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

Completed · Phase 3

Conditions studied: Crohn's Disease, Ulcerative Colitis, Rectal Cancer, Colon Cancer, Colon Polyps, Rectal Polyps, Diverticulitis

In brief

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.

Key facts

Study ID

NCT00467922

Run by

Corewell Health West

People needed

69

Starts

2007-05-01

Expected to finish

2009-10-01

Last updated by the study team

2009-10-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spectrum Health — Grand Rapids, Michigan, United States

Full record on ClinicalTrials.gov

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