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
Phase: NA
Conditions: Ileostomy - Stoma, Inflammatory Bowel Diseases
Sponsor: Dartmouth-Hitchcock Medical Center

 
 
 
Title: STOMA CLOSURE AND REINFORCEMENT (SCAR)-II 
TRIAL  
 
NCT #: NCT04916067 
 
Document Date: 11/29/2021 
 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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v.05.31.2019 
PROTOCOL 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 
 
PRINCIPAL INVESTIGATOR: 
Matthew Z. Wilson, MD MSc FACS FASCRS 
Department of Surgery 
(603) 650-8113 
Matthew.z.wilson@hitchcock.org 
VERSION NUMBER/DATE: 
Version 5.0 (11/10/21) 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
2/9/2021 
Updated consent to provide details on 
bioabsorbable mesh 
Updated protocol to provide further details on 
short-term data from SCAR-1 
yes 
2 
5/5/2021 
Revise ultrasound section 
yes 
3 
5/14/2021 
Revise ultrasound section back to AIC 
yes 
4 
11/10/21 
Update visit windows to include +/- days 
no 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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v.05.31.2019 
 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 7 
5.0 
Study Intervention/Investigational Agent ................................................................ 8 
6.0 
Procedures Involved*............................................................................................... 8 
7.0 
Data and Specimen Banking* ................................. Error! Bookmark not defined. 
8.0 
Sharing of Results with Subjects* ......................................................................... 10 
9.0 
Study Timelines* ................................................................................................... 11 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 11 
11.0 Vulnerable Populations* ........................................................................................ 11 
12.0 Local Number of Subjects ..................................................................................... 11 
13.0 Recruitment Methods ............................................................................................. 11 
14.0 Withdrawal of Subjects* ........................................................................................ 12 
15.0 Risks to Subjects* .................................................................................................. 12 
16.0 Potential Benefits to Subjects* .............................................................................. 12 
17.0 Data Management* and Confidentiality ................................................................ 13 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 14 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 20 
20.0 Compensation for Research-Related Injury ........................................................... 20 
21.0 Economic Burden to Subjects ................................................................................ 20 
22.0 Consent Process ..................................................................................................... 21 
23.0 Process to Document Consent in Writing .............................................................. 21 
24.0 Setting .................................................................................................................... 21 
25.0 Resources Available............................................................................................... 21 
26.0 Multi-Site Research* .............................................. Error! Bookmark not defined. 
 
 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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v.05.31.2019 
1.0 
Study Summary 
 
Study Title 
Stoma Closure and Reinforcement Trial (SCAR)-II 
Study Design 
Cohort 
Primary Objective 
1. To perform a pilot study to evaluate the incidence of 
wound occurrences associated with resorbable 
biosynthetic mesh placement in the study cohort. 
 
Secondary 
Objective(s) 
1. To prospectively evaluate the cohort for evidence of 
hernia formation at the previous stoma site. 
2. To evaluate patient satisfaction and resource 
utilization associated with the procedure. 
Research 
Intervention(s)  
Mesh placement within the abdominal wall at the time of 
ostomy closure as a tissue reinforcement 
Study Population 
Patients diagnosed with Crohn’s and Ulcerative Colitis  
Sample Size 
20 
Study Duration for 
individual 
participants 
Approximately 6 months. 
Study Specific 
Abbreviations/ 
Definitions  
MRSA – Methicillin-resistant Staphylococcus aureus 
P4HB – Poly-4-hydroxybutyrate 
SSI – Surgical Site Infection 
S-SSI - Superficial surgical site infection 
D-SSI – Deep surgical site infection 
O-SSI – Organ space surgical site infection 
SCIP – Surgical Care Improvement Project 
PDS – Polydioxanone 
SSO – Surgical Site Occurrence 
 
 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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2.0 
Objectives* 
2.1 
Primary Objective: To perform a pilot study to evaluate the incidence of 
wound occurrences associated with resorbable biosynthetic mesh placement in the 
study cohort.  
 
2.2 
Secondary Objective #1: To prospectively evaluate the cohort for evidence 
of hernia formation at the previous stoma site.  
 
2.3 
Secondary Objective #2: To evaluate patient satisfaction and resource 
utilization associated with the procedure. 
 
2.4 
Hypothesis: Our central hypothesis is that a resorbable biosynthetic mesh 
reinforcement of the site during closure of an ostomy is safe and will reduce the 
incidence of hernia over time.  The rationale for this project is that the IBD patient 
cohort will continue to increase as medical therapies continue to improve and 
improving the quality of life of patients by reducing long term complications of 
surgical therapy can be achieved through improvements in technique. By the 
completion of this pilot study, our expected outcomes are to have demonstrated a 
high level of procedural fidelity among the operating surgeons of the modified 
ostomy closure technique and comparable costs to the standard procedure as well 
as greater than 80% recruitment and retention of eligible participants, and greater 
than 90% adherence to the study protocol.  We also expect to preliminarily 
demonstrate safety and similar quality of life compared to historical controls on 
short term follow-up.  These results are expected to inform development of an 
appropriately powered, multiple center, randomized controlled trial comparing the 
effectiveness of our novel modification of ostomy closure.  
3.0 
Background* 
3.1 
 Treatment for inflammatory bowel disease (IBD, Crohn’s and Ulcerative 
Colitis) is continually evolving with advances in multi-modality therapies leading 
to a growing cohort of patients with a history of the disease.  Many of these patients 
will have long term complications from these treatments, particularly surgical 
treatment, leading to a reduced quality of life.  Minimally invasive approaches and 
enhanced recovery protocols have improved patient tolerance of bowel resection 
for complications of IBD and reduced short term complications.  Technologic 
improvements have allowed bowel and sphincter preserving surgery to be offered 
to a greater proportion of patients and therefore avoid permanent ostomies.  
However, temporary ostomies are often used as part of these approaches to 
minimize the consequences of a complication at a downstream anastomosis, and 
subsequently closed when clinically appropriate.  Eventual restoration of intestinal 
continuity and closure of the ostomy puts patients at risk of developing a hernia at 
that site – a complication that occurs in approximately one third of patients[1-5].  

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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What is not known is whether the strategies used to treat other types of abdominal 
wall hernias will be applicable in this situation due to its unique circumstances.  
There is a critical need to develop an intervention to reduce the incidence of hernia 
formation at the site of previous ostomies as these hernias at minimum reduce 
quality of life through chronic pain, potential fistulization, and disfigurement and 
at worst may require emergency surgery for intestinal obstruction.  Without an 
improvement in technique, it is likely additional patients will experience this 
complication as the IBD cohort grows.    
 
Incisional hernias are common occurrence with an incidence ranging from 
10 to 58%[1, 6].  Risk factors include obesity, malnutrition, immunosuppression, 
connective tissue disorders, and previous abdominal surgery [7-11]. While some of 
these risk factors (like smoking) may be modifiable, others (such as the level of 
wound contamination) are not [12]. Although often amenable to minimally invasive 
approaches, colon and rectal procedures will frequently require a laparotomy type 
incision [13].  Open procedures are unlikely to be entirely replaced by minimally 
invasive approaches in colorectal practice and these hernias will remain a 
significant clinical burden both for the patient and the clinician.   
 
 
One such incisional hernia is particularly challenging: the hernia at the site 
of a prior intestinal ostomy [1, 3, 4, 6, 14, 15].  The most common ostomy used for 
temporary intestinal diversion for IBD related surgery is the diverting loop 
ileostomy (herein referred to as ileostomy), which is an ostomy fashioned from an 
appropriate segment of the small intestine. An ileostomy is used to protect a 
downstream anastomosis while patients heal from surgery and correct any pre-
existing nutritional abnormalities or wean from steroid therapy.  They may be 
closed at a later time, as dictated by the patient’s underlying disease process, 
restoring intestinal continuity.  Hernias at the site of previous stoma placement are 
poorly understood, but are estimated to occur in up to a third of patients [1-5].  
 
Reinforcement of an ileostomy closure with mesh is a novel approach to addressing 
a clinical scenario that bears many similarities to an abdominal wall hernia.  Ileum 
protrudes through a fascial defect but for the purposes of diversion of the fecal 
stream rather than as the result of a congenital condition or iatrogenic process in a 
previous surgical site.  Primary repair of fascial defects, as is commonly performed 
for closure of ileostomy, is not well supported in the literature for repair of 
abdominal wall hernias because of an unacceptably high recurrence rate, reported 
at up to 43% [16].  Nearly all ostomies will have a fascial defect greater than 2cm 
which is where most surgeons would consider using mesh for a primary hernia 
repair such as an umbilical hernia [17]. Incorporating mesh, whether biologic or 
synthetic, decreases the failure rate of repair [16].  While underreported in the 
literature, most ostomies will have parastomal herniation of preperitoneal fat if not 
intraabdominal structures, indicating the ostomy defect has increased in size and 
adding further evidence to support addressing stoma takedown as a true hernia 
repair [6].  Historically, the data for repairing hernias argues against utilizing mesh 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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in a contaminated or clean contaminated field due to concerns of significant 
complications such as infections, mesh erosion, bowel adhesions, fistula formation, 
and pain [18-20].  Biologic meshes have been used in these situations, with the 
prevailing theory being that biologics are more resistant to infection [21, 22]. More 
recent data suggesting that sublay placement of a macroporous mesh of lightweight 
permanent or bioabsorbable synthetic materials are relatively resistant to chronic 
infection challenge this notion, perhaps indicating the design and plane of 
implantation rather than material of the mesh are most important [22-25].  Other 
reports have suggested the safety of ventral hernia repairs with mesh placement 
concurrently with colorectal surgery [26].  Recent trial data have also suggested 
greater effectiveness in reduction of hernia recurrence at two years from time of 
repair compared to biologic mesh in similar wound classifications in addition to 
fewer wound occurrences in the post-operative period [27]. The cost advantages of 
macroporous and bioabsorbable mesh have also been reported as superior to 
biologic mesh [28, 29]. 
 
 
Anatomical positioning of the mesh during the hernia repair may also 
impact both the short-term complications and the long-term durability of the 
procedure.  Three broad categories classify mesh placement: onlay, underlay, and 
sublay.  Onlay is positioning of a mesh over a closed fascial incision in the 
subcutaneous space. Underlay is positioned within the peritoneal cavity beneath the 
closed fascial incision.  The sublay (retro-rectus) position is within the muscular 
layers of the abdominal wall where fascial planes are closed on both sides of the 
mesh (Figure 1). Multiple reports have indicated intraperitoneal placement of mesh 
is associated with a higher recurrence rate compared to sublay or onlay techniques, 
with the sublay associated with the most favorable long term outcomes [30-32]. 
 
 
Previous efforts to reduce formation of hernias have been described as 
having fair success, however they are limited by heterogeneity both in patient 
selection and in technique [33-37].  These studies have used suboptimal anatomic 
positioning of the mesh reinforcement and are further limited by lack of 
consideration of consistency of technique between surgeons and consideration of 
associated resource costs [38].   

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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v.05.31.2019 
 
 
Recently, the preliminary safety data from the SCAR-I trial (ClinicalTrials.gov 
Identifier: NCT03750461) has demonstrated no early adverse events with respect 
to mesh implantation at the time of ileostomy reversal in any of the twenty patients 
studied.  Specifically, there have been zero incidences of infection or hernia 
formation at 30 days post-operatively.  
Our long-term goal is to develop a technique for closure of ostomy sites that 
minimizes the potential for hernia formation.  The current literature is limited by a 
lack of prospective evaluation of the effectiveness of reinforcement of ostomy 
closure sites.  Therefore, prospectively evaluating the technique will yield a more 
detailed understanding of how and when hernia formation at the ostomy closure 
site occurs and the presence of any unexpected findings.  
 
4.0 
Study Endpoints* 
4.1 
Primary Study Endpoints: The primary end point of the study is the 
validation of the mesh implantation procedure.  We will assess the incidence of 
wound occurrences (defined as S-SSI, D-SSI, organ space 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.  
These incidences will be compared to historical controls 
4.2 
Secondary Study Endpoints: The secondary endpoints will be evaluation of 
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.  The PROMIS SF 2.0 8a 
Ability to Participate in Social Roles and Activities instrument will be used to 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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v.05.31.2019 
assess quality of life and the Colorectal Functional Outcome (COREFO) instrument 
will be used to evaluate bowel function at each interval.    
4.3 
Primary Safety Endpoints: Should a patient participating in the study suffer 
an adverse event resulting in mortality or severe morbidity such as necrotizing 
infection or sepsis as a result of mesh infection, the trial will be suspended pending 
an investigation by the Principal Investigator and the co-investigators as to whether 
the procedure or prosthetic mesh was the inciting cause of the adverse effect.  
Should a patient require return to the operating room for treatment of a 
wound occurrence requiring removal of the mesh, the trial will be suspended 
pending investigation of the case to determine the cause of the wound occurrence 
as well as to evaluate the necessity of modification of the protocol to avoid similar 
occurrences in future patients.   
If either of the above conditions occur, in addition to stopping the trial, the 
D-HH Office of Research Operations will be notified.  
 
5.0 
Study Intervention/Investigational Agent 
5.1 
Investigational Agent: Phasix™ Soft Mesh – a knitted monofilament mesh 
scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material.  It 
is an FDA approved product indicated to reinforce soft tissue where weakness 
exists in patients undergoing plastic and reconstructive surgery, or for use in 
procedures involving soft tissue repair, such as the repair of hernia or other fascial 
defects that require the addition of a reinforcing or bridging material to obtain the 
desired surgical result.  
5.2 
Receipt of supplies and storage: The Phasix™ Soft Mesh is already 
available and in stock in the DHMC operating rooms and will be stored according 
to standard OR protocols.  
 
6.0 
Procedures Involved* 
6.1 
Study design: This is a pilot study evaluating the feasibility of a novel 
modification to an established surgical procedure. The three operating surgeons are 
faculty members of the Division of Colon and Rectal Surgery in the Department of 
Surgery at DHMC.  All radiographs will be reviewed by a single faculty of the 
Department of Radiology.  We will use a modified Simon Two stage approach, the 
first phase will include five patients treated and followed sequentially.  If there are 
1 or fewer major wound occurrences (those requiring return to the operating room) 
then the study will proceed to the second phase which will include a total of 15 
patients followed concurrently.  Alternatively, if the results from the SCAR-I trial 
(actively accruing) are available at the start of SCAR-II enrollment and are without 
safety concerns, we will enroll 20 patients sequentially in a one stage approach. 
 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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6.2 
Encounter 1: Patients will be assessed for ileostomy closure based upon 
degree of healing from surgery, correction of any pre-existing nutritional 
abnormalities, and ability to wean from steroid therapy. Appropriate candidates will 
be determined at the operating surgeon’s discretion based on customary evaluation 
of clinical status.  The informed consent process will be initiated and the patient 
recruited into the study.  
 
 
6.3 
Encounter 2: This encounter is the operative procedure.  The procedure for 
closing the ileostomy (i.e. bowel anastomosis) will be at the discretion of the 
surgeon, provided it is performed through the ileostomy site without additional 
laparotomy incisions. In accordance with SCIP guidelines, pre-operative 
intravenous antibiotic and subcutaneous pharmacologic venous thromboembolism 
prophylaxis will be administered. Patients with a history of MRSA infection will 
also receive a dose of intravenous vancomycin prior to the procedure.  
The abdominal wall reconstruction portion of the procedure will be 
standardized to ensure consistency between surgeons.  The posterior rectus sheath 
is closed with native tissue either primarily, using hernia sac if present, or bridged 
with Vicryl-type mesh and a quickly absorbing suture material.  This is done to 
isolate the mesh from the peritoneal cavity.  The retrorectus plane is developed 
using electrocautery and blunt dissection to provide adequate placement of mesh 
such that it overlaps the posterior sheath defect by a minimum of 3cm 
circumferentially.  The mesh is placed in this plane and secured in place with slowly 
absorbable monofilament (0-PDS preferred) sutures placed through the anterior 
fascia or with application of fibrin sealant at the surgeon’s discretion.  This space 
is then thoroughly irrigated with of 0.05% chlorhexidine gluconate (CHG) solution, 
patients with a history of MRSA will receive a dose of IV vancomycin pre-
operatively. The anterior rectus sheath is then closed in a running fashion with 
slowly absorbing monofilament suture (0-PDS preferred).  Again, (volume) of the 
CHG solution is used as irrigation.  A closed suction drain may be left in the 
retrorectus space at the discretion of the surgeon.  Scarpa’s layer is closed if 
possible and then skin closed with a circumferential purse string absorbable suture 
and the subcutaneous cavity packed with Iodoform gauze.  This gauze is then 
removed on post-operative day 2.  Post operatively the patient will receive standard 
care.  
The ileostomy reversal will be performed in an accepted standard of care 
fashion and the abdominal wall reconstruction will be performed exactly as 
specified by the protocol outlined above. The combination of these two entities will 
lessen the probability and magnitude of risk. 
 
6.4 
Encounter 3 and 4.: The patients will be seen at 30 days (+/- 2 weeks) 
following discharge from hospitalization for stoma closure for a clinical 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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v.05.31.2019 
examination. Concurrently, evaluation of clinical evidence of hernia formation as 
well as assessment of patient experience with the stoma site will be performed.  
Patients will also undergo ultrasound examination of the ostomy closure site at 30d 
(+/- 2 weeks) and 6 months (+/- 30 days) post operatively.  
Sonographic evaluation of the stoma site will be obtained in the Advanced 
Imaging Center under the supervision of Dr. Roberta diFlorio-Alexander. Cine 
clips will include all margins of the mesh repair to ensure adequate coverage of the 
repair site. Specific images to be captured are as follows:  
 
SUPINE: Patients will initially be examined in the supine position. 
1. 
Longitudinal and Transverse images of the stoma site will be 
obtained with normal breathing followed by a video clip in long or 
transverse plane. 
2. 
Longitudinal and Transverse images of the stoma site will be 
obtained with Valsalva maneuver followed by a video clip in long 
or transverse plane with Valsalva.  
3. 
If a stoma site hernia is identified, measurements of the abdominal 
wall defect will be obtained  with and without Valsalva.  
4. 
If a stoma site hernia is identified Longitudinal and Transverse 
images of the stoma site will be obtained with transducer 
compression followed by a video clip in long or transverse plane. 
 
STANDING: Patients will then be examined in the standing position. 
1. Longitudinal and Transverse images of the stoma site will be 
obtained with normal breathing  followed by a video clip in long or 
transverse plane. 
2. Longitudinal and Transverse images of the stoma site will be 
obtained with transducer compression followed by a video clip in long 
or transverse plane. 
3. If a stoma site hernia is identified on standing views only, 
measurements of the abdominal wall defect will be obtained with and 
without Valsalva.  
4. If a stoma site hernia is identified on standing views only, 
Longitudinal and Transverse images of  the stoma site will be obtained 
with transducer compression followed by a video clip in long or 
transverse plane. 
7.0 
Sharing of Results with Subjects* 
7.1 Study results will not be shared with subjects. The ultrasounds are being done 
only for purposes of the study.  The results will be read by Dr. diFlorio-
Alexander, but not shared with individual research subjects or uploaded to 
their medical record. If the ultrasound examination reveals a health concern, 
the subject will be referred for appropriate clinical follow up.   

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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v.05.31.2019 
8.0 
Study Timelines* 
8.1 Duration of individual subject’s participation: Each subject will be 
participating in the study for a period of ~ 6 months, from encounter 1 (pre-
operative visit) to encounter 3 (6-month ultrasound surveillance visit).  
8.2 The duration anticipated to enroll all study subjects: The study is estimated to 
last 3 years from time of first enrollment.  
9.0 
Subject Population* 
9.1 Inclusion Criteria 
1. Age > 18years. 
2. Patient is undergoing closure of loop ileostomy. 
3. Patient has a diagnosis of Inflammatory bowel disease treated with resection 
and diverting loop ileostomy. 
4. Patient has been evaluated by a qualified surgeon and found to be a suitable 
candidate for surgery. 
9.2 Exclusion Criteria 
1. Pre-existing systemic infection at the time of ileostomy takedown 
2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder 
3. Previous abdominal hernia repair with mesh placement 
4. Concurrent surgical procedures in addition to closure of diverting loop 
ileostomy 
5. Ileostomy closure not completed through the previous stoma site (i.e. those 
requiring exploratory laparotomy for closure) 
9.3 Specifically Excluded Populations 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
10.0 Vulnerable Populations* 
10.1 Not Applicable 
11.0 Local Number of Subjects 
11.1 The study intends to recruit 20 patients at DHMC. 
12.0 Recruitment Methods 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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12.1 Patients will be recruited from the clinical practice of the Dartmouth Hitchcock 
Department of Surgery, Division of Colon and Rectal Surgery. 
12.2 Patients will be seen as referrals from the DHMC Division of Gastroenterology 
as well as providers outside the DH system. 
12.3 Patients will be deemed eligible for the study based upon clinical indicators 
for appropriateness of ostomy closure based upon clinical indicators for the 
appropriateness of ostomy closure.   
12.4 There is no financial compensation to study subjects 
13.0 Withdrawal of Subjects* 
13.1 Patients may be withdrawn from the study at any time based upon withdraw 
of consent.  Patients may also be withdrawn if the study treatment cannot be 
tolerated (i.e. removal of mesh device is required).  Patients must continue to 
participate for 30 days post-operatively in order for inclusion in the analysis 
of the primary endpoint data.   
13.2 Data related to the time period of the subject’s participation will be included 
in the analysis of the treatment effect.   
 
14.0 Risks to Subjects* 
14.1 The primary concern is for surgical site occurrences.  In the absence of mesh, 
the incidence of infection in ileostomy closures is estimated between 6 and 
18%.[39-41]  This rate is minimized with the use of a purse string skin closure 
with iodine impregnated gauze packing vs partial closure with an open ended 
drain (Penrose type) or primary skin closure.[42]  Prospective trial data 
estimates the overall incidence of infections when bioabsorbable mesh is 
placed in Class II and III ventral hernia repairs at 18%.  None required mesh 
explantation and all wounds eventually healed.[27]  Other reports of 
macroporous polypropylene mesh in clean-contaminated and contaminated 
wounds suggest an infection rate of 7.1% for clean contaminated and 19% for 
contaminated cases. [23]  Surgical site occurrences will be treated on an 
individual patient basis determined by the clinical consequences of the 
occurrence.  Infection may potentially be treated with antibiotics, local wound 
care, operative debridement, radiographically guided drainage procedures, 
vacuum assisted wound closure devices, or mesh removal at the discretion of 
the study team.  Other potential adverse events are those inherent to intestinal 
surgery; anastomotic leak, peritoneal abscess formation, bowel obstruction, or 
ileus, in addition to the risks associated with general anesthesia. 
15.0 Potential Benefits to Subjects* 

 
 
PROTOCOL 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 
SCAR-II v 11/10/21 
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15.1 Potential benefits to participants include possible decreased likelihood of 
developing a stoma-site hernia in the future and avoidance of another 
operation.  
16.0 Data Management* and Confidentiality 
16.1 
Sample Size Determination: This is a pilot study and therefore the 
anticipated number of patients included (20) represents an attainable number within 
the planned study period (3 years) based on the clinical volume of our group.  Our 
group treats approximately 35-40 patients per year who would likely meet inclusion 
criteria for this trial.  We estimate a cohort of 200 patients in a randomized trial will 
be required to demonstrate superiority of the technique, and a 10% sample of that 
cohort will be sufficient provide preliminary safety data as well as to demonstrate 
feasibility of a future trial.   
16.2 
Statistical Methods: The results of this study will be compared using a 
univariate analysis to historical control data obtained from the DHMC ACS-NSQIP 
database, with emphasis on surgical site occurrences including all types of SSI, and 
unplanned return to the operating room data points. The preliminary safety and 
feasibility data obtained from this study will be used to inform design of a larger 
study to test the hypothesis that the procedure can obtain a 50% reduction in the 
incidence of hernia formation at previous ileostomy sites compared to rates reported 
in the literature.  The secondary objectives have not been previously reported in the 
literature either for patient reported outcomes or prospective evaluation of hernia 
formation.  Further work, based on the data from this study, will attempt to show 
the superiority of the technique over currently used closure techniques as well as 
patient satisfaction with the procedure.   
16.3 
Subject Population(s) for Analysis: The statistical analysis for this study 
will use an all-treated population:  Any subject who participated in the study and 
underwent the study procedure.  Patients without complete follow-up data will be 
excluded from the final analysis.   
16.4 
Confidentiality: Information about study subjects will be kept confidential 
and managed according to the requirements of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA).  Those regulations require a signed subject 
authorization informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in 
this study 
• Who will have access to that information and why? 
• Who will use or disclose that information? 
• The rights of a research subject to revoke their authorization for use of their 
PHI.  

 
 
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In the event that a subject revokes authorization to collect or use PHI, the 
investigator, by regulation, retains the ability to use all information collected prior 
to the revocation of subject authorization.  For subjects that have revoked 
authorization to collect or use PHI, attempts should be made to obtain permission 
to collect at least vital status (i.e. that the subject is alive) at the end of their 
scheduled study period. 
16.5 
Source Documents: Source data is all information, original records of 
clinical findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial.  Source data are contained in source 
documents.  Examples of these original documents, and data records include: 
hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ 
diaries or evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being 
accurate and complete, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, 
and at medico-technical departments involved in the clinical trial. 
16.6 
Case Report Forms: The study case report form (CRF) is the primary data 
collection instrument for the study.  All data requested on the CRF must be 
recorded.  All missing data must be explained.  If a space on the CRF is left blank 
because the procedure was not done or the question was not asked, write “N/D”.  If 
the item is not applicable to the individual case, write “N/A”.  All entries should be 
printed legibly in black ink.  If any entry error has been made, to correct such an 
error, draw a single straight line through the incorrect entry and enter the correct 
data above it.  All such changes must be initialed and dated.  DO NOT ERASE OR 
WHITE OUT ERRORS.  For clarification of illegible or uncertain entries, print the 
clarification above the item, then initial and date it. 
16.7 
Records Retention: Data related to the study subjects and the trial will be 
maintained for a minimum of 5 years following the procedure.  This data will be 
secured using the Velos eResearch Database.    
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
17.1 
Safety and Adverse Device Effects: 
• Definitions: 
o Unanticipated Problems Involving Risk to Subjects or Others: Any 
incident, experience, or outcome that meets all of the following 
criteria:  
a. Unexpected in nature, severity, or frequency (i.e. not described 
in study-related documents such as the IRB-approved protocol 
or consent form, the investigators brochure, etc. 

 
 
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b. Related or possibly related to participation in the research (i.e. 
possibly related means there is a reasonable possibility that the 
incident experience, or outcome may have been caused by the 
procedures involved in the research) 
c. Suggests that the research places subjects or others at greater risk 
of harm (including physical, psychological, economic, or social 
harm). 
o Adverse Event: An adverse event (AE) is any symptom, sign, illness 
or experience that develops or worsens in severity during the course 
of the study.  Intercurrent illnesses or injuries should be regarded as 
adverse events.  Abnormal results of diagnostic procedures are 
considered to be adverse events if the abnormality: 
a. results in study withdrawal 
b. is associated with a serious adverse event 
c. is associated with clinical signs or symptoms 
d. leads to additional treatment or to further diagnostic tests 
e. is considered by the investigator to be of clinical significance 
o Unanticipated Adverse Device Effect (UADE): An unanticipated 
adverse device effect is any serious adverse effect on health or 
safety, or any life-threatening problem or death, caused by or 
associated with an investigational device.  Internal Unanticipated 
Adverse Device Effects (UADE) reports must be made within 10 
working days. 
o Adverse Event Reporting Period: The study period during which 
adverse events must be reported is normally defined as the period 
from the initiation of any study procedures to the end of the study 
treatment follow-up.  For this study, the study treatment follow-up 
is defined as 90 days following hospital discharge from the 
ileostomy closure procedure 
o Preexisting Condition: A preexisting condition is one that is present 
at the start of the study.  A preexisting condition should be recorded 
as an adverse event if the frequency, intensity, or the character of 
the condition worsens during the study period. 
o General Physical Examination Findings: At screening, any 
clinically significant abnormality should be recorded as a 
preexisting condition.  At the end of the study, any new clinically 
significant findings/abnormalities that meet the definition of an 

 
 
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adverse event must also be recorded and documented as an adverse 
event.  
o Post-study Adverse Event: All unresolved adverse events should be 
followed by the investigator until the events are resolved, the subject 
is lost to follow-up, or the adverse event is otherwise explained.  At 
the last scheduled visit, the investigator should instruct each subject 
to report any subsequent event(s) that the subject, or the subject’s 
personal physician, believes might reasonably be related to 
participation in this study.  The investigator should notify the study 
sponsor of any death or adverse event occurring at any time after a 
subject has discontinued or terminated study participation that may 
reasonably be related to this study.  The sponsor should also be 
notified if the investigator should become aware of the development 
of cancer or of a congenital anomaly in a subsequently conceived 
offspring of a subject that has participated in this study.  
o Abnormal Laboratory Values: A clinical laboratory abnormality 
should be documented as an adverse event if any one of the 
following conditions is met:  
a. The laboratory abnormality is not otherwise refuted by a repeat 
test to confirm the abnormality 
b. The abnormality suggests a disease and/or organ toxicity 
c. The abnormality is of a degree that requires active 
management; e.g. change of dose, discontinuation of the drug, 
more frequent follow-up assessments, further diagnostic 
investigation, etc. 
o Hospitalization, Prolonged Hospitalization or Surgery: Any adverse 
event that results in hospitalization or prolonged hospitalization 
should be documented and reported as a serious adverse event unless 
specifically instructed otherwise in this protocol.  Any condition 
responsible for surgery should be documented as an adverse event 
if the condition meets the criteria for and adverse event. Neither the 
condition, hospitalization, prolonged hospitalization, nor surgery 
are reported as an adverse event in the following circumstances: 
a. Hospitalization or prolonged hospitalization for diagnostic or 
elective surgical procedures for a preexisting condition.  
Surgery should not be reported as an outcome of an adverse 
event if the purpose of the surgery was elective or diagnostic 
and the outcome was uneventful. 

 
 
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b. Hospitalization or prolonged hospitalization required to allow 
efficacy measurement for the study. 
c. Hospitalization or prolonged hospitalization for therapy of the 
target disease of the study, unless it is a worsening or increase 
in frequency of hospital admissions as judged by the clinical 
investigator. 
17.2 
Recording of Adverse Events: At each contact with the subject, the 
investigator must seek information on adverse events by specific questioning and, 
as appropriate, by examination.  Information on all adverse events should be 
recorded immediately in the source document, and also in the appropriate adverse 
event module of the case report form (CRF).  All clearly related signs, symptoms, 
and abnormal diagnostic procedures results should be recorded in the source 
document, though should be grouped under one diagnosis.  The monitoring period 
for Serious Adverse Events (SAE) will continue for 6 months after the study 
procedure.   
All adverse events, including those possibly related, occurring during the 
study period must be recorded.  The clinical course of each event should be 
followed until resolution, stabilization, or until it has been determined that the study 
treatment or participation is not the cause.  Serious adverse events that are still 
ongoing at the end of the study period must be followed up to determine the final 
outcome.  Any serious adverse event that occurs after the study period and is 
considered to be possibly related to the study treatment or study participation 
should be recorded and reported immediately. 
17.3 
Reporting of Unanticipated Adverse Device Effects and Unanticipated 
Problems: Investigators and the protocol sponsor must conform to the 
reporting timelines, formats and requirements of the various entities to 
which they are responsible, but at a minimum those events that must be 
reported are those that are: 
• Related, or possibly related, to study participation, unexpected, and 
serious or involve risks to subjects or others  
• If the report is supplied as a narrative, the minimum necessary 
information to be provided at the time of the initial report includes: 
o Study identifier 
o Study Center 
o Subject number 
o A description of the event 
o Date of onset  

 
 
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o Current status 
o Whether study treatment was discontinued 
o The reason why the event is classified as serious 
o Investigator assessment of the association between the event and 
study treatment 
17.4 
Investigator reporting - notifying the Dartmouth IRB: This section describes 
the requirements for safety reporting by investigators who are Dartmouth faculty, 
affiliated with a Dartmouth research site, or otherwise responsible for safety 
reporting to the Dartmouth IRB. The Dartmouth Hitchcock IRB requires expedited 
reporting of those events related to study participation that are unforeseen and 
indicate that participants or others are at increased risk of harm.  The Dartmouth 
IRB will not acknowledge safety reports or bulk adverse event submissions that do 
not meet the criteria outlined below.  The Dartmouth IRB requires researchers to 
submit reports of the following problems within 10 working days from the time the 
investigator becomes aware of the event: 
Any adverse event (regardless of whether the event is serious or 
non-serious, on-site or off-site) that occurs any time during or after the 
research study, which in the opinion of the principal investigator is: 
• Unexpected (An event is “unexpected” when its specificity and severity 
are not accurately reflected in the protocol-related documents, such as 
the IRB-approved research protocol, any applicable investigator 
brochure, and the current IRB-approved informed consent document 
and other relevant sources of information, such as product labeling and 
package inserts.) 
AND 
• Related to the research procedures (An event is “related to the research 
procedures” if in the opinion of the principal investigator or sponsor, the 
event was more likely than not to be caused by the research procedures.) 
Reporting Process: Unanticipated problems posing risks to subjects or others as 
noted above will be reported to the Dartmouth IRB using the form: “Unanticipated 
Problems Posing Risks to Subjects or Others Including Reportable Adverse Events” 
or as a written report of the event (including a description of the event with 
information regarding its fulfillment of the above criteria, follow-up/resolution and 
need for revision to consent form and/or other study documentation). Internal 
Unanticipated Adverse Device Effects (UADE) reports must be made within 10 
working days. 
Copies of each report and documentation of IRB notification and receipt 
will be kept in the Clinical Investigator’s study file. 

 
 
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17.5 
Stopping Rules:  
• Should a patient participating in the study suffer an adverse event 
resulting in mortality or severe morbidity such as necrotizing infection 
or sepsis as a result of mesh infection, the trial will be suspended 
pending an investigation by the Principal Investigator and the co-
investigators as to whether the procedure or prosthetic mesh was the 
inciting cause of the adverse effect. 
• Should a patient require return to the operating room for treatment of a 
wound occurrence requiring removal of the mesh, the trial will be 
suspended pending investigation of the case to determine the cause of 
the wound occurrence as well as to evaluate the necessity of 
modification of the protocol to avoid similar occurrences in future 
patients.   
• If either of the above conditions occur, in addition to stopping the trial, 
the D-HH IRB will be notified.   
17.6 
Medical Monitoring: It is the responsibility of the Principal Investigator to 
oversee the safety of the study at his/her site.  This safety monitoring will include 
careful assessment and appropriate reporting of adverse events as noted above, as 
well as the implementation of a site data and safety-monitoring plan. Medical 
monitoring will include a regular assessment of the number and type of 
unanticipated adverse device effects. 
17.7 
Safety and Data Monitoring: 
The 
preliminary 
safety 
data 
from 
the 
SCAR-I 
trial 
(ClinicalTrials.gov Identifier: NCT03750461) has demonstrated no early 
adverse events with respect to mesh implantation at the time of ileostomy 
reversal; specifically there have been zero incidences of infection. Given 
these findings, the level of risk associated with the study intervention in the 
SCAR-II trial does not warrant oversight from an external DSMB.  
17.8 
On-Site Monitoring: 
Participation as an investigator in this study implies acceptance of potential 
inspection by government regulatory authorities, and applicable Dartmouth and 
institutional compliance and quality assurance offices. Investigators will permit 
study-related audits and inspections by the Dartmouth and local IRB, CTO Clinical 
Trials Office, government regulatory bodies, and Dartmouth-Hitchcock or 
institutional compliance and quality assurance groups of all study related 
documents (e.g., source documents, regulatory documents, data collection 
instruments, study data etc.) The investigator will ensure the capability for 
inspections of applicable study-related facilities (e.g., diagnostic laboratory). 

 
 
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This study is to be conducted according to US and international standards 
of Good Clinical Practice (FDA Title 21 part 312 and International Conference on 
Harmonization guidelines), applicable government regulations and Institutional 
research policies and procedures. 
This protocol and any amendments will be submitted to a properly 
constituted independent Ethics Committee (EC) or Institutional Review Board 
(IRB), in agreement with local legal prescriptions, for formal approval of the study 
conduct.  The decision of the EC/IRB concerning the conduct of the study will be 
made in writing to the investigator and a copy of this decision will be provided to 
the sponsor before commencement of this study.  The investigator should provide 
a list of EC/IRB members and their affiliate to the sponsor. 
All subjects for this study will be provided a consent form describing this 
study and providing sufficient information for subjects to make an informed 
decision about their participation in this study.  See Attachment A for a copy of the 
Subject Informed Consent Form.  This consent form will be submitted with the 
protocol for review and approval by the EC/IRB for the study.  The formal consent 
of a subject, using the EC/IRB-approved consent form, must be obtained before 
that subject undergoes any study procedure.  The consent form must be signed by 
the subject or legally acceptable surrogate, and the investigator-designated research 
professional obtaining the consent.  
18.0 Provisions to Protect the Privacy Interests of Subjects 
18.1 
Study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).   
18.2 
In the event that a subject revokes authorization to collect or use PHI, the 
investigator, by regulation, retains the ability to use all information collected prior 
to the revocation of subject authorization.  For subjects that have revoked 
authorization to collect or use PHI, attempts should be made to obtain permission 
to collect at least vital status (i.e. that the subject is alive) at the end of their 
scheduled study period. 
 
19.0 Compensation for Research-Related Injury 
19.1 There will be no monetary compensation in the event of research related 
injury. 
20.0 Economic Burden to Subjects 
20.1 Study subjects will be responsible for expenses related to travel to and from 
DHMC for their pre-operative, and post-operative care. The only additional 

 
 
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expense to the subjects related to the study is travel expenses for the 4th 
encounter (6-month sonographic evaluation). All other travel expenses would 
be the same for a standard ileostomy reversal.  
20.2 Study subjects and/or their insurance will be responsible for the cost of the 
surgical procedure. 
20.3 The mesh is provided by B-D. 
20.4 The ultrasounds will be paid for by the study and not billed to the subjects or 
their insurance. 
20.5  
21.0 Consent Process 
21.1 Consent will be ascertained at the pre-operative clinic visit following the 
“SOP: Informed Consent Process for Research (HRP-090).” 
21.2 Non-English-Speaking Subjects: 
• 
If subjects are eligible to participate and do not speak English, a DH 
translator will be present for the clinic visit and to review the consent in 
its entirety.  
21.3 Cognitively Impaired Adults and Adults unable to consent: 
• 
If a cognitively impaired adult or an adult whom is unable to consent is 
eligible for participation, the procedure and consent ill be reviewed with 
a representative for the patient using the following order: durable power 
of attorney for health care, court appointed guardian for health care 
decisions, spouse, and adult child. 
21.4 Consent will be ascertained from all study participants and the consent 
document will be stored with the subject’s medical record.  
 
22.0 Process to Document Consent in Writing 
22.1 Consent will be documented in writing (Appendix A). The “SOP: Written 
Documentation of Consent (HRP-091)” will be followed.  
23.0 Setting 
23.1 All research activities will be conducted at DHMC.  
23.2 Patients will be recruited from the clinical practice of the Dartmouth Hitchcock 
Department of Surgery, Division of Colon and Rectal Surgery. 
23.3 Patients will be seen as referrals from the DHMC Division of Gastroenterology 
as well as providers outside the DH system. 

 
 
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23.4 Resources Available: 
• 
The recruitment and enrollment of 20 subjects will serve as a 
pilot study for a future multicenter RCT. The 20 subjects 
represent 10% of proposed future enrollment. 
• 
The study team will devote ~1 business day per week related to 
research activities  
• 
All personnel involved with the research are continuously 
updated on changes to the protocol, procedures, and what their 
responsibilities are. All members of the team are CITI certified 
and will maintain credentialing throughout the study period.  
 
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Lee, J.T., et al., Pursestring closure of the stoma site leads to fewer wound 
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