Clinical trial NCT01792557: Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study
Official title: Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Sinus
Keywords: Pilonidal sinus
Crystallized phenol
Limberg Flap
Modified Limberg Flap
Karydakis
Recurrence
Complications
Recovery duration
Time to return to work
Lead sponsor: S.B. Konya Education and Research Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 200
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: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with pilonidal disease

Exclusion Criteria:

* Previous history of pilonidal disease treatment
* Pregnant or breast-feeding women
* Systemic diseases that would affect wound healing
* Diabetes
* Chronic renal failure
* Autoimmune diseases
* Malignant diseases

Primary outcomes:
measure: Assessment of recurrence
timeFrame: 3rd year
Secondary outcomes:
measure: Assessment of patient comfort
timeFrame: 1st year
measure: Assessment of recovery duration
timeFrame: 3rd month
measure: Assessment of complications
timeFrame: 3rd month
Other outcomes:
measure: Assessment of time before patient returns to work/routine physical activity
timeFrame: 3rd month
Locations:
city: Meram
country: Turkey
facility: Konya Education and Research Hospital
state: Konya
Study officials:
affiliation: Konya Education and Research Hospital
name: Osman Doğru, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.