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

Phase 3

Completed

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

• Registration Number: NCT00467922
• Lead Sponsor: Spectrum Health Hospitals

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 offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-30
• Study Start: 2007-05
• Study First Posted: 2007-05-01
• Primary Completion: 2009-09
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-20
• Last Update Posted: 2009-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the relative effects of a standard, colloid or crystalloid based strategy for hand-assisted laparoscopic colectomy surgery on decreasing length of stay	90 days

Secondary Outcome Measures

Name	Time	Method
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.	90 days

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States