NCT03271996

Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dimitri Christoforidis · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Pilonidal Sinus

Interventions

Type	Name	Description
PROCEDURE	Primary closure	Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
PROCEDURE	Fistulectomy	Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2017-09-05
• Last updated: 2017-09-05

Locations

1 site across 1 country: Switzerland