Know Cancer

forgot password

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

Phase 1/Phase 2
21 Years
70 Years
Not Enrolling
Colonic Neoplasms

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy of large bowel cleansing as assessed by the physician performing the colonoscopy

Outcome Description:

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.

Outcome Time Frame:

Upto 24 weeks

Safety Issue:


Principal Investigator

Vijaypal Arya, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wyckoff Heights Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

January 2011

Related Keywords:

  • Colonic Neoplasms
  • Colonoscopy
  • Yoga
  • Complementary and alternative medicine
  • Bowel cleansing
  • Large bowel preparation
  • Cancer screening
  • Colorectal cancer
  • Neoplasms
  • Colonic Neoplasms



Vikalp Inc. Middle Village, New York  11379