Recurrent Pilonidal Sinus DiseaseNCT02287935
Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
A study testing Limberg flap and Karydakis procedure in people with Recurrent Pilonidal Sinus Disease, run by Adana Numune Training and Research Hospital.
Trial summary
It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pilonidal Sinus Disease
- What is being tested?
- Limberg flap and Karydakis procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Sep 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 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients willing to give written informed consent
- There should be recurrent pilonidal sinus
- 2. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus
- 3. International normalizing ratio (INR) less than 1.5
- 4. Prothrombin time (PT) should be less than 15 s
- 5. Partial thromboplastin (PTT) time should be near normal
Show all 9Show fewer
- 6. Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding
- 7. There must be no infection at the time of surgery
- -
Who cannot join
- Patients not willing to give informed consent
- Age less than 16 years
- Patient presenting with conditions mimicking pilonidal sinus
- Diabetes mellitus, renal failure, immunosuppression e.g. were excluded
- -
About this study
Official title: Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.
Read the detailed description
Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery.
It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.
- Conditions
- Recurrent Pilonidal Sinus Disease
- Being tested
- Limberg flap, Karydakis procedure
- Keywords
- Karydakis procedure, Limberg flap, recurrent 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.
Limberg flapProcedure or surgery
Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions
Karydakis procedureProcedure or surgery
Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions
| Study group | Role | What they receive |
|---|---|---|
| Limberg flap | Active comparator | Patients were divided into two groups, group 1 were treated with Limberg flap technique Receives: Procedure: Limberg flap |
| Karydakis procedure | Active comparator | Patients were divided into two groups, group 2 were treated with Karydakis procedure Receives: Procedure: Karydakis procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease
Superiority as measured by rates of recurrence and complication, length of hospital stay, return work, VAS skore, patient satisfaction and complet healing duration.
Measured: January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionSep 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 Recurrent Pilonidal Sinus 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana Numune Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Aziret, Adana Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287935
- Sponsor's protocol ID
- AdanaNTRH
- Status last verified
- Nov 2014
- First submitted
- 24 Oct 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bali I, Aziret M, Sozen S, Emir S, Erdem H, Cetinkunar S, Irkorucu O. Effectiveness of Limberg and Karydakis flap in recurrent pilonidal sinus disease. Clinics (Sao Paulo). 2015 May;70(5):350-5. doi: 10.6061/clinics/2015(05)08. Epub 2015 May 1.
PubMed 26039952
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
- ClinicalTrials.gov ID
- NCT02287935
- Acronym / sponsor ID
- AdanaNTRH
- Conditions
- Recurrent Pilonidal Sinus Disease
- Keywords
- Karydakis procedure, Limberg flap, recurrent pilonidal sinus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Adana Numune Training and Research HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Nov 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.
It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.
Detailed description
Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery.
It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limberg flap | Active comparator | Procedure: Limberg flapPatients were divided into two groups, group 1 were treated with Limberg flap technique |
| Karydakis procedure | Active comparator | Procedure: Karydakis procedurePatients were divided into two groups, group 2 were treated with Karydakis procedure |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patients willing to give written informed consent
- There should be recurrent pilonidal sinus
- 2. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus
- 3. International normalizing ratio (INR) less than 1.5
- 4. Prothrombin time (PT) should be less than 15 s
Key exclusion criteria (5 listed)
- Patients not willing to give informed consent
- Age less than 16 years
- Patient presenting with conditions mimicking pilonidal sinus
- Diabetes mellitus, renal failure, immunosuppression e.g. were excluded
- -
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 |
|---|---|---|
| Limberg flapPatients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions | Procedure or surgery | Limberg flap |
| Karydakis procedurePatients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions | Procedure or surgery | Karydakis procedure |
Primary outcome
Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease
Time frame: January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals
Superiority as measured by rates of recurrence and complication, length of hospital stay, return work, VAS skore, patient satisfaction and complet healing duration.
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 11 Nov 2014.
- Derived from this study: PubMed 26039952Bali I, Aziret M, Sozen S, Emir S, Erdem H, Cetinkunar S, Irkorucu O. Effectiveness of Limberg and Karydakis flap in recurrent pilonidal sinus disease. Clinics (Sao Paulo). 2015 May;70(5):350-5. doi: 10.6061/clinics/2015(05)08. Epub 2015 May 1.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Limberg flap and Karydakis procedure in people with Recurrent Pilonidal Sinus Disease, run by Adana Numune Training and Research Hospital.
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 9 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: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease (time frame: January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals). 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 NCT02287935, 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 11 Nov 2014.