Umbilical HerniaNCT07881354
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
A study testing Duramesh and Mesh in people with Umbilical Hernia and Ventral Hernia, run by Northwestern University at 1 site in United States.
Trial summary
Umbilical hernias are common, and repair with mesh lowers the risk of the hernia coming back compared with stitches alone. Most evidence comes from lower-risk patients. Patients with obesity, diabetes, smoking, or COPD have more complications after hernia repair, and the best repair for them is unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia, Ventral Hernia
- What is being tested?
- Duramesh and Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2026to Oct 2029
- 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
- Symptomatic umbilical hernia with fascial defect ≥1 cm
- At least one high-risk comorbidity: BMI ≥30, active smoking, diabetes, or COPD
- Undergoing elective repair
Who cannot join
- Hernia defect >6 cm
- Urgent or emergent presentation
- CDC wound class II-IV
- Prior mesh at the umbilicus
- Ascites
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Nancy Ly, 3126956868, nancy.ly@nm.org
About this study
Official title: Duramesh Versus Minimally Invasive Intraperitoneal Onlay Mesh (IPOM) for High-Risk Umbilical Hernia Repairs: A Randomized Controlled Trial
Umbilical hernias are common, and repair with mesh lowers the risk of the hernia coming back compared with stitches alone. Most evidence comes from lower-risk patients. Patients with obesity, diabetes, smoking, or COPD have more complications after hernia repair, and the best repair for them is unclear. Minimally invasive intraperitoneal onlay mesh (IPOM) places mesh inside the abdomen, which may cause pain and long-term mesh problems. Duramesh is a mesh suture that spreads tension across the repair and avoids placing flat mesh in the abdomen. This randomized trial will compare Duramesh repair with minimally invasive IPOM in 160 high-risk adults having elective umbilical hernia repair at Northwestern Medicine. The main question is whether pain on the day after surgery with Duramesh is no worse than with IPOM. The study will also compare complications, quality of life, return to normal activity, costs, and hernia recurrence up to 2 years after surgery.
Read the detailed description
This single-center, registry-based randomized trial tests whether Duramesh suture repair is non-inferior to minimally invasive IPOM for postoperative pain in high-risk patients undergoing umbilical hernia repair.
Randomization is performed in clinic after consent, using REDCap with a fixed block size of 4. This allows the operating room to be set up in advance.
All patients receive preoperative bilateral ultrasound-guided rectus sheath blocks with 0.5% bupivacaine. Port sites, sham incisions, and periumbilical incisions are infiltrated with 0.25% bupivacaine with epinephrine. Postoperative care and discharge analgesia are standardized across arms. Patients are told which repair they received at 1 year, or earlier if they have a recurrence or reoperation.
POD1 pain is collected by a research team member by phone between 9 and 11 AM. Testing is hierarchical and analysis is intent-to-treat. Non-inferiority is concluded if the upper bound of the two-sided 95% CI for the mean difference (Duramesh - IPOM) is below 2 points, the minimal clinically important difference. If non-inferiority is shown, superiority is tested. The sample size of 64 per arm assumes a mean POD1 NRS of 5, an SD of 2.5 (Petro et al., 2021), one-sided alpha 0.025, and 80% power. It is inflated to 80 per arm to allow for 20% loss to follow-up.
Most secondary outcomes come from the Abdominal Core Health Quality Collaborative (ACHQC) registry, which collects them as standard of care. Recurrence is determined by a consensus algorithm that combines clinical exam, CT, and the Ventral Hernia Recurrence Inventory, with CT used to confirm a suspected recurrence on exam. Rectus diastasis is recorded in all patients, and a prespecified subgroup analysis compares outcomes in patients with and without it.
- Conditions
- Umbilical Hernia, Ventral Hernia
- Being tested
- Duramesh, Mesh
- Keywords
- Duramesh, mesh suture, intraperitoneal onlay mesh, IPOM, ventral hernia
- Medical subject headings
- Hernia, Umbilical, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurameshDevice
Also called mesh suture
#1 Duramesh sutures
MeshDevice
Also called coated polypropylene intraperitoneal mesh
Coated polypropylene intraperitoneal mesh
| Study group | Role | What they receive |
|---|---|---|
| Duramesh repair | Experimental | Open periumbilical repair with interrupted #1 Duramesh sutures and no additional mesh. Includes two sham 5 mm skin incisions for blinding. MAC or general anesthesia. Receives: Device: Duramesh |
| IPOM | Active comparator | Laparoscopic or robotic repair with fascial defect closure and intraperitoneal coated polypropylene mesh (≥4 cm overlap), fixed with sutures or permanent tacks. General anesthesia. Receives: Device: Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Day 1 Pain
Pain on the Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable), collected by phone.
Measured: Postoperative Day 1
Secondary outcomes (9)
Postoperative pain on day of surgery
Pain intensity measured with the Numeric Rating Scale (NRS) for pain, scored from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.
Measured: Post-anesthesia care unit, day of surgery
Postoperative Day 7 Pain
Pain intensity measured with the Numeric Rating Scale (NRS) for pain, scored from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.
Measured: Postoperative day 7
Wound complications
seroma, suture sinus, and mesh-related complications
Measured: 30 days, 1 year and 2 year
Hospital readmissions
Hospital readmissions following surgery
Measured: 30 day, 1 year, 2 year
Reoperations
Events where reoperation is done for the hernia
Measured: 30 day, 1 year, 2 year
Return to Normal Activity
Number of patients reporting a full return to preoperative daily activities
Measured: 30 days
Hernia Recurrence
Recurrence by consensus definition (clinical exam, CT imaging, and Ventral Hernia Recurrence Inventory survey)
Measured: 1 and 2 years
Hospital Admission After Surgery
Proportion of patients requiring admission instead of same-day discharge, and time in recovery before discharge
Measured: Postoperative day zero, index hospitalization
Costs
OR direct costs; hospital direct costs; procedural costs
Measured: Baseline through hospital discharge, average 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start23 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Melland-Smith, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881354
- Sponsor's protocol ID
- STU00226299
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data are held in the ACHQC registry under its data-use policies, and there is no current plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duramesh Versus Minimally Invasive Intraperitoneal Onlay Mesh (IPOM) for High-Risk Umbilical Hernia Repairs: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07881354
- Acronym / sponsor ID
- STU00226299
- Conditions
- Umbilical Hernia, Ventral Hernia
- Keywords
- Duramesh, mesh suture, intraperitoneal onlay mesh, IPOM, ventral hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 19 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.
Umbilical hernias are common, and repair with mesh lowers the risk of the hernia coming back compared with stitches alone. Most evidence comes from lower-risk patients. Patients with obesity, diabetes, smoking, or COPD have more complications after hernia repair, and the best repair for them is unclear. Minimally invasive intraperitoneal onlay mesh (IPOM) places mesh inside the abdomen, which may cause pain and long-term mesh problems. Duramesh is a mesh suture that spreads tension across the repair and avoids placing flat mesh in the abdomen. This randomized trial will compare Duramesh repair with minimally invasive IPOM in 160 high-risk adults having elective umbilical hernia repair at Northwestern Medicine. The main question is whether pain on the day after surgery with Duramesh is no worse than with IPOM. The study will also compare complications, quality of life, return to normal activity, costs, and hernia recurrence up to 2 years after surgery.
Detailed description
This single-center, registry-based randomized trial tests whether Duramesh suture repair is non-inferior to minimally invasive IPOM for postoperative pain in high-risk patients undergoing umbilical hernia repair.
Randomization is performed in clinic after consent, using REDCap with a fixed block size of 4. This allows the operating room to be set up in advance.
All patients receive preoperative bilateral ultrasound-guided rectus sheath blocks with 0.5% bupivacaine. Port sites, sham incisions, and periumbilical incisions are infiltrated with 0.25% bupivacaine with epinephrine. Postoperative care and discharge analgesia are standardized across arms. Patients are told which repair they received at 1 year, or earlier if they have a recurrence or reoperation.
POD1 pain is collected by a research team member by phone between 9 and 11 AM. Testing is hierarchical and analysis is intent-to-treat. Non-inferiority is concluded if the upper bound of the two-sided 95% CI for the mean difference (Duramesh - IPOM) is below 2 points, the minimal clinically important difference. If non-inferiority is shown, superiority is tested. The sample size of 64 per arm assumes a mean POD1 NRS of 5, an SD of 2.5 (Petro et al., 2021), one-sided alpha 0.025, and 80% power. It is inflated to 80 per arm to allow for 20% loss to follow-up.
Most secondary outcomes come from the Abdominal Core Health Quality Collaborative (ACHQC) registry, which collects them as standard of care. Recurrence is determined by a consensus algorithm that combines clinical exam, CT, and the Ventral Hernia Recurrence Inventory, with CT used to confirm a suspected recurrence on exam. Rectus diastasis is recorded in all patients, and a prespecified subgroup analysis compares outcomes in patients with and without it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duramesh repair | Experimental | Device: DurameshOpen periumbilical repair with interrupted #1 Duramesh sutures and no additional mesh. Includes two sham 5 mm skin incisions for blinding. MAC or general anesthesia. |
| IPOM | Active comparator | Device: MeshLaparoscopic or robotic repair with fascial defect closure and intraperitoneal coated polypropylene mesh (≥4 cm overlap), fixed with sutures or permanent tacks. General anesthesia. |
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
- Symptomatic umbilical hernia with fascial defect ≥1 cm
- At least one high-risk comorbidity: BMI ≥30, active smoking, diabetes, or COPD
- Undergoing elective repair
Key exclusion criteria (6 listed)
- Hernia defect >6 cm
- Urgent or emergent presentation
- CDC wound class II-IV
- Prior mesh at the umbilicus
- Ascites
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 |
|---|---|---|
| DurameshAlso: mesh suture#1 Duramesh sutures | Device | Duramesh repair |
| MeshAlso: coated polypropylene intraperitoneal meshCoated polypropylene intraperitoneal mesh | Device | IPOM |
Primary outcome
Postoperative Day 1 Pain
Time frame: Postoperative Day 1
Pain on the Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable), collected by phone.
9 secondary outcomes
Postoperative pain on day of surgery
Time frame: Post-anesthesia care unit, day of surgery
Postoperative Day 7 Pain
Time frame: Postoperative day 7
Wound complications
Time frame: 30 days, 1 year and 2 year
Hospital readmissions
Time frame: 30 day, 1 year, 2 year
Reoperations
Time frame: 30 day, 1 year, 2 year
Return to Normal Activity
Time frame: 30 days
Hernia Recurrence
Time frame: 1 and 2 years
Hospital Admission After Surgery
Time frame: Postoperative day zero, index hospitalization
Costs
Time frame: Baseline through hospital discharge, average 5 days
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 6 Nov 2026.
- Individual participant dataSharing planned: No. Data are held in the ACHQC registry under its data-use policies, and there is no current plan to share individual participant data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duramesh and Mesh in people with Umbilical Hernia and Ventral Hernia, run by Northwestern University 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 6 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 Nancy Ly, MD (3126956868, nancy.ly@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Day 1 Pain (time frame: Postoperative Day 1). 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 6 Nov 2026.