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Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods

K

Konya Meram State Hospital

Status

Completed

Conditions

Pilonidal Disease
Complication
Recurrence

Treatments

Procedure: karydakis
Procedure: tension free primary closure
Procedure: Limberg flap

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.

There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • having pilonidal sinus disease
  • desire for surgical treatment
  • accept to be involved in the study

Exclusion criteria

  • patients under age of 18
  • recurrent cases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 3 patient groups

tension free primary closure
Experimental group
Description:
patients treated by tension free primary closure
Treatment:
Procedure: tension free primary closure
karydakis
Experimental group
Description:
patients treated by Karydakis method
Treatment:
Procedure: karydakis
Limberg flap
Experimental group
Description:
patients treated by Limberg flap procedure
Treatment:
Procedure: Limberg flap

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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