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

Not Applicable

Completed

• Conditions: Pilonidal Sinus

• Registration Number: NCT05851690
• Lead Sponsor: Atlas University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-16
• Primary Completion: 2017-01-18
• Study Completion: 2020-01-25
• Status Verified: 2023-04
• Study First Submitted: 2023-04-30
• Study First Submitted QC: 2023-04-30
• Last Update Submitted: 2023-04-30
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain	1 day	The 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.
Time taken to return to work/school	The patients' return to work ranged from 11 to 49 days.	Time to return to work in daily life after surgery

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	The patients' length of hospital stay ranged from 1 to 4 days.	Time to discharge from hospital after surgery
Recurrence of the disease	43 months	Recurrence of the disease