Clinical trial · Interventional
GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus
Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.
- 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)
Surgical treatment is still gold standard for pilonidal sinus disease. Several surgical techniques have been proposed to treat this disease in the last two decades. A new method - midline excision of pilonidal sinus and wound closure using gluteus maximus fascia plasty flap (GMFF) - was proposed recently as a new method of treatment that results in low reccurence rate and good cosmetic results. The aim of this study is to compare a new method (GMFF) with a traditional method (midline excision and primary closure) in terms of recurrence rate, complications and patient satisfaction with results.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gluteus Maximus Fascia Plasty Flap | Procedure | — | UNRESOLVED |
| Primary Closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Primary Closure
- description
- After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture
- interventionNames
- Procedure: Primary Closure
- type
- ACTIVE_COMPARATOR
- label
- Gluteus Maximus Plasty Flap
- description
- After pilonidal sinus is excised, gluteus maximus fascia flaps will be mobilised, approximated in the midline and fixed with a running suture. Subcutaneous fat and skin are closed in midline with a running suture.
- interventionNames
- Procedure: Gluteus Maximus Fascia Plasty Flap
Primary outcomes (1)
- measure
- Recurrence rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent 2. Chronic primary or recurrent pilonidal sinus at the remission stage. 3. Presence or absence of secondary orifices. 4. Planned surgical treatment with excision of pilonidal sinus. 5. Location of secondary orifices less than 2 cm from the natal cleft. 6. The distance between bilateral symmetrical secondary orifices less than 2 cm. 7. American Society Anesthesiologists (ASA) score 1 to 3 Non-inclusion Criteria: 1. Acute pilonidal sinus abscess. 2. The secondary openings (orifice) position more than 2 cm from the midline. 3. ASA 4-5. 4. Predictable impossibility of following the protocol. 5. Pregnancy Exclusion criteria: 1 The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.
References
Publications (5)
- RESULTChintapatla S, Safarani N, Kumar S, Haboubi N. Sacrococcygeal pilonidal sinus: historical review, pathological insight and surgical options. Tech Coloproctol. 2003 Apr;7(1):3-8. doi: 10.1007/s101510300001. PMID 12750948
- RESULTSondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585. PMID 7745322
- RESULTIesalnieks I, Ommer A, Petersen S, Doll D, Herold A. German national guideline on the management of pilonidal disease. Langenbecks Arch Surg. 2016 Aug;401(5):599-609. doi: 10.1007/s00423-016-1463-7. Epub 2016 Jun 16. PMID 27311698
- RESULTMilone M, Velotti N, Manigrasso M, Anoldo P, Milone F, De Palma GD. Long-term follow-up for pilonidal sinus surgery: A review of literature with metanalysis. Surgeon. 2018 Oct;16(5):315-320. doi: 10.1016/j.surge.2018.03.009. Epub 2018 Apr 24. PMID 29699781
- 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