Hernia, InguinalNCT03247985
Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair
A study testing PROLENE Polypropylene Tacking Mesh and ProGrip Self-fixating Mesh in people with Hernia, Inguinal, run by Mayo Clinic at 1 site in United States.
Trial summary
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- PROLENE Polypropylene Tacking Mesh and ProGrip Self-fixating Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 30 Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients regardless of sex or age who were diagnosed with a inguinal hernia and underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in Rochester, Minnesota from June 2013 - June 2014.
Who cannot join
- Patients who did not elect to undergo a hernia repair or who elected to undergo a different type of hernia repair instead of a TEP procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.
Read the detailed description
Participants will be placed into two groups. One group of participants will have mesh tacked into place for their hernia repairs. The other group will have self-fixating mesh into place. Both groups will have a piece of mesh that will widely cover the hernia defect. Before surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no pain and 10 is the worst pain they can imagine. Investigators will record information about general medical condition, medications and activity level. During the operation information will be recorded about the pain medicines the participant may receive. In the recovery room the participant will be asked to rate their pain on the 0-10 scale and more information will be recorded about any additional pain medicines that they may receive and assess activity level. Following surgery, Investigators will contact the participants by survey to obtain more information about pain level, medication use, and activity level.
- Conditions
- Hernia, Inguinal
- Being tested
- PROLENE Polypropylene Tacking Mesh, ProGrip Self-fixating Mesh
- Keywords
- Mesh, Repair, Peritoneal
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROLENE Polypropylene Tacking MeshDevice
Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
ProGrip Self-fixating MeshDevice
ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open \& laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of "Velcro" to the soft tissue surfaces resulting in self-fixation
| Study group | Role | What they receive |
|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Active comparator | Participants will be randomized to Tacking Mesh for their inguinal hernia surgery. Receives: Device: PROLENE Polypropylene Tacking Mesh |
| ProGrip Self-fixating Mesh | Active comparator | Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery Receives: Device: ProGrip Self-fixating Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Operative Time
Length of time needed to complete surgery.
Measured: First incision to closure, approximately one hour
Number of Participants With Early Postoperative Complications
Any complication which occurred within 30 days after the operation.
Measured: Within 30 days
Secondary outcomes (3)
Pain Score at Baseline
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Measured: baseline
Pain Score at One Week
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Measured: One Week Postoperative
Pain Score at Four Weeks
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Measured: Four Weeks Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study startJun 2013
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David R. Farley, Mayo Clinic
- Investigators
- David Farley, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247985
- Sponsor's protocol ID
- 13-003616
- Status last verified
- May 2018
- First submitted
- 10 Aug 2017
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh
- ClinicalTrials.gov ID
- NCT03247985
- Acronym / sponsor ID
- 13-003616
- Conditions
- Hernia, Inguinal
- Keywords
- Mesh, Repair, Peritoneal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 17 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.
Detailed description
Participants will be placed into two groups. One group of participants will have mesh tacked into place for their hernia repairs. The other group will have self-fixating mesh into place. Both groups will have a piece of mesh that will widely cover the hernia defect. Before surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no pain and 10 is the worst pain they can imagine. Investigators will record information about general medical condition, medications and activity level. During the operation information will be recorded about the pain medicines the participant may receive. In the recovery room the participant will be asked to rate their pain on the 0-10 scale and more information will be recorded about any additional pain medicines that they may receive and assess activity level. Following surgery, Investigators will contact the participants by survey to obtain more information about pain level, medication use, and activity level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Active comparator | Device: PROLENE Polypropylene Tacking MeshParticipants will be randomized to Tacking Mesh for their inguinal hernia surgery. |
| ProGrip Self-fixating Mesh | Active comparator | Device: ProGrip Self-fixating MeshParticipants will be randomized to Self-fixing mesh for their inguinal hernia surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients regardless of sex or age who were diagnosed with a inguinal hernia and underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in Rochester, Minnesota from June 2013 - June 2014.
Key exclusion criteria (1 listed)
- Patients who did not elect to undergo a hernia repair or who elected to undergo a different type of hernia repair instead of a TEP procedure.
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 |
|---|---|---|
| PROLENE Polypropylene Tacking MeshProlene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks | Device | PROLENE Polypropylene Tacking Mesh |
| ProGrip Self-fixating MeshProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open \& laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of "Velcro" to the soft tissue surfaces resulting in self-fixation | Device | ProGrip Self-fixating Mesh |
Primary outcome
Mean Operative Time
Time frame: First incision to closure, approximately one hour
Length of time needed to complete surgery.
Number of Participants With Early Postoperative Complications
Time frame: Within 30 days
Any complication which occurred within 30 days after the operation.
3 secondary outcomes
Pain Score at Baseline
Time frame: baseline
Pain Score at One Week
Time frame: One Week Postoperative
Pain Score at Four Weeks
Time frame: Four Weeks Postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Farley principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROLENE Polypropylene Tacking Mesh and ProGrip Self-fixating Mesh in people with Hernia, Inguinal, run by Mayo Clinic 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 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 15 Jun 2018. 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. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Operative Time (time frame: First incision to closure, approximately one hour). The study lists 2 primary outcomes in all. 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 15 Jun 2018; AzTrials last refreshed its copy on 28 Oct 2026.