Pilonidal SinusNCT04418336
Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique
A study testing Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in people with Pilonidal Sinus, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 2 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with symptoms from sacrococcygeal pilonidal sinus .
Who cannot join
- Abscess formation
- Immunodeficiency.
- Patients with congenital asymptomatic pits.
- Patient with psychiatric disease disabling surgical intervention. . Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate
Mohamed Hamada Mohamed Hamada, +20 109 212 7930, irb.mfm@hotmail.com
About this study
Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity.
- Conditions
- Pilonidal Sinus
- Being tested
- Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open techniqueProcedure or surgery
Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Pilonidal sinus treatment (EPSIT) | Active comparator | Endoscopic Pilonidal sinus treatment (EPSIT) Receives: Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique |
| Sinus Laser Closure (SiLaC) | Active comparator | Sinus Laser Closure (SiLaC) Receives: Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique |
| lay open technique | Active comparator | lay open technique Receives: Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence of pilonidal sinus after treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion2 Jun 2021 (estimated)
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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418336
- Sponsor's protocol ID
- R.19.04.495.R1 - 2019/05/12
- Status last verified
- May 2020
- First submitted
- 3 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique
- ClinicalTrials.gov ID
- NCT04418336
- Acronym / sponsor ID
- R.19.04.495.R1 - 2019/05/12
- Conditions
- Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 2 Jun 2021 (estimated)
- First posted
- 5 Jun 2020 (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.
Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Pilonidal sinus treatment (EPSIT) | Active comparator | Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open techniqueEndoscopic Pilonidal sinus treatment (EPSIT) |
| Sinus Laser Closure (SiLaC) | Active comparator | Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open techniqueSinus Laser Closure (SiLaC) |
| lay open technique | Active comparator | Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open techniquelay open technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with symptoms from sacrococcygeal pilonidal sinus .
Key exclusion criteria (4 listed)
- Abscess formation
- Immunodeficiency.
- Patients with congenital asymptomatic pits.
- Patient with psychiatric disease disabling surgical intervention. . Pregnant females.
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 |
|---|---|---|
| Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open techniqueEndoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment | Procedure or surgery | Endoscopic Pilonidal sinus treatment (EPSIT), Sinus Laser Closure (SiLaC), lay open technique |
Primary outcome
Recurrence
Time frame: one year
Recurrence of pilonidal sinus after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in people with Pilonidal Sinus, run by Mansoura University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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 Egypt. 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?
Contact Mohamed Arnouse (01099222561, drmhamdy@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: one year). 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 9 Jun 2020.