A Single Blind, Parallel Group, Randomized Controlled Trial Comparing Solution PEG Based Colon Preparation (HalfLytely) Versus Bolus Luke Warm Saline (Shudh) and Yoga Exercise for Large Bowel Cleansing Prior to Colonoscopy
Effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that
undergo the procedure. The use of balanced electrolyte-polyethylene glycol (PEG) solution
have improved the cleansing results and shortened the time needed for preparing the bowel.
The problem with using PEG solution alone is the relatively large volume of the solution
that the patients need to drink. The recommendation is to drink the solution until diarrhea
fluid is clear and often 4 L or more is needed. Many patients refuse to drink the sufficient
volume needed to get a clean colon due to non-palatability. Good results of bowel cleansing
have also been reported with sodium phosphate solution or tablets.
The fluid volume needed to drink along with sodium phosphate is generally no problem but
this regimen causes electrolyte disturbances and renal insufficiency that usually are
subclinical and of no significance. Several combinations of PEG solution and laxatives have
been tested before. Low-volume PEG plus Bisacodyl preparation was better tolerated but it
was not as effective as standard large-volume PEG and associated with abdominal cramping.
PEG solution 2L and Bisacodyl is used for large bowel cleansing in many centers in the
United States and is the standard regimen used in our colonoscopy unit. In this study the
investigators compare this standard regimen taken day before colonoscopy with Bolus lukewarm
saline solution taken orally with yoga exercise on the day of colonoscopy.
The result of large bowel cleansing is evaluated during the colonoscopy according to a
validated scoring method. Time to the first bowel movement and total preparation time are
compared. Solution palatability, patient acceptability, abdominal symptoms, discomfort and
subjective grading of how hard/easy it was to complete the cleansing program are evaluated
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Efficacy of large bowel cleansing as assessed by the physician performing the colonoscopy
The evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon and cecum) on a 5 point scale. Aggregating the segmental scores resulted in overall scores. The rating scale was validated by 4 gastroenterologists and 3 gastroenterology fellows with good correlation. The same scale was used successfully in pilot study.
Upto 24 weeks
Vijaypal Arya, MD
Wyckoff Heights Medical Center
United States: Institutional Review Board
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