Restricted Fluid Therapy in Colorectal Surgery

• Status: Completed
• Trial end date: 2001-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a protocol for a trial carried out from 1999 to 2002. At that time, surgical patients received a large volume of intravenous saline during operations on the colon or the rectum, often so much fluid that their bodyweight increased by 4-6 kilograms. We hypothesized; that a restricted fluid regimen could prevent the development of cardiopulmonary complications and improve wound healing including the healing of an anastomosis of the gut.

We designed a clinical randomized assessor blinded multi-center trial comparing a restricted fluid regimen to a standard fluid regimen, the difference being the volume of saline administered to the patients. Patients undergoing surgery on the colon or the rectum were included after informed oral and written consent.

The restricted regimen aimed at zero-fluid balance with allowance for a body weight increase of 1 kg. The standard regimen was a bit "dryer" than the actual standard; our patients in the standard group received saline causing a body weight increase of only 3-4 kg. The fluid therapy started at midnight the day of operation, went on through the operation and continued on the wards until discharge. The patients were encouraged to eat and drink as much and as soon as possible after the operation.

The primary outcome was the number of patients who died or suffered a complication measured within 30 days of surgery. We looked at all complications, but especially heart and lung complications and complications related to the healing of wounds and anastomosis.

The patients was examined in the outpatient clinic after 30 days, and in addition, blinded assessors were reviewing the medical files for registration of postoperative complications.

The results are published in The Annals of Surgery 2003; 238(5)641-48. The restricted regimen nearly halved the number of patients with complications, and heart and lung complications were almost eliminated.

Other investigators confirmed the results, and a more restricted approach to fluid therapy to surgical patients has been implemented worldwide.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Holbaek Sygehus
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; Bispebjerg Hospital; Glostrup University Hospital, Copenhagen; Herlev Hospital; Hillerod Hospital, Denmark; University Hospital, Gentofte, Copenhagen; Vejle Hospital; Zealand University Hospital

Criteria

Inclusion Criteria:

• Patients scheduled for planned surgery on the colon or the rectum

• ASA group 1-3

Exclusion Criteria:

• Patients unable to give informed consent (mental disorders, dementia, language problems)

Patients with:

• Diabetes mellitus

• Renal insufficiency

• Disseminated cancers or secondary cancers

• Inflammatory bowel disease

• Diseases hindering epidural analgesia

• Alcohol consumption more than 35 drinks pr. Week

• Pregnant and lactating woman.