NCT02627729已完成不适用
J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer: Short and Long-Term Outcomes of a Prospective Randomized Trial
Dr. Lutfi Kirdar Kartal Training and Research Hospital0 个研究点目标入组 74 人开始时间: 2009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
- 74
- 主要终点
- Short Form 36 Quality of life Questionnaire
研究概览
简要总结
Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope
排除标准
- •refusal of the patient to participate
- •pregnancy,
- •previous radiation therapy,
- •those have cancers other than adenocarcinoma,
- •those planned to have local excision or abdominoperineal resection
结局指标
主要结局
Short Form 36 Quality of life Questionnaire
时间窗: Change from baseline scores at 4th, 8th and 12th months after stoma reversal
次要结局
- Postoperative complications(30 days postoperatively)
- Functional outcome measured with Fecal Incontinence Severity Index(Change from baseline scores at 4th, 8th and 12th months after stoma reversal)
- Functional outcome measured with Sexual Health Inventory(Change from baseline scores at 4th, 8th and 12th months after stoma reversal)
- Functional outcome measured with Overactive Bladder validated 8 scale(Change from baseline scores at 4th, 8th and 12th months after stoma reversal)
研究者
Nuri Okkabaz
MD
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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