Randomised Trial of Doppler-Optimised Fluid Balance in Elective Colectomy

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Perioperative fluid management has been historically dictated by outdated, contradictory concepts.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.

Conditions

• Colorectal Cancer
• Colectomy
• Surgery
• Perioperative Care

Interventions

DEVICE

Oesophageal Doppler

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

PROCEDURE

Intraoperative fluid restriction

Current best practice of avoiding fluid overload by intraoperative fluid restriction

Sponsors & Collaborators

• Counties Manukau Health

  collaborator OTHER

• Waitemata District Health Board

  collaborator OTHER_GOV

• University of Auckland, New Zealand

  lead OTHER

Principal Investigators

• Andrew G Hill, MBChB MD FRACS · South Auckland Clinical School, University of Auckland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2011-09-30

Completion

2011-10-31

Countries

• New Zealand

Study Locations