Colonic Neoplasms
Conditions
Keywords
Colonoscopy, Yoga, Complementary and alternative medicine, Bowel cleansing, Large bowel preparation, Cancer screening, Colorectal cancer
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.
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.
DRUGHalfLytely
A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
Sponsors
Arya, Vijaypal, M.D., P.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy | Within 48 hours of bowel preparation | 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
| Measure | Time frame | Description |
|---|---|---|
| Palatability of Bowel Prep | Upto 24 weeks | 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. | Upto 24 weeks | Subjects rated the SCC as Willingness to repeat the same prep in future |
| Patient-reported Adverse Events. | Upto 24 weeks | Patients from both groups reported adverse events in a symptom questionnaire. |
| Total Preparation Time | Upto 24 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 74 |
| HalfLytely Colon Prep (HCP) Group Patients followed the preparation method according to the manufacturer's standard instructions. | 73 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 5 |
Baseline characteristics
| Characteristic | HalfLytely Colon Prep (HCP) Group | Shudh Colon Cleanse (SCC) Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 72 Participants | 145 Participants |
| Age, Continuous | 44.8 years STANDARD_DEVIATION 10 | 43.6 years STANDARD_DEVIATION 10.5 | 44.2 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 73 participants | 74 participants | 147 participants |
| Sex: Female, Male Female | 43 Participants | 48 Participants | 91 Participants |
| Sex: Female, Male Male | 30 Participants | 26 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 65 | 28 / 68 |
| serious Total, serious adverse events | 0 / 65 | 0 / 68 |
Outcome results
Primary
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.
Time frame: Within 48 hours of bowel preparation
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shudh Colon Cleanse (SCC) Group | Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy | 18.69 Score | Standard Deviation 5.34 |
| HalfLytely Colon Prep (HCP) Group | Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy | 20.1 Score | Standard Deviation 3.51 |
Secondary
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.
Time frame: Upto 24 weeks
Population: All subjects enrolled and completed the bowel preparation. .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shudh Colon Cleanse (SCC) Group | Palatability of Bowel Prep | 48 participants |
| HalfLytely Colon Prep (HCP) Group | Palatability of Bowel Prep | 38 participants |
Secondary
Patient-reported Adverse Events.
Patients from both groups reported adverse events in a symptom questionnaire.
Time frame: Upto 24 weeks
Population: Patients from both groups reported adverse events in a symptom questionnaire.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shudh Colon Cleanse (SCC) Group | Patient-reported Adverse Events. | 32 participants |
| HalfLytely Colon Prep (HCP) Group | Patient-reported Adverse Events. | 46 participants |
Secondary
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
Time frame: Upto 24 weeks
Population: Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shudh Colon Cleanse (SCC) Group | Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation. | 44 participants |
| HalfLytely Colon Prep (HCP) Group | Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation. | 40 participants |
Secondary
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.
Time frame: Upto 24 weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Shudh Colon Cleanse (SCC) Group | Total Preparation Time | 1.9 hours |
| HalfLytely Colon Prep (HCP) Group | Total Preparation Time | 10.9 hours |