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Strattice in Repair of Inguinal Hernias (RING)

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Inguinal hernia repair with Ultrapro
Inguinal hernia repair with Strattice
Sponsored by
LifeCell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring surgical mesh, inguinal hernia repair, chronic groin pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital of St Raphael
  • Tulane University Health Sciences Center
  • University of Maryland School of Medicine
  • Creighton University
  • Regional Surgical Associates
  • Oregon Health Sciences University
  • Baylor College of Medicine
  • Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

lightweight polypropylene mesh

Strattice

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 15, 2008
Last Updated
April 6, 2016
Sponsor
LifeCell
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1. Study Identification

Unique Protocol Identification Number
NCT00681291
Brief Title
Strattice in Repair of Inguinal Hernias
Acronym
RING
Official Title
Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeCell

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
surgical mesh, inguinal hernia repair, chronic groin pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
lightweight polypropylene mesh
Arm Title
2
Arm Type
Active Comparator
Arm Description
Strattice
Intervention Type
Device
Intervention Name(s)
Inguinal hernia repair with Ultrapro
Other Intervention Name(s)
Ultrapro (Ethicon, Somerville NJ)
Intervention Description
surgical mesh (15x15cm) to support Lichtenstein repair
Intervention Type
Device
Intervention Name(s)
Inguinal hernia repair with Strattice
Other Intervention Name(s)
Strattice Reconstructive Tissue Matrix
Intervention Description
Surgical mesh (10x16) used to support Lichtenstein repair
Primary Outcome Measure Information:
Title
Change From Baseline in Activities Assessment Scale at 3 Months
Description
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.
Time Frame
Baseline to 3 Months
Title
Change From Baseline in Activities Assessment Scale at 6 Months
Description
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.
Time Frame
Baseline to 6 Months
Title
Change From Baseline in Activities Assessment Scale at 12 Months
Description
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.
Time Frame
Baseline to 12 Months
Title
Change From Baseline in Activities Assessment Scale at 24 Months
Description
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.
Time Frame
Baseline to 24 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult male symptomatic and palpable inguinal hernia open, elective, primary unilateral inguinal hernia repair Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bellows, MD, FACS
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samir Awad, MD, FACS
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Fitzgibbons, MD, FACS
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of St Raphael
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
Facility Name
Regional Surgical Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21222008
Citation
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.
Results Reference
derived

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Strattice in Repair of Inguinal Hernias

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