CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 172 enrolled
Drug / intervention
Salinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03537989
NCT03537989Phase 4Completed

Perioperative Fluid Treatment in Colorectal Surgery

Holbaek Sygehus·interventional·Posted May 25, 2018·Updated Oct 5, 2018

In Brief

A Phase 4 clinical trial evaluating Saline for Colorectal Surgery and Postoperative Complications. Completed, enrolled 172 participants.

Detailed 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.

Study Details

Timeline

Phase 4CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2018
Enrollment StartNov 1, 1999
Primary CompletionAug 31, 2001
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.1 years ago

Interventions

Salinedrug

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