Andrew A. Shelton, M.D.
Parastomal Hernia Prevention With Strattice (PriSm)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: Strattice Reconstructive Matrix
- Procedure: Standard ostomy creation
Phase:
Phase 4Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- adults
- need for permanent ileostomy or colostomy
Key Exclusion Criteria:
- history of hernia at new ostomy site
- has previously implanted surgical mesh at site of planned ostomy
- requires a temporary ostomy
- has need for multiple ostomies
- is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder
- is bedridden or otherwise non-ambulatory
Additional Study Details
Official Title:
A Prospective, Multicenter, Randomized, Controlled, Third-Party Blinded Study of Strattice Fascial Inlay to Prevent Parastomal Hernia Formation in Patients Undergoing Surgery for Permanent Abdominal Wall OstomiesAnticipated start date:
4/8/2009Lead Sponsor:
LifeCell CorpInvestigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Occurrence of parastomal hernia [ Time Frame: 24 months ]
Secondary Outcomes:
- Stoma Quality of Life [ Time Frame: Serially over 24 months ]
- Stoma complications [ Time Frame: more than 1 month postoperatively ]
- Stoma complications [ Time Frame: 30 days ]
Total Number to be Enrolled:
220Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- LFC 2008.01.01
- NCT00771407
- VAR0035
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/10/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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