Clinical trial NCT01547130: Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colonic Neoplasms
Keywords: Colonoscopy
Yoga
Complementary and alternative medicine
Bowel cleansing
Large bowel preparation
Cancer screening
Colorectal cancer
Lead sponsor: Arya, Vijaypal, M.D., P.C.
Sponsor class: INDIV
First posted: 2012-03-07
Enrollment: 133
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy
timeFrame: Within 48 hours of bowel preparation
Secondary outcomes:
measure: Palatability of Bowel Prep
timeFrame: Upto 24 weeks
measure: Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.
timeFrame: Upto 24 weeks
measure: Patient-reported Adverse Events.
timeFrame: Upto 24 weeks
measure: Total Preparation Time
timeFrame: Upto 24 weeks
Other outcomes:
Locations:
city: Middle Village
country: United States
facility: Vikalp Inc.
state: New York
Study officials:
affiliation: Wyckoff Heights Medical Center
name: Vijaypal Arya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.