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Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study

Primary Purpose

Pilonidal Sinus

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Crystallized phenol
Limberg Flap
Modified Limberg Flap
Karydakis Flap
Sponsored by
S.B. Konya Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring Pilonidal sinus, Crystallized phenol, Limberg Flap, Modified Limberg Flap, Karydakis, Recurrence, Complications, Recovery duration, Time to return to work

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Konya Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Phenol

Limberg

Modified Limberg

Karydakis

Arm Description

Crystallized Phenol Group

Limberg Flap Group

Modified Limberg Flap Group

Karydakis Flap Group

Outcomes

Primary Outcome Measures

Assessment of recurrence
Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.

Secondary Outcome Measures

Assessment of patient comfort
Patients will be queried for patient comfort at the end of first year
Assessment of recovery duration
Post procedure wound recovery duration will be recorded
Assessment of complications
Patients will be followed up for procedure related complications.

Full Information

First Posted
February 11, 2013
Last Updated
March 21, 2014
Sponsor
S.B. Konya Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01792557
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S.B. Konya Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
Pilonidal sinus, Crystallized phenol, Limberg Flap, Modified Limberg Flap, Karydakis, Recurrence, Complications, Recovery duration, Time to return to work

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenol
Arm Type
Active Comparator
Arm Description
Crystallized Phenol Group
Arm Title
Limberg
Arm Type
Active Comparator
Arm Description
Limberg Flap Group
Arm Title
Modified Limberg
Arm Type
Active Comparator
Arm Description
Modified Limberg Flap Group
Arm Title
Karydakis
Arm Type
Active Comparator
Arm Description
Karydakis Flap Group
Intervention Type
Drug
Intervention Name(s)
Crystallized phenol
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Limberg Flap
Intervention Description
Limberg Flap surgery for pilonidal disease treatment
Intervention Type
Procedure
Intervention Name(s)
Modified Limberg Flap
Intervention Description
Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.
Intervention Type
Procedure
Intervention Name(s)
Karydakis Flap
Intervention Description
Karydakis Flap surgery for pilonidal disease treatment
Primary Outcome Measure Information:
Title
Assessment of recurrence
Description
Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.
Time Frame
3rd year
Secondary Outcome Measure Information:
Title
Assessment of patient comfort
Description
Patients will be queried for patient comfort at the end of first year
Time Frame
1st year
Title
Assessment of recovery duration
Description
Post procedure wound recovery duration will be recorded
Time Frame
3rd month
Title
Assessment of complications
Description
Patients will be followed up for procedure related complications.
Time Frame
3rd month
Other Pre-specified Outcome Measures:
Title
Assessment of time before patient returns to work/routine physical activity
Description
Patients will be queried for when they felt comfortable to return to work and/or their routine physical activity.
Time Frame
3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osman Doğru, M.D.
Organizational Affiliation
Konya Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Konya Education and Research Hospital
City
Meram
State/Province
Konya
ZIP/Postal Code
42040
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
15622588
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.
Results Reference
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PubMed Identifier
20676861
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.
Results Reference
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PubMed Identifier
17305997
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.
Results Reference
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PubMed Identifier
15043735
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.
Results Reference
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Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study

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