ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000717853

Ethics application status

Approved

Date submitted

4/07/2012

Date registered

5/07/2012

Date last updated

20/11/2019

Date data sharing statement initially provided

20/11/2019

Date results provided

20/11/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Fluid restriction compared to fluid optimisation with the oesophageal doppler in colorectal surgery: a randomized clinical trial of efficacy

Scientific title

The effect of fluid optimisation with the oesophageal doppler compared to fluid restriction on perioperative morbidity in major elective colorectal surgery with an Enhanced Recovery After Surgery protocol.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1131-8049

Trial acronym

RESORT

"RES"trictive "OR T"argetted

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colorectal surgery

Fluid therapy intraoperative

Perioperative morbidity

Haemodynamic state intraoperative

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The fluid optimisation group will have an oesophageal doppler inserted after induction. A maintenance rate of Hartmann's solution at 6mls/kg/hr will run intravenously at the start to the end of the operative period. The anaesthetist will use the oesophageal doppler to administer colloid boluses intravenously (250mls Hydroxyethyl starch 130/0.4, Volulyte, Fresenius Kabi) based on the stroke volume and flow time parameters.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control group will have a "restrictive" fluid regimen as follows:
Maintenance 6mls/kg/hr Hartmann's solution with boluses to replace blood loss. Boluses can be crystalloid or colloid or blood.

Control group

Active

Outcomes

Primary outcome [1]

Complication rate: number of complications during hospital stay.
We will use a standardised classfication and severity grading scale, based on the work of Dindo and Clavien.
This has a 17 point classification of complications (eg. Venous thromboembolism, sepsis, AMI). The severity grading scale is a 7 point scale (from I - deviation from normal postoperative course without the need for intervention to V-death). Further details can be found at http://www.surgicalcomplication.info

Timepoint [1]

at hospital discharge

Primary outcome [2]

Length of Stay - defined by from date of admission to date of discharge.

Timepoint [2]

At hospital discharge

Secondary outcome [1]

Change in Velocity Time Integral on Doppler examination across the Left Ventricular Outflow Tract.

Timepoint [1]

At the beginning and end of surgery

Secondary outcome [2]

Change in the stroke volume and cardiac output using intraoperative trans thoracic echocardiography.

Timepoint [2]

At the beginning and end of surgery

Secondary outcome [3]

Volume of fluid administration

Timepoint [3]

Intraoperative

Secondary outcome [4]

Vasopressor use

Timepoint [4]

Intra-operative and until discharge from the recovery unit.

Eligibility

Key inclusion criteria

Elective major colorectal surgery
>18yrs of age
Enrollment into the Enhance Recovery After Surgery clinical care pathway.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Emergency surgery
Significant renal impairment
Hepatic dysfunction
Oesophageal pathology that is a contraindication to a oesophageal doppler probe
Inability to give informed consent
Pregnancy

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Randomisation will be stratified according to whether the patient is anticipated to have a STOMA or NO STOMA pathway.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/06/2012

Actual

17/04/2012

Date of last participant enrolment

Anticipated

Actual

19/12/2013

Date of last data collection

Anticipated

Actual

1/02/2014

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Research Endowment Fund

Address [1]

41 Victoria Pde
Fitzroy Victoria 3065

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Tuong Dien Phan

Address

PO Box 2900
Department of Anaesthesia
St Vincent's Hospital
Fitzroy Victoria 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's HREC

Ethics committee address [1]

41 Victoria Pde
Fitzroy Victoria 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/03/2012

Ethics approval number [1]

039_12

Ethics committee name [2]

St Vincent's Private Ethics Committee

Ethics committee address [2]

59-61 Victoria Pde
Fitzroy Victoria 3065

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

26/06/2012

Approval date [2]

Ethics approval number [2]

HREC-D 039/12

Summary

Brief summary

During surgery on the bowel it is routine to replace blood and fluid loss with intravenous fluids.  However, it is still unclear what the optimal amount and method is to replace this loss.  This study compares giving a smaller amount of fluid, called fluid restriction, to giving fluid guided by a cardiac output monitor, called targetted fluid administration.  We will assess the impact these two methods have on patient's recovery and also the effect on observed clinical signs such as cardiac output at the end of the operation.

Trial website

Trial related presentations / publications

Phan T, An V, Dsouza B, Rattray M, Johnston M, B Cowie.  A randomised controlled trial of fluid restriction compared to oesophageal Doppler-guided goal-directed fluid therapy in elective major colorectal surgery within an Enhanced Recovery After Surgery program. Anaesth Intensive Care, 2014. 42(6): p. 752-60

Public notes

Contacts

Principal investigator

Name

Dr Tuong Phan

Address

PO BOX 2900
Department of Anaesthesia
St Vincent's Hospital Melbourne
FITZROY VIC 3065

Country

Australia

Phone

+61 3 92882253

Fax

[email protected]

Contact person for public queries

Name

Dr Tuong D Phan

Address

Mail:
PO Box 2900
Department of Anaesthesia
St Vincent's Hospital
Fitzroy Vic 3065

Country

Australia

Phone

+61 3 92882253

Fax

+61 3 9288 4255

[email protected]

Contact person for scientific queries

Name

Dr Tuong D Phan

Address

Mail:
PO Box 2900
Department of Anaesthesia
St Vincent's Hospital
Fitzroy Vic 3065

Country

Australia

Phone

+61 3 92882253

Fax

+61 3 9288 4255

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Consent for public sharing of data not explicitly obtained.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5778	Ethical approval					362630-(Uploaded-25-07-2019-10-24-52)-Study-related document.pdf
5780	Informed consent form					362630-(Uploaded-30-07-2019-12-29-54)-Study-related document.doc

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	A Randomised Controlled Trial of Fluid Restriction Compared to Oesophageal Doppler-Guided Goal-Directed Fluid Therapy in Elective Major Colorectal Surgery within an Enhanced Recovery after Surgery Program	2014	https://doi.org/10.1177/0310057x1404200611

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically