Colorectal Surgery
Conditions
Keywords
Near-Infrared Spectroscopy, Intraoperative Care
Brief summary
The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the amount of fluid needed during colorectal surgery. The study hypothesis is that intraoperative fluid limitation can be safely accomplished when guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction in postoperative morbidity when compared to standard monitoring and fluid therapy.
Interventions
PROCEDURERestricted intraoperative fluid management
Intraoperative fluid management guided by Sto2.
Sponsors
Hutchinson Technology Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective open colorectal surgery * Age greater than or equal to 18 years * Low to moderate risk colorectal surgery patients
Exclusion criteria
* Unacceptable Baseline vital sign measurements * High risk colorectal surgery patients * Jehovah's Witness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major postoperative complications | within the first 30 days of the postoperative period |
Secondary
| Measure | Time frame |
|---|---|
| StO2 changes during intraoperative fluid management, hospital-free days, surgical site infections, time to first bowel movement, total fluid and total intraoperative fluid volumes, daily fluid volumes through 3 days postoperative, daily weights | within the first 30 days of the postoperative period |
Countries
United States
Outcome results
None listed