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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05919836
Other study ID # lap hernia in pediatrics
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date June 2025

Study information

Verified date June 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison between multiple approaches of laparoscopic hernia ( percutaneous assisted laparoscopic hernia, purse string closure of hernial sac, total dissection of hernial sac).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 69
Est. completion date June 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 1 Month to 5 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic assisted hernia
Percutaneous assisted laparoscopic hernia
Laparoscopic hernia by purse string closure
Laparoscopic purse string closure of hernial sac
Total laparoscopic dissection of hernial sac
Total laparoscopic dissection of hernial sac

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Operative time Comparison between operative time in the three approaches 4 months
Primary Early recurrence Comparison between early recurrence of hernia in the three approaches 4 months
Primary Post operative pain duration Comparison between post operative pain duration between the three approaches 4 months
See also
  Status Clinical Trial Phase
Completed NCT02239185 - Laparoscopic Inguinal Hernia Repair in Infancy and Childhood N/A
Recruiting NCT04372212 - Needlescopic Inversion and Snaring Versus Ligation of Hernia Sac in Girls N/A