Colon CancerSCARNCT03750461
Stoma Closure and Reinforcement Trial
A study testing Mesh Implantation in people with Colon Cancer and Rectal Cancer, 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
- Colon Cancer, Rectal Cancer, Ileostomy - Stoma
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Feb 2023
- 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 left sided colon or rectal cancer 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
- On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone >10mg/day)
- Previous abdominal hernia repair with mesh placement
- Concurrent 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) Trial - A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Left Sided Colon and Rectal Cancer 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 large pore monofilament polypropylene 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
- Colon Cancer, Rectal Cancer, Ileostomy - Stoma
- Being tested
- Mesh Implantation
- Keywords
- ileostomy, hernia, rectal cancer, colon cancer
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh ImplantationDevice
Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement 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 Participants With Wound Occurrences
Incidence 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
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
The incidence 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 30days, 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 compared to historical controls.
Measured: 30 days
Secondary outcomes (3)
Preliminary Efficacy Based on Number of Participants With Hernia Formation
Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.
Measured: 30 days, and then 6 months post procedure
Bowel Function After Mesh Implantation
Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.
Measured: 2 years
Quality of Life After Mesh Implantation
Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Jan 2019
- Primary completion30 Jan 2021
- Study completion1 Feb 2023
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.
- Other trials for Colon CancerStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hitchcock Foundation
- 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
- NCT03750461
- Sponsor's protocol ID
- D18101
- Acronym
- SCAR
- Status last verified
- Feb 2023
- First submitted
- 13 Nov 2018
- Last updated
- 22 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stoma Closure and Reinforcement (SCAR) Trial - A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Left Sided Colon and Rectal Cancer Patients
- ClinicalTrials.gov ID
- NCT03750461
- Acronym / sponsor ID
- SCAR / D18101
- Conditions
- Colon Cancer, Rectal Cancer, Ileostomy - Stoma
- Keywords
- ileostomy, hernia, rectal cancer, colon cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Hitchcock Foundation
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 10 Mar 2022
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 large pore monofilament polypropylene 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 left sided colon or rectal cancer 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 (6 listed)
- Pre-existing systemic infection at the time of ileostomy takedown
- Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
- On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone >10mg/day)
- Previous abdominal hernia repair with mesh placement
- Concurrent procedures in addition to closure of diverting loop ileostomy
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 permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation | Device | Intervention |
Primary outcome
Number of Participants With Wound Occurrences
Time frame: 30 days
Incidence 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.
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
Time frame: 30 days
The incidence 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 30days, 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 compared to historical controls.
3 secondary outcomes
Preliminary Efficacy Based on Number of Participants With Hernia Formation
Time frame: 30 days, and then 6 months post procedure
Bowel Function After Mesh Implantation
Time frame: 2 years
Quality of Life After Mesh Implantation
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Colon Cancer and Rectal Cancer, 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 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: finished, as of the sponsor's last update on 22 Feb 2023. 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 10 Mar 2022). 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 Participants With Wound Occurrences (time frame: 30 days). The study lists 2 primary outcomes in all. 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 22 Feb 2023.