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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1139-3538 | Other Identifier | WHO Universal Trial Number |
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Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
Pilonidal sinus disease (PSD) is usually located at sacrococcygeal region of the body and mostly effect young males causing loss of labor and school time. Its incidence is reported 26 per 100000 in a Norwegian study. Although there are many treatment modalities either surgical or conservative, ideal treatment is still a matter of debate. Surgical techniques such as limberg flap, modified limberg flap and karydakis are most popular treatment methods for pilonidal disease crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We would like to compare flap techniques and crystallized phenol application for complications, recurrence, patient comfort, duration of recovery and return to work. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenol | Active Comparator | Crystallized Phenol Group |
|
| Limberg | Active Comparator | Limberg Flap Group |
|
| Modified Limberg | Active Comparator | Modified Limberg Flap Group |
|
| Karydakis | Active Comparator | Karydakis Flap Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystallized phenol | Drug | Crystallized phenol application for pilonidal disease treatment. After sacrococcygeal region of the patient is cleaned from hairs, hairs inside the sinus are removed than crystallized phenol is applied in to the cleaned sinus. Following 2 minutes of phenol exposure, crystallized phenol is removed from the sinus. Crystallized phenol application will be repeated weekly for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of recurrence | Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year. | 3rd year |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of patient comfort | Patients will be queried for patient comfort at the end of first year | 1st year |
| Assessment of recovery duration | Post procedure wound recovery duration will be recorded |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of time before patient returns to work/routine physical activity | Patients will be queried for when they felt comfortable to return to work and/or their routine physical activity. | 3rd month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osman DoÄŸru, M.D. | Konya Education and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konya Education and Research Hospital | Meram | Konya | 42040 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15622588 | Background | Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. doi: 10.1007/s10350-004-0720-y. | |
| 20676861 | Background | Akin M, Leventoglu S, Mentes BB, Bostanci H, Gokbayir H, Kilic K, Ozdemir E, Ferahkose Z. Comparison of the classic Limberg flap and modified Limberg flap in the treatment of pilonidal sinus disease: a retrospective analysis of 416 patients. Surg Today. 2010 Aug;40(8):757-62. doi: 10.1007/s00595-008-4098-7. Epub 2010 Jul 30. |
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| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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|
| Limberg Flap | Procedure | Limberg Flap surgery for pilonidal disease treatment |
|
| Modified Limberg Flap | Procedure | Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area. |
|
| Karydakis Flap | Procedure | Karydakis Flap surgery for pilonidal disease treatment |
|
| 3rd month |
| Assessment of complications | Patients will be followed up for procedure related complications. | 3rd month |
| 17305997 | Background | Keshava A, Young CJ, Rickard MJ, Sinclair G. Karydakis flap repair for sacrococcygeal pilonidal sinus disease: how important is technique? ANZ J Surg. 2007 Mar;77(3):181-3. doi: 10.1111/j.1445-2197.2006.04003.x. |
| 15043735 | Background | Cihan A, Mentes BB, Tatlicioglu E, Ozmen S, Leventoglu S, Ucan BH. Modified Limberg flap reconstruction compares favourably with primary repair for pilonidal sinus surgery. ANZ J Surg. 2004 Apr;74(4):238-42. doi: 10.1111/j.1445-2197.2004.02951.x. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |