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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
Spectrum Health Hospitals
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
April 27, 2007
Last Updated
October 20, 2009
Sponsor
Spectrum Health Hospitals
Collaborators
Deltex Medical, Inc.
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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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