Colonic NeoplasmsPhase 1/2NCT01547130
Yoga and Bolus Lukewarm Saline as Rapid Colonoscopy Preparation
A Phase 1/2 study testing Normal (0.9%) saline and HalfLytely in people with Colonic Neoplasms, run by Arya, Vijaypal, M.D., P.C. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Normal (0.9%) saline and HalfLytely
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Sodium chloride sensitivity.
- Limitation to exercise.
- Earlier resection of the large bowel or rectum.
- Known active colitis.
- Ileus or gastrointestinal obstruction.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Colonic Neoplasms
- Being tested
- Normal (0.9%) saline, HalfLytely
- Keywords
- Colonoscopy, Yoga, Complementary and alternative medicine, Bowel cleansing, Large bowel preparation, Cancer screening, Colorectal cancer
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal (0.9%) salineDrug
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.
HalfLytelyDrug
A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
| Study group | Role | What they receive |
|---|---|---|
| BLS and Yoga exercise | Active comparator | Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. Receives: Drug: Normal (0.9%) saline |
| PEG (HalfLytely) | Active comparator | Patients followed the preparation method according to the manufacturer's standard instructions. Receives: Drug: HalfLytely |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 48 hours of bowel preparation
Secondary outcomes (4)
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".
Measured: Upto 24 weeks
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"
Measured: Upto 24 weeks
Patient-reported Adverse Events.
Patients from both groups reported adverse events in a symptom questionnaire.
Measured: Upto 24 weeks
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.
Measured: Upto 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arya, Vijaypal, M.D., P.C.
- Responsible party
- Principal investigator, Vijaypal Arya MD, FACP, FACG, AGAF., Arya, Vijaypal, M.D., P.C.
- Investigators
- Vijaypal Arya, MD, Principal investigator, Wyckoff Heights Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547130
- Sponsor's protocol ID
- WHMC-2008-35
- Status last verified
- Feb 2015
- First submitted
- 26 Feb 2012
- Last updated
- 4 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23456498
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01547130
- Acronym / sponsor ID
- WHMC-2008-35
- Conditions
- Colonic Neoplasms
- Keywords
- Colonoscopy, Yoga, Complementary and alternative medicine, Bowel cleansing, Large bowel preparation, Cancer screening, Colorectal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Arya, Vijaypal, M.D., P.C.
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 4 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLS and Yoga exercise | Active comparator | Drug: Normal (0.9%) salinePatients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. |
| PEG (HalfLytely) | Active comparator | Drug: HalfLytelyPatients followed the preparation method according to the manufacturer's standard instructions. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Sodium chloride sensitivity.
- Limitation to exercise.
- Earlier resection of the large bowel or rectum.
- Known active colitis.
- Ileus or gastrointestinal obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal (0.9%) salineA 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. | Drug | BLS and Yoga exercise |
| HalfLytelyA total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear. | Drug | PEG (HalfLytely) |
Primary outcome
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.
4 secondary outcomes
Palatability of Bowel Prep
Time frame: Upto 24 weeks
Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.
Time frame: Upto 24 weeks
Patient-reported Adverse Events.
Time frame: Upto 24 weeks
Total Preparation Time
Time frame: Upto 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23456498Arya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijaypal Arya, MD principal investigator
Wyckoff Heights Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Normal (0.9%) saline and HalfLytely in people with Colonic Neoplasms, run by Arya, Vijaypal, M.D., P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy (time frame: Within 48 hours of bowel preparation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.