NCT00911391

Brief Summary

Perioperative fluid management has been historically dictated by outdated, contradictory concepts. Excessive or inadequate fluid administration around surgery is deleterious and hence goal-directed fluid therapy using Oesophageal Doppler-derived cardiac indices is preferable to optimize tissue perfusion. Previous studies in this area have been hampered by lack of standardization in other aspects of perioperative care and none have explored the impact of individualized fluid therapy on post-operative fatigue.The investigators proposed a study involving 80 patients having open/ laparoscopic colonic surgery to investigate the effect of Oesophageal Doppler guided fluid administration intraoperatively compared to current best practice of fluid restriction. The investigators have an optimized peri-operative care pathway established at the Manukau Surgical Centre (MSC), Middlemore Hospital. All patients will be cared for under the Enhanced Recovery After Surgery (ERAS) multimodal care plan therefore ensuring that all other aspects of care besides intraoperative fluid administration remain homogenous. Outcomes will include post-operative recovery, clinical outcomes as well as physiological data with follow-up to 30 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

1.8 years

First QC Date

May 28, 2009

Last Update Submit

November 25, 2011

Conditions

Colorectal CancerColectomySurgeryPerioperative Care

Keywords

DopplerColectomyERASFluidPerioperative Care

Outcome Measures

Primary Outcomes (1)

  • Post-operative functional recovery

    7 day

Secondary Outcomes (1)

  • Perioperative Complications

    30 day

Study Arms (2)

Fluid restriction

ACTIVE COMPARATOR

Current best practice of intraoperative fluid restriction

Procedure: Intraoperative fluid restriction

Oesophageal Doppler

EXPERIMENTAL

Oesophageal Doppler-guided fluid administration

Device: Oesophageal Doppler

Interventions

Oesophageal DopplerDEVICE

Non-invasive measurement of doppler-derived cardiovascular variables (CO, aortic flow rate). Used safely over 800, 000 times

Also known as: CardioQ Deltex Oesophageal Doppler
Oesophageal Doppler
Intraoperative fluid restrictionPROCEDURE

Current best practice of avoiding fluid overload by intraoperative fluid restriction

Fluid restriction

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • consecutive patients undergoing open/ laparoscopic colonic resection at Manukau surgical Centre (MSC)or North Shore Hospital, Auckland.

You may not qualify if:

  • severe oesophageal disease
  • recent oesophageal or upper airway surgery
  • moderate or severe aortic valve disease as proven by echocardiogram
  • documented bleeding diathesis
  • preoperative steroid use
  • cognitive impairment
  • ASA\>3
  • patient choice.
  • rectal tumour (defined as less an 15cm from anal verge on preop investigations)
  • creation of stoma
  • difficulty in obtaining reliable measurements from ODM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manukau Surgery Centre-Middlemore Hospital

Auckland, Auckland, 2240, New Zealand

Location

North Shore Hospital

Auckland, New Zealand

Location

Related Publications (1)

  • Srinivasa S, Taylor MH, Singh PP, Yu TC, Soop M, Hill AG. Randomized clinical trial of goal-directed fluid therapy within an enhanced recovery protocol for elective colectomy. Br J Surg. 2013 Jan;100(1):66-74. doi: 10.1002/bjs.8940. Epub 2012 Nov 6.

    PMID: 23132508DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Andrew G Hill, MBChB MD FRACS

    South Auckland Clinical School, University of Auckland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Andrew G Hill

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

NZ(2)