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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | No Intervention | Standard intraoperative fluid management | |
| Restricted | Experimental | Restricted intraoperative fluid management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restricted intraoperative fluid management | Procedure | Intraoperative fluid management guided by Sto2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major postoperative complications | within the first 30 days of the postoperative period |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Cohn, MD, FACS | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305-5640 | United States | ||
| University of Texas Health Science Center (UTHSCSA) |
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| San Antonio |
| Texas |
| 78229 |
| United States |