Ileostomy - Stoma, Incisional Hernia
Conditions
Keywords
duramesh,
Brief summary
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.
Interventions
DEVICEduramesh
Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure
DEVICEControl
standard closure of fascia
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis) * Age 18 or greater * Surgical oncology patient where routine radiologic surveillance for malignancy is planned * Patient accepts participation and gives informed consent
Exclusion criteria
* • Pregnancy * Prior mesh hernia repair at laparotomy site * Life expectancy less than 1 years * Patient is unable / unwilling to provide informed consent * Patient is unable to comply with the protocol or proposed follow-up visits * Patient is enrolled in another hernia study * Non-English-speaking participants * Data from children will not analyzed in this study. * Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study. * Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hernia rates | 1 year | Compare hernia rates after ileostomy closure between Duramesh™ and standard monofilament closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| infection rate | 1 year | Evaluate potential side effects including infections and need for re intervention associated with Duramesh™ vs standard closure |
Countries
United States
Outcome results
None listed