Clinical trial · Interventional
Stoma Closure and Reinforcement Trial
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Ileostomy - Stoma | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mesh Implantation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall
- interventionNames
- Device: Mesh Implantation
Primary outcomes (2)
- measure
- Number of Participants With Wound Occurrences
- timeFrame
- 30 days
- description
- 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.
- measure
- Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18years 2. Patient is undergoing closure of loop ileostomy 3. Patient has a diagnosis of left sided colon or rectal cancer 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. On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone \>10mg/day) 4. Previous abdominal hernia repair with mesh placement 5. Concurrent procedures in addition to closure of diverting loop ileostomy 6. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
References
Publications (0)
Data not yet available