Minimal Access Repair of Contralateral Hernias (MARCH Trial)

January 19, 2022 updated by: Institute of Child Health
Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • Edinburgh, United Kingdom
        • Royal Hospital for Sick Children
      • London, United Kingdom
        • Great Ormond Street Hospital
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • Chelsea and Westminster Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral inguinal hernia

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Laparoscopic repair
Laparoscopic repair, with closure of contralateral patent processus vaginalis
Procedure: Repair of unilateral inguinal hernia
Other: Open repair
Procedure: Repair of unilateral inguinal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
development of metachronous contralateral inguinal hernia
Time Frame: Until end of follow-up
Until end of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
development of recurrent hernia
Time Frame: Until end of follow-up
Until end of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Child Health

Investigators

  • Principal Investigator: Agostino Pierro, Great Ormond Street Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2006

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04SG07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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