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

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn's Disease, Ulcerative Colitis, Rectal Cancer, Colon Cancer, Colon Polyps, Rectal Polyps, Diverticulitis

Intervention / Treatment
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* Drug: Hextend
* Drug: Lactated Ringers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand-assisted colorectal surgery, colorectal disease, Crohn's, diverticulitis, Colorectal resections