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

NCT ID: NCT02186964

Last Updated: 2014-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-05-31

Brief Summary

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.

Conditions

Pilonidal Disease; Recurrence; Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tension free primary closure

patients treated by tension free primary closure

Group Type: EXPERIMENTAL

tension free primary closure

Intervention Type: PROCEDURE

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

karydakis

patients treated by Karydakis method

Group Type: EXPERIMENTAL

karydakis

Intervention Type: PROCEDURE

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

Limberg flap

patients treated by Limberg flap procedure

Group Type: EXPERIMENTAL

Limberg flap

Intervention Type: PROCEDURE

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

Interventions

tension free primary closure

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

Intervention Type: PROCEDURE

karydakis

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

Intervention Type: PROCEDURE

Limberg flap

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya Meram State Hospital

OTHER

Sponsor Role: lead

Responsible Party

barış sevinç

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ömer Karahan, Professor

Role: STUDY_DIRECTOR

Konya Meram State Hospital

Locations

Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sevinc B, Karahan O, Okus A, Ay S, Aksoy N, Simsek G. Randomized prospective comparison of midline and off-midline closure techniques in pilonidal sinus surgery. Surgery. 2016 Mar;159(3):749-54. doi: 10.1016/j.surg.2015.09.024. Epub 2015 Oct 31.

Reference Type: DERIVED

PMID: 26531235 (View on PubMed)

Other Identifiers

PS42

Identifier Type: -

Identifier Source: org_study_id