Clinical trial · Interventional
Randomised Trial of Doppler-Optimised Fluid Balance in Elective Colectomy
Prospective, Double-Blinded, Randomised Controlled Trial of Doppler-Optimised Fluid Balance in Elective Colectomy Within an ERAS Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Perioperative fluid management has been historically dictated by outdated, contradictory concepts.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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colectomy | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Perioperative Care | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative fluid restriction | Procedure | — | UNRESOLVED |
| Oesophageal Doppler | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fluid restriction
- description
- Current best practice of intraoperative fluid restriction
- interventionNames
- Procedure: Intraoperative fluid restriction
- type
- EXPERIMENTAL
- label
- Oesophageal Doppler
- description
- Oesophageal Doppler-guided fluid administration
- interventionNames
- Device: Oesophageal Doppler
Primary outcomes (1)
- measure
- Post-operative functional recovery
- timeFrame
- 7 day
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * consecutive patients undergoing open/ laparoscopic colonic resection at Manukau surgical Centre (MSC)or North Shore Hospital, Auckland. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDSrinivasa 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 23132508