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Desarda Repair for Inguinal Hernia

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lichtenstein tension free reair
Desarda's repair
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

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

Inclusion Criteria:

  • inguinal hernia

Exclusion Criteria:

  • recurrent inguinal hernia
  • giant inguinal hernia
  • mental disorder
  • refusal to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Lichtenstein tension free reair

    Desarda's repair

    Arm Description

    mesh repair of inguinal hernia

    non-mesh repair of inguinal hernia

    Outcomes

    Primary Outcome Measures

    number of patients with recurrence of inguinal hernia

    Secondary Outcome Measures

    VAS score for pain
    number of patients develped postoperative complications

    Full Information

    First Posted
    December 30, 2014
    Last Updated
    December 30, 2014
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02329938
    Brief Title
    Desarda Repair for Inguinal Hernia
    Official Title
    Desarda Versus Lichtenstein's Repair for Inguinal Hernia: a Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    5. Study Description

    Brief Summary
    Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    155 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lichtenstein tension free reair
    Arm Type
    Active Comparator
    Arm Description
    mesh repair of inguinal hernia
    Arm Title
    Desarda's repair
    Arm Type
    Active Comparator
    Arm Description
    non-mesh repair of inguinal hernia
    Intervention Type
    Procedure
    Intervention Name(s)
    Lichtenstein tension free reair
    Other Intervention Name(s)
    pure synthetic repair
    Intervention Description
    a mesh is apllied on the posterior wall of the inguinal canal and sutured to the inguinal ligament below, to the internal oblique muscle above , and to rectus sheath medially.
    Intervention Type
    Procedure
    Intervention Name(s)
    Desarda's repair
    Other Intervention Name(s)
    pure tissue reapir
    Intervention Description
    the repair is done using a flap of the external oblique aponeurosis sutured to the inguinal ligament below and to the aponeurotic part of the internal oblique muscle above.
    Primary Outcome Measure Information:
    Title
    number of patients with recurrence of inguinal hernia
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    VAS score for pain
    Time Frame
    one year
    Title
    number of patients develped postoperative complications
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: inguinal hernia Exclusion Criteria: recurrent inguinal hernia giant inguinal hernia mental disorder refusal to participate

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26074293
    Citation
    Youssef T, El-Alfy K, Farid M. Randomized clinical trial of Desarda versus Lichtenstein repair for treatment of primary inguinal hernia. Int J Surg. 2015 Aug;20:28-34. doi: 10.1016/j.ijsu.2015.05.055. Epub 2015 Jun 11.
    Results Reference
    derived

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    Desarda Repair for Inguinal Hernia

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