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Minimal Access Repair of Contralateral Hernias (MARCH Trial)

Primary Purpose

Unilateral Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Repair of unilateral inguinal hernia
Sponsored by
Institute of Child Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Inguinal Hernia

Eligibility Criteria

0 Years - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: unilateral inguinal hernia Exclusion Criteria: -

Sites / Locations

  • Addenbrookes Hospital
  • Royal Hospital for Sick Children
  • Chelsea and Westminster Hospital
  • Great Ormond Street Hospital
  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Laparoscopic repair

Open repair

Arm Description

Laparoscopic repair, with closure of contralateral patent processus vaginalis

Open repair

Outcomes

Primary Outcome Measures

development of metachronous contralateral inguinal hernia

Secondary Outcome Measures

development of recurrent hernia

Full Information

First Posted
February 17, 2006
Last Updated
January 19, 2022
Sponsor
Institute of Child Health
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1. Study Identification

Unique Protocol Identification Number
NCT00293995
Brief Title
Minimal Access Repair of Contralateral Hernias (MARCH Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2006 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Child Health

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic repair
Arm Type
Other
Arm Description
Laparoscopic repair, with closure of contralateral patent processus vaginalis
Arm Title
Open repair
Arm Type
Other
Arm Description
Open repair
Intervention Type
Procedure
Intervention Name(s)
Repair of unilateral inguinal hernia
Primary Outcome Measure Information:
Title
development of metachronous contralateral inguinal hernia
Time Frame
Until end of follow-up
Secondary Outcome Measure Information:
Title
development of recurrent hernia
Time Frame
Until end of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral inguinal hernia Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agostino Pierro
Organizational Affiliation
Great Ormond Street Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital
City
London
Country
United Kingdom
Facility Name
Great Ormond Street Hospital
City
London
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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Minimal Access Repair of Contralateral Hernias (MARCH Trial)

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