Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
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| First Received Date ICMJE | February 26, 2012 | ||||
| Last Updated Date | March 3, 2012 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Efficacy of large bowel cleansing as assessed by the physician performing the colonoscopy [ Time Frame: Upto 24 weeks ] [ Designated as safety issue: No ] The evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon and cecum) on a 5 point scale. Aggregating the segmental scores resulted in overall scores. The rating scale was validated by 4 gastroenterologists and 3 gastroenterology fellows with good correlation. The same scale was used successfully in pilot study. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01547130 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Colonic Neoplasms | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 133 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01547130 | ||||
| Other Study ID Numbers ICMJE | WHMC-2008-35 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Vijaypal Arya MD, FACP, FACG, AGAF., Arya, Vijaypal, M.D., P.C. | ||||
| Study Sponsor ICMJE | Arya, Vijaypal, M.D., P.C. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Arya, Vijaypal, M.D., P.C. | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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