Benign Neoplasm of Intestinal Tract Clinical Trial
Official title:
Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes Following Elective Open Colorectal Surgery
Verified date | March 2017 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 186 |
Est. completion date | April 18, 2012 |
Est. primary completion date | April 18, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity | Reduction in post-operative complications at the time of hospital discharge after the surgical episode | 5-7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01750619 -
Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
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