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临床试验/NCT02399631
NCT02399631终止不适用

Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Kyungpook National University Hospital2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
180
试验地点
2
主要终点
Length of hospital stay

研究概览

简要总结

An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. However, such studies are rarely conducted in South Korea. The purpose of this study is to evaluate the feasibility and efficacy of a postoperative enhanced recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary hospital in Korea.

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility rule of enrollment
  • Pathologically diagnosed colon cancer
  • Stage I-III
  • No functional disturbance in liver, kidney, bone marrow
  • Informed consent

排除标准

  • Emergent operation
  • Obstructive or perforated cancer
  • Rectosigmoid or rectal cancer
  • Synchronous tumor
  • Uncontrolled psychiatric or neurologic problems
  • Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
  • Renal dysfunction (Cr ≥2mg/dl)
  • Recent MI, CVA, nitrate medication

研究组 & 干预措施

ERAS group

Experimental

early recovery program with no preoperative mechanical bowel preparation, early diet initiation, and prevention of postoperative ileus after elective laparoscopic colon cancer surgery

干预措施: Enhanced recovery program (Other)

Congrol group

No Intervention

Traditional, conventional perioperative treatment

结局指标

主要结局

Length of hospital stay

时间窗: 30 days post-operatively

Duration of hospital stay from the date of operation to the date when a patient meets the following "discharge criteria". Discharge criteria: * Tolerance of consecutive 3 soft diet * Recovery of bowel function (without PONV) * No necessity of intravenous analgesics * Stable vital sign (afebrile)

Actual hospital stay

时间窗: 30 days post-operatively

次要结局

  • Quality of life(up to 30days from time of surgery)
  • Nutritional status(up to 30days from time of surgery)
  • Readmission rate(30 days from time of surgery)
  • 30-day morbidity(30 days from time of surgery)
  • 30-day mortality(30 days from time of surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gyu-Seog Choi

Director, Head of colorectal cancer center, Principal Investigator, Professor

Kyungpook National University Hospital

研究点 (2)

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