Phasix Mesh Underlay During Loop Ileostomy Closure: A Single Center Prospective Trial
Corewell Health West
Summary
This prospective study will evaluate whether placement of long-acting absorbable Phasix mesh during loop ileostomy closure reduces the development of an incisional hernia at the ileostomy closure site in patients with a BMI greater than 25. Participants will undergo mesh-reinforced closure and will be followed for two years after surgery. The primary outcome is development of an incisional hernia at the ileostomy closure site, confirmed by CT imaging at two years.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years or older * History of creation of a loop ileostomy * Presenting for loop ileostomy closure * BMI greater than 25 Exclusion Criteria: * Patients involved in other clinical research trials * Unable to close posterior rectus sheath * Cannot consent or are unwilling to consent * Belong to a vulnerable population group such as pediatric patients, prisoners, pregnant patients, individuals with limited English proficiency, visually impaired individuals, or non-readers * Patients with prohibitive medical risk including congestive heart failure, renal failure, or l…
Interventions
- DeviceLong-acting absorbable mesh
Lon-acting absorbable Phasix mesh is placed in the retro-rectus space during loop ileostomy closure to reinforce the closure site. The posterior rectus sheath is closed prior to mesh placement, and the mesh is not fixated to surrounding tissue. If the posterior rectus sheath is not intact or cannot be closed, mesh-reinforced closure is not performed and standard primary closure with suture is used.
Location
- Corewell Health WestGrand Rapids, Michigan