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Quality of Life of TEP vs Lichtenstein Hernioplasty

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open Lichtenstein Hernioplasty
Laparoscopic TEP Hernioplasty
Sponsored by
Sarawak General Hospital
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:

  • 18 years of age and older
  • Both genders
  • Unilateral inguinal hernias
  • Reducible inguinal hernias
  • Elective setting

Exclusion Criteria

  • ASA Physical Status (American Society of Anaesthesiologists) Grade > 2
  • Recurrence
  • Inguinal-scrotal hernias
  • Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
  • Pregnancy
  • Refusal for general anaesthesia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Open modified Lichtenstein repair

    Laparoscopic TEP inguinal hernia repair

    Arm Description

    Patients will undergo open repair of their inguinal hernias

    Patients will undergo laparoscopic repair of their inguinal hernias

    Outcomes

    Primary Outcome Measures

    Quality of life
    Carolina Comfort Scale

    Secondary Outcome Measures

    Operating time
    Duration of hospitalization
    Complications
    Recurrence
    Recurrence of hernia after repair

    Full Information

    First Posted
    March 14, 2016
    Last Updated
    March 24, 2016
    Sponsor
    Sarawak General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02723045
    Brief Title
    Quality of Life of TEP vs Lichtenstein Hernioplasty
    Official Title
    The Comparison of the Quality of Life and Outcomes in Patient's With Reducible Inguinal Hernias: Laparoscopic Totally Extra-peritoneal (TEP) Versus Modified Lichtenstein Hernioplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sarawak General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty
    Detailed Description
    Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

    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
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Open modified Lichtenstein repair
    Arm Type
    Active Comparator
    Arm Description
    Patients will undergo open repair of their inguinal hernias
    Arm Title
    Laparoscopic TEP inguinal hernia repair
    Arm Type
    Active Comparator
    Arm Description
    Patients will undergo laparoscopic repair of their inguinal hernias
    Intervention Type
    Procedure
    Intervention Name(s)
    Open Lichtenstein Hernioplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic TEP Hernioplasty
    Primary Outcome Measure Information:
    Title
    Quality of life
    Description
    Carolina Comfort Scale
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Operating time
    Time Frame
    12 months
    Title
    Duration of hospitalization
    Time Frame
    12 months
    Title
    Complications
    Time Frame
    12 monthts
    Title
    Recurrence
    Description
    Recurrence of hernia after repair
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age and older Both genders Unilateral inguinal hernias Reducible inguinal hernias Elective setting Exclusion Criteria ASA Physical Status (American Society of Anaesthesiologists) Grade > 2 Recurrence Inguinal-scrotal hernias Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery Pregnancy Refusal for general anaesthesia

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Quality of Life of TEP vs Lichtenstein Hernioplasty

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