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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Neoplasms
• Intervention / Treatment: Drug: Normal (0.9%) saline; Drug: HalfLytely

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Middle Village, New York, United States, 11379
      • Vikalp Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: HalfLytely; A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arya, Vijaypal, M.D., P.C.
• Investigators: Principal Investigator: Vijaypal Arya, MD, Wyckoff Heights Medical Center

Publications and helpful links

General Publications

• Arya V, Gupta KA, Valluri A, Arya SV, Lesser ML. Rapid colonoscopy preparation using bolus lukewarm saline combined with sequential posture changes: a randomized controlled trial. Dig Dis Sci. 2013 Aug;58(8):2156-66. doi: 10.1007/s10620-013-2598-9. Epub 2013 Mar 2.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: February 26, 2012
• First Submitted That Met QC Criteria: March 3, 2012
• First Posted (ESTIMATE): March 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 4, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Yoga; Colorectal cancer; Colonoscopy; Complementary and alternative medicine; Cancer screening; Bowel cleansing; Large bowel preparation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: WHMC-2008-35