Pilonidal SinusNCT06508086
Pilonidal Sinus Disease
A study testing laser ablation technique in the treatment of pilonidal sinus and Karydakis technique in the treatment of pilonidal sinus in people with Pilonidal Sinus, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- laser ablation technique in the treatment of pilonidal sinus and Karydakis technique in the treatment of pilonidal sinus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to 1 Jun 2025
- 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
- All patients with a clinical diagnosis of symptomatic uncomplicated pilonidal sinus, males or females, any age will be included in our study.
Who cannot join
- Patients with pilonidal abscess and any associated acute condition.
- Patients with hidradenitis suppurativa.
- Refusal.
- Unfit for surgery.
- Recurrence.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, professor
About this study
Official title: LASER ABLATION VERSUS KARYDAKIS TECHNIQUE IN THE TREATMENT OF PILONIDAL SINUS DISEASE: A COMPARATIVE STUDY
The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.
- Conditions
- Pilonidal Sinus
- Being tested
- laser ablation technique in the treatment of pilonidal sinus, Karydakis technique in the treatment 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.
laser ablation technique in the treatment of pilonidal sinusProcedure or surgery
group (A) will include patients with pilonidal sinus disease who will be operated by sinus tract ablation procedure using 1470 nm Diode laser
Karydakis technique in the treatment of pilonidal sinusProcedure or surgery
group (B) will include patients with pilonidal sinus disease who will be operated by Karydakis technique
| Study group | Role | What they receive |
|---|---|---|
| group (A) LASER ABLATION | Active comparator | Not described Receives: Procedure: laser ablation technique in the treatment of pilonidal sinus |
| group (B) KARYDAKIS TECHNIQUE | Active comparator | Not described Receives: Procedure: Karydakis technique in the treatment of pilonidal sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate in the treatment of pilonidal disease
the patients undergo follow up at the outpatient clinic for manifestations of recurrence eg. discharge, multiple pits
Measured: 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start10 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assem Mahmoud Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508086
- Sponsor's protocol ID
- Soh-Med-24-06-26MS
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.
PubMed 27084534Doll D, Matevossian E, Wietelmann K, Evers T, Kriner M, Petersen S. Family history of pilonidal sinus predisposes to earlier onset of disease and a 50% long-term recurrence rate. Dis Colon Rectum. 2009 Sep;52(9):1610-5. doi: 10.1007/DCR.0b013e3181a87607.
PubMed 19690490Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.
PubMed 28056720
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LASER ABLATION VERSUS KARYDAKIS TECHNIQUE IN THE TREATMENT OF PILONIDAL SINUS DISEASE: A COMPARATIVE STUDY
- ClinicalTrials.gov ID
- NCT06508086
- Acronym / sponsor ID
- Soh-Med-24-06-26MS
- Conditions
- Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 18 Jul 2024 (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.
The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (A) LASER ABLATION | Active comparator | Procedure: laser ablation technique in the treatment of pilonidal sinus |
| group (B) KARYDAKIS TECHNIQUE | Active comparator | Procedure: Karydakis technique in the treatment of pilonidal sinus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a clinical diagnosis of symptomatic uncomplicated pilonidal sinus, males or females, any age will be included in our study.
Key exclusion criteria (5 listed)
- Patients with pilonidal abscess and any associated acute condition.
- Patients with hidradenitis suppurativa.
- Refusal.
- Unfit for surgery.
- Recurrence.
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 |
|---|---|---|
| laser ablation technique in the treatment of pilonidal sinusgroup (A) will include patients with pilonidal sinus disease who will be operated by sinus tract ablation procedure using 1470 nm Diode laser | Procedure or surgery | group (A) LASER ABLATION |
| Karydakis technique in the treatment of pilonidal sinusgroup (B) will include patients with pilonidal sinus disease who will be operated by Karydakis technique | Procedure or surgery | group (B) KARYDAKIS TECHNIQUE |
Primary outcome
recurrence rate in the treatment of pilonidal disease
Time frame: 6 months after the operation
the patients undergo follow up at the outpatient clinic for manifestations of recurrence eg. discharge, multiple pits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 27084534Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.
- Background: PubMed 19690490Doll D, Matevossian E, Wietelmann K, Evers T, Kriner M, Petersen S. Family history of pilonidal sinus predisposes to earlier onset of disease and a 50% long-term recurrence rate. Dis Colon Rectum. 2009 Sep;52(9):1610-5. doi: 10.1007/DCR.0b013e3181a87607.
- Background: PubMed 28056720Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.
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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 laser ablation technique in the treatment of pilonidal sinus and Karydakis technique in the treatment of pilonidal sinus in people with Pilonidal Sinus, run by Sohag 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 5 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 18 Jul 2024. 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 Assem M Ahmed, Resident (01111544547, asemereby3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate in the treatment of pilonidal disease (time frame: 6 months after the operation). 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 NCT06508086, which also lists 3 linked publications.
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 18 Jul 2024.