Original Contribution

The American Journal of Gastroenterology (2003) 98, 2187–2191; doi:10.1111/j.1572-0241.2003.07690.x

Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing

Mark Cleveland, Ph.D., is vice-president for new drug development for Braintree Laboratories, and Jack DiPalma, M.D., serves as a consultant for Braintree Laboratories.

Jack A DiPalma MD, FACG1,2,3, Bruce G Wolff MD1,2, Alan Meagher MD1,2 and Mark vB Cleveland PhD1,3

  1. 1Division of Gastroenterology, University of South Alabama College of Medicine, Mobile, Alabama, USA
  2. 2Department of Surgery, Mayo Clinic, Rochester, Minnesota, USA
  3. 3Braintree Laboratories, Braintree, Massachusetts, USA

Correspondence: Jack A DiPalma, MD, University of South Alabama, Director, Division of Gastroenterology, 5600 Girby Road, Mobile, AL 36693, USA.

Received 3 February 2003; Accepted 22 April 2003.

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Abstract

OBJECTIVE:

 

In an attempt to improve patient tolerance for colonoscopy cleansing, a reduced volume lavage regimen with 2 L sulfate-free electrolyte lavage solution (SF-ELS, NuLYTELY, Braintree Laboratories, Braintree, MA) plus 20 mg p.o. bisacodyl (Half Lytely, Braintree Laboratories) was compared with standard 4 L SF-ELS lavage for safety and efficacy.

METHODS:

 

At two centers, 200 patients undergoing colonoscopy for routine indications were randomized to receive the reduced volume or standard 4 L method. The day before scheduled colonoscopy, study subjects were allowed a normal breakfast and clear liquids for lunch and dinner. Those randomized to receive the reduced volume method received four 5-mg bisacodyl tablets p.o. at noon. Six hours later, they received 2 L SF-ELS given as 10 oz every 10 min. Subjects randomized to receive 4 L SF-ELS also drank their solution at 6:00 PM in a similar fashion. Colonoscopists, unaware as to the randomized preparation received, rated efficacy of cleansing. Patient tolerance and various hematological and biochemical parameters were assessed.

RESULTS:

 

Physician assessment of colon cleansing showed no differences between those patients randomized to receive reduced volume (n = 93) or 4 L (n = 93) SF-ELS cleansing (p= 0.16). There was a profound reduction in preparation side effects. The reduced volume preparation had less fullness (p < 0.01), nausea (p < 0.01), vomiting (p= 0.01), and overall discomfort (p < 0.01). There were no clinically significant changes in hematology or blood chemistry associated with either preparation.

CONCLUSIONS:

 

Reduced volume preparation with 2 L SF-ELS and bisacodyl is safe and effective. Clinical symptoms from the reduced volume preparation are significantly reduced compared with traditional 4 L gut lavage.