CompletedNot Applicable

Restrictive or Doppler-guided Fluid Treatment in Colorectal Surgery

150 participantsStarted 2008-03-01

Plain-language summary

This is a clinical randomised double blinded multicentre trial of two different fluid treatments during colorectal surgery in an enhanced recovery programme A restricted fluid regimen aiming at zero fluid balance and less than two kilograms bodyweight change was compared with another fluid regimen where intravenous fluids were given to reach near maximal stroke volume of the heart, guided by a Doppler in the oesophagus. The primary outcome was a composite outcome of postoperative complications and death. Included was 150 patients undergoing elective colorectal surgery. No difference was found between the two groups. Both fluid therapies resulted in low complication rates. The difference in fluid volume between the groups was only 600 ml on the day of operation. The results are published, see reference section.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients scheduled for colorectal resections if it is preoperatively estimated that the surgery may be cancer radical. * ASA level 1-4. Exclusion Criteria: * Emergency surgery, * Alcohol consumption \> 5 units daily, * Inability to give informed consent (language problems, unconscious, psychosis (including confusion)) * Pregnant and lactating women * Contraindication for the use of HES (severe renal impairment, allergy, severe bleeding disorders and pregnancy) * Other non-radically treated malignant diseases

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with a postoperative complication

Timeframe: 30 day follow-up

Trial details

NCT IDNCT03677622

SponsorHolbaek Sygehus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07-31

View on ClinicalTrials.gov More Fluid Overload trials