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

Spectrum Health Hospitals

Status and phase: Completed; Phase 3

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

Treatments: Drug: Hextend; Drug: Lactated Ringers

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00467922

2007-109

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind