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Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05851690
Enrollment
102
Registered
2023-05-10
Start date
2016-06-16
Completion date
2020-01-25
Last updated
2023-05-10

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 disease, Flap, Karydakis, Bilaterally parallel elliptic

Brief summary

Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.

Interventions

PROCEDURESurgical treatment of pilonidal sinus disease

Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Sponsors

Atlas University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Underwent surgery due to pilonidal sinus disease

Exclusion criteria

* Patients with a history of previous pilonidal sinus surgery, * An acute pilonidal abscess, * immunodeficiency, * using immunosuppressive drugs, * refuse to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Time taken to return to work/schoolThe patients' return to work ranged from 11 to 49 days.Time to return to work in daily life after surgery
Postoperative pain1 dayThe pain scores of the patients were determined on the first postoperative day. The Visual Analog Scale (VAS), scored from 1 to 10, was administered to the patients to evaluate their postoperative pain levels.

Secondary

MeasureTime frameDescription
Length of hospital stayThe patients' length of hospital stay ranged from 1 to 4 days.Time to discharge from hospital after surgery
Recurrence of the disease43 monthsRecurrence of the disease

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026