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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
时间窗: 30 days
The 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 30days, 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 compared to historical controls.
Number of Participants With Wound Occurrences
时间窗: 30 days
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.
次要结局
- Preliminary Efficacy Based on Number of Participants With Hernia Formation(30 days, and then 6 months post procedure)
- Bowel Function After Mesh Implantation(2 years)
- Quality of Life After Mesh Implantation(2 years)
研究者
Matthew Z. Wilson
Assistant Professor of Surgery
Dartmouth-Hitchcock Medical Center