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

NCT00467922 | Completed Phase 3

• 1 other identifier: 2007-109
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Hextend DRUG

Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid

Lactated Ringers DRUG

Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health West: lead
• Deltex Medical, Inc.: collaborator

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Rectal Neoplasms; Colonic Neoplasms; Colonic Polyps; Diverticulitis

Interventions

Hydroxyethyl Starch Derivatives; Ringer's Lactate

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Diverticular Diseases

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anthony Senagore, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 21, 2009

Record last verified: 2009-10

Locations

US (1)