Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonic Neoplasms |
Drug: Normal (0.9%) saline Drug: HalfLytely |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
- 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.
- Subjective grading by all study patients on palatability of the large bowel preparation treatment [ Time Frame: Upto 24 weeks ] [ Designated as safety issue: No ]Patients completed a symptom questionnaire where they rated solution palatability of their assigned prep on a 1-5 Liekert scale.
- Subjective grading by patients on willingness to repeat the large bowel preparation. [ Time Frame: Upto 24 weeks ] [ Designated as safety issue: No ]Patients completed a symptom questionnaire where they rated willingness to repeat the preps on a 1-5 Liekert scale.
- Patient-reported adverse events. [ Time Frame: Upto 24 weeks ] [ Designated as safety issue: Yes ]Patients from both groups reported adverse events in a symptom questionnaire.
- Total preparation time [ Time Frame: Upto 24 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 133 |
| Study Start Date: | May 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: BLS and Yoga exercise
Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
|
Drug: Normal (0.9%) saline
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.
|
|
Active Comparator: PEG (HalfLytely)
Patients followed the preparation method according to the manufacturer's standard instructions.
|
Drug: HalfLytely
A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| United States, New York | |
| Vikalp Inc. | |
| Middle Village, New York, United States, 11379 | |
| Principal Investigator: | Vijaypal Arya, MD | Wyckoff Heights Medical Center |
More Information
No publications provided
| Responsible Party: | Vijaypal Arya MD, FACP, FACG, AGAF., Associate Director, Endoscopy, Arya, Vijaypal, M.D., P.C. |
| ClinicalTrials.gov Identifier: | NCT01547130 History of Changes |
| Other Study ID Numbers: | WHMC-2008-35 |
| Study First Received: | February 26, 2012 |
| Last Updated: | March 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Arya, Vijaypal, M.D., P.C.:
|
Colonoscopy Yoga Complementary and alternative medicine Bowel cleansing |
Large bowel preparation Cancer screening Colorectal cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013