Pilonidal SinusNCT05289297
Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease
A study testing Karydakis Flap Procedure and Burow's Triangle Advancement Flap Procedure in people with Pilonidal Sinus and Sacrococcygeal Pilonidal Disease, run by Istanbul Sultanbeyli State Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pilonidal Sinus, Sacrococcygeal Pilonidal Disease
- What is being tested?
- Karydakis Flap Procedure and Burow's Triangle Advancement Flap Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2022to 1 Dec 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-65
- Primary pilonidal sinus disease
- No abscess and absence of active infection during the operation
Who cannot join
- Patients under the age of 18 and over the age of 65
- Recurrent pilonidal sinus cases
- Patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease
- Patients with an ASA score of 3-4
- Patients with a body mass index greater than 35 kg/m2
- Patients with drug and alcohol addiction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Sultanbeyli State Hospital
Istanbul, 34935
Muhammer Ergenç, MD
About this study
Official title: Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease
In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.
Read the detailed description
Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.
PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.
In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.
- Conditions
- Pilonidal Sinus, Sacrococcygeal Pilonidal Disease
- Being tested
- Karydakis Flap Procedure, Burow's Triangle Advancement Flap Procedure
- Keywords
- Karydakis Flap, Pilonidal Cyst
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karydakis Flap ProcedureProcedure or surgery
Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.
Burow's Triangle Advancement Flap ProcedureProcedure or surgery
Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.
| Study group | Role | What they receive |
|---|---|---|
| Karydakis Flap Procedure | Active comparator | Vertical eccentric elliptical incision down to the post-sacral fascia, complete removal of unhealthy tissue, and normal tissue around the cyst and sinus tracts. Mobilization of the medial wound edge and advancement of the skin. Flap along the midline to the post-sacral fascia and suturing its margin to the lateral wound margin. Receives: Procedure: Karydakis Flap Procedure |
| Burow's Triangle Advancement Flap Procedure | Active comparator | The flap is incised along the base of the wedge-shaped defect, and a small Burow's triangle is excised on the opposite side. The skin is mobilized and shifted in the direction of the arrow to close the defect. Excising the small Burow's triangle eliminates a dog ear at the base of the flap. Receives: Procedure: Burow's Triangle Advancement Flap Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score according to the visual analogue scale
Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)
Measured: 1-3 days
Postoperative wound healing time
Number of weeks of complete duration epithelialization of the wound
Measured: 4 to 6 weeks
Procedure-related complications
Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)
Measured: 1 to 6 weeks
Time to return to normal activity
The number of weeks it passes the patient to return to normal activity.
Measured: 4 to 6 weeks
Secondary outcomes (1)
Recurrence of Pilonidal Sinus
Number of patients with recurrence pilonidal disease
Measured: 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start12 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Sultanbeyli State Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Muhammer Ergenç, MD, Principal investigator, Istanbul Sultanbeyli State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289297
- Sponsor's protocol ID
- 2022s01
- Status last verified
- Sep 2023
- First submitted
- 13 Mar 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doll D, Orlik A, Maier K, Kauf P, Schmid M, Diekmann M, Vogt AP, Stauffer VK, Luedi MM. Impact of geography and surgical approach on recurrence in global pilonidal sinus disease. Sci Rep. 2019 Oct 22;9(1):15111. doi: 10.1038/s41598-019-51159-z.
PubMed 31641150Harries RL, Alqallaf A, Torkington J, Harding KG. Management of sacrococcygeal pilonidal sinus disease. Int Wound J. 2019 Apr;16(2):370-378. doi: 10.1111/iwj.13042. Epub 2018 Nov 15.
PubMed 30440104Luedi MM, Schober P, Stauffer VK, Diekmann M, Doll D. Global Gender Differences in Pilonidal Sinus Disease: A Random-Effects Meta-Analysis. World J Surg. 2020 Nov;44(11):3702-3709. doi: 10.1007/s00268-020-05702-z. Epub 2020 Jul 17.
PubMed 32681319Alvandipour M, Zamani MS, Ghorbani M, Charati JY, Karami MY. Comparison of Limberg Flap and Karydakis Flap Surgery for the Treatment of Patients With Pilonidal Sinus Disease: A Single-Blinded Parallel Randomized Study. Ann Coloproctol. 2019 Dec 31;35(6):313-318. doi: 10.3393/ac.2018.09.27. Epub 2019 May 22.
PubMed 31113167Can MF, Sevinc MM, Hancerliogullari O, Yilmaz M, Yagci G. Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease. Am J Surg. 2010 Sep;200(3):318-27. doi: 10.1016/j.amjsurg.2009.08.042. Epub 2010 Feb 1.
PubMed 20122682Arslan K, Said Kokcam S, Koksal H, Turan E, Atay A, Dogru O. Which flap method should be preferred for the treatment of pilonidal sinus? A prospective randomized study. Tech Coloproctol. 2014 Jan;18(1):29-37. doi: 10.1007/s10151-013-0982-2. Epub 2013 Feb 21.
PubMed 23430349Oberemok S, Eliezri Y, Desciak E. Burow's wedge flap revisited. Dermatol Surg. 2005 Feb;31(2):210-6; discussion 216. doi: 10.1111/j.1524-4725.2005.31043. No abstract available.
PubMed 15762217Bali 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 26039952Ergenç, M., Uprak, T.K. Gender-specific prevalence of sacrococcygeal pilonidal sinus disease in Turkey: A retrospective analysis of a large cohort. Eur Surg 55, 43-47 (2023). https://doi.org/10.1007/s10353-022-00777-5
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease
- ClinicalTrials.gov ID
- NCT05289297
- Acronym / sponsor ID
- 2022s01
- Conditions
- Pilonidal Sinus, Sacrococcygeal Pilonidal Disease
- Keywords
- Karydakis Flap, Pilonidal Cyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul Sultanbeyli State HospitalOther government
- Study start
- 12 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 Mar 2022 (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.
In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.
Detailed description
Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.
PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.
In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Karydakis Flap Procedure | Active comparator | Procedure: Karydakis Flap ProcedureVertical eccentric elliptical incision down to the post-sacral fascia, complete removal of unhealthy tissue, and normal tissue around the cyst and sinus tracts. Mobilization of the medial wound edge and advancement of the skin. Flap along the midline to the post-sacral fascia and suturing its margin to the lateral wound margin. |
| Burow's Triangle Advancement Flap Procedure | Active comparator | Procedure: Burow's Triangle Advancement Flap ProcedureThe flap is incised along the base of the wedge-shaped defect, and a small Burow's triangle is excised on the opposite side. The skin is mobilized and shifted in the direction of the arrow to close the defect. Excising the small Burow's triangle eliminates a dog ear at the base of the flap. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18-65
- Primary pilonidal sinus disease
- No abscess and absence of active infection during the operation
Key exclusion criteria (6 listed)
- Patients under the age of 18 and over the age of 65
- Recurrent pilonidal sinus cases
- Patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease
- Patients with an ASA score of 3-4
- Patients with a body mass index greater than 35 kg/m2
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 |
|---|---|---|
| Karydakis Flap ProcedurePilonidal sinus surgery will be performed with the Karydakis Flap procedure. | Procedure or surgery | Karydakis Flap Procedure |
| Burow's Triangle Advancement Flap ProcedurePilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure. | Procedure or surgery | Burow's Triangle Advancement Flap Procedure |
Primary outcome
Pain score according to the visual analogue scale
Time frame: 1-3 days
Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)
Postoperative wound healing time
Time frame: 4 to 6 weeks
Number of weeks of complete duration epithelialization of the wound
Procedure-related complications
Time frame: 1 to 6 weeks
Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)
Time to return to normal activity
Time frame: 4 to 6 weeks
The number of weeks it passes the patient to return to normal activity.
1 secondary outcome
Recurrence of Pilonidal Sinus
Time frame: 6 - 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 31641150Doll D, Orlik A, Maier K, Kauf P, Schmid M, Diekmann M, Vogt AP, Stauffer VK, Luedi MM. Impact of geography and surgical approach on recurrence in global pilonidal sinus disease. Sci Rep. 2019 Oct 22;9(1):15111. doi: 10.1038/s41598-019-51159-z.
- Background: PubMed 30440104Harries RL, Alqallaf A, Torkington J, Harding KG. Management of sacrococcygeal pilonidal sinus disease. Int Wound J. 2019 Apr;16(2):370-378. doi: 10.1111/iwj.13042. Epub 2018 Nov 15.
- Background: PubMed 32681319Luedi MM, Schober P, Stauffer VK, Diekmann M, Doll D. Global Gender Differences in Pilonidal Sinus Disease: A Random-Effects Meta-Analysis. World J Surg. 2020 Nov;44(11):3702-3709. doi: 10.1007/s00268-020-05702-z. Epub 2020 Jul 17.
- Background: PubMed 31113167Alvandipour M, Zamani MS, Ghorbani M, Charati JY, Karami MY. Comparison of Limberg Flap and Karydakis Flap Surgery for the Treatment of Patients With Pilonidal Sinus Disease: A Single-Blinded Parallel Randomized Study. Ann Coloproctol. 2019 Dec 31;35(6):313-318. doi: 10.3393/ac.2018.09.27. Epub 2019 May 22.
- Background: PubMed 20122682Can MF, Sevinc MM, Hancerliogullari O, Yilmaz M, Yagci G. Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease. Am J Surg. 2010 Sep;200(3):318-27. doi: 10.1016/j.amjsurg.2009.08.042. Epub 2010 Feb 1.
- Background: PubMed 23430349Arslan K, Said Kokcam S, Koksal H, Turan E, Atay A, Dogru O. Which flap method should be preferred for the treatment of pilonidal sinus? A prospective randomized study. Tech Coloproctol. 2014 Jan;18(1):29-37. doi: 10.1007/s10151-013-0982-2. Epub 2013 Feb 21.
- Background: PubMed 15762217Oberemok S, Eliezri Y, Desciak E. Burow's wedge flap revisited. Dermatol Surg. 2005 Feb;31(2):210-6; discussion 216. doi: 10.1111/j.1524-4725.2005.31043. No abstract available.
- Background: 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.
- BackgroundErgenç, M., Uprak, T.K. Gender-specific prevalence of sacrococcygeal pilonidal sinus disease in Turkey: A retrospective analysis of a large cohort. Eur Surg 55, 43-47 (2023). https://doi.org/10.1007/s10353-022-00777-5
- Individual participant dataSharing planned: No
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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.
Muhammer Ergenç, MD principal investigator
Istanbul Sultanbeyli 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 Karydakis Flap Procedure and Burow's Triangle Advancement Flap Procedure in people with Pilonidal Sinus and Sacrococcygeal Pilonidal Disease, run by Istanbul Sultanbeyli 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 6 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 28 Sep 2023. 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 Muhammer Ergenç, MD (902165642400 ext. 1321, muhammerergenc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score according to the visual analogue scale (time frame: 1-3 days). The study lists 4 primary outcomes in all. 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 NCT05289297, which also lists 9 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 28 Sep 2023.