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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
Atlas University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 30, 2023
    Last Updated
    April 30, 2023
    Sponsor
    Atlas University
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    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:
    PubMed Identifier
    32792519
    Citation
    Bi S, Sun K, Chen S, Gu J. Surgical procedures in the pilonidal sinus disease: a systematic review and network meta-analysis. Sci Rep. 2020 Aug 13;10(1):13720. doi: 10.1038/s41598-020-70641-7.
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    27188235
    Citation
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    30640830
    Citation
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    PubMed Identifier
    4128725
    Citation
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    Citation
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    23173633
    Citation
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    27451868
    Citation
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    Citation
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    Citation
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    Citation
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    Citation
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    Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

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