Status:
COMPLETED
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
Lead Sponsor:
Corewell Health West
Collaborating Sponsors:
Deltex Medical, Inc.
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers o...
Eligibility Criteria
Inclusion
- Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis
- Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology
Exclusion
- Patients requiring stoma formation as part of the operative procedure
- Patients undergoing loop ileostomy or colostomy closure thru the stomal site
- Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values)
- Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification \>2
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00467922
Start Date
May 1 2007
End Date
October 1 2009
Last Update
October 21 2009
Active Locations (1)
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1
Spectrum Health
Grand Rapids, Michigan, United States, 49503