Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vijaypal Arya MD, FACP, FACG, AGAF., Arya, Vijaypal, M.D., P.C.
ClinicalTrials.gov Identifier:
NCT01547130
First received: February 26, 2012
Last updated: March 3, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Arya, Vijaypal, M.D., P.C.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01547130

Locations
United States, New York
Vikalp Inc.
Middle Village, New York, United States, 11379
Sponsors and Collaborators
Arya, Vijaypal, M.D., P.C.
Investigators
Principal Investigator: Vijaypal Arya, MD Wyckoff Heights Medical Center
  More Information

No publications provided by Arya, Vijaypal, M.D., P.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014