N/A
N=112
Stoma Closure and Reinforcement Trial
Colon Cancer · Rectal Cancer · Ileostomy - Stoma
Bottom Line
View on ClinicalTrials.gov: NCT03750461 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Wound Occurrences — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mesh Implantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wound Occurrences |
— | — |
| PRIMARY Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls |
0; 5; 0; 0; 0; 4 | — |
| SECONDARY Preliminary Efficacy Based on Number of Participants With Hernia Formation |
0; 0 | — |
| SECONDARY Bowel Function After Mesh Implantation |
12 | — |
| SECONDARY Quality of Life After Mesh Implantation |
33 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03750461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.