Experience, LifeNCT06002776
Our Anesthesia Experiences in Hepatopancreatobiliary Surgery Practices: a Retrospective Study
An observational study of Experience, Life, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Has the evolving anesthetic management in major abdominal surgeries had a positive impact on patients' one-year postoperative mortality and length of hospital stay? Which of the anesthetic management parameters have influenced mortality and hospital stay duration in these patients? To address these questions, we have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Experience, Life
- What is being tested?
- a retrospective study
- How many people
- 6 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2023to 30 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: data from all patients aged 18 and above who underwent major abdominal surgery with diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy
Who may be able to join
- The study will include data from patients who have undergone their first operation with the diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy during the period from October 2017 to February 2022.
Who cannot join
- Data from patients who were deemed inoperable during the perioperative period after being taken into surgery with their current diagnosis, as well as data from patients who underwent repeat operations, were excluded from the study for their second and subsequent hospitalizations.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Researching Hospital
Istanbul, Sarıyer, 34396
Merve Gökçe, Ass. Dr., +905301414222, merve__duman@hotmail.com
Ayşe Surhan Çınar, Prof. Dr., +905326850929, asurhan@yahoo.com
About this study
Has the evolving anesthetic management in major abdominal surgeries had a positive impact on patients' one-year postoperative mortality and length of hospital stay? Which of the anesthetic management parameters have influenced mortality and hospital stay duration in these patients? To address these questions, we have planned to retrospectively review patients who underwent surgery at our center.
Read the detailed description
In our study, we aimed to compile our practices over the last 5 years by evaluating the impact of perioperative and postoperative anesthetic management on morbidity and mortality in hepatopancreatobiliary surgical patients. Our primary outcome was to form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group. Our secondary outcome was to assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.
- Conditions
- Experience, Life
- Being tested
- a retrospective study
- Keywords
- major abdominal surgery, Revised Cardiac Risk Index, Epidural analgesia, perioperative fluid management, ERAS protocols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a retrospective studyOther
a retrospective study
| Study group | Role | What they receive |
|---|---|---|
| preoperative and perioperative anaesthetic management | We have planned to retrospectively review data for patients aged 18 and above who underwent major abdominal surgery at our center between October 2017 and February 2022. The study aims to record data regarding the administration of thromboprophylaxis, preoperative hemoglobin values, and Revised Cardiac Risk Index scores and their impact on one-year postoperative mortality. Additionally, we intend to examine the effects of the amount of fluid administered during the perioperative period, the application of epidural analgesia, and the use of blood products on hospital stay duration and one-year postoperative mortality. Receives: Other: a retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group
Measured: october2017-february2022
Secondary outcomes (1)
assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.
Measured: october2017-february2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startAug 2023 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Experience, LifeStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gokce, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002776
- Sponsor's protocol ID
- Sisli Hamidiye Etfal TRH
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient data will be kept confidential.
Publications
Snowden C, Prentis J. Anesthesia for hepatobiliary surgery. Anesthesiol Clin. 2015 Mar;33(1):125-41. doi: 10.1016/j.anclin.2014.11.008. Epub 2014 Dec 31.
PubMed 25701932Hemmerling TM. Pain management in abdominal surgery. Langenbecks Arch Surg. 2018 Nov;403(7):791-803. doi: 10.1007/s00423-018-1705-y. Epub 2018 Oct 3.
PubMed 30284029von der Forst M, Weiterer S, Dietrich M, Loos M, Lichtenstern C, Weigand MA, Siegler BH. [Perioperative fluid management in major abdominal surgery]. Anaesthesist. 2021 Feb;70(2):127-143. doi: 10.1007/s00101-020-00867-7. German.
PubMed 33034685
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Anesthesia Experiences in Hepatopancreatobiliary Surgery Practices: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06002776
- Acronym / sponsor ID
- Sisli Hamidiye Etfal TRH
- Conditions
- Experience, Life
- Keywords
- major abdominal surgery, Revised Cardiac Risk Index, Epidural analgesia, perioperative fluid management, ERAS protocols
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Aug 2023 (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.
Has the evolving anesthetic management in major abdominal surgeries had a positive impact on patients' one-year postoperative mortality and length of hospital stay? Which of the anesthetic management parameters have influenced mortality and hospital stay duration in these patients? To address these questions, we have planned to retrospectively review patients who underwent surgery at our center.
Detailed description
In our study, we aimed to compile our practices over the last 5 years by evaluating the impact of perioperative and postoperative anesthetic management on morbidity and mortality in hepatopancreatobiliary surgical patients. Our primary outcome was to form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group. Our secondary outcome was to assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative and perioperative anaesthetic management | – | Other: a retrospective studyWe have planned to retrospectively review data for patients aged 18 and above who underwent major abdominal surgery at our center between October 2017 and February 2022. The study aims to record data regarding the administration of thromboprophylaxis, preoperative hemoglobin values, and Revised Cardiac Risk Index scores and their impact on one-year postoperative mortality. Additionally, we intend to examine the effects of the amount of fluid administered during the perioperative period, the application of epidural analgesia, and the use of blood products on hospital stay duration and one-year postoperative mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- data from all patients aged 18 and above who underwent major abdominal surgery with diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy
Key inclusion criteria (1 listed)
- The study will include data from patients who have undergone their first operation with the diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy during the period from October 2017 to February 2022.
Key exclusion criteria (1 listed)
- Data from patients who were deemed inoperable during the perioperative period after being taken into surgery with their current diagnosis, as well as data from patients who underwent repeat operations, were excluded from the study for their second and subsequent hospitalizations.
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 |
|---|---|---|
| a retrospective studya retrospective study | Other | preoperative and perioperative anaesthetic management |
Primary outcome
form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group
Time frame: october2017-february2022
1 secondary outcome
assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.
Time frame: october2017-february2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 25701932Snowden C, Prentis J. Anesthesia for hepatobiliary surgery. Anesthesiol Clin. 2015 Mar;33(1):125-41. doi: 10.1016/j.anclin.2014.11.008. Epub 2014 Dec 31.
- Background: PubMed 30284029Hemmerling TM. Pain management in abdominal surgery. Langenbecks Arch Surg. 2018 Nov;403(7):791-803. doi: 10.1007/s00423-018-1705-y. Epub 2018 Oct 3.
- Background: PubMed 33034685von der Forst M, Weiterer S, Dietrich M, Loos M, Lichtenstern C, Weigand MA, Siegler BH. [Perioperative fluid management in major abdominal surgery]. Anaesthesist. 2021 Feb;70(2):127-143. doi: 10.1007/s00101-020-00867-7. German.
- Individual participant dataSharing planned: No. All patient data will be kept confidential.
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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.
Sisli Hamidiye Etfal Training and Researching Hospital
Istanbul, Turkey (Türkiye)
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 Experience, Life, run by Sisli Hamidiye Etfal 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 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group (time frame: october2017-february2022). 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 NCT06002776, which also lists 3 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 21 Aug 2023.