Ileostomy - Stoma, Inflammatory Bowel Diseases
Conditions
Keywords
ileostomy, hernia, inflammatory bowel disease, IBD
Brief 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. 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.
Interventions
DEVICEMesh Implantation
Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation
Sponsors
Dartmouth-Hitchcock Medical Center
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Wound Occurrences | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hernia Formation | 30 days, 6 months | 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. |
| Quality of Life After Mesh Implantation | 30 days, 6 months | 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+ |
| Bowel Function After Mesh Implantation | 30 days, 6 months | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew Z Wilson, MD, Msc
Dartmouth-Hitchcock Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Region of Enrollment United States | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
None listed