NCT02309931已完成不适用
Randomized Clinical Trial Comparing Isoperistaltic Versus Antiperistaltic Side to Side Anastomosis After Right Laparoscopic Hemicolectomy for Cancer.
Hospital Universitario Virgen de la Arrixaca2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2014年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- postoperative complications
研究概览
简要总结
The study will provide a precise control compared to the two interventions (iso vs antiperistaltic anastomoses) with thorough measurements of the postoperative variables and complications to improve the evaluation of the surgical technique. It will also enable an evaluation of the quality of life after the procedures.
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
- Double (Participant, 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
- •The patient has given informed consent to participate
- •No surgery contraindications
- •Elective surgery
- •No pregnancy or nursery during the study
- •Older than 18 years
- •Complete preoperative cancer staging
- •Tumour characteristics:
- •Cecum, ascending, hepatic angle or transverse colon tumour confirmed by endoscopic biopsy
- •Radiologically resectable tumours
- •Absence of vascular, nervous or bone infiltration
- •T4 stages with near organ infiltration
- •Absence of peritoneal carcinomatosis
- •Absence of respiratory pathology that prevents for doing hydrogen breath test
排除标准
- •Pregnancy
- •Intestinal bowel disease like Crohn's disease or ulcerative colitis.
- •Metastatic bone illness
- •Previous abdominal surgery with bowel resection
- •Malabsorption syndromes
结局指标
主要结局
postoperative complications
时间窗: within the first 30 days up to one year after surgery
Number of patients with postoperative complications and grade of Clavien-Dindo
次要结局
- Operating time(During surgery)
- first faeces day(participants will be followed for the duration of hospital stay, an expected average of 4 days)
- Gastrointestinal life quality(up to one year)
- Anastomosis time(From the enteromy to its closure.)
- first flatus day(participants will be followed for the duration of hospital stay, an expected average of 4 days)
- Hospital length of say(participants will be followed for the duration of hospital stay, an expected average of 4 days)
- Orocecal transit(up to one year)
- first tolerance day(participants will be followed for the duration of hospital stay, an expected average of 4 days)
研究者
Jesus Abrisqueta Carrion
Ph D
Hospital Universitario Virgen de la Arrixaca
研究点 (2)
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