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Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polypropelene mesh
Sponsored by
Jabir Ibn Hayyan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Adult inguinal hernia, Mesh, Darn repair, Hernia repair techinques, Primary inguinal hernia

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • primary hernia
  • male

Exclusion Criteria:

  • Female
  • bilateral
  • recurrent hernia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group II MA Mesh alone repair

    Group I CMD Combined Mesh & darn

    Arm Description

    patient use mesh alone as treatment of inguinal hernia

    patients utilize both mesh and darn repair

    Outcomes

    Primary Outcome Measures

    Recurrence rate
    follow up
    Post operative complications
    record complication
    Post operative pain
    Visual Analog Score for pain

    Secondary Outcome Measures

    Full Information

    First Posted
    March 8, 2021
    Last Updated
    July 4, 2021
    Sponsor
    Jabir Ibn Hayyan Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04891601
    Brief Title
    Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males
    Official Title
    Randomised Controlled Trial, Compare Mesh and Combined Mesh and Darn Repair in the Treatment of Adults Inguinal Hernia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    February 2018 (Actual)
    Study Completion Date
    February 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jabir Ibn Hayyan Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A prospective randomized study involved 228 individuals with primary inguinal hernia, operated in our departments, between January 2015 to February 2018. The duration of hospital stay, operative time, duration of returning to routine activities, postsurgical sequels and recurrence rates estimated. We randomly allocated it into two groups: mesh repair was applied to 166 patients (Group 1) and combined both mesh, and darn repair applied to 162 patients (Group 2).
    Detailed Description
    Background In spite of the era of laparoscopy still, open repair in primary inguinal hernia is currently the most commonly performed general surgical operation. To evaluate whether the combined darn repair plus Lichtenstein compare Lichtenstein repair alone in the treatment of inguinal hernias regarding postoperative complication and recurrence. Materials and methods: A prospective randomized study involved with 218 patients with primary inguinal hernia, operated in our departments, between 2015 and 2018. The duration of the operation time, hospitalization, and time to return to daily activities and postoperative complication and recurrence rates were evaluated. We randomly allocated into two groups: Lichtenstein repair was applied to 169 patients (Group 1), and combined both modified darn repair plus Lichtenstein repair was applied to 160 patients (Group 2). Results: The average follow-up period was 48 months. For the alone Lichtenstein procedure, the average duration of operation was 62 min; the average time to return to routine activities was 21 days. The number of patients with postoperative complications was 12 (11.3 %), and the number of patients with recurrence was 1 (0. 9%). For darn repair plus Lichtenstein procedure, the average duration of operation was 72 min; the time to return to daily activities was 21days. The number of patients with postoperative complication was 13 (11.6%), and no recurrences were noted. The hospitalization time of the groups was similar. Conclusion: Two-year follow-up, combined mesh and darn better than mesh alone in recurrence rate, both had the same postoperative complication, hospitalization time and return to routine activity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia
    Keywords
    Adult inguinal hernia, Mesh, Darn repair, Hernia repair techinques, Primary inguinal hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    228 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group II MA Mesh alone repair
    Arm Type
    Active Comparator
    Arm Description
    patient use mesh alone as treatment of inguinal hernia
    Arm Title
    Group I CMD Combined Mesh & darn
    Arm Type
    Active Comparator
    Arm Description
    patients utilize both mesh and darn repair
    Intervention Type
    Procedure
    Intervention Name(s)
    polypropelene mesh
    Intervention Description
    compare use mesh alone or combined mesh and darn repair
    Primary Outcome Measure Information:
    Title
    Recurrence rate
    Description
    follow up
    Time Frame
    two to four year
    Title
    Post operative complications
    Description
    record complication
    Time Frame
    two to four year
    Title
    Post operative pain
    Description
    Visual Analog Score for pain
    Time Frame
    two to four year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: primary hernia male Exclusion Criteria: Female bilateral recurrent hernia

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Yes

    Learn more about this trial

    Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males

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