Condition category
Surgery
Date applied
23/05/2010
Date assigned
04/08/2010
Last edited
02/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Khadra Galaal

ORCID ID

Contact details

Northern Gynaecological Oncology Centre
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 445 2597
khadra.galaal@ghnt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of intra-operative fluid optimisation using the oesophageal Doppler monitor in gynaecological oncology surgery

Acronym

Study hypothesis

Goal directed optimisation of intra-operative haemodynamics using oesophageal Doppler monitoring reduces length of hospital stay and improves outcome.

Ethics approval

Not provided at time of registration

Study design

Single-centre interventional prospective double-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gynaecological oncology surgery

Intervention

Two groups: control and protocol group.

Both groups will have DP6 Doppler probe (product code 9070-7001) inserted at the time of intubation. All patients will have standard pre-operative, intra-operative and post-operative care. Fluids (crystalloid, colloid and blood/blood products) will be given at the discretion of the anaesthetist, guided by standard haemodynamic monitoring and operative losses.

Only the protocol group will have direct measurement of central vascular flow using CardioQ-ODM monitor (product code 9051-7056) including corrected flow time (FTc), stroke volume (SV), stroke distance (SD) and peak velocity (PV) and small colloid (fluid) challenges to maintain FTc greater than 0.35 seconds and optimise SV.

The intervention will last until the end of the operation and the probe will be removed at the time of extubation.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

The aim of this study is to compare the effect of a target driven intra-operative intravenous fluid management using oesophageal Doppler to a standard fluid regimen on complication rate after surgery for corpus uteri, ovarian and cervical cancer. Measured until 5th post-operative day.

Secondary outcome measures

To evaluate the effect of target driven intra-operative fluid management using oesophageal Doppler on hospital stay, measured on day of discharge.

Overall trial start date

01/11/2010

Overall trial end date

01/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 20 - 85 years, female
2. Recruited from the Queen Elizabeth Hospital, Gateshead
3. Written informed consent
4. Undergoing elective major gynaecological oncology surgery for ovarian, endometrial and cervical carcinoma

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70 patients in each group (140 in total)

Participant exclusion criteria

Contraindication to oesophageal Doppler use:
1. Oesophageal surgery or stent
2. Oesophageal stricture
3. Oesophageal varices
4. Pharyngeal pouch
5. Moderate/severe aortic valve disease
6. Patient refusal

Recruitment start date

01/11/2010

Recruitment end date

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Organisation

Gateshead Health NHS Foundation Trust (UK)

Sponsor details

c/o Mrs Alison Harvey
Research and Development
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 445 2155
alison.harvey@ghnt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.gatesheadhealth.nhs.uk/index.php

Funders

Funder type

Hospital/treatment centre

Funder name

Northern Gynaecological Oncology Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes