Incisional Hernia of Anterior Abdominal WallNCT07871630
Phasix Mesh Underlay During Loop Ileostomy Closure
A study testing Long-acting absorbable mesh in people with Incisional Hernia of Anterior Abdominal Wall, run by Corewell Health West at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia of Anterior Abdominal Wall
- What is being tested?
- Long-acting absorbable mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- History of creation of a loop ileostomy
- Presenting for loop ileostomy closure
- BMI greater than 25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ellie Poll contact
United States1 site
Corewell Health West
Grand Rapids, Michigan, 49546
Kendra Selby, RRT, 616-486-0281, kendra.selby@helendevoschildrens.org
Ellie Poll, elise.poll@corewellhealth.org
About this study
Official title: Phasix Mesh Underlay During Loop Ileostomy Closure: A Single Center Prospective Trial
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.
- Being tested
- Long-acting absorbable mesh
- Keywords
- Loop ileostomy closure, Phasix mesh, prophylactic mesh, Mesh reinforcement, Ileostomy site hernia, Incisional Hernia
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting absorbable meshDevice
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 group | Role | What they receive |
|---|---|---|
| Phasix Mesh Reinforced Closure | Experimental | Participants undergoing loop ileostomy closure will receive prophylactic long-acting absorbable Phasix mesh reinforcement at the ileostomy closure site. Receives: Device: Long-acting absorbable mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Hernia at the Loop Ileostomy Closure Site
Development of an incisional hernia at the loop ileostomy closure site, confirmed by CT imaging.
Measured: 2 years after loop ileostomy closure
Secondary outcomes (15)
Operative Time
Duration of the loop ileostomy closure procedure
Measured: During surgery
Blood Transfusions
Occurrence of blood transfusion associated with the loop ileostomy closure procedure.
Measured: Perioperative/Periprocedural
Surgical Site Infection
Occurrence of surgical site infection following loop ileostomy closure.
Measured: Within 30 days after surgery
Postoperative Morbidity
Postoperative mobidity assessed using the Clavien-Dindo Classification.
Measured: Through 6 weeks after surgery
Postoperative Mortality
Occurrence of death following loop ileostomy closure.
Measured: Through 6 weeks after surgery
Hospital Length of Stay
Number of das hospitalized following loop ileostomy closure.
Measured: Up to 6 weeks after surgery
ICU Length of Stay
Number of days spent in the intesive care unit following loop ileostomy closure, if applicable.
Measured: Up to 6 weeks after surgery
Reoperation
Occurrence of reoperation following loop ileostomy closure.
Measured: Through 6 weeks after surgery
Hospital Readmission
Occurence of hospital readmission folloing loop ileostomy closure.
Measured: 30, 60, and 90 days after surgery
Seroma
Occurence of seroma associated with the mesh-reinforced loop ileostomy closure site.
Measured: Through 6 weeks after surgery
Hematoma
Occurrence of hematoma associated with the mesh-reinforced loop ileostomy closure site.
Measured: Through 6 weeks after surgery
Mesh-Related Infection
Occurence of infection associated with the mesh-reinforced loop ileostomy closure site.
Measured: Through 6 weeks after surgery
Mesh-Related Reoperation
Occurence of reoperation related to the mesh-reinforced loop ileostomy closure site.
Measured: Through 6 weeks after surgery
Health-Related Quality of Life (SF-36)
Self-reported health-related quality of life assessed using the Short Form-36 (SF-36) questionnaire.
Measured: Preoperative visit, 6 weeks after surgery, and 2 years after surgery
Activity Level (Activities Assessent Scale)
Self-reported activity level assessed using the Activities Assessment Scale (AAS) questionnaire.
Measured: Preoperative visit, 6 weeks after surgery, and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia of Anterior Abdominal WallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W. Ogilvie, Corewell Health West
- Investigators
- James Ogilvie, MD, Principal investigator, Corewell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871630
- Sponsor's protocol ID
- 2019-475
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phasix Mesh Underlay During Loop Ileostomy Closure: A Single Center Prospective Trial
- ClinicalTrials.gov ID
- NCT07871630
- Acronym / sponsor ID
- 2019-475
- Keywords
- Loop ileostomy closure, Phasix mesh, prophylactic mesh, Mesh reinforcement, Ileostomy site hernia, Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phasix Mesh Reinforced Closure | Experimental | Device: Long-acting absorbable meshParticipants undergoing loop ileostomy closure will receive prophylactic long-acting absorbable Phasix mesh reinforcement at the ileostomy closure site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- History of creation of a loop ileostomy
- Presenting for loop ileostomy closure
- BMI greater than 25
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-acting absorbable meshLon-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. | Device | Phasix Mesh Reinforced Closure |
Primary outcome
Incisional Hernia at the Loop Ileostomy Closure Site
Time frame: 2 years after loop ileostomy closure
Development of an incisional hernia at the loop ileostomy closure site, confirmed by CT imaging.
15 secondary outcomes
Operative Time
Time frame: During surgery
Blood Transfusions
Time frame: Perioperative/Periprocedural
Surgical Site Infection
Time frame: Within 30 days after surgery
Postoperative Morbidity
Time frame: Through 6 weeks after surgery
Postoperative Mortality
Time frame: Through 6 weeks after surgery
Hospital Length of Stay
Time frame: Up to 6 weeks after surgery
ICU Length of Stay
Time frame: Up to 6 weeks after surgery
Reoperation
Time frame: Through 6 weeks after surgery
Hospital Readmission
Time frame: 30, 60, and 90 days after surgery
Seroma
Time frame: Through 6 weeks after surgery
Hematoma
Time frame: Through 6 weeks after surgery
Mesh-Related Infection
Time frame: Through 6 weeks after surgery
Mesh-Related Reoperation
Time frame: Through 6 weeks after surgery
Health-Related Quality of Life (SF-36)
Time frame: Preoperative visit, 6 weeks after surgery, and 2 years after surgery
Activity Level (Activities Assessent Scale)
Time frame: Preoperative visit, 6 weeks after surgery, and 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellie Poll contact
James Ogilvie, MD principal investigator
Corewell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-acting absorbable mesh in people with Incisional Hernia of Anterior Abdominal Wall, run by Corewell Health West at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kendra Selby (616-486-0281, kendra.selby@helendevoschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional Hernia at the Loop Ileostomy Closure Site (time frame: 2 years after loop ileostomy closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.