Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer
2022年4月24日 更新者:The Affiliated Hospital of Qingdao University
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer: A Multicenter Randomized Controlled Trial
The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG).
The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.
研究概览
研究类型
介入性
注册 (预期的)
368
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Yanbing Zhou, MD
- 电话号码:86532-82911324
- 邮箱:zhouyanbing@qduhospital.cn
研究联系人备份
- 姓名:Yuqi Sun, MD
- 电话号码:86532-82911324
- 邮箱:2021010097@qdu.edu.cn
学习地点
-
-
Shandong
-
Qingdao、Shandong、中国、266000
- 招聘中
- Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
-
接触:
- Yanbing Zhou, MD
- 电话号码:86532-82911324
- 邮箱:zhouyanbing@qduhospital.cn
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 至 85年 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Aged 65-85 years;
- Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- G8 score ≤14;
- Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
- Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
- Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
- Date of surgery ≥2 weeks from baseline (T0) assessment;
- Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
- All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time.
Exclusion Criteria:
- Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
- End-stage cardiac insufficiency (LVEF<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
- Cerebral bleeding or infarction (within 6 months);
- Patients with recurrent infection diseases or serious concomitant disease;
- Patients who require synchronous surgery due to other illness;
- Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
- Patients who are participating in any other clinical trials.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Prehabilitation group
The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.
|
Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
|
有源比较器:ERAS group
The ERAS group patients were treated according to the ERAS pathway.
|
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The incidence and severity of postoperative complications
大体时间:Postoperative (≤30 days after surgery)
|
Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications.
The severity of complications was recorded and classified according to Clavien-Dindo classification score.
|
Postoperative (≤30 days after surgery)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cardio-pulmonary function and physical capacity
大体时间:Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
|
The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.
|
Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
|
Quality of life (QoL).
大体时间:Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
|
QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status.
Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status.
Each index score ranges from 1 to 4, with higher scores indicating higher risk.
|
Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
|
Detection of immune and inflammatory indicators
大体时间:Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
|
Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations
|
Baseline (T0), Post-intervention (up to 2 weeks), and POD 30(30 days after surgery)
|
The postoperative other observation parameters
大体时间:Postoperative (≤30 days after surgery)
|
Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate.
|
Postoperative (≤30 days after surgery)
|
Oncological outcomes
大体时间:3 years
|
3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.
|
3 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任:Yanbing Zhou, MD、The Affiliated Hospital of Qingdao University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年5月1日
初级完成 (预期的)
2023年5月1日
研究完成 (预期的)
2026年5月1日
研究注册日期
首次提交
2022年4月18日
首先提交符合 QC 标准的
2022年4月24日
首次发布 (实际的)
2022年4月29日
研究记录更新
最后更新发布 (实际的)
2022年4月29日
上次提交的符合 QC 标准的更新
2022年4月24日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Multimodal prehabilitation program的临床试验
-
Germans Trias i Pujol Hospital完全的
-
University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
-
The University of Hong KongSydney Children's Hospitals Network; SAHK招聘中
-
Ghana Health ServicesKwame Nkrumah University of Science and Technology尚未招聘戒烟 | 减少吸烟 | 吸烟,烟草 | 吸烟行为