Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-31 @ 8:25 AM
Study NCT ID:
NCT00577603
Status:
COMPLETED
Last Update Posted:
2013-04-25
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Controlled, Randomized Study to Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation With and Without Reinforcement With a Collagen Mesh
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to evaluate the use of a material (Alloderm collagen mesh) during the stomal formation operation (surgery that will create a mouth-like opening on the surface of the body to an internal organ). The main purpose of this research study is to see if using this material will lower the hernia rate compared to normal repair without this material. The secondary purpose is to evaluate if using this material will increase or decrease complication rates.
Detailed Description:
This study seeks to examine the ability of an implantable collagen matrix to reduce the incidence of parastomal hernia formation. Patients will be randomized preoperatively by a computer generated random allocation to either receive collagen mesh at the time of stoma formation, or to have stoma formation without mesh. Stomas without mesh will be made in the standard surgical fashion dictated by the type of stoma: ileostomy, colostomy, ileal conduit. Patients randomized to receive mesh will undergo stoma formation in an identical fashion, and will have a 8 cm x 12cm piece of AlloDerm mesh placed as a tissue reinforcement at the stoma site and extending under the midline incision. Patients will be followed with physical examinations at approximately 2weeks post-op, 3, 6, 9, 12, 24 months post-op, and will undergo CT scanning of the abdomen and pelvis at 12 and 24months to determine hernia occurrence.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: