Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Drug: Normal (0.9%) saline
* Drug: HalfLytely


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled to undergo elective complete colonoscopy as an outpatient. Aged 18 or older. The patient gives written informed consent and can understand the information given. The patient can participate in the study only once. Exclusion Criteria: Sodium chloride sensitivity. Limitation to exercise. Earlier resection of the large bowel or rectum. Known active colitis. Ileus or gastrointestinal obstruction.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BLS and Yoga exercise<br>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<br>* 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.<br>|
| Active Comparator: PEG (HalfLytely)<br>Patients followed the preparation method according to the manufacturer's standard instructions. | Drug: HalfLytely<br>* A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the 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. | Within 48 hours of bowel preparation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of Bowel Prep | 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. | Upto 24 weeks | 
| Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation. | Subjects rated the SCC as Willingness to repeat the same prep in future | Upto 24 weeks | 
| Patient-reported Adverse Events. | Patients from both groups reported adverse events in a symptom questionnaire. | Upto 24 weeks | 
| Total Preparation Time | 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. | Upto 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Yoga, Complementary and alternative medicine, Bowel cleansing, Large bowel preparation, Cancer screening, Colorectal cancer