Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorKocaeli City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 years or older.
Histopathological or endoscopic diagnosis of gastric cancer.
Planned elective radical gastrectomy.
Written informed consent to participate in the study.
Disqualifiers
Stage IV metastatic gastric cancer.
Requirement for emergency surgery.
Severe neurological or psychiatric disease preventing completion of cognitive testing.
Incomplete clinical data.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic Gastrectomy
Procedure/SurgeryElective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care. The surgical approach is not assigned by the study
Open Gastrectomy
Procedure/SurgeryElective radical gastrectomy performed using an open approach as part of routine clinical care. The surgical approach is not assigned by the study
Treatment groups
328 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic Surgery1 intervention
Group B: Open Surgery1 intervention
Trial outcomes
Primary outcomes
1
Rate of postoperative complication
According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.
Time frame
Up to 30 days post-operativeSecondary outcomes
1
Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
Change in neutrophil-to-lymphocyte ratio from preoperative baseline to postoperative days 1, 3, and 5
Time frame
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operativeOther outcomes
1
Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values
Change in C-reactive protein from preoperative baseline to postoperative days 1, 3, and 5.
Time frame
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative2
Rate of postoperative delirium
Occurrence of postoperative delirium assessed daily using the Confusion Assessment Method.
Time frame
Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.3
Comparison of length of stay in hospital
Hospital length of stay measured in days from surgery to hospital discharge.
Time frame
From date of surgery until date of hospital discharge, assessed up to 3 months4
Comparison of changes in hand grip strength
Change in handgrip strength from the preoperative assessment to the pre-discharge assessment
Time frame
Baseline, pre-dischargeSponsors and contacts
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Source ClinicalTrials.gov
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