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Strattice in Repair of Inguinal Hernias (RING)

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ClinicalTrials.gov Identifier: NCT00681291
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : March 23, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
LifeCell

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.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Device: Inguinal hernia repair with Ultrapro Device: Inguinal hernia repair with Strattice Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias
Study Start Date : April 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: 1
lightweight polypropylene mesh
Device: Inguinal hernia repair with Ultrapro
surgical mesh (15x15cm) to support Lichtenstein repair
Other Name: Ultrapro (Ethicon, Somerville NJ)

Active Comparator: 2
Strattice
Device: Inguinal hernia repair with Strattice
Surgical mesh (10x16) used to support Lichtenstein repair
Other Name: Strattice Reconstructive Tissue Matrix




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681291


Locations
United States, Connecticut
Hospital of St Raphael
New Haven, Connecticut, United States, 06511
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
United States, North Carolina
Regional Surgical Associates
Durham, North Carolina, United States, 27704
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
LifeCell
Investigators
Principal Investigator: Charles Bellows, MD, FACS Tulane University
Principal Investigator: Samir Awad, MD, FACS Baylor College of Medicine
Principal Investigator: Robert Fitzgibbons, MD, FACS Creighton University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00681291     History of Changes
Other Study ID Numbers: LFC2007.04.01
First Posted: May 21, 2008    Key Record Dates
Results First Posted: March 23, 2016
Last Update Posted: May 10, 2016
Last Verified: April 2016

Keywords provided by LifeCell:
surgical mesh
inguinal hernia repair
chronic groin pain

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal