Gastric Adenocarcinoma, Gastric Cancer
Conditions
Keywords
gastric cancer, fraility, immunonutrition, gastrectomy, cognitive function
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURELaparoscopic Gastrectomy
Elective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care. The surgical approach is not assigned by the study
PROCEDUREOpen Gastrectomy
Elective radical gastrectomy performed using an open approach as part of routine clinical care. The surgical approach is not assigned by the study
Sponsors
Kocaeli City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative complication | Up to 30 days post-operative | According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR) | Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative | Change in neutrophil-to-lymphocyte ratio from preoperative baseline to postoperative days 1, 3, and 5 |
Countries
Turkey (Türkiye)
Contacts
CONTACTAdem Yuksel, Assoc.Prof.
CONTACTSumru Atak, M.D.
PRINCIPAL_INVESTIGATORAdem Yuksel, Assoc.Prof.
Kocaeli City Hospital
Outcome results
None listed