Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03271996

Enrollment

Registered

2017-09-05

Start date

2012-04-30

Completion date

2017-06-30

Last updated

2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus

Keywords

Pilonidal sinus, Bascom, Cleft lift, Fistulectomy, Karydakis

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

Interventions

PROCEDUREFistulectomy

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

PROCEDUREPrimary 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized controlled study

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pilonidal cyst requiring surgery * Signed Informed Consent Form

Exclusion criteria

* Abnormal lesions * Injuries requiring a closing with rotation flap

Design outcomes

Primary

Measure	Time frame	Description
Complete healing	3 weeks	percentage of complete healing

Secondary

Measure	Time frame	Description
Time to recovery	12 months	Time to completely recovery
percentage of relapse	12 months	percentage of relapse after surgery

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026