An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
Primary Purpose
Crohn's Disease, Ulcerative Colitis, Rectal Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hextend
Lactated Ringers
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Hand-assisted colorectal surgery, colorectal disease, Crohn's, diverticulitis, Colorectal resections
Eligibility Criteria
Inclusion Criteria:
- Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis
- Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology
Exclusion Criteria:
- Patients requiring stoma formation as part of the operative procedure
- Patients undergoing loop ileostomy or colostomy closure thru the stomal site
- Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values)
- Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification >2
Sites / Locations
- Spectrum Health
Outcomes
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
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.
Full Information
NCT ID
NCT00467922
First Posted
April 27, 2007
Last Updated
October 20, 2009
Sponsor
Spectrum Health Hospitals
Collaborators
Deltex Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00467922
Brief Title
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Spectrum Health Hospitals
Collaborators
Deltex Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis, Rectal Cancer, Colon Cancer, Colon Polyps, Rectal Polyps, Diverticulitis
Keywords
Hand-assisted colorectal surgery, colorectal disease, Crohn's, diverticulitis, Colorectal resections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Hextend
Intervention Description
Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
Intervention Type
Drug
Intervention Name(s)
Lactated Ringers
Intervention Description
Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis
Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology
Exclusion Criteria:
Patients requiring stoma formation as part of the operative procedure
Patients undergoing loop ileostomy or colostomy closure thru the stomal site
Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values)
Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification >2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Senagore, MD
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
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