Phasix Mesh Underlay During Loop Ileostomy Closure

• 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.

Primary outcomes

• Incisional Hernia at the Loop Ileostomy Closure Site [2 years after loop ileostomy closure]: Development of an incisional hernia at the loop ileostomy closure site, confirmed by CT imaging.

Secondary outcomes

• Operative Time [During surgery]: Duration of the loop ileostomy closure procedure
• Blood Transfusions [Perioperative/Periprocedural]: Occurrence of blood transfusion associated with the loop ileostomy closure procedure.
• Surgical Site Infection [Within 30 days after surgery]: Occurrence of surgical site infection following loop ileostomy closure.
• Postoperative Morbidity [Through 6 weeks after surgery]: Postoperative mobidity assessed using the Clavien-Dindo Classification.
• Postoperative Mortality [Through 6 weeks after surgery]: Occurrence of death following loop ileostomy closure.
• Hospital Length of Stay [Up to 6 weeks after surgery]: Number of das hospitalized following loop ileostomy closure.
• ICU Length of Stay [Up to 6 weeks after surgery]: Number of days spent in the intesive care unit following loop ileostomy closure, if applicable.
• Reoperation [Through 6 weeks after surgery]: Occurrence of reoperation following loop ileostomy closure.
• Hospital Readmission [30, 60, and 90 days after surgery]: Occurence of hospital readmission folloing loop ileostomy closure.
• Seroma [Through 6 weeks after surgery]: Occurence of seroma associated with the mesh-reinforced loop ileostomy closure site.
• Hematoma [Through 6 weeks after surgery]: Occurrence of hematoma associated with the mesh-reinforced loop ileostomy closure site.
• Mesh-Related Infection [Through 6 weeks after surgery]: Occurence of infection associated with the mesh-reinforced loop ileostomy closure site.
• Mesh-Related Reoperation [Through 6 weeks after surgery]: Occurence of reoperation related to the mesh-reinforced loop ileostomy closure site.
• Health-Related Quality of Life (SF-36) [Preoperative visit, 6 weeks after surgery, and 2 years after surgery]: Self-reported health-related quality of life assessed using the Short Form-36 (SF-36) questionnaire.
• Activity Level (Activities Assessent Scale) [Preoperative visit, 6 weeks after surgery, and 2 years after surgery]: Self-reported activity level assessed using the Activities Assessment Scale (AAS) questionnaire.

Sex: All, ages: 18 Years to any

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 liver failure, based on the discretion of the principal investigator and operating surgeon
* Allergy to tetracycline hydrochloride or kanamycin sulfate
* Women planning to become pregnant during study participation has context menu

• James Ogilvie, MD, Principal investigator, Corewell Health