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
1 other identifier
interventional
133
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedResults Posted
Study results publicly available
March 4, 2015
CompletedMarch 4, 2015
February 1, 2015
2.6 years
February 26, 2012
January 17, 2015
February 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Palatability of Bowel Prep
Upto 24 weeks
Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.
Upto 24 weeks
Patient-reported Adverse Events.
Upto 24 weeks
Total Preparation Time
Upto 24 weeks
Study Arms (2)
BLS and Yoga exercise
ACTIVE COMPARATORPatients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
PEG (HalfLytely)
ACTIVE COMPARATORPatients followed the preparation method according to the manufacturer's standard instructions.
Interventions
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.
A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Sodium chloride sensitivity.
- Limitation to exercise.
- Earlier resection of the large bowel or rectum.
- Known active colitis.
- Ileus or gastrointestinal obstruction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vikalp Inc.
Middle Village, New York, 11379, United States
Related Publications (1)
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.
PMID: 23456498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr Vijaypal Arya
- Organization
- Wyckoff Heights Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Vijaypal Arya, MD
Wyckoff Heights Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director, Endoscopy
Study Record Dates
First Submitted
February 26, 2012
First Posted
March 7, 2012
Study Start
May 1, 2008
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
March 4, 2015
Results First Posted
March 4, 2015
Record last verified: 2015-02