NCT03537989

Restricted Fluid Therapy in Colorectal Surgery

Completed Phase 4 Last updated 5 October 2018

What this trial tests

Phase 4 trial testing Saline in Colorectal Surgery in 172 participants. Completed in 31 August 2001.

Timeline

1 November 1999

Primary endpoint
31 August 2001

31 August 2001

Quick facts

Lead sponsor	Holbaek Sygehus
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	172
Start date	1 November 1999
Primary completion	31 August 2001
Estimated completion	31 August 2001

Drugs / interventions tested

• Saline

Conditions studied

• Colorectal Surgery — all drugs for Colorectal Surgery →
• Postoperative Complications — all drugs for Postoperative Complications →

Sponsor

Holbaek Sygehus — full company profile →

Who can join

18 and older, any sex, with Colorectal Surgery or Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Influence of Perioperative Fluid Therapy on N-terminal-pro-brain Natriuretic Peptide and the Association With Heart and Lung Complications in Patients Undergoing Colorectal Surgery: Secondary Results of a Clinical Randomized Assessor-blinded Multicenter Trial.
   Brandstrup B, Beier-Holgersen R, Iversen LH, Starup CB, et al · · 2020 · cited 6× · PMID 31850996 · DOI 10.1097/sla.0000000000003724