Clinical trial NCT05851690: Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease
Official title: Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Keywords: Pilonidal sinus disease
Flap
Karydakis
Bilaterally parallel elliptic
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time taken to return to work/school
timeFrame: The patients' return to work ranged from 11 to 49 days.
measure: Postoperative pain
timeFrame: 1 day
Secondary outcomes:
measure: Length of hospital stay
timeFrame: The patients' length of hospital stay ranged from 1 to 4 days.
measure: Recurrence of the disease
timeFrame: 43 months
Other outcomes:
Locations:
Study officials:
References:
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