Trial Outcomes & Findings for Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation (NCT NCT01547130)
NCT ID: NCT01547130
Last Updated: 2015-03-04
Results Overview
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.
COMPLETED
PHASE1/PHASE2
133 participants
Within 48 hours of bowel preparation
2015-03-04
Participant Flow
This was a randomized, single-center, single-blinded (to the endoscopists) and active-control study. Patients undergoing elective colonoscopy between May 2008 and December 2010 were recruited. Location: Medical Clinic.
No events were recorded. None of the enrolled participants were excluded from the trial before assignment to groups. However, 14 no show ups for procedure were identified.
Participant milestones
| Measure |
Shudh Colon Cleanse (SCC) Group
Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
|
HalfLytely Colon Prep (HCP)
Patients followed the preparation method according to the manufacturer's standard instructions.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
73
|
|
Overall Study
COMPLETED
|
65
|
68
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Shudh Colon Cleanse (SCC) Group
Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
|
HalfLytely Colon Prep (HCP)
Patients followed the preparation method according to the manufacturer's standard instructions.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
Baseline Characteristics
Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
Baseline characteristics by cohort
| Measure |
Shudh Colon Cleanse (SCC) Group
n=74 Participants
Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
|
HalfLytely Colon Prep (HCP) Group
n=73 Participants
Patients followed the preparation method according to the manufacturer's standard instructions.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
44.8 years
STANDARD_DEVIATION 10 • n=107 Participants
|
44.2 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=99 Participants
|
73 participants
n=107 Participants
|
147 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 48 hours of bowel preparationPopulation: 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.
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.
Outcome measures
| Measure |
Shudh Colon Cleanse (SCC) Group
n=65 Participants
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.
|
HalfLytely Colon Prep (HCP) Group
n=68 Participants
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.
|
|---|---|---|
|
Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy
|
18.69 Score
Standard Deviation 5.34
|
20.1 Score
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Upto 24 weeksPopulation: All subjects enrolled and completed the bowel preparation. .
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".
Outcome measures
| Measure |
Shudh Colon Cleanse (SCC) Group
n=65 Participants
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.
|
HalfLytely Colon Prep (HCP) Group
n=68 Participants
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.
|
|---|---|---|
|
Palatability of Bowel Prep
|
48 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Upto 24 weeksPopulation: Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale.
Subjects rated the SCC as "Willingness to repeat the same prep in future"
Outcome measures
| Measure |
Shudh Colon Cleanse (SCC) Group
n=65 Participants
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.
|
HalfLytely Colon Prep (HCP) Group
n=68 Participants
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.
|
|---|---|---|
|
Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.
|
44 participants
|
40 participants
|
SECONDARY outcome
Timeframe: Upto 24 weeksPopulation: Patients from both groups reported adverse events in a symptom questionnaire.
Patients from both groups reported adverse events in a symptom questionnaire.
Outcome measures
| Measure |
Shudh Colon Cleanse (SCC) Group
n=65 Participants
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.
|
HalfLytely Colon Prep (HCP) Group
n=68 Participants
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.
|
|---|---|---|
|
Patient-reported Adverse Events.
|
32 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Upto 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Shudh Colon Cleanse (SCC) Group
n=65 Participants
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.
|
HalfLytely Colon Prep (HCP) Group
n=68 Participants
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.
|
|---|---|---|
|
Total Preparation Time
|
1.9 hours
Interval 1.25 to 4.0
|
10.9 hours
Interval 4.0 to 18.0
|
Adverse Events
Shudh Colon Cleanse (SCC) Group
HalfLytely Colon Prep (HCP) Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Shudh Colon Cleanse (SCC) Group
n=65 participants at risk
Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
|
HalfLytely Colon Prep (HCP) Group
n=68 participants at risk
Patients followed the preparation method according to the manufacturer's standard instructions.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
38.5%
25/65 • Same day
|
41.2%
28/68 • Same day
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
3/65 • Same day
|
17.6%
12/68 • Same day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place