Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Not Applicable

Terminated

• Conditions: Pilonidal Sinus
• Interventions: Procedure: Primary closure; Procedure: Fistulectomy

• Registration Number: NCT03271996
• Lead Sponsor: Dimitri Christoforidis

Brief 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

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Study First Submitted: 2017-08-17
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-01
• Last Update Submitted: 2017-09-01
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Pilonidal cyst requiring surgery
• Signed Informed Consent Form

Exclusion Criteria

• Abnormal lesions
• Injuries requiring a closing with rotation flap

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary closure	Primary closure	Excision of sinus and paramedian closure according to modified Karydakis technique
Fistulectomy	Fistulectomy	Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention

Primary Outcome Measures

Name	Time	Method
Complete healing	3 weeks	percentage of complete healing

Secondary Outcome Measures

Name	Time	Method
percentage of relapse	12 months	percentage of relapse after surgery
Time to recovery	12 months	Time to completely recovery

Trial Locations

Locations (1)

Ospedale Regionale di Lugano; 🇨🇭 Lugnao, Switzerland