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Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics

Primary Purpose

Congenital Inguinal Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic assisted hernia
Laparoscopic hernia by purse string closure
Total laparoscopic dissection of hernial sac
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Inguinal Hernia

Eligibility Criteria

1 Month - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients in the age limit with congenital inguinal hernia Exclusion Criteria: recurrent hernias cases inwhich laparoscopic surgery is contraindicated cases with collagen defect diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Percutaneous assisted laparoscopic hernia

    Laparoscopic Purse string closure of hernial sac

    Laparoscopic Total dissection of hernial sac

    Arm Description

    Outcomes

    Primary Outcome Measures

    Operative time
    Comparison between operative time in the three approaches
    Early recurrence
    Comparison between early recurrence of hernia in the three approaches
    Post operative pain duration
    Comparison between post operative pain duration between the three approaches

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2023
    Last Updated
    June 16, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05919836
    Brief Title
    Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics
    Official Title
    Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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
    Comparison between multiple approaches of laparoscopic hernia ( percutaneous assisted laparoscopic hernia, purse string closure of hernial sac, total dissection of hernial sac).
    Detailed Description
    In pediatric age, indirect inguinal hernia represents more than 95% of the hernial disease. It is a congenital type, in contrast with adulthood in which acquired forms are more frequently found. Inguinal hernia repair is one of the most frequently performed surgical procedure in infants and young children. Laparoscopic hernia repair in infancy and childhood is still debatable. There are many techniques available for laparoscopic hernia repair in pediatrics. Laparoscopic hernial repair is increasingly adopted even for neonates and has achieved a high success rate with low recurrence rate with long-term follow-up. The main advantages of laparoscopy are no incision of the fascia, exploration of the other side in case of bilateral hernia, and visualization and safeguarding of the vas deferens and the spermatic vessels. Moreover, it is advantageous over open technique in case of recurrent hernia. Different modalities of techniques have been used for repair such as needlescopic disconnection of hernia sac, flip flap technique, muscular arch repair, and ring closure.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Percutaneous assisted laparoscopic hernia
    Arm Type
    Active Comparator
    Arm Title
    Laparoscopic Purse string closure of hernial sac
    Arm Type
    Active Comparator
    Arm Title
    Laparoscopic Total dissection of hernial sac
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic assisted hernia
    Intervention Description
    Percutaneous assisted laparoscopic hernia
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic hernia by purse string closure
    Intervention Description
    Laparoscopic purse string closure of hernial sac
    Intervention Type
    Procedure
    Intervention Name(s)
    Total laparoscopic dissection of hernial sac
    Intervention Description
    Total laparoscopic dissection of hernial sac
    Primary Outcome Measure Information:
    Title
    Operative time
    Description
    Comparison between operative time in the three approaches
    Time Frame
    4 months
    Title
    Early recurrence
    Description
    Comparison between early recurrence of hernia in the three approaches
    Time Frame
    4 months
    Title
    Post operative pain duration
    Description
    Comparison between post operative pain duration between the three approaches
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients in the age limit with congenital inguinal hernia Exclusion Criteria: recurrent hernias cases inwhich laparoscopic surgery is contraindicated cases with collagen defect diseases

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics

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