Phasix Mesh Underlay During Loop Ileostomy Closure

Conditions

• Incisional Hernia of Anterior Abdominal Wall

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Long-acting absorbable mesh — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Oct 13, 2026

Start date

Oct 30, 2026

Status verified

Oct 2026

Primary completion

Oct 30, 2027

Completion

Oct 30, 2028

Study Design

Enrollment

65 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Phasix Mesh Reinforced Closure
  Participants undergoing loop ileostomy closure will receive prophylactic long-acting absorbable Phasix mesh reinforcement at the ileostomy closure site.

Primary Outcome Measure

Incisional Hernia at the Loop Ileostomy Closure Site [ Time Frame: 2 years after loop ileostomy closure ]

Central Contacts

• Kendra Selby
  616-486-0281
  [email protected]
• Ellie Poll
  [email protected]

Locations (1)

Find similar trials in Grand Rapids, MI