NCT01670851已完成不适用
Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
University Hospitals, Leicester3 个研究点 分布在 3 个国家目标入组 20 人开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Perineal wound healing
研究概览
简要总结
This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.
详细描述
About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary cancers undergoing curative surgery (R0)
- •Life expectancy > 2 yrs
- •Neoadjuvant radiotherapy with or without chemotherapy
排除标准
- •Pelvic extenteration or extended resections
- •Previously irradiated patients (i.e. radiation therapy for a previous cancer)
- •Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder
- •sensitivity to porcine derived products or polysorbate
结局指标
主要结局
Perineal wound healing
时间窗: 12 months
Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.
次要结局
- Incidence of parastomal hernia(24 months)
- Incidence of perineal herniation(24 months)
研究者
研究点 (3)
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