NCT05919836

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

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

First Submitted

Initial submission to the registry

April 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

April 20, 2023

Last Update Submit

June 16, 2023

Conditions

Congenital Inguinal Hernia

Outcome Measures

Primary Outcomes (3)

  • Operative time

    Comparison between operative time in the three approaches

    4 months

  • Early recurrence

    Comparison between early recurrence of hernia in the three approaches

    4 months

  • Post operative pain duration

    Comparison between post operative pain duration between the three approaches

    4 months

Study Arms (3)

Percutaneous assisted laparoscopic hernia

ACTIVE COMPARATOR
Procedure: Laparoscopic assisted hernia

Laparoscopic Purse string closure of hernial sac

ACTIVE COMPARATOR
Procedure: Laparoscopic hernia by purse string closure

Laparoscopic Total dissection of hernial sac

ACTIVE COMPARATOR
Procedure: Total laparoscopic dissection of hernial sac

Interventions

Laparoscopic assisted herniaPROCEDURE

Percutaneous assisted laparoscopic hernia

Percutaneous assisted laparoscopic hernia
Laparoscopic hernia by purse string closurePROCEDURE

Laparoscopic purse string closure of hernial sac

Laparoscopic Purse string closure of hernial sac
Total laparoscopic dissection of hernial sacPROCEDURE

Total laparoscopic dissection of hernial sac

Laparoscopic Total dissection of hernial sac

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients in the age limit with congenital inguinal hernia

You may not qualify if:

  • recurrent hernias
  • cases inwhich laparoscopic surgery is contraindicated
  • cases with collagen defect diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 20, 2023

First Posted

June 26, 2023

Study Start

September 1, 2023

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

June 26, 2023

Record last verified: 2023-06