Phase 4
Completed N=58
Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum
Source: ClinicalTrials.gov NCT01175317 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Peak Value of I-FABP — 440.8; 522.4 pg/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Value of I-FABP |
440.8; 522.4 | — |
| SECONDARY Average Intraoperative CO2 Gap |
-0.1; 0.4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01175317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.