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Trial registered on ANZCTR


Registration number
ACTRN12623000975695
Ethics application status
Approved
Date submitted
23/08/2023
Date registered
7/09/2023
Date last updated
2/10/2024
Date data sharing statement initially provided
7/09/2023
Date results information initially provided
2/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of an individualized patient-specific surgery specific intraoperative haemodynamic algorithm on patient outcomes after major hepatobiliary-pancreatic surgery
Scientific title
The impact of an individualized patient-specific surgery specific intraoperative haemodynamic algorithm on textbook outcomes after major hepatobiliary-pancreatic surgery
Secondary ID [1] 310379 0
Nil
Universal Trial Number (UTN)
U1111-1296-6134
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatobiliary-Pancreatic Surgery 331119 0
Post-operative recovery 331145 0
Liver conditions 331307 0
Condition category
Condition code
Anaesthesiology 327905 327905 0 0
Other anaesthesiology
Surgery 327906 327906 0 0
Other surgery
Oral and Gastrointestinal 327907 327907 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 327923 327923 0 0
Liver
Cancer 327924 327924 0 0
Pancreatic
Cardiovascular 327995 327995 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective analysis of post operative textbook outcomes in patients who underwent major hepatobiliary-pancreatic (HPB) surgery between January 2011 and December 2022 and were monitored intraoperatively with routine care monitoring i.e., the Usual care group) or advanced haemodynamic monitoring (AHDM), i.e., the AHDM group during this time period.

Usual care haemodynamic monitoring includes an invasive arterial line to measure continuous blood pressure and a central venous catheter to measure central venous pressure. AHDM includes an invasive arterial line and central venous catheter (as above), in addition to measuring cardiac output, stroke volume, systemic vascular resistance, and stroke volume variation.

Patients who underwent major HPB surgery at three university teaching hospitals between January 2011 and December 2022 will be included. Austin Hospital is a university hospital in Melbourne, Australia with a dedicated high volume hepato-pancreatic-biliary and liver transplant centre. Knox Private and Warringal Private Hospitals are teaching hospitals with expertise in major hepato-pancreatic-biliary surgery. All data will be collected from patient electronic medical records, with no additional involvement by the participant required.

The following data points will be collected for each patient:

• Patient demographics (e.g., age, sex, weight, height)
• Blood workup results
• Year of surgery, surgical procedure (laparoscopic, open or hybrid) and hospital performing the surgery
• Total duration of surgery (minutes)
• Use of AHDM or usual care
• Vital signs
• Urine output
• Bleeding requiring blood and/or blood products
• Intra-operative inotropic support and fluid use (including crystalloids and colloids)
• Post-operative complications
• ICU admission
• Hospital length of stay
• In-hospital or 90-day mortality
• Readmission within 90-days after hospital discharge, due to surgery related complications

As this is a retrospective study, data will be collected from medical records and there will be no patient involvement.
Intervention code [1] 326798 0
Diagnosis / Prognosis
Comparator / control treatment
Patients who underwent elective major hepatobiliary-pancreatic surgery and received usual care.

Usual care will include patients who were not monitored with advanced haemodynamic monitoring intra-operatively.
Control group
Active

Outcomes
Primary outcome [1] 335775 0
The effect of using a patient-specific surgery specific AHDM algorithm on achieving a textbook outcome for liver surgery.

For liver surgery, textbook outcome will be defined as a composite measure of all of the following parameters:

• Absence of a postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery)
• Absence of postoperative liver failure grade B or C (according to the severity grading of the International Study Group of Liver Surgery)
• No major postoperative complications (Clavien– Dindo grade III or higher)
• No readmission within 90 days after discharge due to surgery-related major complications (Clavien– Dindo Grade III or higher)
• No in-hospital or 90-day mortality
• Hospital length of stay < 7 days (defined as the median)

These data points will be collected from patient's electronic medical records .
Timepoint [1] 335775 0
Timing will begin on completion of surgery to 90 postoperative days.
Primary outcome [2] 335776 0
The effect of using a patient-specific surgery specific AHDM algorithm on achieving a textbook outcome for pancreatic surgery.

For pancreatic surgery, a textbook outcome will be defined as a composite measure of all of the following:

• Absence of a postoperative pancreatic fistula of grade B or C
• Absence of a postoperative bile leak grade B or C (according to the severity grading of the International Study Group of Liver Surgery),
• Absence of post-pancreatectomy haemorrhage grade B or C (according to the severity grading of the International Study Group of pancreatic Surgery)],
• No major postoperative complications (Clavien– Dindo grade III or higher),
• No readmission within 90 days after discharge due to surgery-related major complications (Clavien– Dindo Grade III or higher)
• No in-hospital or 90-day mortality
• Hospital length of stay < 14 days (defined as the median).

These data points will be collected from patient's electronic medical records .
Timepoint [2] 335776 0
Timing will begin upon completion of surgery to 90 days. Timing will begin on completion of surgery to 90 postoperative days.
Secondary outcome [1] 425568 0
Postoperative bile leak grade B or C (according to the severity grading of the International Study Group of Liver Surgery)

This will be collected from patient's electronic medical records.
Timepoint [1] 425568 0
Timing will begin on completion of surgery to 90 days.
Secondary outcome [2] 425569 0
ICU admission. This will be collected from patient's electronic medical records.
Timepoint [2] 425569 0
This will be measured in days, commencing from when the patient is admitted into ICU to when the patient is discharged to the ward or home.
Secondary outcome [3] 425570 0
Hospital length of stay. This will be collected from patient's electronic medical records.
Timepoint [3] 425570 0
Timing will begin on from completion of surgery to hospital discharge.
Secondary outcome [4] 425571 0
Rate of AHDM use compared to usual care use for patients undergoing major HPB surgery.
Timepoint [4] 425571 0
This will be measured during the intra-operative period. It will be collected from patient's electronic medical records/ anaesthetic paper records.
Secondary outcome [5] 425572 0
Surgical complications.

Complications will be defined as any deviation from the normal postoperative course, guided by the European Perioperative Clinical Outcome definitions. Complications will be graded using Clavien-Dindo Classification - a widely used and validated approach to surgical outcome assessment that assigns severity grades to surgical complications. These data will be collected from the electronic medical records.
Timepoint [5] 425572 0
This will be measured from completion of surgery to hospital discharge..
Secondary outcome [6] 425573 0
Intravenous fluid use. This will be collected from the patient's hospital electronic medical record.
Timepoint [6] 425573 0
This will be measured intra-operatively for the duration of surgery.
Secondary outcome [7] 425574 0
Intravenous blood product administration. This will be collected from the patient's hospital electronic medical record.
Timepoint [7] 425574 0
This will be measured intra-operatively for the duration of surgery.
Secondary outcome [8] 425575 0
Surgical duration in minutes. This will be collected from the patient's hospital electronic medical record.
Timepoint [8] 425575 0
From skin incision to completion of surgery.
Secondary outcome [9] 425576 0
Operation type, which will include whether the surgery is one of the following:

1.. Major liver surgery
2. Minor liver surgery
3. Whipple’s procedure
4. Other pancreatic resection

This will be collected from the electronic medical records.
Timepoint [9] 425576 0
This will be measured for the duration of the surgery.
Secondary outcome [10] 425577 0
Vasopressor/inotrope use intra-operatively. This will be collected from the electronic medical records.
Timepoint [10] 425577 0
This will be measured intra-operatively for the duration of surgery.
Secondary outcome [11] 425578 0
Comparison of blood results pre-operatively and post-operatively. Blood results will include haemoglobin level, liver function tests, platelet count, and creatinine. This will be collected from the electronic medical records.
Timepoint [11] 425578 0
This will be measured pre-operatively and post-operatively within the first 24hours.
Secondary outcome [12] 426184 0
Major postoperative complications (Clavien– Dindo grade III or higher). This will be collected from the electronic medical records.
Timepoint [12] 426184 0
This will be measured from completion of surgery to hospital discharge.
Secondary outcome [13] 426185 0
Readmission within 90 days after discharge due to surgery-related major complications (Clavien– Dindo Grade III or higher). This will be collected from the electronic medical records.
.
Timepoint [13] 426185 0
This will be measured from hospital discharge to 90 postoperative days.
Secondary outcome [14] 426186 0
Postoperative mortality. This will be collected from the electronic medical records.
Timepoint [14] 426186 0
This will be measured from hospital discharge to 90 postoperative days.
Secondary outcome [15] 426187 0
Hospital length of stay. This will be collected from the electronic medical records.
Timepoint [15] 426187 0
This will be measured from completion of surgery to hospital discharge.

Eligibility
Key inclusion criteria
Inclusion criteria for this study include:
1. Equal to or greater than 18 years of age
2. Elective major HPB surgery via laparoscopic, open or a hybrid approach (between Jan 2011 and Dec 2022)
3. HPB surgery is not in conjunction with any other abdominal surgery (e.g., bowel resection)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for this study include:

1. Emergency major HPB surgery
2. HPB surgery in conjunction with any other abdominal surgery (e.g., bowel resection)
3. Patients undergoing liver transplantation

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using IBM SPSS statistics for Windows, version 23 (IBM Corporation, NY, USA) and R system version 4.2.3 (R Development Core Team, Vienna, Austria, 2023). Patients who fulfill inclusion criteria will be divided into two categorical groups, namely:

1. Usual care group
2. AHDM group

Where feasible, inferential statistics will be undertaken to look for differences between the groups. Continuous variables will be evaluated for normality using a visual check of normal Q-Q plots and histograms. If the normality is violated, nonparametric statistical methods will be applied for these variables. Extreme values will also be checked with the 1st and 3rd quartiles and the step of the twofold interquartile range. All extreme values will be reconciled with the original values of the data source.

Statistical analysis will be performed by grouping the patients according to whether AHDM was used during intraoperative anesthesia management. Student’s t-test, Mann-Whitney U test, chi-square test, and Cochran-Armitage trend test will be applied according to the characteristics of the variables. Propensity score matching and weighting methods will be used to control the effects of covariates and reduce possible biases, and the balance of propensity scores across the groups will be evaluated with a visual check of distributions. Inverse probability treatment weighting will be used to control confound parameters.

The effect of AHDM use in achieving a TO will be evaluated with the weighted chi-square test, and the effect on other results such as postoperative complications, surgery-specific complications, LOS, ICU admission, and ICU stay time will be evaluated using the weighted chi-square test, weighted t-test, and weighted Mann-Whitney U test.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2023
Actual
23/09/2023
Date of last participant enrolment
Anticipated
28/09/2023
Actual
28/09/2023
Date of last data collection
Anticipated
10/10/2023
Actual
10/10/2023
Sample size
Target
462
Accrual to date
Final
462
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25386 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 25387 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [3] 25388 0
Knox Private Hospital - Wantirna
Recruitment postcode(s) [1] 41126 0
3084 - Heidelberg
Recruitment postcode(s) [2] 41127 0
3152 - Wantirna

Funding & Sponsors
Funding source category [1] 314580 0
Hospital
Name [1] 314580 0
Austin Health - Austin Hospital, Heidelberg
Country [1] 314580 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Austin Hospital, Heidelberg
Address
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 316561 0
None
Name [1] 316561 0
Address [1] 316561 0
Country [1] 316561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313615 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 313615 0
Level 8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
Ethics committee country [1] 313615 0
Australia
Date submitted for ethics approval [1] 313615 0
23/08/2023
Approval date [1] 313615 0
23/09/2023
Ethics approval number [1] 313615 0
Approval number: approval number 2022/Austin/34

Summary
Brief summary
The purpose of this study is to identify whether intra-operative advanced haemodynamic monitoring (AHDM) as compared to usual care monitoring for patient's undergoing major hepatobiliary-pancreatic (HPB) surgery results in increased rates of textbook outcomes (optimal post-surgical outcomes).

Who is it for?
The study will include adult patients undergoing major HPB surgery. This is a retrospective study to test the hypothesis that AHDM monitoring when compared to usual care monitoring will increase the rates of textbook outcomes for these patients. People aged 18 years or older who have undergone a liver or pancreatic surgery for one of a number of reasons, including removal of cancerous tissue, between January 2011 and December 2022 at the Austin Hospital, Knox Private or Warringal Private Hospitals may be included in this study. Please be advised that this study will not involve any active participation, only a review of previously recorded medical information from hospital records.

Study details
The aim of this study is to evaluate the rate of textbook outcomes for patients undergoing major HPB surgery who are monitored with AHDM (AHDM group) as compared to routine monitoring (usual care group). A textbook outcome represents the optimal course following a surgical episode, which is achieved when predefined parameters are fulfilled according to an all-or-none principle. Textbook outcomes will include absence of post operative leak, absence of liver failure, absence of pancreatic fistula, absence of pancreatic haemorrhage, no major post operative complications, no readmission within 90 days due to surgical complications, no in hospital or 90-day mortality and hospital length of stay less than the median length of stay.

It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the use of AHDM for textbook outcomes for patients undergoing major HPB surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128754 0
Prof Laurence Weinberg
Address 128754 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 128754 0
Australia
Phone 128754 0
+61394965249
Fax 128754 0
+61394966421
Email 128754 0
[email protected]
Contact person for public queries
Name 128755 0
Laurence Weinberg
Address 128755 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 128755 0
Australia
Phone 128755 0
+61394965249
Fax 128755 0
+61394966421
Email 128755 0
[email protected]
Contact person for scientific queries
Name 128756 0
Laurence Weinberg
Address 128756 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 128756 0
Australia
Phone 128756 0
+61394965249
Fax 128756 0
+61394966421
Email 128756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patients have not consented for sharing of their data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20109Study protocol  [email protected]
20110Statistical analysis plan  [email protected]
20111Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleNohttps://doi.org/ DOI: 10.3389/fsurg.2024.1353143

Documents added automatically
No additional documents have been identified.