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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLS and Yoga exercise | Active Comparator | Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. |
|
| PEG (HalfLytely) | Active Comparator | Patients followed the preparation method according to the manufacturer's standard instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal (0.9%) saline | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vijaypal Arya, MD | Wyckoff Heights Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vikalp Inc. | Middle Village | New York | 11379 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23456498 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | HalfLytely Colon Prep (HCP) | Patients followed the preparation method according to the manufacturer's standard instructions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | HalfLytely Colon Prep (HCP) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Score | Within 48 hours of bowel preparation |
Same day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vijaypal Arya | Wyckoff Heights Medical Center | 718-326-0400 | varyamd@yahoo.com |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| HalfLytely | Drug | A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear. |
|
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 |
Patients followed the preparation method according to the manufacturer's standard instructions.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Shudh Colon Cleanse (SCC) Group | 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. |
| OG001 | HalfLytely Colon Prep (HCP) Group | 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. |
|
|
| 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". | All subjects enrolled and completed the bowel preparation. . | Posted | Number | participants | Upto 24 weeks |
|
|
|
| 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" | Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale. | Posted | Number | participants | Upto 24 weeks |
|
|
|
| Secondary | Patient-reported Adverse Events. | Patients from both groups reported adverse events in a symptom questionnaire. | Patients from both groups reported adverse events in a symptom questionnaire. | Posted | Number | participants | Upto 24 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Full Range | hours | Upto 24 weeks |
|
|
|
| 0 |
| 65 |
| 25 |
| 65 |
| EG001 | HalfLytely Colon Prep (HCP) Group | Patients followed the preparation method according to the manufacturer's standard instructions. | 0 | 68 | 28 | 68 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017670 |
| Sodium Compounds |