NCT03796702终止不适用
Early Versus Late Closure of Preventive Ileostomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Postoperative morbidity
研究概览
简要总结
The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.
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 (Care Provider)
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
- •Patients with temporary ileostomy after rectal resection for rectal cancer
- •Patients willing to participate in the study
排除标准
- •Anastomosis insufficiency detected clinically or radiologically.
- •Patients, who are physically and mentally unfit to undergo surgery or to be followed-up
研究组 & 干预措施
Late closure of preventive ileostomy
Experimental
A preventive ileostomy is closed 90 days after the primary surgery
干预措施: Deileostomy (Procedure)
Early closure of preventive ileostomy
Experimental
A preventive ileostomy is closed 30 days after the primary surgery
干预措施: Deileostomy (Procedure)
结局指标
主要结局
Postoperative morbidity
时间窗: 30 days after surgery
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
次要结局
- Quality of life of patients after ileostomy closure(at 3, 6, 9 and 12 moths after surgery)
- Hospitalization time after ileostomy closure(30 days after surgery)
- 30-days re-admission rate(30 days after surgery)
研究者
Rimantas Bausys
Investigator
Vilnius University
研究点 (1)
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