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OpenTrials
Completed

NCT Number: NCT02186964

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

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.

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Key information

Conditions

Pilonidal Disease Complication Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya Training and Research Hospital

Konya, 42180, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tension free primary closure

Procedure

tension free primary closure of the defects created by excision of the pilonidal sinus

karydakis

Procedure

the defect after excision of the pilonidal sinus is closed by Karydakis procedure

Limberg flap

Procedure

defect after excision of the pilonidal sinus is closed by Limberg flap procedure

Primary outcomes

  1. recurrence

    Time frame: 2 years

    recurrence rates two years after the surgery

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Jul 10, 2014
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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