Clinical trial NCT00681291: Strattice in Repair of Inguinal Hernias
Official title: Prospective, Randomized, Controlled, Third-Party Blinded Multicenter Evaluation of Strattice/LTM in the Repair of Inguinal Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia, Inguinal
Keywords: surgical mesh
inguinal hernia repair
chronic groin pain
Lead sponsor: LifeCell
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 172
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Activities Assessment Scale at 3 Months
timeFrame: Baseline to 3 Months
measure: Change From Baseline in Activities Assessment Scale at 6 Months
timeFrame: Baseline to 6 Months
measure: Change From Baseline in Activities Assessment Scale at 12 Months
timeFrame: Baseline to 12 Months
measure: Change From Baseline in Activities Assessment Scale at 24 Months
timeFrame: Baseline to 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Hospital of St Raphael
state: Connecticut
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Durham
country: United States
facility: Regional Surgical Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: Tulane University
name: Charles Bellows, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Samir Awad, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Creighton University
name: Robert Fitzgibbons, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
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.