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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Crohn's Disease, Ulcerative Colitis, Rectal Cancer, Colon Cancer, Colon Polyps, Rectal Polyps, Diverticulitis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

90 days

Safety Issue:

No

Principal Investigator

Anthony Senagore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Spectrum Health Hospitals

Authority:

United States: Institutional Review Board

Study ID:

2007-109

NCT ID:

NCT00467922

Start Date:

May 2007

Completion Date:

October 2009

Related Keywords:

  • Crohn's Disease
  • Ulcerative Colitis
  • Rectal Cancer
  • Colon Cancer
  • Colon Polyps
  • Rectal Polyps
  • Diverticulitis
  • Hand-assisted colorectal surgery
  • colorectal disease
  • Crohn's
  • diverticulitis
  • Colorectal resections
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colitis
  • Colitis, Ulcerative
  • Colonic Polyps
  • Crohn Disease
  • Diverticulitis
  • Polyps
  • Ulcer

Name

Location
Spectrum Health Grand Rapids, Michigan  49503