Gastric Cancer Enhanced Recovery After Surgery Pathway
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Rate and type of post-operative complications
研究概览
简要总结
This phase II trial studies how well an early recovery after surgery protocol works in enhancing quality of life in participants with stage 0-IIIC gastric cancer undergoing surgery. The early recovery after surgery protocol may decrease pain and nausea, promote bowl function, decrease the number of days hospitalized, and improve a participant's ability to function normally after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Determine how the enhanced recovery after surgery (ERAS) protocol affects patient?s length of hospital stay after radical gastrectomy.
II. Determine the association between ambulation (number of steps taken) while hospitalized and complications.
III. Determine the association between pre-operatively and postoperatively drawn biochemical markers and complications, disease free survival, and overall survival.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to be included are those with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk.
- •Patients with clinical stage 0-IIIC will be included.
- •Any performance status and any life expectancy.
- •The effects of gastric surgery on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- •All subjects must have the ability to understand and the willingness to sign a written informed consent.
- •Prior therapy will not be used as a limitation in this study.
排除标准
- •Patients will be excluded if they are not candidates for surgery
- •Patients will be excluded from the study if they have had prior gastric surgery, with the exception of a gastrostomy tube.
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
研究组 & 干预措施
Observational (ERAS protocol)
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
干预措施: Best Practice (Other)
Observational (ERAS protocol)
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
干预措施: Quality-of-Life Assessment (Other)
Observational (ERAS protocol)
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Rate and type of post-operative complications
时间窗: Up to 1 year
Length of stay
时间窗: from date of surgery to discharge from hospital, assessed up to 30 days
Will determine the length of hospital stay after surgery
次要结局
- Overall quality of life assessment(One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery)
- QoL after stomach cancer surgery(One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery)