Pilonidal SinusPEVESNCT03923621
Pilonidal Excision Versus Endoscopic Surgery
A study testing EPSiT and Excision in people with Pilonidal Sinus, run by St Helens & Knowsley Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- EPSiT and Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to 31 Jan 2019
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA I or II
- Pilonidal disease <3 previous treatments
- Previous incision and drainage allowed
- Over 16 years
Who cannot join
- Co-morbidity >ASA II
- Unable to consent themselves
- Under 16 years
- Vulnerable adults
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Helens & Knowsley Hospitals NHS Trust
Prescot, Merseyside, L35 5DR
About this study
Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.
Read the detailed description
Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use.
Allocation ratio 2:1
- Conditions
- Pilonidal Sinus
- Being tested
- EPSiT, Excision
- Keywords
- Endoscopic Pilonidal Sinus Treatment (EPSiT)
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPSiTProcedure or surgery
Also called Endoscopic Pilonidal Sinus Treatment
Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.
ExcisionProcedure or surgery
Surgery to remove all affected tissue, followed by wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - EPSiT | Experimental | Endoscopic Pilonidal Sinus Treatment Receives: Procedure: EPSiT |
| Control - excision | Active comparator | Excision treatment Receives: Procedure: Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
As described by Dindo et al 2004
Measured: 12 months
Secondary outcomes (1)
Quality of life (QoL)
QoL utilising validated tool
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study startMar 2016
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Helens & Knowsley Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923621
- Sponsor's protocol ID
- RBN955/V1
- Acronym
- PEVES
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilonidal Excision Versus Endoscopic Surgery
- ClinicalTrials.gov ID
- NCT03923621
- Acronym / sponsor ID
- PEVES / RBN955/V1
- Conditions
- Pilonidal Sinus
- Keywords
- Endoscopic Pilonidal Sinus Treatment (EPSiT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- St Helens & Knowsley Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 22 Apr 2019 (actual)
- 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.
Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.
Detailed description
Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use.
Allocation ratio 2:1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - EPSiT | Experimental | Procedure: EPSiTEndoscopic Pilonidal Sinus Treatment |
| Control - excision | Active comparator | Procedure: ExcisionExcision treatment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I or II
- Pilonidal disease <3 previous treatments
- Previous incision and drainage allowed
- Over 16 years
Key exclusion criteria (4 listed)
- Co-morbidity >ASA II
- Unable to consent themselves
- Under 16 years
- Vulnerable adults
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 |
|---|---|---|
| EPSiTAlso: Endoscopic Pilonidal Sinus TreatmentSpecialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation. | Procedure or surgery | Experimental - EPSiT |
| ExcisionSurgery to remove all affected tissue, followed by wound closure. | Procedure or surgery | Control - excision |
Primary outcome
Complication rate
Time frame: 12 months
As described by Dindo et al 2004
1 secondary outcome
Quality of life (QoL)
Time frame: 12 months
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 22 Apr 2019.
- Individual participant dataSharing planned: No
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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 EPSiT and Excision in people with Pilonidal Sinus, run by St Helens & Knowsley Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 4 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 22 Apr 2019. 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 United Kingdom. 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?
Complication rate (time frame: 12 months). 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 22 Apr 2019.