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

Ulcerative Colitis Clinical Trial

Official title:

A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467922
• Other study ID #: 2007-109
• Secondary ID: 2007-109
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2007
• Last updated: October 20, 2009
• Start date: May 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Colon Cancer
• Colon Polyps
• Crohn Disease
• Crohn's Disease
• Diverticulitis
• Polyps
• Rectal Cancer
• Rectal Polyps
• Ulcerative Colitis

Intervention

Drug:
• Hextend
Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
• Lactated Ringers
Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	Deltex Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No