A Controlled, Randomized Study to Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation With and Without Reinforcement With a Collagen Mesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of parastomal hernia formation.
研究概览
简要总结
This study is being done to evaluate the use of a material (Alloderm collagen mesh) during the stomal formation operation (surgery that will create a mouth-like opening on the surface of the body to an internal organ). The main purpose of this research study is to see if using this material will lower the hernia rate compared to normal repair without this material. The secondary purpose is to evaluate if using this material will increase or decrease complication rates.
详细描述
This study seeks to examine the ability of an implantable collagen matrix to reduce the incidence of parastomal hernia formation. Patients will be randomized preoperatively by a computer generated random allocation to either receive collagen mesh at the time of stoma formation, or to have stoma formation without mesh. Stomas without mesh will be made in the standard surgical fashion dictated by the type of stoma: ileostomy, colostomy, ileal conduit. Patients randomized to receive mesh will undergo stoma formation in an identical fashion, and will have a 8 cm x 12cm piece of AlloDerm mesh placed as a tissue reinforcement at the stoma site and extending under the midline incision. Patients will be followed with physical examinations at approximately 2weeks post-op, 3, 6, 9, 12, 24 months post-op, and will undergo CT scanning of the abdomen and pelvis at 12 and 24months to determine hernia occurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Patients will be at least 18 years of age.
- •Male or female (excluding pregnant females).
- •Patients will require stoma formation.
- •Patients with ASA <
- •Patients informed about the study, and will have read; understood and signed the patient informed consent and authorization to use their PHI, as applicable.
- •Patients will be willing and able to submit to postoperative follow-up evaluations.
排除标准
- •Patients that have had prior surgical treatment parastomal herniation.
- •Patients that refuse stoma formation.
- •Patients with ASA >
- •Patients who have certain metabolic conditions (e.g., chronic hepatic or renal disease).
- •Patients with evidence of pre-existing systemic or local infections.
- •Patients with wound-healing or autoimmune disorders.
- •Patients who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study.
- •Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.
研究组 & 干预措施
2
mesh reinforcement at stoma
干预措施: mesh reinforcement of stoma (Procedure)
Arm 1
standard stoma
干预措施: no intervention (Other)
结局指标
主要结局
Rate of parastomal hernia formation.
时间窗: 2 years post-op
次要结局
未报告次要终点
研究者
Laurie Mihalik
General Surgery Clinical Study Coordinator
Mayo Clinic