NCT01861379已完成3 期
The Role of Ghost Ileostomy in Laparoscopic Rectal Resection
University of Roma La Sapienza0 个研究点目标入组 107 人开始时间: 2007年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 主要终点
- Presence of Clinical Evident Anastomotic Leak
研究概览
简要总结
To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a prospective randomized controlled study comparing 2 groups of patients undergoing anterior resection of the rectum laparoscopically. In the first group of patients at the end of the procedure was always performed a Ghost Ileostomy while in the second group no protective stoma was built at the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical Indication for Laparoscopic Anterior Rectal Resection
- •Medium risk of anastomotic leakage
排除标准
- •High risk of anastomotic leakage
- •Lower risk of anastomotic leakage
- •Advanced neoplasia (T4)
- •Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
- •Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
结局指标
主要结局
Presence of Clinical Evident Anastomotic Leak
时间窗: 15 days
次要结局
- Postoperative complication(15 days)
- Ghost Ileostomy complications(15 days)
研究者
Francesco Saverio Mari
Research Fellow
University of Roma La Sapienza
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