Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03271996
• Other study ID #: 11-016
• Status: Terminated
• Phase: N/A
• First received: August 17, 2017
• Last updated: September 1, 2017
• Start date: April 2012
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Pilonidal cyst requiring surgery

• Signed Informed Consent Form

Exclusion Criteria:

• Abnormal lesions

• Injuries requiring a closing with rotation flap

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

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.
• 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

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Lugano	Lugnao

Sponsors (1)

Lead Sponsor	Collaborator
Dimitri Christoforidis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing	percentage of complete healing	3 weeks
Secondary	Time to recovery	Time to completely recovery	12 months
Secondary	percentage of relapse	percentage of relapse after surgery	12 months