Pilonidal DiseaseNCT02186964
Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods
A study testing tension free primary closure, karydakis and Limberg flap in people with Pilonidal Disease and Recurrence, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Disease, Recurrence, Complication
- What is being tested?
- tension free primary closure, karydakis and Limberg flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to May 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having pilonidal sinus disease
- desire for surgical treatment
- accept to be involved in the study
Who cannot join
- patients under age of 18
- recurrent cases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42180
About this study
Official title: Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease
Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.
There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.
- Conditions
- Pilonidal Disease, Recurrence, Complication
- Being tested
- tension free primary closure, karydakis, Limberg flap
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tension free primary closureProcedure or surgery
tension free primary closure of the defects created by excision of the pilonidal sinus
karydakisProcedure or surgery
the defect after excision of the pilonidal sinus is closed by Karydakis procedure
Limberg flapProcedure or surgery
defect after excision of the pilonidal sinus is closed by Limberg flap procedure
| Study group | Role | What they receive |
|---|---|---|
| tension free primary closure | Experimental | patients treated by tension free primary closure Receives: Procedure: tension free primary closure |
| karydakis | Experimental | patients treated by Karydakis method Receives: Procedure: karydakis |
| Limberg flap | Experimental | patients treated by Limberg flap procedure Receives: Procedure: Limberg flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
recurrence rates two years after the surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionMay 2014
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 DiseaseStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, barış sevinç, Konya Meram State Hospital
- Investigators
- Ömer Karahan, Professor, Study director, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186964
- Sponsor's protocol ID
- PS42
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sevinc B, Karahan O, Okus A, Ay S, Aksoy N, Simsek G. Randomized prospective comparison of midline and off-midline closure techniques in pilonidal sinus surgery. Surgery. 2016 Mar;159(3):749-54. doi: 10.1016/j.surg.2015.09.024. Epub 2015 Oct 31.
PubMed 26531235
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease
- ClinicalTrials.gov ID
- NCT02186964
- Acronym / sponsor ID
- PS42
- Conditions
- Pilonidal Disease, Recurrence, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Jul 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.
Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.
There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tension free primary closure | Experimental | Procedure: tension free primary closurepatients treated by tension free primary closure |
| karydakis | Experimental | Procedure: karydakispatients treated by Karydakis method |
| Limberg flap | Experimental | Procedure: Limberg flappatients treated by Limberg flap procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having pilonidal sinus disease
- desire for surgical treatment
- accept to be involved in the study
Key exclusion criteria (2 listed)
- patients under age of 18
- recurrent cases
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 |
|---|---|---|
| tension free primary closuretension free primary closure of the defects created by excision of the pilonidal sinus | Procedure or surgery | tension free primary closure |
| karydakisthe defect after excision of the pilonidal sinus is closed by Karydakis procedure | Procedure or surgery | karydakis |
| Limberg flapdefect after excision of the pilonidal sinus is closed by Limberg flap procedure | Procedure or surgery | Limberg flap |
Primary outcome
recurrence
Time frame: 2 years
recurrence rates two years after the 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 10 Jul 2014.
- Derived from this study: PubMed 26531235Sevinc B, Karahan O, Okus A, Ay S, Aksoy N, Simsek G. Randomized prospective comparison of midline and off-midline closure techniques in pilonidal sinus surgery. Surgery. 2016 Mar;159(3):749-54. doi: 10.1016/j.surg.2015.09.024. Epub 2015 Oct 31.
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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.
Ömer Karahan, Professor study director
Konya Meram State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tension free primary closure, karydakis and Limberg flap in people with Pilonidal Disease and Recurrence, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 3 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 10 Jul 2014. 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 Turkey (Türkiye). 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?
recurrence (time frame: 2 years). 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 NCT02186964, 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 10 Jul 2014.