Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease
Primary Purpose
Pilonidal Sinus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgical treatment of pilonidal sinus disease
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus focused on measuring Pilonidal sinus disease, Flap, Karydakis, Bilaterally parallel elliptic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bilateral Parallel Elliptic Flap
Karydakis Flap
Arm Description
Patients operated with the bilateral parallel elliptic flap technique.
Patients operated with the karydakis flap technique.
Outcomes
Primary Outcome Measures
Time taken to return to work/school
Time to return to work in daily life after surgery
Postoperative pain
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.
Secondary Outcome Measures
Length of hospital stay
Time to discharge from hospital after surgery
Recurrence of the disease
Recurrence of the disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05851690
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2016 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
January 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlas University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
Pilonidal sinus disease, Flap, Karydakis, Bilaterally parallel elliptic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral Parallel Elliptic Flap
Arm Type
Active Comparator
Arm Description
Patients operated with the bilateral parallel elliptic flap technique.
Arm Title
Karydakis Flap
Arm Type
Active Comparator
Arm Description
Patients operated with the karydakis flap technique.
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment of pilonidal sinus disease
Intervention Description
Advancement flap techniques in surgical treatment of pilonidal sinus disease.
Primary Outcome Measure Information:
Title
Time taken to return to work/school
Description
Time to return to work in daily life after surgery
Time Frame
The patients' return to work ranged from 11 to 49 days.
Title
Postoperative pain
Description
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 Frame
1 day
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Time to discharge from hospital after surgery
Time Frame
The patients' length of hospital stay ranged from 1 to 4 days.
Title
Recurrence of the disease
Description
Recurrence of the disease
Time Frame
43 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
One year from the date of publication.
Citations:
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Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease
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