Phase 2
N=147
Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
Colonic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01547130 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy — 18.69; 20.1 Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Normal (0.9%) saline (Drug); HalfLytely (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Arya, Vijaypal, M.D., P.C.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy |
18.69; 20.1 | — |
| SECONDARY Palatability of Bowel Prep |
48; 38 | — |
| SECONDARY Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation. |
44; 40 | — |
| SECONDARY Patient-reported Adverse Events. |
32; 46 | — |
| SECONDARY Total Preparation Time |
1.9; 10.9 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01547130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.