Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-10-31

Brief Summary

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58 patients undergoing surgery of the large bowel are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. Between group differences are measured primarily by markers of intestinal damage in plasma and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the gut).

The investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.

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Detailed Description

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Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Goal-directed fluid optimization

Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.

Group Type EXPERIMENTAL

Goal-directed fluid optimization

Intervention Type PROCEDURE

Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.

Regimen based on expertise anaesthesist

Fluid regimen based on expertise anaesthesist

Group Type OTHER

Regimen based on expertise anaesthesist

Intervention Type OTHER

Fluid regimen based on expertise anaesthesist

Interventions

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Goal-directed fluid optimization

Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.

Intervention Type PROCEDURE

Regimen based on expertise anaesthesist

Fluid regimen based on expertise anaesthesist

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing elective colorectal surgery with anastomosis;
* Minimum age 18 years;
* Giving informed consent.

Exclusion Criteria

* Other causes of intestinal damage: eg. IBD, occlusive disease;
* Steroid use;
* Esophageal varices and other esophageal disease;
* Aortic valve disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No