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

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 4

Conditions: Colorectal Carcinoma

Treatments: Procedure: Goal-directed fluid optimization; Other: Regimen based on expertise anaesthesist

Study type: Interventional

Funder types: Other

Identifiers

NCT01175317

MEC 09-2-089

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Goal-directed fluid optimization

Experimental group

Description:

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

Treatment:

Procedure: Goal-directed fluid optimization

Regimen based on expertise anaesthesist

Other group

Description:

Fluid regimen based on expertise anaesthesist

Treatment:

Other: Regimen based on expertise anaesthesist