Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00467922 |
Date of registration:
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27/04/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
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Scientific title:
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A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid |
Date of first enrolment:
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May 2007 |
Target sample size:
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69 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00467922 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Anthony Senagore, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Spectrum Health Hospitals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or
rectal polyps and chronic or subacute diverticulitis
2. Subjects who will undergo hand-assisted laparoscopic colectomy for benign or
malignant pathology
Exclusion Criteria:
1. Patients requiring stoma formation as part of the operative procedure
2. Patients undergoing loop ileostomy or colostomy closure thru the stomal site
3. Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine
>1.6 or liver enzymes > 50% upper limit of normal values)
4. Congestive heart failure, unstable angina, or valvular heart disease with New York
Heart Classification >2
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colon Cancer
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Rectal Cancer
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Colon Polyps
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Diverticulitis
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Ulcerative Colitis
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Crohn's Disease
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Rectal Polyps
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Intervention(s)
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Drug: Hextend
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Drug: Lactated Ringers
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Primary Outcome(s)
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Determine the relative effects of a standard, colloid or crystalloid based strategy for hand-assisted laparoscopic colectomy surgery on decreasing length of stay
[Time Frame: 90 days]
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Secondary Outcome(s)
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1. Determine the effects of the three fluid management strategies on post-operative fluid requirements in colorectal surgery. on the incidence and severity of post-operative complications. on return of gastrointestinal function.
[Time Frame: 90 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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