Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
2 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
328
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Adem Yuksel, Assoc.Prof.
- Numéro de téléphone: 5053455259
- E-mail: drademyuksel@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Sumru Atak, M.D.
- Numéro de téléphone: 5546664272
- E-mail: berilsumru@gmail.com
Lieux d'étude
-
-
İZMİT
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Kocaeli, İZMİT, Turquie (Türkiye)
- Kocaeli City Hospital
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Contact:
- Adem Yuksel, Assoc.Prof.
- Numéro de téléphone: +90 505 345 52 59
- E-mail: drademyuksel@gmail.com
-
Chercheur principal:
- Adem Yuksel, Assoc.Prof.
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Elective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care.
The surgical approach is not assigned by the study
|
|
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.
|
Elective radical gastrectomy performed using an open approach as part of routine clinical care.
The surgical approach is not assigned by the study
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of postoperative complication
Délai: Up to 30 days post-operative
|
According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.
|
Up to 30 days post-operative
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
Délai: 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
|
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values
Délai: 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.
|
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
|
Rate of postoperative delirium
Délai: Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
|
Occurrence of postoperative delirium assessed daily using the Confusion Assessment Method.
|
Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
|
|
Comparison of length of stay in hospital
Délai: From date of surgery until date of hospital discharge, assessed up to 3 months
|
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
Délai: Baseline, pre-discharge
|
Change in handgrip strength from the preoperative assessment to the pre-discharge assessment
|
Baseline, pre-discharge
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Adem Yuksel, Assoc.Prof., Kocaeli City Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 août 2028
Achèvement de l'étude (Estimé)
1 août 2028
Dates d'inscription aux études
Première soumission
25 août 2026
Première soumission répondant aux critères de contrôle qualité
2 septembre 2026
Première publication (Réel)
3 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 septembre 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-194 (Medical Ethics Committee of Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
There is no plan to share individual participant data with other researchers.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .