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

NCT ID: NCT01792557

Last Updated: 2014-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Phenol

Crystallized Phenol Group

Group Type ACTIVE_COMPARATOR

Crystallized phenol

Intervention Type 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.

Limberg

Limberg Flap Group

Group Type ACTIVE_COMPARATOR

Limberg Flap

Intervention Type PROCEDURE

Limberg Flap surgery for pilonidal disease treatment

Modified Limberg

Modified Limberg Flap Group

Group Type ACTIVE_COMPARATOR

Modified Limberg Flap

Intervention Type 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

Karydakis Flap Group

Group Type ACTIVE_COMPARATOR

Karydakis Flap

Intervention Type PROCEDURE

Karydakis Flap surgery for pilonidal disease treatment

Interventions

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Crystallized phenol

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 DRUG

Limberg Flap

Limberg Flap surgery for pilonidal disease treatment

Intervention Type PROCEDURE

Modified Limberg Flap

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

Karydakis Flap

Karydakis Flap surgery for pilonidal disease treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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S.B. Konya Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osman Doğru, M.D.

Role: STUDY_DIRECTOR

Konya Education and Research Hospital

Locations

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Konya Education and Research Hospital

Meram, Konya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 15622588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20676861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17305997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15043735 (View on PubMed)

Other Identifiers

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U1111-1139-3538

Identifier Type: OTHER

Identifier Source: secondary_id

KEAH06021301

Identifier Type: -

Identifier Source: org_study_id

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