NCT00996554终止3 期
Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Frequency of clinical anastomostic leaks
研究概览
简要总结
The purpose of this study is to examine the frequency of postoperative complications depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer suture.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •at least 18 years old,
- •planned for elective surgery
- •at least one hand-sutured ileo-colonic or colo-colonic anastomosis
排除标准
- •ASA-Score > 3,
- •missing written consent of the informed patient
- •no existing choice between suture-techniques according to the surgeon
- •patient not able to cooperate/non-compliance
- •rectal anastomoses
研究组 & 干预措施
Double-Layer-Suture
Experimental
Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
干预措施: double layer-suture (Procedure)
Single-layer suture
Active Comparator
Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread).
干预措施: Single-layer suture (Procedure)
结局指标
主要结局
Frequency of clinical anastomostic leaks
时间窗: 3 months
次要结局
- postoperative morbidity(30 days)
- death of any cause within 3 months post-operatively(3 months)
- Frequency of anastomotic strictures(3 months)
- Duration of anastomosis (min)(1-3 hours)
研究者
Prof Dr. Stefan Post
Prof. Dr. med., Director of Surgical Department
Universitätsmedizin Mannheim
研究点 (1)
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