Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
2026年9月2日 更新者：Adem Yüksel、Kocaeli City Hospital
The Effects of Multidimensional Frailty Phenotypes, Immunonutritional Status, and Surgical Approach on Biological Recovery in Elderly Patients Undergoing Gastric Cancer Surgery: A Prospective Observational Study
This prospective observational cohort study will evaluate the effects of multidimensional frailty phenotypes, immunonutritional status, and surgical approach on biological recovery in patients aged 60 years and older undergoing surgery for gastric cancer.
Preoperative assessment will include physical and cognitive frailty, nutritional status, handgrip strength, and skeletal muscle characteristics on computed tomography.
Patients will be followed prospectively during the perioperative period, including assessment of inflammatory markers, postoperative complications, delirium, hospital length of stay, and functional recovery.
The study aims to determine whether multidimensional frailty and immunonutritional factors are associated with postoperative outcomes and whether surgical approach influences biological recovery in older patients with gastric cancer.
A total of 328 patients are planned to be included at Kocaeli City Hospital.
研究概览
详细说明
This prospective, observational, analytical cohort study will be conducted at the General Surgery Clinic of Kocaeli City Hospital. The study will include patients aged 60 years and older who have gastric cancer and are scheduled for elective radical gastrectomy. A total of 328 patients are planned to be enrolled.
Preoperative assessment will include multidimensional frailty-related parameters, including the modified Frailty Index-11 (mFI-11), Montreal Cognitive Assessment (MoCA), handgrip strength, Nutritional Risk Screening 2002 (NRS-2002), Prognostic Nutritional Index (PNI), and skeletal muscle characteristics assessed on computed tomography at the L3 level. Baseline neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) levels will also be recorded.
Intraoperative data will include surgical approach, operative duration, and intraoperative blood loss. Postoperatively, NLR and CRP will be assessed on postoperative days 1, 3, and 5. Delirium will be evaluated using the Confusion Assessment Method (CAM). Postoperative complications will be recorded according to the Clavien-Dindo classification, together with hospital length of stay and handgrip strength before discharge.
The primary purpose of the study is to evaluate the association between multidimensional frailty phenotypes and postoperative outcomes and biological recovery in older patients undergoing gastric cancer surgery. The study will also investigate whether the surgical approach is associated with differences in biological recovery among patients with different frailty profiles.
研究类型
观察性的
注册 (估计的)
328
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：Adem Yuksel, Assoc.Prof.
- 电话号码：5053455259
- 邮箱：drademyuksel@gmail.com
研究联系人备份
- 姓名：Sumru Atak, M.D.
- 电话号码：5546664272
- 邮箱：berilsumru@gmail.com
学习地点
-
-
İZMİT
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Kocaeli、İZMİT、土耳其（türkiye）
- Kocaeli City Hospital
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接触：
- Adem Yuksel, Assoc.Prof.
- 电话号码：+90 505 345 52 59
- 邮箱：drademyuksel@gmail.com
-
首席研究员：
- Adem Yuksel, Assoc.Prof.
-
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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
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population will consist of patients aged 60 years and older with gastric cancer who are scheduled for elective radical gastrectomy at the General Surgery Clinic of Kocaeli City Hospital.
Eligible participants will be enrolled prospectively according to the predefined inclusion and exclusion criteria.
A total of 328 participants are planned to be included.
描述
Inclusion Criteria:
- Age 60 years or older.
- Histopathological or endoscopic diagnosis of gastric cancer.
- Planned elective radical gastrectomy.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Stage IV metastatic gastric cancer.
- Requirement for emergency surgery.
- Severe neurological or psychiatric disease preventing completion of cognitive testing.
- Incomplete clinical data.
- Refusal to participate in the study.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Laparoscopic Surgery
Patients undergoing elective radical gastrectomy through a laparoscopic approach.
The surgical approach is determined by routine clinical practice and is not assigned by the study.
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Elective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care.
The surgical approach is not assigned by the study
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Open Surgery
Patients undergoing elective radical gastrectomy through an open approach.
The surgical approach is determined by routine clinical practice and is not assigned by the study.
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Elective radical gastrectomy performed using an open approach as part of routine clinical care.
The surgical approach is not assigned by the study
|
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 |
|---|---|---|
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Rate of postoperative complication
大体时间：Up to 30 days post-operative
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According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.
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Up to 30 days post-operative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
大体时间：Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
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Change in neutrophil-to-lymphocyte ratio from preoperative baseline to postoperative days 1, 3, and 5
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Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values
大体时间：Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
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Change in C-reactive protein from preoperative baseline to postoperative days 1, 3, and 5.
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Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
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Rate of postoperative delirium
大体时间：Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
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Occurrence of postoperative delirium assessed daily using the Confusion Assessment Method.
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Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
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Comparison of length of stay in hospital
大体时间：From date of surgery until date of hospital discharge, assessed up to 3 months
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Hospital length of stay measured in days from surgery to hospital discharge.
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From date of surgery until date of hospital discharge, assessed up to 3 months
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Comparison of changes in hand grip strength
大体时间：Baseline, pre-discharge
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Change in handgrip strength from the preoperative assessment to the pre-discharge assessment
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Baseline, pre-discharge
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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。
调查人员
- 首席研究员：Adem Yuksel, Assoc.Prof.、Kocaeli City Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494.
- McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Japanese Gastric Cancer Association. Gastric cancer treatment guidelines 2021. Gastric Cancer. 2022;25:1-21.
- Ethun CG, Bilen MA, Jani AB, et al. Frailty and cancer surgery outcomes. Ann Surg Oncol. 2017;24:2131-2139.
- Shimada H, Makizako H, Lee S, Doi T, Lee S, Tsutsumimoto K, Harada K, Hotta R, Bae S, Nakakubo S, Harada K, Suzuki T. Impact of Cognitive Frailty on Daily Activities in Older Persons. J Nutr Health Aging. 2016;20(7):729-35. doi: 10.1007/s12603-016-0685-2.
- Jia G, Li K. Prognostic Nutritional Index is A Useful Predictive Marker for Morbidity and Mortality in Surgery for Perforated Peptic Ulcer. J Inflamm Res. 2025 Aug 14;18:11021-11028. doi: 10.2147/JIR.S519037. eCollection 2025.
- Kanasaki H, Oride A, Miyazaki K. Laparoscopic surgery in elderly patients aged 65 years and older with gynecologic disease. ISRN Obstet Gynecol. 2012;2012:678201. doi: 10.5402/2012/678201. Epub 2012 Nov 21.
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 (估计的)
2026年9月1日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2028年8月1日
研究注册日期
首次提交
2026年8月25日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月3日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 2026-194 (Medical Ethics Committee of Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is no plan to share individual participant data with other researchers.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.