Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
2 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
328
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Adem Yuksel, Assoc.Prof.
- Número de teléfono: 5053455259
- Correo electrónico: drademyuksel@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Sumru Atak, M.D.
- Número de teléfono: 5546664272
- Correo electrónico: berilsumru@gmail.com
Ubicaciones de estudio
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-
İZMİT
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Kocaeli, İZMİT, Turquía (Türkiye)
- Kocaeli City Hospital
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Contacto:
- Adem Yuksel, Assoc.Prof.
- Número de teléfono: +90 505 345 52 59
- Correo electrónico: drademyuksel@gmail.com
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Investigador principal:
- Adem Yuksel, Assoc.Prof.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of postoperative complication
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Adem Yuksel, Assoc.Prof., Kocaeli City Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de agosto de 2028
Finalización del estudio (Estimado)
1 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
25 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-194 (Medical Ethics Committee of Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
There is no plan to share individual participant data with other researchers.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .