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NCT05289297 Clinical Trial

Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease

Pilonidal Sinus Clinical Trial

Official title:
Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05289297
Other study ID # 2022s01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 12, 2022
Est. completion date December 1, 2024

Study information
Verified date September 2023
Source Istanbul Sultanbeyli State Hospital
Contact Muhammer Ergenç, MD
Phone 902165642400
Email muhammerergenc@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Karydakis Flap Procedure
Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.
• Burow's Triangle Advancement Flap Procedure
Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.

Locations
Country Name City State
Turkey Istanbul Sultanbeyli State Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Sultanbeyli State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Alvandipour 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. — View 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. — View 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. — View Citation

Can 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. — View Citation

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. — View 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

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. — View Citation

Luedi 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. — View Citation

Oberemok 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 1-3 days
Primary Postoperative wound healing time Number of weeks of complete duration epithelialization of the wound 4 to 6 weeks
Primary Procedure-related complications Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection) 1 to 6 weeks
Primary Time to return to normal activity The number of weeks it passes the patient to return to normal activity. 4 to 6 weeks
Secondary Recurrence of Pilonidal Sinus Number of patients with recurrence pilonidal disease 6 - 12 months
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