Systemic Immune ActivationNCT04891146
The Effect of Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries
An observational study of Systemic Immune Activation and Cancer Gi, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effects of different anesthesia methods on the immune system are variable. In this study, we investigated the effect of inhalation anesthesia and total intravenous anesthesia on the SII value in major abdominal cancer surgeries. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Systemic Immune Activation, Cancer Gi, Cancer of Endometrium
- What is being tested?
- Systemic inflammatory immmune index
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2020to 12 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: major abdominal cancer patients between 18-85 years included. 40 patients in sevoflurane group and 44 patients in TIVA group collected
Who may be able to join
- major abdominal cancer surgeries
Who cannot join
- blood transfusion in last 72 hours
- patients with infection
- hematologic malignancy
- patient controlled analgesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Research and Trainee Hospital
Ankara, Yenimahalle, 06200
About this study
Official title: The Effect of Inhalation Anesthesia and Total Intravenous Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries
The effects of different anesthesia methods on the immune system are variable. In this study, we investigated the effect of inhalation anesthesia and total intravenous anesthesia on the SII value in major abdominal cancer surgeries.
Read the detailed description
The study was planned prospectively, observationally, on a total of 90 patients who underwent major abdominal cancer surgery. 84 patients were evaluated. The patients were seperated in two groups as inhalation anesthesia and total intravenous anesthesia (TIVA). The demographic data of the patients, type of cancer, type of surgery performed, ASA classification, preoperative chemotherapy intake, preoperative hemogram, postoperative 2nd and 24th hour hemogram, intraoperative and postoperative blood transfusion, and duration of surgery were recorded. Platelet, neutrophil, lymphocyte and SII values were saved.
- Conditions
- Systemic Immune Activation, Cancer Gi, Cancer of Endometrium
- Being tested
- Systemic inflammatory immmune index
- Medical subject headings
- Gastrointestinal Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic inflammatory immmune indexOther
Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count
| Study group | Role | What they receive |
|---|---|---|
| Inhalation anesthesia | Sevoflurane for opioid remifentanyl used Receives: Other: Systemic inflammatory immmune index | |
| Total Intravenous Anesthesia | Propofol for opioid remifentanyl used Receives: Other: Systemic inflammatory immmune index |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the effect of anesthesia management on the change of preoperative systemic inflammatory immune index(SII) and postoperative 2.hour and 24.hour SII value
systemic inflammatory immune index calculated by (platelet x neutrophil)/lymphocyte
Measured: preoperative SII noted, postoperative 2.hour noted and postoperative 24.hour noted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start5 Mar 2020
- Primary completion15 Sep 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Immune ActivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arsen Güngör, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Arsen Gungor, Principal investigator, arsen.gungor@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891146
- Sponsor's protocol ID
- AbdurrahmanYAOTRH
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: shared after published
Publications
Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.
PubMed 25271081Lee JH, Kang SH, Kim Y, Kim HA, Kim BS. Effects of propofol-based total intravenous anesthesia on recurrence and overall survival in patients after modified radical mastectomy: a retrospective study. Korean J Anesthesiol. 2016 Apr;69(2):126-32. doi: 10.4097/kjae.2016.69.2.126. Epub 2016 Mar 30.
PubMed 27066202
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inhalation Anesthesia and Total Intravenous Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries
- ClinicalTrials.gov ID
- NCT04891146
- Acronym / sponsor ID
- AbdurrahmanYAOTRH
- Conditions
- Systemic Immune Activation, Cancer Gi, Cancer of Endometrium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of different anesthesia methods on the immune system are variable. In this study, we investigated the effect of inhalation anesthesia and total intravenous anesthesia on the SII value in major abdominal cancer surgeries.
Detailed description
The study was planned prospectively, observationally, on a total of 90 patients who underwent major abdominal cancer surgery. 84 patients were evaluated. The patients were seperated in two groups as inhalation anesthesia and total intravenous anesthesia (TIVA). The demographic data of the patients, type of cancer, type of surgery performed, ASA classification, preoperative chemotherapy intake, preoperative hemogram, postoperative 2nd and 24th hour hemogram, intraoperative and postoperative blood transfusion, and duration of surgery were recorded. Platelet, neutrophil, lymphocyte and SII values were saved.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalation anesthesia | – | Other: Systemic inflammatory immmune indexSevoflurane for opioid remifentanyl used |
| Total Intravenous Anesthesia | – | Other: Systemic inflammatory immmune indexPropofol for opioid remifentanyl used |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- major abdominal cancer patients between 18-85 years included. 40 patients in sevoflurane group and 44 patients in TIVA group collected
Key inclusion criteria (1 listed)
- major abdominal cancer surgeries
Key exclusion criteria (4 listed)
- blood transfusion in last 72 hours
- patients with infection
- hematologic malignancy
- patient controlled analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic inflammatory immmune indexSystemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count | Other | Inhalation anesthesia, Total Intravenous Anesthesia |
Primary outcome
investigate the effect of anesthesia management on the change of preoperative systemic inflammatory immune index(SII) and postoperative 2.hour and 24.hour SII value
Time frame: preoperative SII noted, postoperative 2.hour noted and postoperative 24.hour noted
systemic inflammatory immune index calculated by (platelet x neutrophil)/lymphocyte
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Results publication: PubMed 25271081Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.
- Results publication: PubMed 27066202Lee JH, Kang SH, Kim Y, Kim HA, Kim BS. Effects of propofol-based total intravenous anesthesia on recurrence and overall survival in patients after modified radical mastectomy: a retrospective study. Korean J Anesthesiol. 2016 Apr;69(2):126-32. doi: 10.4097/kjae.2016.69.2.126. Epub 2016 Mar 30.
- Individual participant dataSharing planned: Undecided. shared after published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arsen Gungor principal investigator
arsen.gungor@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Immune Activation and Cancer Gi, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the effect of anesthesia management on the change of preoperative systemic inflammatory immune index(SII) and postoperative 2.hour and 24.hour SII value (time frame: preoperative SII noted, postoperative 2.hour noted and postoperative 24.hour noted). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891146, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.