Inguinal HerniaNCT02062775
Comparison of Self-Fixating vs Non-Fixating Hernia Mesh
A study testing Use of self-fixating mesh for inguinal hernia repair, Use of non-fixating mesh for inguinal hernia repair and Absorbable tacks may be used in hernias >2cm in people with Inguinal Hernia, run by Endeavor Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Use of self-fixating mesh for inguinal hernia repair, Use of non-fixating mesh for inguinal hernia repair and Absorbable tacks may be used in hernias >2cm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 10 Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- ASA Classification I, II, III
- scheduled for elective TEP inguinal hernia repair
Who cannot join
- ASA Classification IV or greater
- needing emergency surgery
- known history of narcotic dependence
- undergoing bilateral inguinal or combined umbilical hernia repair
- undergoing other procedures during same anesthetic
- undergoing recurrent inguinal hernia repair
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.
Read the detailed description
This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.
- Conditions
- Inguinal Hernia
- Being tested
- Use of self-fixating mesh for inguinal hernia repair, Use of non-fixating mesh for inguinal hernia repair, Absorbable tacks may be used in hernias >2cm
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of self-fixating mesh for inguinal hernia repairProcedure or surgery
Also called Parietex ProGrip
Parietex ProGrip will be used to repair inguinal hernia
Use of non-fixating mesh for inguinal hernia repairProcedure or surgery
Also called Parietex Anatomic
Parietex Anatomic mesh will be used to repair inguinal hernias.
Absorbable tacks may be used in hernias >2cmProcedure or surgery
Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures >2cm
| Study group | Role | What they receive |
|---|---|---|
| Self-Fixating Hernia Mesh | Active comparator | Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair. Receives: Procedure: Use of self-fixating mesh for inguinal hernia repair; Procedure: Absorbable tacks may be used in hernias >2cm |
| Non-Fixating Hernia Mesh | Placebo comparator | Non-fixating polyester mesh will be used for laparoscopic hernia repair. Receives: Procedure: Use of non-fixating mesh for inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postoperative pain
Measured: 1 year
Secondary outcomes (1)
Incidence of hernia recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startAug 2013
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- John Linn, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062775
- Sponsor's protocol ID
- EH13-356
- Status last verified
- Sep 2019
- First submitted
- 11 Feb 2014
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02062775
- Acronym / sponsor ID
- EH13-356
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Aug 2013
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 14 Feb 2014 (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.
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.
Detailed description
This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Fixating Hernia Mesh | Active comparator | Procedure: Use of self-fixating mesh for inguinal hernia repair, Procedure: Absorbable tacks may be used in hernias >2cmSelf-fixating polyester mesh will be used for laparoscopic inguinal hernia repair. |
| Non-Fixating Hernia Mesh | Placebo comparator | Procedure: Use of non-fixating mesh for inguinal hernia repairNon-fixating polyester mesh will be used for laparoscopic hernia repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years
- ASA Classification I, II, III
- scheduled for elective TEP inguinal hernia repair
Key exclusion criteria (6 listed)
- ASA Classification IV or greater
- needing emergency surgery
- known history of narcotic dependence
- undergoing bilateral inguinal or combined umbilical hernia repair
- undergoing other procedures during same anesthetic
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 |
|---|---|---|
| Use of self-fixating mesh for inguinal hernia repairAlso: Parietex ProGripParietex ProGrip will be used to repair inguinal hernia | Procedure or surgery | Self-Fixating Hernia Mesh |
| Use of non-fixating mesh for inguinal hernia repairAlso: Parietex AnatomicParietex Anatomic mesh will be used to repair inguinal hernias. | Procedure or surgery | Non-Fixating Hernia Mesh |
| Absorbable tacks may be used in hernias >2cmPatients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures >2cm | Procedure or surgery | Self-Fixating Hernia Mesh |
Primary outcome
Chronic postoperative pain
Time frame: 1 year
1 secondary outcome
Incidence of hernia recurrence
Time frame: 1 year
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 11 Sep 2019.
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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.
John Linn, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of self-fixating mesh for inguinal hernia repair, Use of non-fixating mesh for inguinal hernia repair and Absorbable tacks may be used in hernias >2cm in people with Inguinal Hernia, run by Endeavor Health at 1 site in United States.
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 3 inclusion and 6 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Chronic postoperative pain (time frame: 1 year). 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 11 Sep 2019.