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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00467922
• Date of registration: 27/04/2007
• Prospective Registration: Yes
• Primary sponsor: Spectrum Health Hospitals
• Public title: An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
• Scientific 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
• Date of first enrolment: May 2007
• Target sample size: 69
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00467922
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Anthony Senagore, MD
• Affiliation: Spectrum Health Hospitals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colon Cancer

Ulcerative Colitis

Colon Polyps

Diverticulitis

Rectal Cancer

Crohn's Disease

Rectal Polyps

Intervention(s)

Drug: Lactated Ringers

Drug: Hextend

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

2007-109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Deltex Medical, Inc.