Overview

An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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 offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Spectrum Health Hospitals
Collaborator:
Deltex Medical, Inc.
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