NCT05011786

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
Last Updated

August 18, 2021

Status Verified

July 1, 2021

Enrollment Period

2.6 years

First QC Date

July 20, 2021

Last Update Submit

August 13, 2021

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

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

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

Interventions

hernia repair/ligation of the hernial sacPROCEDURE

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 groupOpen repair group

Eligibility Criteria

Age6 Months - 13 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibrahim Khrais

Amman, Please Select, 11831, Jordan

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

July 20, 2021

First Posted

August 18, 2021

Study Start

January 1, 2017

Primary Completion

July 30, 2019

Study Completion

December 30, 2020

Last Updated

August 18, 2021

Record last verified: 2021-07

Locations

JO(1)