Restricted Fluid Therapy in Colorectal Surgery

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.

Conditions

• Colorectal Surgery
• Postoperative Complications

Interventions

DRUG

Saline

To reduce the volume of saline administered during surgery of the colon and the rectum

Sponsors & Collaborators

• Bispebjerg Hospital

  collaborator OTHER

• University Hospital, Gentofte, Copenhagen

  collaborator OTHER

• Glostrup University Hospital, Copenhagen

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Holbaek Sygehus

  lead OTHER

Principal Investigators

• Birgitte Brandstrup, PhD · Holbaek Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-11-01

Primary Completion

2001-08-31

Completion

2001-08-31