NCT01792557

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

4 years

First QC Date

February 11, 2013

Last Update Submit

March 21, 2014

Conditions

Pilonidal Sinus

Keywords

Pilonidal sinusCrystallized phenolLimberg FlapModified Limberg FlapKarydakisRecurrenceComplicationsRecovery durationTime to return to work

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Assessment of patient comfort

    1st year

  • Assessment of recovery duration

    3rd month

  • Assessment of complications

    3rd month

Other Outcomes (1)

  • Assessment of time before patient returns to work/routine physical activity

    3rd month

Study Arms (4)

Phenol

ACTIVE COMPARATOR

Crystallized Phenol Group

Drug: Crystallized phenol

Limberg

ACTIVE COMPARATOR

Limberg Flap Group

Procedure: Limberg Flap

Modified Limberg

ACTIVE COMPARATOR

Modified Limberg Flap Group

Procedure: Modified Limberg Flap

Karydakis

ACTIVE COMPARATOR

Karydakis Flap Group

Procedure: Karydakis Flap

Interventions

Crystallized phenolDRUG

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.

Phenol
Limberg FlapPROCEDURE

Limberg Flap surgery for pilonidal disease treatment

Limberg
Modified Limberg FlapPROCEDURE

Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.

Modified Limberg
Karydakis FlapPROCEDURE

Karydakis Flap surgery for pilonidal disease treatment

Karydakis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pilonidal disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Education and Research Hospital

Meram, Konya, 42040, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 15622588BACKGROUND

  • 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.

    PMID: 20676861BACKGROUND

  • 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.

    PMID: 17305997BACKGROUND

  • 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.

    PMID: 15043735BACKGROUND

MeSH Terms

Conditions

Pilonidal SinusRecurrence

Condition Hierarchy (Ancestors)

CystsNeoplasmsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Osman Doğru, M.D.

    Konya Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 15, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

TU(1)