Ileostomy - StomaSCAR-llNCT04916067
Stoma Closure and Reinforcement Trial ll
A study testing Mesh Implantation in people with Ileostomy - Stoma and Inflammatory Bowel Diseases, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma, Inflammatory Bowel Diseases
- What is being tested?
- Mesh Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 > 18years.
- Patient is undergoing closure of loop ileostomy.
- Patient has a diagnosis of Inflammatory bowel disease treated with resection and diverting loop ileostomy.
- Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery.
Who cannot join
- Pre-existing systemic infection at the time of ileostomy takedown
- Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
- Previous abdominal hernia repair with mesh placement
- Concurrent surgical procedures in addition to closure of diverting loop ileostomy
- Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Stoma Closure and Reinforcement (SCAR)-II Trial: A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Inflammatory Bowel Disease Patients
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of monofilament bioresorbable mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.
- Conditions
- Ileostomy - Stoma, Inflammatory Bowel Diseases
- Being tested
- Mesh Implantation
- Keywords
- ileostomy, hernia, inflammatory bowel disease, IBD
- Medical subject headings
- Inflammatory Bowel Diseases, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh ImplantationDevice
Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall Receives: Device: Mesh Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Wound Occurrences
Number of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.
Measured: 30 days
Secondary outcomes (3)
Incidence of Hernia Formation
The incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and at 6 months from the date of ileostomy closure.
Measured: 30 days, 6 months
Quality of Life After Mesh Implantation
Patient will be evaluated with regards to their quality-of-life outcomes the Patient-Reported Outcome Measurement Information System Short Form (PROMIS SF) 2.0, Ability to Participate in Social Roles and Activities, instrument at 30 days and 6 months from the date of ileostomy closure.
Data represents mean and standard deviation of the normalized scores. Range for PROMIS Physical Health Score is 16-68 with a higher score being a more positive view, healthy people score 50+ Range for PROMIS Mental Health Score is 21-68, with a higher score representing better functioning, health people score 50+
Measured: 30 days, 6 months
Bowel Function After Mesh Implantation
Patient will be evaluated with regards to their bowel function using the Colorectal Functional Outcome (COREFO) instrument at 30 days and 6 months from the date of ileostomy closure.
Scores range from 0-100 with lower scores meaning better function (0- No symptoms/ Normal function; 100- Maximum impairment/ worst bowel function)
Measured: 30 days, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Dec 2021
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Why it stopped: terminated due to inability to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ileostomy - StomaStudies 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
- Model description
- Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Principal investigator, Matthew Z. Wilson, Dartmouth-Hitchcock Medical Center
- Investigators
- Matthew Z Wilson, MD, Msc, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916067
- Sponsor's protocol ID
- STUDY02000875
- Acronym
- SCAR-ll
- Status last verified
- Feb 2026
- First submitted
- 1 Jun 2021
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goldwag JL, Wilson LR, Ivatury SJ, Pauli EM, Tsapakos MJ, Wilson MZ. Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial. Contemp Clin Trials Commun. 2020 Jun 9;19:100582. doi: 10.1016/j.conctc.2020.100582. eCollection 2020 Sep.
PubMed 32577580
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stoma Closure and Reinforcement (SCAR)-II Trial: A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT04916067
- Acronym / sponsor ID
- SCAR-ll / STUDY02000875
- Conditions
- Ileostomy - Stoma, Inflammatory Bowel Diseases
- Keywords
- ileostomy, hernia, inflammatory bowel disease, IBD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to inability to complete the study
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of monofilament bioresorbable mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Mesh ImplantationPatients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall |
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 > 18years.
- Patient is undergoing closure of loop ileostomy.
- Patient has a diagnosis of Inflammatory bowel disease treated with resection and diverting loop ileostomy.
- Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery.
Key exclusion criteria (5 listed)
- Pre-existing systemic infection at the time of ileostomy takedown
- Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
- Previous abdominal hernia repair with mesh placement
- Concurrent surgical procedures in addition to closure of diverting loop ileostomy
- Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
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 |
|---|---|---|
| Mesh ImplantationImplantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation | Device | Intervention |
Primary outcome
Number of Wound Occurrences
Time frame: 30 days
Number of wound occurrences (defined as superficial surgical site infection [s-SSI], deep surgical site infection [d-SSI], organ space surgical site infection [O-SSI], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.
3 secondary outcomes
Incidence of Hernia Formation
Time frame: 30 days, 6 months
Quality of Life After Mesh Implantation
Time frame: 30 days, 6 months
Bowel Function After Mesh Implantation
Time frame: 30 days, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32577580Goldwag JL, Wilson LR, Ivatury SJ, Pauli EM, Tsapakos MJ, Wilson MZ. Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial. Contemp Clin Trials Commun. 2020 Jun 9;19:100582. doi: 10.1016/j.conctc.2020.100582. eCollection 2020 Sep.
- 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. This study is not recruiting at the moment.
Matthew Z Wilson, MD, Msc principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh Implantation in people with Ileostomy - Stoma and Inflammatory Bowel Diseases, run by Dartmouth-Hitchcock Medical Center 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 5 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: stopped early, as of the sponsor's last update on 27 Feb 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?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Wound Occurrences (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916067, which also lists 1 linked publication.
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 27 Feb 2026.