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Not yet recruitingNCT07871630Updated Oct 13, 2026

Phasix Mesh Underlay During Loop Ileostomy Closure

An interventional study of Long-acting absorbable mesh in Incisional Hernia of Anterior Abdominal Wall, sponsored by Corewell Health West. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Corewell Health West · Not applicable, Interventional, and Prevention

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Incisional Hernia of Anterior Abdominal Wall

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Keywords

  • Loop ileostomy closure
  • Phasix mesh
  • prophylactic mesh
  • Mesh reinforcement
  • Ileostomy site hernia
  • Incisional Hernia
03

In context

Incisional Hernia

226 studies on the registry are indexed under Incisional Hernia; 53 are open to participants now.

This study's planned enrollment of 65 is below the median of 107 across 142 interventional studies indexed under Incisional Hernia.

Browse Incisional Hernia studies →

Lead sponsor

Corewell Health West is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study 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.

    Device: Long-acting absorbable mesh

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.

06

What researchers measure

Primary outcomes

  1. Incisional Hernia at the Loop Ileostomy Closure Site

    Development of an incisional hernia at the loop ileostomy closure site, confirmed by CT imaging.

    Time frame: 2 years after loop ileostomy closure

Secondary outcomes

  1. Operative Time

    Duration of the loop ileostomy closure procedure

    Time frame: During surgery

  2. Blood Transfusions

    Occurrence of blood transfusion associated with the loop ileostomy closure procedure.

    Time frame: Perioperative/Periprocedural

  3. Surgical Site Infection

    Occurrence of surgical site infection following loop ileostomy closure.

    Time frame: Within 30 days after surgery

  4. Postoperative Morbidity

    Postoperative mobidity assessed using the Clavien-Dindo Classification.

    Time frame: Through 6 weeks after surgery

  5. Postoperative Mortality

    Occurrence of death following loop ileostomy closure.

    Time frame: Through 6 weeks after surgery

  6. Hospital Length of Stay

    Number of das hospitalized following loop ileostomy closure.

    Time frame: Up to 6 weeks after surgery

  7. ICU Length of Stay

    Number of days spent in the intesive care unit following loop ileostomy closure, if applicable.

    Time frame: Up to 6 weeks after surgery

  8. Reoperation

    Occurrence of reoperation following loop ileostomy closure.

    Time frame: Through 6 weeks after surgery

  9. Hospital Readmission

    Occurence of hospital readmission folloing loop ileostomy closure.

    Time frame: 30, 60, and 90 days after surgery

  10. Seroma

    Occurence of seroma associated with the mesh-reinforced loop ileostomy closure site.

    Time frame: Through 6 weeks after surgery

  11. Hematoma

    Occurrence of hematoma associated with the mesh-reinforced loop ileostomy closure site.

    Time frame: Through 6 weeks after surgery

  12. Mesh-Related Infection

    Occurence of infection associated with the mesh-reinforced loop ileostomy closure site.

    Time frame: Through 6 weeks after surgery

  13. Mesh-Related Reoperation

    Occurence of reoperation related to the mesh-reinforced loop ileostomy closure site.

    Time frame: Through 6 weeks after surgery

  14. Health-Related Quality of Life (SF-36)

    Self-reported health-related quality of life assessed using the Short Form-36 (SF-36) questionnaire.

    Time frame: Preoperative visit, 6 weeks after surgery, and 2 years after surgery

  15. Activity Level (Activities Assessent Scale)

    Self-reported activity level assessed using the Activities Assessment Scale (AAS) questionnaire.

    Time frame: Preoperative visit, 6 weeks after surgery, and 2 years after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 64 non-industry interventional studies with no phase under Incisional Hernia, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 60. This study's planned 12 months is below that.

Counting every sponsor, half of 71 studies reached it within 43 months; a quarter within 23 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2026
First posted
Oct 13, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Oct 30, 2027
CompletionEst.
Oct 30, 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871630
Lead sponsor
Corewell Health West
Responsible party
James W. Ogilvie (Principal Investigator, Corewell Health West) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Oct 30, 2027 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Kendra Selby
Contact
kendra.selby@helendevoschildrens.org
616-486-0281
James Ogilvie, MD
principal investigator · Corewell Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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