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Reduction Dead Space Volume With Karydakis Modification

Primary Purpose

PILONIDAL SINUS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A new surgical technique
Sponsored by
Siverek Devlet Hastanesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PILONIDAL SINUS focused on measuring karydakis modification, pilonidal sinus, complication

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18 years
  • patients who accept the procedure
  • chronic p.sinüs disease

Exclusion Criteria:

  • previous sinüs surgery
  • active infection
  • patients who did not accept the procedure
  • patients under age of 18.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    modified Karydakis,surgical technique

    Arm Description

    a new surgical technique(modified Karydakis) to be compared with standard Karydakis

    Outcomes

    Primary Outcome Measures

    Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery
    OUTCOME MEASURE: Extracted sinus volume The number of patients with complications Delayed wound healing seroma hematoma formation wound infection

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2015
    Last Updated
    October 13, 2015
    Sponsor
    Siverek Devlet Hastanesi
    Collaborators
    Harran University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02574936
    Brief Title
    Reduction Dead Space Volume With Karydakis Modification
    Official Title
    Effects of Reduction Dead Space Volume With Karydakis Modification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Siverek Devlet Hastanesi
    Collaborators
    Harran University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.
    Detailed Description
    The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PILONIDAL SINUS
    Keywords
    karydakis modification, pilonidal sinus, complication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    modified Karydakis,surgical technique
    Arm Type
    Other
    Arm Description
    a new surgical technique(modified Karydakis) to be compared with standard Karydakis
    Intervention Type
    Procedure
    Intervention Name(s)
    A new surgical technique
    Other Intervention Name(s)
    Modified Karydakis
    Intervention Description
    Description of a new surgical technique in pilonidal sinüs surgery in order to reduce dead space volume. A flap extending across the cut (Karydakis) is prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap is shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin is excised along the incision in the flap side. Skin is approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used
    Primary Outcome Measure Information:
    Title
    Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery
    Description
    OUTCOME MEASURE: Extracted sinus volume The number of patients with complications Delayed wound healing seroma hematoma formation wound infection
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients older than 18 years patients who accept the procedure chronic p.sinüs disease Exclusion Criteria: previous sinüs surgery active infection patients who did not accept the procedure patients under age of 18.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali Uzunköy
    Organizational Affiliation
    Harran University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Reduction Dead Space Volume With Karydakis Modification

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