- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01792557
Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study
March 21, 2014 updated by: S.B. Konya Education and Research Hospital
Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Konya
-
Meram, Konya, Turkey, 42040
- Konya Education and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Phenol
Crystallized Phenol Group
|
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.
|
ACTIVE_COMPARATOR: Limberg
Limberg Flap Group
|
Limberg Flap surgery for pilonidal disease treatment
|
ACTIVE_COMPARATOR: Modified Limberg
Modified Limberg Flap Group
|
Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.
|
ACTIVE_COMPARATOR: Karydakis
Karydakis Flap Group
|
Karydakis Flap surgery for pilonidal disease treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of recurrence
Time Frame: 3rd year
|
Patients will be followed up for recurrence for three years.
Total recurrence will be evaluated at the end of 3rd year.
|
3rd year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of patient comfort
Time Frame: 1st year
|
Patients will be queried for patient comfort at the end of first year
|
1st year
|
Assessment of recovery duration
Time Frame: 3rd month
|
Post procedure wound recovery duration will be recorded
|
3rd month
|
Assessment of complications
Time Frame: 3rd month
|
Patients will be followed up for procedure related complications.
|
3rd month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of time before patient returns to work/routine physical activity
Time Frame: 3rd month
|
Patients will be queried for when they felt comfortable to return to work and/or their routine physical activity.
|
3rd month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Osman Doğru, M.D., Konya Education and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ANTICIPATED)
March 1, 2017
Study Completion (ANTICIPATED)
March 1, 2018
Study Registration Dates
First Submitted
February 11, 2013
First Submitted That Met QC Criteria
February 13, 2013
First Posted (ESTIMATE)
February 15, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 24, 2014
Last Update Submitted That Met QC Criteria
March 21, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEAH06021301
- U1111-1139-3538 (OTHER: WHO Universal Trial Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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