Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Hernia
Interventions
PROCEDURE

mesh reinforcement of stoma

Patients randomized to receive mesh will undergo stoma formation and will have a 8 cm x 12 cm piece of AlloDerm graft placed as a tissue reinforcement around the stoma and extending under the midline incision. The mesh will be trimmed to provide a minimum of 3cm of overlap around the stoma in all directions. The mesh will be secured with transabdominal number one Prolene (Ethicon, Inc) sutures every 4cm around the mesh. Additional fixation will be provided with Protack spiral tacks (US Surgical, Inc) every 1cm around the mesh. The midline fascia will be closed with running number one Prolene sutures. Skin will be closed in standard fashion.

OTHER

no intervention

Trial Locations (1)

85054

Mayo Clinic, Phoenix

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER