Clinical trial · Interventional
Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease
Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical treatment of pilonidal sinus disease | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bilateral Parallel Elliptic Flap
- description
- Patients operated with the bilateral parallel elliptic flap technique.
- interventionNames
- Procedure: Surgical treatment of pilonidal sinus disease
- type
- ACTIVE_COMPARATOR
- label
- Karydakis Flap
- description
- Patients operated with the karydakis flap technique.
- interventionNames
- Procedure: Surgical treatment of pilonidal sinus disease
Primary outcomes (2)
- measure
- Time taken to return to work/school
- timeFrame
- The patients' return to work ranged from 11 to 49 days.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Underwent surgery due to pilonidal sinus disease Exclusion Criteria: * Patients with a history of previous pilonidal sinus surgery, * An acute pilonidal abscess, * immunodeficiency, * using immunosuppressive drugs, * refuse to participate in the study
References
Publications (21)
- RESULTBi S, Sun K, Chen S, Gu J. Surgical procedures in the pilonidal sinus disease: a systematic review and network meta-analysis. Sci Rep. 2020 Aug 13;10(1):13720. doi: 10.1038/s41598-020-70641-7. PMID 32792519
- RESULTDuman K, Girgin M, Harlak A. Prevalence of sacrococcygeal pilonidal disease in Turkey. Asian J Surg. 2017 Nov;40(6):434-437. doi: 10.1016/j.asjsur.2016.04.001. Epub 2016 May 14. PMID 27188235
- RESULTJohnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available. PMID 30640830
- RESULTKarydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available. PMID 4128725
- RESULTIesalnieks I, Ommer A, Herold A, Doll D. German National Guideline on the management of pilonidal disease: update 2020. Langenbecks Arch Surg. 2021 Dec;406(8):2569-2580. doi: 10.1007/s00423-020-02060-1. Epub 2021 May 5. PMID 33950407
- RESULTYuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. doi: 10.4149/bll_2012_165. PMID 23173633
- RESULTKeshvari A, Keramati MR, Fazeli MS, Kazemeini A, Nouritaromlou MK. Risk factors for complications and recurrence after the Karydakis flap. J Surg Res. 2016 Jul;204(1):55-60. doi: 10.1016/j.jss.2016.04.035. Epub 2016 Apr 23. PMID 27451868