Hernia, InguinalPhase 4RINGNCT00681291

Strattice in Repair of Inguinal Hernias

A Phase 4 study testing Inguinal hernia repair with Ultrapro and Inguinal hernia repair with Strattice in people with Hernia, Inguinal, run by LifeCell at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hernia, Inguinal
What is being tested?: Inguinal hernia repair with Ultrapro and Inguinal hernia repair with Strattice
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: 8 sitesUnited States
Study dates: Apr 2008to Jun 2012
Phase: Phase 4
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

adult male
symptomatic and palpable inguinal hernia
open, elective, primary unilateral inguinal hernia repair

Who cannot join

bilateral inguinal hernia repair
BMI >35
chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or COPD
chronic prostatitis, orchitis, testicular pain
local or systemic infection at time of repair
known collagen disorder
chronic pain syndrome or under active pain management

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Maryland School of Medicine
Baltimore, Maryland, 21201
Regional Surgical Associates
Durham, North Carolina, 27704
Baylor College of Medicine
Houston, Texas, 77030
Hospital of St Raphael
New Haven, Connecticut, 06511
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Creighton University
Omaha, Nebraska, 68178
Oregon Health Sciences University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias

This is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing Strattice to light weight polypropylene mesh. Performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.

Conditions: Hernia, Inguinal
Being tested: Inguinal hernia repair with Ultrapro, Inguinal hernia repair with Strattice
Keywords: surgical mesh, inguinal hernia repair, chronic groin pain
Medical subject headings: Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inguinal hernia repair with UltraproDevice
Also called Ultrapro (Ethicon, Somerville NJ)
surgical mesh (15x15cm) to support Lichtenstein repair
Inguinal hernia repair with StratticeDevice
Also called Strattice Reconstructive Tissue Matrix
Surgical mesh (10x16) used to support Lichtenstein repair

Study groups in NCT00681291
Study group	Role	What they receive
1	Active comparator	lightweight polypropylene mesh Receives: Device: Inguinal hernia repair with Ultrapro
2	Active comparator	Strattice Receives: Device: Inguinal hernia repair with Strattice

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Activities Assessment Scale at 3 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty = 1" to "Not able to do it = 5." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Measured: Baseline to 3 Months
Change From Baseline in Activities Assessment Scale at 6 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Measured: Baseline to 6 Months
Change From Baseline in Activities Assessment Scale at 12 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Measured: Baseline to 12 Months
Change From Baseline in Activities Assessment Scale at 24 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Measured: Baseline to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jun 2012

First posted21 May 2008 (estimated)
Study startApr 2008
Primary completionJun 2012
Study completionJun 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hernia, InguinalStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00681291
Sponsor's protocol ID: LFC2007.04.01
Acronym: RING
Status last verified: Apr 2016
First submitted: 15 May 2008
Last updated: 10 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bellows CF, Shadduck PP, Helton WS, Fitzgibbons RJ. The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. Hernia. 2011 Jun;15(3):325-32. doi: 10.1007/s10029-010-0773-x. Epub 2011 Jan 8.
PubMed 21222008

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
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Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
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Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
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All Hernia, Inguinal trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias
ClinicalTrials.gov ID: NCT00681291
Acronym / sponsor ID: RING / LFC2007.04.01
Conditions: Hernia, Inguinal
Keywords: surgical mesh, inguinal hernia repair, chronic groin pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: LifeCellIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 21 May 2008 (estimated)
Results: Posted 23 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Device: Inguinal hernia repair with Ultraprolightweight polypropylene mesh
2	Active comparator	Device: Inguinal hernia repair with StratticeStrattice

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

adult male
symptomatic and palpable inguinal hernia
open, elective, primary unilateral inguinal hernia repair

Key exclusion criteria (7 listed)

bilateral inguinal hernia repair
BMI >35
chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or COPD
chronic prostatitis, orchitis, testicular pain
local or systemic infection at time of repair

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
Inguinal hernia repair with UltraproAlso: Ultrapro (Ethicon, Somerville NJ)surgical mesh (15x15cm) to support Lichtenstein repair	Device	1
Inguinal hernia repair with StratticeAlso: Strattice Reconstructive Tissue MatrixSurgical mesh (10x16) used to support Lichtenstein repair	Device	2

Primary outcome

Change From Baseline in Activities Assessment Scale at 3 Months
Time frame: Baseline to 3 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty = 1" to "Not able to do it = 5." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Change From Baseline in Activities Assessment Scale at 6 Months
Time frame: Baseline to 6 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Change From Baseline in Activities Assessment Scale at 12 Months
Time frame: Baseline to 12 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.
Change From Baseline in Activities Assessment Scale at 24 Months
Time frame: Baseline to 24 Months
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.

Results and safety

Results posted to the registry on 23 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r	88	75
2Strattice (Utilized for Inguinal Hernia Repair)	84	57

Primary outcome: Change From Baseline in Activities Assessment Scale at 3 Months

Time frame: Baseline to 3 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n = 81	2Strattice (Utilized for Inguinal Hernia Repair) n = 77
Value	-7.49 (8.961)	-6.12 (8.666)

Population analysed: Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months.

Primary outcome: Change From Baseline in Activities Assessment Scale at 6 Months

Time frame: Baseline to 6 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n = 83	2Strattice (Utilized for Inguinal Hernia Repair) n = 70
Value	-8.17 (9.475)	-7.20 (8.818)

Population analysed: Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months.

Primary outcome: Change From Baseline in Activities Assessment Scale at 12 Months

Time frame: Baseline to 12 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n = 83	2Strattice (Utilized for Inguinal Hernia Repair) n = 70
Value	-8.78 (9.221)	-7.61 (9.059)

Population analysed: Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months.

Primary outcome: Change From Baseline in Activities Assessment Scale at 24 Months

Time frame: Baseline to 24 Months. Mean (Standard Deviation). Unit: units on a scale

Measure	1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r n = 75	2Strattice (Utilized for Inguinal Hernia Repair) n = 57
Value	-7.57 (8.098)	-7.53 (9.356)

Population analysed: Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r	2 of 88 (2.3%)	47 of 88 (53.4%)	Not reported
2Strattice (Utilized for Inguinal Hernia Repair)	4 of 84 (4.8%)	49 of 84 (58.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21222008Bellows CF, Shadduck PP, Helton WS, Fitzgibbons RJ. The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. Hernia. 2011 Jun;15(3):325-32. doi: 10.1007/s10029-010-0773-x. Epub 2011 Jan 8.

Related trials for Hernia, Inguinal

Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
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Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
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Recruiting
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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.

Charles Bellows, MD, FACS principal investigator

Tulane University

Samir Awad, MD, FACS principal investigator

Baylor College of Medicine

Robert Fitzgibbons, MD, FACS principal investigator

Creighton University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inguinal hernia repair with Ultrapro and Inguinal hernia repair with Strattice in people with Hernia, Inguinal, run by LifeCell at 8 sites 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 7 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2016). 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?

Change From Baseline in Activities Assessment Scale at 3 Months (time frame: Baseline to 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00681291, which also lists 1 linked publication.

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 10 May 2016.