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
About this trial
This is an interventional treatment trial for Congenital Inguinal Hernia
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
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
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
Learn more about this trial
Different Laparoscopic Techniques for Management of Congenital Inguinal Hernia in Pediatrics
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