- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06002776
Our Anesthesia Experiences in Hepatopancreatobiliary Surgery Practices: a Retrospective Study
August 16, 2023 updated by: Merve Gokce, Sisli Hamidiye Etfal Training and Research Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
6
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
-
-
Sarıyer
-
Istanbul, Sarıyer, Turkey, 34396
- Sisli Hamidiye Etfal Training and Researching Hospital
-
Contact:
- Merve Gökçe, Ass. Dr.
- Phone Number: +905301414222
- Email: merve__duman@hotmail.com
-
Contact:
- Ayşe Surhan Çınar, Prof. Dr.
- Phone Number: +905326850929
- Email: asurhan@yahoo.com
-
-
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
data from all patients aged 18 and above who underwent major abdominal surgery with diagnoses of liver malignancy, cholangiocarcinoma, and pancreatic malignancy
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
|
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.
|
a retrospective study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
form a comprehensive understanding of our anesthesia experiences during the preoperative, perioperative, and postoperative periods in this patient group
Time Frame: october2017-february2022
|
october2017-february2022
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
assess the influence of preoperative and perioperative anesthetic management on the morbidity and mortality of these patients.
Time Frame: october2017-february2022
|
october2017-february2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- 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.
- Hemmerling 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.
- von 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.
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 (Estimated)
August 1, 2023
Primary Completion (Estimated)
September 20, 2023
Study Completion (Estimated)
September 30, 2023
Study Registration Dates
First Submitted
August 16, 2023
First Submitted That Met QC Criteria
August 16, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 16, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sisli Hamidiye Etfal TRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All patient data will be kept confidential.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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