NCT06811753

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 27, 2025

Last Update Submit

January 31, 2025

Conditions

Keywords

gastric cancerminimally invasive gastrectomysystemic immune-inflammation indexRobotic surgery

Outcome Measures

Primary Outcomes (1)

  • Systemic inflammatory index

    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

Study Arms (3)

Group 1

robotic surgery

Procedure: robotic surgery

Group 2

laparoscopic surgery

Group 3

open surgery

Interventions

minimally invasive surgery

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients operated for gastric cancer

You may qualify if:

  • gastric cancer patients treated with surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Basakşehir, 212, Turkey (Türkiye)

Location

Related Publications (7)

  • Lin GS, Huang XY, Lu J, Wu D, Zheng HL, Xu BB, Zheng CH, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Lin GT, Huang ZN, Lin JL, Huang CM. A good preoperative immune prognostic index is predictive of better long-term outcomes after laparoscopic gastrectomy compared with open gastrectomy for stage II gastric cancer in elderly patients. Surg Endosc. 2022 Mar;36(3):1814-1826. doi: 10.1007/s00464-021-08461-7. Epub 2021 Jun 2.

    PMID: 34076769BACKGROUND
  • Zhu RH, Li PC, Zhang J, Song HH. Impact of minimally invasive surgery on immune function and stress response in gastric cancer patients. World J Gastrointest Surg. 2024 Aug 27;16(8):2484-2493. doi: 10.4240/wjgs.v16.i8.2484.

    PMID: 39220065BACKGROUND
  • Aziz MH, Sideras K, Aziz NA, Mauff K, Haen R, Roos D, Saida L, Suker M, van der Harst E, Mieog JS, Bonsing BA, Klaver Y, Koerkamp BG, van Eijck CH. The Systemic-immune-inflammation Index Independently Predicts Survival and Recurrence in Resectable Pancreatic Cancer and its Prognostic Value Depends on Bilirubin Levels: A Retrospective Multicenter Cohort Study. Ann Surg. 2019 Jul;270(1):139-146. doi: 10.1097/SLA.0000000000002660.

    PMID: 29334554BACKGROUND
  • Hirahara N, Matsubara T, Fujii Y, Kaji S, Kawabata Y, Hyakudomi R, Yamamoto T, Taniura T, Tajima Y. Comparison of the prognostic value of immunoinflammation-based biomarkers in patients with gastric cancer. Oncotarget. 2020 Jul 7;11(27):2625-2635. doi: 10.18632/oncotarget.27653. eCollection 2020 Jul 7.

    PMID: 32676164BACKGROUND
  • Margraf A, Ludwig N, Zarbock A, Rossaint J. Systemic Inflammatory Response Syndrome After Surgery: Mechanisms and Protection. Anesth Analg. 2020 Dec;131(6):1693-1707. doi: 10.1213/ANE.0000000000005175.

    PMID: 33186158BACKGROUND
  • Kinoshita T, Sato R, Akimoto E, Tanaka Y, Okayama T, Habu T. Reduction in postoperative complications by robotic surgery: a case-control study of robotic versus conventional laparoscopic surgery for gastric cancer. Surg Endosc. 2022 Mar;36(3):1989-1998. doi: 10.1007/s00464-021-08483-1. Epub 2021 Apr 12.

    PMID: 33844086BACKGROUND
  • Nagata H, Kinoshita T, Komatsu M, Habu T, Yoshida M, Yura M. Comparison of robotic versus laparoscopic total gastrectomy for gastric cancer: A single-center retrospective cohort study in a Japanese high-volume center. Eur J Surg Oncol. 2024 Dec;50(12):108706. doi: 10.1016/j.ejso.2024.108706. Epub 2024 Sep 28.

    PMID: 39357414BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Yiğit Düzköylü, assoc. prof.

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 6, 2025

Study Start

December 1, 2023

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

February 6, 2025

Record last verified: 2025-01

Locations