NL-OMON45096已完成3 期
ongterm outcome of biological mesh closure of the pelvic floor after extralevator abdominoperineal resection for rectal cancer. - BIOPEX-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •(1) Primary rectal cancer
- •(2) Age of 18 years or higher
- •(3) Planned for extralevator abdominoperineal excision after neo-adjuvant (chemo)radiotherapy
- •(4) Life expectancy of more than 2 years
- •(5) Ability to return for all scheduled and required study visits
- •(6) Written informed consent for study participation
排除标准
- •(1) Previous pelvic irradiation for other cancers (i.e. prostate cancer)
- •(2) Total exenteration or sacral resection above level S4/S5)
- •(3) Sensitivity to porcine derived products or polysorbate
- •(4) Severe systemic diseases affecting wound healing
- •(5) The patient has a collagen diseases
- •(6) Participation of the patient in other scientific research affecting wound healing
- •(7) Non-correctable coagulopathy (INR>2; or platelets <90E9 109/l) present
- •(8) ASA-classification * 4
研究者
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