Unilateral Inguinal HerniaNCT00293995
Minimal Access Repair of Contralateral Hernias (MARCH Trial)
A study testing Repair of unilateral inguinal hernia in people with Unilateral Inguinal Hernia, run by Institute of Child Health at 5 sites in United Kingdom.
Trial summary
Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair Read more about this study
- Who is it for?
- Ages 0 years to 1 year
- Conditions the study is for
- Unilateral Inguinal Hernia
- What is being tested?
- Repair of unilateral inguinal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Mar 2006to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- unilateral inguinal hernia
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Addenbrookes Hospital
Cambridge
Royal Hospital for Sick Children
Edinburgh
Chelsea and Westminster Hospital
London
Great Ormond Street Hospital
London
King's College Hospital
London
About this study
Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair
- Conditions
- Unilateral Inguinal Hernia
- Being tested
- Repair of unilateral inguinal hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of unilateral inguinal herniaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic repair | Other | Laparoscopic repair, with closure of contralateral patent processus vaginalis Receives: Procedure: Repair of unilateral inguinal hernia |
| Open repair | Other | Open repair Receives: Procedure: Repair of unilateral inguinal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of metachronous contralateral inguinal hernia
Measured: Until end of follow-up
Secondary outcomes (1)
development of recurrent hernia
Measured: Until end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agostino Pierro, Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293995
- Sponsor's protocol ID
- 04SG07
- Status last verified
- Jan 2022
- First submitted
- 17 Feb 2006
- Last updated
- 3 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Access Repair of Contralateral Hernias (MARCH Trial)
- ClinicalTrials.gov ID
- NCT00293995
- Acronym / sponsor ID
- 04SG07
- Conditions
- Unilateral Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Mar 2006 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic repair | Other | Procedure: Repair of unilateral inguinal herniaLaparoscopic repair, with closure of contralateral patent processus vaginalis |
| Open repair | Other | Procedure: Repair of unilateral inguinal herniaOpen repair |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- unilateral inguinal hernia
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair of unilateral inguinal hernia | Procedure or surgery | Laparoscopic repair, Open repair |
Primary outcome
development of metachronous contralateral inguinal hernia
Time frame: Until end of follow-up
1 secondary outcome
development of recurrent hernia
Time frame: Until end of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agostino Pierro principal investigator
Great Ormond Street Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of unilateral inguinal hernia in people with Unilateral Inguinal Hernia, run by Institute of Child Health at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of metachronous contralateral inguinal hernia (time frame: Until end of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.