Clinical trial NCT05289297: Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease
Official title: Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pilonidal Sinus
Sacrococcygeal Pilonidal Disease
Keywords: Karydakis Flap
Pilonidal Cyst
Lead sponsor: Istanbul Sultanbeyli State Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-65
* Primary pilonidal sinus disease
* No abscess and absence of active infection during the operation

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain score according to the visual analogue scale
timeFrame: 1-3 days
measure: Postoperative wound healing time
timeFrame: 4 to 6 weeks
measure: Procedure-related complications
timeFrame: 1 to 6 weeks
measure: Time to return to normal activity
timeFrame: 4 to 6 weeks
Secondary outcomes:
measure: Recurrence of Pilonidal Sinus
timeFrame: 6 - 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sultanbeyli State Hospital
Study officials:
affiliation: Istanbul Sultanbeyli State Hospital
name: Muhammer Ergenç, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Harries 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.
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citation: Arslan 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.
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citation: 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.
citation: Ergenç, 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