NCT04630483

Brief Summary

Cancer is a major cause of morbidity and mortality worldwide. Despite the use of surgery in an attempt to cure the majority of solid tumors, metastasis from residual cancer cells still remains a major cause of morbidity and mortality. General anesthesia and surgical stress during surgery suppress the immune response by directly affecting the immune system or by activating the hypothalamic-pituitaryadrenal axis and the sympathetic nervous system. The aim of our prospective observational study was to assess the value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio regarding outcome underwent cancer surgery. Primary aim is to assess the preoperative and postoperative values of inhalational anesthesia vs total intravenous anesthesia.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

November 10, 2020

Last Update Submit

April 28, 2022

Conditions

CancerUrologic NeoplasmsGynecologic Cancer

Keywords

Cancer surgeryAnesthesiaNeutrophil-to-lymphocyte ratioPlatelet-to-lymphocyte ratio

Outcome Measures

Primary Outcomes (1)

  • The value of NLR and PLR ratio

    Primary aim is to assess the preoperative and postoperative values of inhalational anesthesia vs total intravenous anesthesia.

    Average 6 months, through study completion

Study Arms (2)

Group I: INHA

Inhalational anesthesia (INHA)

Other: INHA

Group II: TIVA

Total intravenous anesthesia (TIVA)

Other: TIVA

Interventions

INHAOTHER

NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values

Group I: INHA
TIVAOTHER

NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values

Group II: TIVA

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Scheduled for elective cancer surgery (urology, general surgery, gynecologic)

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for elective cancer surgery (urology, general surgery, gynecologic) under general anesthesia

You may not qualify if:

  • Secondary sepsis and/or septic shock with an underlying condition
  • Active infection such as severe peritonitis, pancreatitis, or trauma
  • Long-term ICU stay
  • Preexisting immunodeficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

  • Kim R. Anesthetic technique and cancer recurrence in oncologic surgery: unraveling the puzzle. Cancer Metastasis Rev. 2017 Mar;36(1):159-177. doi: 10.1007/s10555-016-9647-8.

    PMID: 27866303BACKGROUND

  • Kim R. Effects of surgery and anesthetic choice on immunosuppression and cancer recurrence. J Transl Med. 2018 Jan 18;16(1):8. doi: 10.1186/s12967-018-1389-7.

    PMID: 29347949BACKGROUND

  • Djordjevic D, Rondovic G, Surbatovic M, Stanojevic I, Udovicic I, Andjelic T, Zeba S, Milosavljevic S, Stankovic N, Abazovic D, Jevdjic J, Vojvodic D. Neutrophil-to-Lymphocyte Ratio, Monocyte-to-Lymphocyte Ratio, Platelet-to-Lymphocyte Ratio, and Mean Platelet Volume-to-Platelet Count Ratio as Biomarkers in Critically Ill and Injured Patients: Which Ratio to Choose to Predict Outcome and Nature of Bacteremia? Mediators Inflamm. 2018 Jul 15;2018:3758068. doi: 10.1155/2018/3758068. eCollection 2018.

    PMID: 30116146BACKGROUND

MeSH Terms

Conditions

NeoplasmsUrologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 16, 2020

Study Start

November 23, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

We will not plan to share IPD

Locations

TU(1)