Impact of Robotic Surgery on Systemic Immune-inflammation Index

January 31, 2025 updated by: Başakşehir Çam & Sakura City Hospital

Impact of Robotic Surgery on Systemic Immune-inflammation Index in Gastric Cancer Patients

Robotic surgery has been gaining attention because of the physical and metabolic morbidity of the conventional open technique.The systemic immune-inflammation index(SII) has emerged as a recent and more reliable biomarker.In our single-center retrospective cohort study, the investigators investigate SII in robotic gastrectomy in order to show the advantageous effect on immune system which the investigators think as the first study in the literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who underwent robotic gastrectomy between January 2021 and September 2024 were included in the study. The primary outcome was to ascertain the beneficial effects of robotic surgery in gastric cancer patients in terms of immune response. The secondary outcome was to examine the reliability of SII as a serum biomarker in comparison to previous studies on the diagnosis and postoperative follow-up of gastric cancer.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Basakşehir
      • İstanbul, Basakşehir, Turkey, 212
        • Basaksehir Cam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients operated for gastric cancer

Description

Inclusion Criteria:

gastric cancer patients treated with surgery

Exclusion Criteria:

patients with haematologic malignancy, immune system disorder, antiplatelet drug usage, operations including splenectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
robotic surgery
minimally invasive surgery
Group 2
laparoscopic surgery
Group 3
open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic inflammatory index
Time Frame: One year
Systemic inflammatory index (SII= (platelet count x neutrophil count)/lymphocyte count) was predicted to be lower in patients undergoing minimally invasive surgery. The neutrophil-lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLT) have been the subject of investigation as potential biomarkers to show the immune response to the surgical procedure.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yiğit Düzköylü, assoc. prof., Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

demographics, surgery type, blood counts

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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