Open and Laparoscopic Hernia Repair. A Comparative Study

Is the Open Approach Superior to the Laparoscopic Hernia Repair in Children? A Retrospective Comparative Study.

A retrospective comparative study in a pediatric surgery center to compare the outcomes of 2 approaches of hernia repair in the pediatric population.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: hernia repair/ligation of the hernial sac

Detailed Description

The investigators reviewed the records of all children who underwent open or laparoscopic hernia repair between January 2017 and July 2019 at the pediatric surgery center at the Jordan University Hospital. Data collection included the age, gender, laterality of the hernia, the surgical approach, duration of surgery, time to discharge and time to full recovery.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Jordan
  • Please Select
    • Amman, Please Select, Jordan, 11831
      • Ibrahim Khrais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 13 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all children aged between 6 months and 13 years who underwent open or laparoscopic inguinal hernia repair at the Jordan University Hospital in the period between January 2017 and July 2019

Description

Inclusion Criteria:

• All children within the age limit specified were included in the study

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open repair group; children with inguinal hernia who were repaired with open high ligation of the hernia sac through an inguinal incision.	Procedure: hernia repair/ligation of the hernial sac; the inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group
Laparoscopic repair group; children with inguinal hernia who were repaired laparoscopically by closing the the PPV at the level of internal ring with a purse string suture	Procedure: hernia repair/ligation of the hernial sac; the inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OR duration		During surgery
Length of stay LOS		1 year
Post operative complications		1 year
Hernia Recurrence		1 year
Total Cost of Surgery		1 year
Cosmesis	What does the parents of the children think of the cosmetic outcomes of the surgery on a scale from 1-5	1 Year
Recovery	Time from discharge to resuming normal daily activities	year

Collaborators and Investigators

• Sponsor: Ibrahim Khrais

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 67-2019-5771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No