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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00467922
Date of registration: 27/04/2007
Prospective Registration: Yes
Primary sponsor: Spectrum Health Hospitals
Public title: An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
Scientific title: 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: May 2007
Target sample size: 69
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00467922
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Anthony Senagore, MD
Address: 
Telephone:
Email:
Affiliation:  Spectrum Health Hospitals
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Colon Cancer
Rectal Cancer
Colon Polyps
Diverticulitis
Ulcerative Colitis
Crohn's Disease
Rectal Polyps
Intervention(s)
Drug: Hextend
Drug: Lactated Ringers
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
Secondary ID(s)
2007-109
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Deltex Medical, Inc.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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