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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467922
First Posted: May 1, 2007
Last Update Posted: October 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deltex Medical, Inc.
Information provided by:
Spectrum Health Hospitals
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Anthony Senagore, Spectrum Health
ClinicalTrials.gov Identifier: NCT00467922     History of Changes
Other Study ID Numbers: 2007-109
First Submitted: April 27, 2007
First Posted: May 1, 2007
Last Update Posted: October 21, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Polyps
Diverticulitis
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Pathological Conditions, Anatomical
Intraabdominal Infections
Infection