Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
|Colonic Neoplasms||Drug: Normal (0.9%) saline Drug: HalfLytely||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy [ Time Frame: Within 48 hours of bowel preparation ]The primary endpoint was the "success" rate of the preparations. Preparation efficacy was evaluated by a single, blinded endoscopist (V.A.), who performed all of the colonoscopies. The evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon and cecum) on the 5 point Arya Bowel Prep Scale (ABPS). Aggregating the segmental scores resulted in overall scores. Grade A was defined as a total overall score of 19-24, grade B as a score of 13-18, grade C as a score of 7-12, and grade D as a score of 0-6. Grade A or B preparation was considered "successes", while grade C or D was considered "failures." To assess the reliability of ABPS, we trained 4 gastroenterologists and 3 fellows.
- Palatability of Bowel Prep [ Time Frame: Upto 24 weeks ]Patients completed a symptom questionnaire where they rated solution palatability of their assigned prep on a 1-5 Likert scale. A rating of more than 3 was considered as "Palatable".
- Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation. [ Time Frame: Upto 24 weeks ]Subjects rated the SCC as "Willingness to repeat the same prep in future"
- Patient-reported Adverse Events. [ Time Frame: Upto 24 weeks ]Patients from both groups reported adverse events in a symptom questionnaire.
- Total Preparation Time [ Time Frame: Upto 24 weeks ]Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.
|Study Start Date:||May 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: BLS and Yoga exercise
Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
Drug: Normal (0.9%) saline
A total of 2L solution at lukewarm temperature (37.2-38.8 degrees Centigrade)consumed as bolus intake (8-16 oz in one to two minutes) alternating with yoga exercises.
Active Comparator: PEG (HalfLytely)
Patients followed the preparation method according to the manufacturer's standard instructions.
A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
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 with questionnaires.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547130
|United States, New York|
|Middle Village, New York, United States, 11379|
|Principal Investigator:||Vijaypal Arya, MD||Wyckoff Heights Medical Center|