Minimal Access Repair of Contralateral Hernias (MARCH Trial) | NCT00293995

Studies
Minimal Access Repair of Contralateral Hernias (MARCH Trial)

NCT00293995

Sponsor

Institute of Child Health

Status

Completed

Last Update Posted

Feb 3, 2022Actual

Enrollment

360Actual

Phase

Not Applicable

Conditions

Unilateral Inguinal Hernia

Interventions

Repair of unilateral inguinal hernia

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006Actual

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Feb 17, 2006

First Submission Date that Met QC Criteria

Feb 17, 2006

First Posted Date

Feb 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2022

Last Update Posted Date

Feb 3, 2022Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Repair of unilateral inguinal hernia	Procedure		Laparoscopic repair Open repair

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unilateral inguinal hernia

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agostino Pierro	Great Ormond Street Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Addenbrookes Hospital		Cambridge			United Kingdom
Royal Hospital for Sick Children