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Completed

NCT Number: NCT00467922

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

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.

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Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colon Cancer Colon Polyps Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Crohn Disease Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Cancer Rectal Diseases Rectal Neoplasms Rectal Polyps Ulcerative Colitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: 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.

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Deltex Medical, Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 1, 2007
Registry last updated
Oct 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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