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NCT Number: NCT07803159

Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastric Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli City Hospital

Kocaeli, İZMİT, Turkey (Türkiye)

Location contact

Adem Yuksel, Assoc.Prof.

CONTACT

[email protected]

+90 505 345 52 59

Adem Yuksel, Assoc.Prof.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic Gastrectomy

Procedure

Elective 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

Elective radical gastrectomy performed using an open approach as part of routine clinical care. The surgical approach is not assigned by the study

Primary outcomes

  1. Rate of postoperative complication

    Time frame: Up to 30 days post-operative

    According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.

Secondary outcomes

  1. Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)

    Time frame: 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

Other outcomes

  1. Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values

    Time frame: Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative

    Change in C-reactive protein from preoperative baseline to postoperative days 1, 3, and 5.

  2. Rate of postoperative delirium

    Time frame: 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.

  3. Comparison of length of stay in hospital

    Time frame: 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.

  4. Comparison of changes in hand grip strength

    Time frame: Baseline, pre-discharge

    Change in handgrip strength from the preoperative assessment to the pre-discharge assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Adem Yuksel, Assoc.Prof.

CONTACT

[email protected]

5053455259

Sumru Atak, M.D.

CONTACT

[email protected]

5546664272

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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