NCT00293995

Brief Summary

Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

February 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

7.7 years

First QC Date

February 17, 2006

Last Update Submit

January 19, 2022

Conditions

Unilateral Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • development of metachronous contralateral inguinal hernia

    Until end of follow-up

Secondary Outcomes (1)

  • development of recurrent hernia

    Until end of follow-up

Study Arms (2)

Laparoscopic repair

OTHER

Laparoscopic repair, with closure of contralateral patent processus vaginalis

Procedure: Repair of unilateral inguinal hernia

Open repair

OTHER

Open repair

Procedure: Repair of unilateral inguinal hernia

Interventions

Repair of unilateral inguinal herniaPROCEDURE
Laparoscopic repairOpen repair

Eligibility Criteria

Age0 Years - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • unilateral inguinal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Addenbrookes Hospital

Cambridge, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, United Kingdom

Location

Chelsea and Westminster Hospital

London, United Kingdom

Location

Great Ormond Street Hospital

London, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Study Officials

  • Agostino Pierro

    Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 20, 2006

Study Start

March 1, 2006

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations

GB(5)