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Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

Primary Purpose

Colonic Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Normal (0.9%) saline
HalfLytely
Sponsored by
Arya, Vijaypal, M.D., P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms focused on measuring Colonoscopy, Yoga, Complementary and alternative medicine, Bowel cleansing, Large bowel preparation, Cancer screening, Colorectal cancer

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vikalp Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

BLS and Yoga exercise

PEG (HalfLytely)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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"
Patient-reported Adverse Events.
Patients from both groups reported adverse events in a symptom questionnaire.
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.

Full Information

First Posted
February 26, 2012
Last Updated
February 17, 2015
Sponsor
Arya, Vijaypal, M.D., P.C.
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1. Study Identification

Unique Protocol Identification Number
NCT01547130
Brief Title
Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arya, Vijaypal, M.D., P.C.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Colonoscopy, Yoga, Complementary and alternative medicine, Bowel cleansing, Large bowel preparation, Cancer screening, Colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLS and Yoga exercise
Arm Type
Active Comparator
Arm Description
Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
Arm Title
PEG (HalfLytely)
Arm Type
Active Comparator
Arm Description
Patients followed the preparation method according to the manufacturer's standard instructions.
Intervention Type
Drug
Intervention Name(s)
Normal (0.9%) saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HalfLytely
Intervention Description
A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
Primary Outcome Measure Information:
Title
Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy
Description
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.
Time Frame
Within 48 hours of bowel preparation
Secondary Outcome Measure Information:
Title
Palatability of Bowel Prep
Description
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".
Time Frame
Upto 24 weeks
Title
Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.
Description
Subjects rated the SCC as "Willingness to repeat the same prep in future"
Time Frame
Upto 24 weeks
Title
Patient-reported Adverse Events.
Description
Patients from both groups reported adverse events in a symptom questionnaire.
Time Frame
Upto 24 weeks
Title
Total Preparation Time
Description
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.
Time Frame
Upto 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijaypal Arya, MD
Organizational Affiliation
Wyckoff Heights Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vikalp Inc.
City
Middle Village
State/Province
New York
ZIP/Postal Code
11379
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23456498
Citation
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.
Results Reference
derived

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Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

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