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OpenTrials
Completed

NCT Number: NCT01547130

Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vikalp Inc.

Middle Village, New York, 11379, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normal (0.9%) saline

Drug

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

Drug

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

Primary outcomes

  1. Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy

    Time frame: Within 48 hours of bowel preparation

    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.

Secondary outcomes

  1. Palatability of Bowel Prep

    Time frame: Upto 24 weeks

    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".

  2. Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.

    Time frame: Upto 24 weeks

    Subjects rated the SCC as "Willingness to repeat the same prep in future"

  3. Patient-reported Adverse Events.

    Time frame: Upto 24 weeks

    Patients from both groups reported adverse events in a symptom questionnaire.

  4. Total Preparation Time

    Time frame: Upto 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Arya, Vijaypal, M.D., P.C.

Indiv

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Mar 7, 2012
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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