Video assisted ablation of pilonidal sinus and Bascom Cleft lift procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Nov 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic sacrococcygeal pilonidal sinus
Who cannot join
- Absence of consent to the study
- Acute abscess
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure
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).
- Conditions
- Chronic Sacrococcygeal Pilonidal Sinus
- Being tested
- Video assisted ablation of pilonidal sinus, Bascom Cleft lift procedure
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
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.
Bascom Cleft lift procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| VAAPS group | Experimental | patients undergoing video assisted ablation of pilonidal sinus Receives: Procedure: Video assisted ablation of pilonidal sinus |
| conventional treatment group | Active comparator | patients undergoing conventional off-midline Bascom cleft lift procedure Receives: Procedure: Bascom Cleft lift procedure |
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: at 30 days after surgery
Secondary outcomes (4)
recurrence
recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.
Measured: at 1 year after surgery
return at work
Measured: up to 30 days after surgery
Pain
A vas-score scale (0-10) will be used
Measured: up to 30 days after surgery
satisfaction
a Vas-score scale (0-10) and a SF_36 model will be used
Measured: up to six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startApr 2012
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sacrococcygeal Pilonidal SinusStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT02222298
- Sponsor's protocol ID
- framar
- Status last verified
- Nov 2015
- First submitted
- 19 Aug 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure
- ClinicalTrials.gov ID
- NCT02222298
- Acronym / sponsor ID
- framar
- Conditions
- Chronic Sacrococcygeal Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2015 (actual)
- First posted
- 21 Aug 2014 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAAPS group | Experimental | Procedure: Video assisted ablation of pilonidal sinuspatients undergoing video assisted ablation of pilonidal sinus |
| conventional treatment group | Active comparator | Procedure: Bascom Cleft lift procedurepatients undergoing conventional off-midline Bascom cleft lift procedure |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic sacrococcygeal pilonidal sinus
Key exclusion criteria (2 listed)
- Absence of consent to the study
- Acute abscess
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 sinusA 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. | Procedure or surgery | VAAPS group |
| Bascom Cleft lift procedure | Procedure or surgery | conventional treatment group |
Primary outcome
Infection
Time frame: at 30 days after surgery
Wound infection was defined as redness and/or oedema of the skin and/or discharge.
4 secondary outcomes
recurrence
Time frame: at 1 year after surgery
return at work
Time frame: up to 30 days after surgery
Pain
Time frame: up to 30 days after surgery
satisfaction
Time frame: up to six months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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 and Bascom Cleft lift procedure in people with Chronic Sacrococcygeal 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 2 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: finished, as of the sponsor's last update on 3 Nov 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: at 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2015.