Health TrialsbyHealthPanel

Phasix Mesh Underlay During Loop Ileostomy Closure

ConditionIncisional Hernia of Anterior Abdominal Wall
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health West

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

History of creation of a loop ileostomy

Presenting for loop ileostomy closure

BMI greater than 25

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Phasix Mesh Reinforced ClosureExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corewell Health West

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: