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Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.
The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard fluid volume | Active Comparator | Subject receives normal fluid volume during peri-operative period |
|
| Reduced Fluid Volume | Experimental | Subject receives a reduced fluid volume during the peri-operative period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal fluid volume | Procedure | Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total |
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| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Reduction in post-operative complications at the time of hospital discharge after the surgical episode | 5-7 days |
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Inclusion Criteria:
Exclusion Criteria:
Patients younger than 18 years old
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| Name | Affiliation | Role |
|---|---|---|
| Lucci Stocchi, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| Reduced fluid volume | Procedure | Subject receives 80 cc/ hr LR during the peri-operative period |
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