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NOT YET RECRUITING
NCT07871630
NA

Phasix Mesh Underlay During Loop Ileostomy Closure

Sponsor: Corewell Health West

View on ClinicalTrials.gov

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.

Official title: Phasix Mesh Underlay During Loop Ileostomy Closure: A Single Center Prospective Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2026-10-30

Completion Date

2028-10-30

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DEVICE

Long-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.

Locations (1)

Corewell Health West

Grand Rapids, Michigan, United States