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

This study has been completed.
Sponsor:
Collaborator:
Deltex Medical, Inc.
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00467922
First received: April 27, 2007
Last updated: October 20, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Ulcerative Colitis
Rectal Cancer
Colon Cancer
Colon Polyps
Rectal Polyps
Diverticulitis
 Drug: Hextend
Drug: Lactated Ringers
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • Determine the relative effects of a standard, colloid or crystalloid based strategy for hand-assisted laparoscopic colectomy surgery on decreasing length of stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 69
Study Start Date: May 2007
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hextend
    Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
    Drug: Lactated Ringers
    Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467922

Locations
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Deltex Medical, Inc.
Investigators
Principal Investigator: Anthony Senagore, MD Spectrum Health Hospitals
  More Information

No publications provided

Responsible Party: Dr. Anthony Senagore, Spectrum Health
ClinicalTrials.gov Identifier: NCT00467922     History of Changes
Other Study ID Numbers: 2007-109, 2007-109
Study First Received: April 27, 2007
Last Updated: October 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Spectrum Health Hospitals:
Hand-assisted colorectal surgery
colorectal disease
Crohn's
diverticulitis
Colorectal resections

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Colitis
Colitis, Ulcerative
Colonic Polyps
Crohn Disease
Diverticulitis
Polyps
Ulcer
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Gastroenteritis
Inflammatory Bowel Diseases
Intestinal Polyps
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013