Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery
18 Years
N/A
Both
Benign Neoplasm of Intestinal Tract, Primary Malignant Neoplasm of Intestinal Tract, Secondary Malignant Neoplasm of Intestinal Tract
Trial Information
Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal 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.
Inclusion Criteria:
- Patients 18 years or older
- ASA I-III
- Ability to provide informed consent
- Creatinine less than or equal to 1.3 mg/mL)
Exclusion Criteria:
Patients younger than 18 years old
- ASA IV or higher
- Urgent or emergent surgery
- Mental disease or addictive disorders impairing ability to provide informed consent
- Renal insufficiency (Cr greater than 1.3 mg/mL)
- Significant language barriers
- Cirrhosis causing ascites
- NYHA III or IV, EF less than 25%
- Use of intraoperative epidural anesthesia
- Uncontrolled diabetes
- Uncontrolled hypertension in the opinion of the enrolling surgeon
- ETOH consumption greater than 35 drinks weekly
- Cachexia or absolute neutrophil count of less than 1,200/mm3
- Existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Morbidity
Outcome Description:
Reduction in post-operative complications at the time of hospital discharge after the surgical episode
Outcome Time Frame:
5-7 days
Safety Issue:
Yes
Principal Investigator
Lucci Stocchi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Institutional Review Board
Study ID:
07-016
NCT ID:
NCT01563991
Start Date:
February 2007
Completion Date:
Related Keywords:
- Benign Neoplasm of Intestinal Tract
- Primary Malignant Neoplasm of Intestinal Tract
- Secondary Malignant Neoplasm of Intestinal Tract
- surgery
- fluid
- morbidity
- Neoplasms
- Intestinal Neoplasms
- Brain Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Cleveland Clinic | Cleveland, Ohio 44195 |
