Pilonidal SinusNCT04217824
Comparison of Karydakis and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study
A study testing pilonidal sinus excision in people with Pilonidal Sinus and Postoperative Complications, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Pilonidal sinus disease (PSD) is a chronic inflammation and infection of the sacrococcygeal region. Produces clinic findings with abscess and discharge in the sacrococcygeal region or painful sinus tract in the natal cleft. Its incidence rate among Turkish servicemen is reported to be 8.8% in a study. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pilonidal Sinus, Postoperative Complications
- What is being tested?
- pilonidal sinus excision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2019to 22 May 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pilonidal sinus disease
Who cannot join
- Other disease than pilonidal sinus disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Onikisubat, 46050
ahmet gökhan güler, +905057702633, drgokhanguler@gmail.com
About this study
Official title: a Prospective, Randomized, Double-blind Study. comparıson of Karydakis Flap and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study
Pilonidal sinus disease (PSD) is a chronic inflammation and infection of the sacrococcygeal region. Produces clinic findings with abscess and discharge in the sacrococcygeal region or painful sinus tract in the natal cleft. Its incidence rate among Turkish servicemen is reported to be 8.8% in a study. Although pilonidal sinus disease is common in men, this is the opposite in adolescence. Because adolescent girls are 2 or 3 times more.
Karydakis flap and Limberg flap operations widely preferred in recent years in the surgical treatment of PSD. In our study, we aim to compare these two techniques prospectively and randomly.
Read the detailed description
The best treatment technique for pilonidal sinus disease (PSD) is still controversial. While some researchers prefer minimally invasive methods, some researchers prefer surgical treatment. The most important concern in surgical treatment options is the prolongation of the disease recovery time and recurrence of the disease. Complications that may develop after treatment prolong the treatment period. The aim of this prospective, randomized study was to compare the results of the widely used Limberg and Karydakis flap operations in recent years. The parameters that will be used in the comparison will be an infection, recurrence and wound decomposition.
- Conditions
- Pilonidal Sinus, Postoperative Complications
- Being tested
- pilonidal sinus excision
- Keywords
- pilonidal sinus, presakral apse, limberg flap, karydakis flap
- Medical subject headings
- Pilonidal Sinus, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilonidal sinus excisionProcedure or surgery
Closure of the defect in pilonidal sinus excision with one of the randomly selected flap methods.
| Study group | Role | What they receive |
|---|---|---|
| karydakis flap | Active comparator | An asymmetric elliptical excision is performed, defective tissues between the lower and upper ends are removed until they reach healthy borders. The wound edge is then mobilized and the flap is slid over the corresponding wound edge by suturing to the fascia and the skin to the appropriate wound layers. Thus, the gluteal groove is lateralized. Subcutaneous tissue and skin are closed. Receives: Procedure: pilonidal sinus excision |
| limberg flap | Active comparator | Rhomboid excision and pilonidal sinuses together with damaged tissue. On the right side of the patient, the intact skin is shifted to the medial area where the tissues are removed without tension. Thus, the defective part and gluteal groove are corrected. Receives: Procedure: pilonidal sinus excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recurrence
pain, swelling and redness in examination
Measured: 1 month
Secondary outcomes (2)
Postoperative infection
purulent drainage
Measured: 1 week
Postoperative wound dehiscence
wound separation
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start22 May 2019
- Primary completion22 May 2021 (estimated)
- Study completion22 May 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gökhan Güler, Kahramanmaras Sutcu Imam University
- Investigators
- ahmet gökhan güler, Principal investigator, kahramanmarasSUI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217824
- Sponsor's protocol ID
- 2019/04-02
- Status last verified
- Jul 2020
- First submitted
- 2 Jan 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective, Randomized, Double-blind Study. comparıson of Karydakis Flap and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study
- ClinicalTrials.gov ID
- NCT04217824
- Acronym / sponsor ID
- 2019/04-02
- Conditions
- Pilonidal Sinus, Postoperative Complications
- Keywords
- pilonidal sinus, presakral apse, limberg flap, karydakis flap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 May 2021 (estimated)
- Study completion
- 22 May 2021 (estimated)
- First posted
- 3 Jan 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.
Pilonidal sinus disease (PSD) is a chronic inflammation and infection of the sacrococcygeal region. Produces clinic findings with abscess and discharge in the sacrococcygeal region or painful sinus tract in the natal cleft. Its incidence rate among Turkish servicemen is reported to be 8.8% in a study. Although pilonidal sinus disease is common in men, this is the opposite in adolescence. Because adolescent girls are 2 or 3 times more.
Karydakis flap and Limberg flap operations widely preferred in recent years in the surgical treatment of PSD. In our study, we aim to compare these two techniques prospectively and randomly.
Detailed description
The best treatment technique for pilonidal sinus disease (PSD) is still controversial. While some researchers prefer minimally invasive methods, some researchers prefer surgical treatment. The most important concern in surgical treatment options is the prolongation of the disease recovery time and recurrence of the disease. Complications that may develop after treatment prolong the treatment period. The aim of this prospective, randomized study was to compare the results of the widely used Limberg and Karydakis flap operations in recent years. The parameters that will be used in the comparison will be an infection, recurrence and wound decomposition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| karydakis flap | Active comparator | Procedure: pilonidal sinus excisionAn asymmetric elliptical excision is performed, defective tissues between the lower and upper ends are removed until they reach healthy borders. The wound edge is then mobilized and the flap is slid over the corresponding wound edge by suturing to the fascia and the skin to the appropriate wound layers. Thus, the gluteal groove is lateralized. Subcutaneous tissue and skin are closed. |
| limberg flap | Active comparator | Procedure: pilonidal sinus excisionRhomboid excision and pilonidal sinuses together with damaged tissue. On the right side of the patient, the intact skin is shifted to the medial area where the tissues are removed without tension. Thus, the defective part and gluteal groove are corrected. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pilonidal sinus disease
Key exclusion criteria (1 listed)
- Other disease than pilonidal sinus disease.
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 |
|---|---|---|
| pilonidal sinus excisionClosure of the defect in pilonidal sinus excision with one of the randomly selected flap methods. | Procedure or surgery | karydakis flap, limberg flap |
Primary outcome
Postoperative recurrence
Time frame: 1 month
pain, swelling and redness in examination
2 secondary outcomes
Postoperative infection
Time frame: 1 week
Postoperative wound dehiscence
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
ahmet gökhan güler principal investigator
kahramanmarasSUI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pilonidal sinus excision in people with Pilonidal Sinus and Postoperative Complications, run by Kahramanmaras Sutcu Imam University 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 1 inclusion and 1 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 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmet gokhan guler (+905057702633, drgokhanguler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recurrence (time frame: 1 month). 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 Jul 2020.