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

October 20, 2009 updated by: Spectrum Health Hospitals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health Hospitals

Collaborators

Deltex Medical, Inc.

Investigators

Principal Investigator: Anthony Senagore, MD, Spectrum Health Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 30, 2007

First Posted (Estimate)