Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

Colonic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547130
• Other study ID #: WHMC-2008-35
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 26, 2012
• Last updated: February 17, 2015
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2015
• Source: Arya, Vijaypal, M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

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.
• HalfLytely
A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.

Locations

Country	Name	City	State
United States	Vikalp Inc.	Middle Village	New York

Sponsors (1)

Lead Sponsor	Collaborator
Arya, Vijaypal, M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Within 48 hours of bowel preparation	No
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".	Upto 24 weeks	No
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"	Upto 24 weeks	No
Secondary	Patient-reported Adverse Events.	Patients from both groups reported adverse events in a symptom questionnaire.	Upto 24 weeks	Yes
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.	Upto 24 weeks	No