Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Dimitri Christoforidis

Status: Terminated

Conditions: Pilonidal Sinus

Treatments: Procedure: Primary closure; Procedure: Fistulectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03271996

11-016

Details and patient eligibility

About

This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.

Full description

This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)

Group A: excision and paramedian closure according to modified Karydakis technique

Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention

Enrollment: 60 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pilonidal cyst requiring surgery
• Signed Informed Consent Form

Exclusion criteria

• Abnormal lesions
• Injuries requiring a closing with rotation flap

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Primary closure

Experimental group

Description:

Excision of sinus and paramedian closure according to modified Karydakis technique

Treatment:

Procedure: Primary closure

Fistulectomy

Experimental group

Description:

Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention

Treatment:

Procedure: Fistulectomy