Subjets Requiring a ColonoscopyPhase 4B-CLEANNCT02547571

The Bowel CLEAnsing: A National Initiative

A Phase 4 study testing High volume PEG split-dose, Low volume PEG split-dose and High volume PEG non split, day before in people with Subjets Requiring a Colonoscopy, run by Alan Barkun at 10 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare diet, type of bowel preparation and time of colonoscopy to determine if one method is better than the other and, if they are the same, identify the one which is the most convenient for the patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Subjets Requiring a Colonoscopy
What is being tested?: High volume PEG split-dose, Low volume PEG split-dose and High volume PEG non split, day before
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,476 participants
Where: 10 sitesCanada
Study dates: Mar 2016to Sep 2018
Phase: Phase 4
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatients
18 years or older
Able to comprehend the trial
Have an indication for full colonoscopy

Who cannot join

Subjects are excluded from enrollment into the study if any of the following are present:
General exclusion criteria:
Subject refusal
Previous bowel preparation in the last 14 days
Pregnancy or breastfeeding
Reduced mobility

Show all 16Show fewer

Medical/Endoscopic exclusion criteria:
Suspected or diagnosed with bowel obstruction
Any colonic surgery
Toxic megacolon
Ileus
Ischemic colitis
Decompensated heart failure
Severe acute renal failure
Severe liver disease
Severe electrolyte imbalance

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Canada10 sites

Forzani & MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8
QEII HSC
Halifax, Nova Scotia, B3H 2Y9
Western University
London, Ontario, N6A 5W9
CHUM
Montreal, Quebec, H2W 2J3
McGill University Health Centre
Montreal, Quebec, H3G 1A4
The Ottawa Hospital
Ottawa, Ontario, K1H 1A2
Hôpital St-Sacrement, CHU de Québec-Université Laval
Québec, G1S 4L8
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2K5
Health Sciences center and St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Read the detailed description

The objective of the current proposed trial is thus to compare the cleanliness achieved with PEG high-volume (2L+2L) split-dose versus PEG (1L+1L)+Bisacodyl low-volume split-dose, or PEG high volume (4L) non-split day before versus PEG low volume (2L) non-split same day preparation, according to time of endoscopy (early or later), as well as assess the role of diet (low residue or clear liquid diet) according to these different Canadian outpatient preparation regimens.

Conditions: Subjets Requiring a Colonoscopy
Being tested: High volume PEG split-dose, Low volume PEG split-dose, High volume PEG non split, day before, Low volume PEG non split, same day, Clear liquid diet
Keywords: Outpatient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High volume PEG split-doseDrug
Also called Colyte® or PegLyte®
Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.
Low volume PEG split-doseDrug
Also called Bi-PegLyte®
Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.
High volume PEG non split, day beforeDrug
Also called Colyte® or PegLyte®
Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.
Low volume PEG non split, same dayDrug
Also called Bi-PegLyte®
Bi-PegLyte® will be provided to the subject, who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.
Clear liquid dietOther
Low residue dietOther
Early colonoscopy (stratified)Other
"Early" appointments: 7:30 AM to 10h30 AM
Later colonoscopy (stratified)Other
"Later" appointments: 10:30 AM to 4:30 PM.

Study groups in NCT02547571
Study group	Role	What they receive
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Active comparator	Not described Receives: Drug: High volume PEG split-dose; Other: Clear liquid diet; Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue	Active comparator	Not described Receives: Drug: High volume PEG split-dose; Other: Low residue diet; Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Active comparator	Not described Receives: Drug: Low volume PEG split-dose; Other: Clear liquid diet; Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue	Active comparator	Not described Receives: Drug: Low volume PEG split-dose; Other: Low residue diet; Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid	Active comparator	Not described Receives: Drug: High volume PEG non split, day before; Other: Clear liquid diet; Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue	Active comparator	Not described Receives: Drug: High volume PEG non split, day before; Other: Low residue diet; Other: Early colonoscopy (stratified)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Active comparator	Not described Receives: Drug: High volume PEG split-dose; Other: Clear liquid diet; Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue	Active comparator	Not described Receives: Drug: High volume PEG split-dose; Other: Low residue diet; Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Active comparator	Not described Receives: Drug: Low volume PEG split-dose; Other: Clear liquid diet; Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue	Active comparator	Not described Receives: Drug: Low volume PEG split-dose; Other: Low residue diet; Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid	Active comparator	Not described Receives: Drug: Low volume PEG non split, same day; Other: Clear liquid diet; Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume day before; 3)Low residue	Active comparator	Not described Receives: Drug: Low volume PEG non split, same day; Other: Low residue diet; Other: Later colonoscopy (stratified)

What is being measured

The primary outcome is the main question the study is designed to answer.

Bowel cleansing according to the Boston Scale
Measured: Day of colonoscopy

Secondary outcomes (12)

Subject willingness to repeat the preparation (survey)
Measured: Day of colonoscopy
Withdrawal time and total procedural time
Measured: Day of colonoscopy
Cecal or ileal intubation rate for colonoscopies
Measured: Day of colonoscopy
Polyp detection and polypectomy rate
Measured: Day of colonoscopy
Right colon polyp detection rate
Measured: Day of colonoscopy
Specific lesional rates identified according to pathology
Measured: up to 30 days
% of preparation taken by the subject
Measured: Day of colonoscopy
Subject travel time to endoscopy unit (hrs)
Measured: Day of colonoscopy
Incontinence
Measured: Day of colonoscopy
Fecal Immunochemical Test value
Measured: Day of colonoscopy
Montreal score compared to BBPS
Measured: Day of colonoscopy
Ottawa Bowel Preparation Scores compared to BBPS
Measured: Day of colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Sep 2018

First posted11 Sep 2015 (estimated)
Study startMar 2016
Primary completionSep 2018
Study completionSep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (46)Papers the sponsor has linked to this study.
Other trials for Subjets Requiring a ColonoscopyStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 3,476 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547571
Sponsor's protocol ID: V2015-001
Acronym: B-CLEAN
Status last verified: Sep 2018
First submitted: 1 Sep 2015
Last updated: 13 Sep 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Assal C, Watson PY. Angioedema as a hypersensitivity reaction to polyethylene glycol oral electrolyte solution. Gastrointest Endosc. 2006 Aug;64(2):294-5. doi: 10.1016/j.gie.2006.02.008. Epub 2006 May 19. No abstract available.
PubMed 16860094
Brahmania M, Ou G, Bressler B, Ko HK, Lam E, Telford J, Enns R. 2 L versus 4 L of PEG3350 + electrolytes for outpatient colonic preparation: a randomized, controlled trial. Gastrointest Endosc. 2014 Mar;79(3):408-416.e4. doi: 10.1016/j.gie.2013.08.035. Epub 2013 Oct 24.
PubMed 24206747
Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.
PubMed 25053529
Cesaro P, Hassan C, Spada C, Petruzziello L, Vitale G, Costamagna G. A new low-volume isosmotic polyethylene glycol solution plus bisacodyl versus split-dose 4 L polyethylene glycol for bowel cleansing prior to colonoscopy: a randomised controlled trial. Dig Liver Dis. 2013 Jan;45(1):23-7. doi: 10.1016/j.dld.2012.07.011. Epub 2012 Aug 21.
PubMed 22917636
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716
Chorev N, Chadad B, Segal N, Shemesh I, Mor M, Plaut S, Fraser G, Geller A, Gal E, Niv Y. Preparation for colonoscopy in hospitalized patients. Dig Dis Sci. 2007 Mar;52(3):835-9. doi: 10.1007/s10620-006-9591-5.
PubMed 17253131
Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503
de Leone A, Tamayo D, Fiori G, Ravizza D, Trovato C, De Roberto G, Fazzini L, Dal Fante M, Crosta C. Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG: Bowel cleansing for late-morning colonoscopy. World J Gastrointest Endosc. 2013 Sep 16;5(9):433-9. doi: 10.4253/wjge.v5.i9.433.
PubMed 24044042
El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. doi: 10.1067/mge.2003.318.
PubMed 12838218
Eun CS, Han DS, Hyun YS, Bae JH, Park HS, Kim TY, Jeon YC, Sohn JH. The timing of bowel preparation is more important than the timing of colonoscopy in determining the quality of bowel cleansing. Dig Dis Sci. 2011 Feb;56(2):539-44. doi: 10.1007/s10620-010-1457-1. Epub 2010 Nov 2.
PubMed 21042853
Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
PubMed 15758907
Hangartner PJ, Munch R, Meier J, Ammann R, Buhler H. Comparison of three colon cleansing methods: evaluation of a randomized clinical trial with 300 ambulatory patients. Endoscopy. 1989 Nov;21(6):272-5. doi: 10.1055/s-2007-1012967.
PubMed 2693078
Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.
PubMed 12838225
Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011
Hendry PO, Jenkins JT, Diament RH. The impact of poor bowel preparation on colonoscopy: a prospective single centre study of 10,571 colonoscopies. Colorectal Dis. 2007 Oct;9(8):745-8. doi: 10.1111/j.1463-1318.2007.01220.x. Epub 2007 Mar 7.
PubMed 17477852

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Bowel CLEAnsing: A National Initiative
ClinicalTrials.gov ID: NCT02547571
Acronym / sponsor ID: B-CLEAN / V2015-001
Conditions: Subjets Requiring a Colonoscopy
Keywords: Outpatient
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,476 participants (actual)
Lead sponsor: Alan BarkunUniversity, hospital or other
Collaborators: Pendopharm
Study start: Mar 2016
Primary completion: Sep 2018 (actual)
Study completion: Sep 2018 (actual)
First posted: 11 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 12

Arm	Type	Receives
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Active comparator	Drug: High volume PEG split-dose, Other: Clear liquid diet, Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue	Active comparator	Drug: High volume PEG split-dose, Other: Low residue diet, Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Active comparator	Drug: Low volume PEG split-dose, Other: Clear liquid diet, Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue	Active comparator	Drug: Low volume PEG split-dose, Other: Low residue diet, Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid	Active comparator	Drug: High volume PEG non split, day before, Other: Clear liquid diet, Other: Early colonoscopy (stratified)
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue	Active comparator	Drug: High volume PEG non split, day before, Other: Low residue diet, Other: Early colonoscopy (stratified)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Active comparator	Drug: High volume PEG split-dose, Other: Clear liquid diet, Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue	Active comparator	Drug: High volume PEG split-dose, Other: Low residue diet, Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Active comparator	Drug: Low volume PEG split-dose, Other: Clear liquid diet, Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue	Active comparator	Drug: Low volume PEG split-dose, Other: Low residue diet, Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid	Active comparator	Drug: Low volume PEG non split, same day, Other: Clear liquid diet, Other: Later colonoscopy (stratified)
1) Later colonoscopy; 2) Low volume day before; 3)Low residue	Active comparator	Drug: Low volume PEG non split, same day, Other: Low residue diet, Other: Later colonoscopy (stratified)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Outpatients
18 years or older
Able to comprehend the trial
Have an indication for full colonoscopy

Key exclusion criteria (16 listed)

Subject refusal
Previous bowel preparation in the last 14 days
Pregnancy or breastfeeding
Reduced mobility
Suspected or diagnosed with bowel 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
High volume PEG split-doseAlso: Colyte® or PegLyte®Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.	Drug	1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid, 1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue, 1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid, 1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue
Low volume PEG split-doseAlso: Bi-PegLyte®Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.	Drug	1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid, 1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue, 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid, 1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue
High volume PEG non split, day beforeAlso: Colyte® or PegLyte®Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.	Drug	1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid, 1) Early colonoscopy; 2) High-dose, day before; 3)Low residue
Low volume PEG non split, same dayAlso: Bi-PegLyte®Bi-PegLyte® will be provided to the subject, who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.	Drug	1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid, 1) Later colonoscopy; 2) Low volume day before; 3)Low residue
Clear liquid diet	Other	1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid, 1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid, 1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid, 1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid, 1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid, 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid
Low residue diet	Other	1) Early colonoscopy; 2) High-dose, day before; 3)Low residue, 1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue, 1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue, 1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue, 1) Later colonoscopy; 2) Low volume day before; 3)Low residue, 1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue
Early colonoscopy (stratified)"Early" appointments: 7:30 AM to 10h30 AM	Other	1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid, 1) Early colonoscopy; 2) High-dose, day before; 3)Low residue, 1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid, 1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue, 1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid, 1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue
Later colonoscopy (stratified)"Later" appointments: 10:30 AM to 4:30 PM.	Other	1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid, 1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue, 1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid, 1) Later colonoscopy; 2) Low volume day before; 3)Low residue, 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid, 1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue

Primary outcome

Bowel cleansing according to the Boston Scale
Time frame: Day of colonoscopy

12 secondary outcomes

Subject willingness to repeat the preparation (survey)
Time frame: Day of colonoscopy
Withdrawal time and total procedural time
Time frame: Day of colonoscopy
Cecal or ileal intubation rate for colonoscopies
Time frame: Day of colonoscopy
Polyp detection and polypectomy rate
Time frame: Day of colonoscopy
Right colon polyp detection rate
Time frame: Day of colonoscopy
Specific lesional rates identified according to pathology
Time frame: up to 30 days
% of preparation taken by the subject
Time frame: Day of colonoscopy
Subject travel time to endoscopy unit (hrs)
Time frame: Day of colonoscopy
Incontinence
Time frame: Day of colonoscopy
Fecal Immunochemical Test value
Time frame: Day of colonoscopy
Montreal score compared to BBPS
Time frame: Day of colonoscopy
Ottawa Bowel Preparation Scores compared to BBPS
Time frame: Day of colonoscopy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
Results publication: PubMed 16860094Assal C, Watson PY. Angioedema as a hypersensitivity reaction to polyethylene glycol oral electrolyte solution. Gastrointest Endosc. 2006 Aug;64(2):294-5. doi: 10.1016/j.gie.2006.02.008. Epub 2006 May 19. No abstract available.
Results publication: PubMed 24206747Brahmania M, Ou G, Bressler B, Ko HK, Lam E, Telford J, Enns R. 2 L versus 4 L of PEG3350 + electrolytes for outpatient colonic preparation: a randomized, controlled trial. Gastrointest Endosc. 2014 Mar;79(3):408-416.e4. doi: 10.1016/j.gie.2013.08.035. Epub 2013 Oct 24.
Results publication: PubMed 25053529Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.
Results publication: PubMed 22917636Cesaro P, Hassan C, Spada C, Petruzziello L, Vitale G, Costamagna G. A new low-volume isosmotic polyethylene glycol solution plus bisacodyl versus split-dose 4 L polyethylene glycol for bowel cleansing prior to colonoscopy: a randomised controlled trial. Dig Liver Dis. 2013 Jan;45(1):23-7. doi: 10.1016/j.dld.2012.07.011. Epub 2012 Aug 21.
Results publication: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Results publication: PubMed 17253131Chorev N, Chadad B, Segal N, Shemesh I, Mor M, Plaut S, Fraser G, Geller A, Gal E, Niv Y. Preparation for colonoscopy in hospitalized patients. Dig Dis Sci. 2007 Mar;52(3):835-9. doi: 10.1007/s10620-006-9591-5.
Results publication: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
Results publication: PubMed 24044042de Leone A, Tamayo D, Fiori G, Ravizza D, Trovato C, De Roberto G, Fazzini L, Dal Fante M, Crosta C. Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG: Bowel cleansing for late-morning colonoscopy. World J Gastrointest Endosc. 2013 Sep 16;5(9):433-9. doi: 10.4253/wjge.v5.i9.433.
Results publication: PubMed 12838218El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. doi: 10.1067/mge.2003.318.
Results publication: PubMed 21042853Eun CS, Han DS, Hyun YS, Bae JH, Park HS, Kim TY, Jeon YC, Sohn JH. The timing of bowel preparation is more important than the timing of colonoscopy in determining the quality of bowel cleansing. Dig Dis Sci. 2011 Feb;56(2):539-44. doi: 10.1007/s10620-010-1457-1. Epub 2010 Nov 2.
Results publication: PubMed 15758907Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
Results publication: PubMed 2693078Hangartner PJ, Munch R, Meier J, Ammann R, Buhler H. Comparison of three colon cleansing methods: evaluation of a randomized clinical trial with 300 ambulatory patients. Endoscopy. 1989 Nov;21(6):272-5. doi: 10.1055/s-2007-1012967.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Bowel cleansing according to the Boston Scale (time frame: Day of colonoscopy). 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 NCT02547571, which also lists 46 linked publications.

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 13 Sep 2018.