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Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.

Patients followed the preparation method according to the manufacturer's standard instructions.

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.

Normal (0.9%) saline

A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.

HalfLytely

Vijaypal Arya, MD

A quality colonoscopy examination remains as the gold standard for colorectal cancer screening, but effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. Currently, the most widely used cleansing methods employ balanced electrolyte-polyethylene glycol (PEG) solutions. However, a very large volume of PEG solution is required for it to be effective, and many patients refuse to drink a sufficient amount due to non-palatability. In this study, the investigators compare a novel colon preparation method--bolus lukewarm saline with yoga exercise--with a PEG based solution (HalfLytely) for large bowel cleansing.

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.

Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

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

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.

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".

Subjects rated the SCC as "Willingness to repeat the same prep in future"

Patients from both groups reported adverse events in a symptom questionnaire.

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.

Arya, Vijaypal, M.D., P.C.

Associate Director, Endoscopy

Shudh Colon Cleanse (SCC) Group

HalfLytely Colon Prep (HCP) Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Shudh Colon Cleanse (SCC) is suitable to only 30% of patients who are undergoing colonoscopy. A multi-center study is warranted to confirm these results.

Dr Vijaypal Arya

Yoga contained a 32-oz plastic pitcher and 9-gm salt sachets (Iodine-free table salt - USP grade sodium chloride) for preparation of 0.9% saline (1 sachet in 32-oz lukewarm water (37.2-38.8 degrees Centigrade or 99-102 degrees Fahrenheit)), an instructional leaflet, and a DVD providing instructions of the bowel preparation process. Patients were instructed to fill the pitcher with 16-oz of hot water and 16-oz of room temperature water to reach the lukewarm temperature. Patients could add a twist of lemon if the solution was unpalatable to them.

Patients in the HCP group followed the preparation method according to the manufacturer's standard instructions. Patients were instructed to stay on clear liquids the entire day before the colonoscopy. Two tablets of bisacodyl delayed-release tablets with water were taken at around 1:00 pm. Patients were instructed to start drinking the solution after a bowel movement or around 7 pm if no bowel activity occurred. They were instructed to sip all of the solution at a rate of 8 oz. every 10 minutes.

The non-inferiority margin was set at -15%. This means the intervention will be considered non-inferior if the difference in success rates is less than 15%. The study was designed to have 90% power to establish non-inferiority when the two treatment groups are equivalent using a one-tailed test at the 5% significance level.

Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy

Solution palatability of SCC by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.

Solution palatability of HCP by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.

All subjects enrolled and completed the bowel preparation. .

Palatability of Bowel Prep

Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale.

Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.

Patients take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. Adverse events were recorded on questionnaire.

Patients followed the preparation method according to the manufacturer's standard instructions. Subjects recorded adverse events.

Spots Global Cancer Trial Database for large bowel preparation