Single Dose Versus Split Dose Polyethylene Glycol-based Colonic Lavage for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Proper bowel cleansing prior is an essential requirement for the conduct of colonoscopy. However, due to the nature of cleansing process, the ideal bowel cleansing preparation remains elusive.

The objective of this study is to compare the efficacy, safety and tolerability of oral polyethylene glycol lavage given either as a single dose or split dose. The study will be a randomized controlled single blind two group study. The primary study outcomes will be the previously validated Ottawa bowel preparation score.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

NCT01929590

Bowel Preparation for Colonoscopy

COMPLETED PHASE3

Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

NCT01093274

Bowel Preparation

UNKNOWN NA

Comparison of Bowel Cleansing Regimens Prior to Colonoscopy

NCT01649674

Patients Undergoing Elective Colonoscopy

UNKNOWN PHASE4

Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose

NCT01415687

Bowel Preparation for Colonoscopy

COMPLETED PHASE3

Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

NCT02956057

Colonoscopy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All patients between the age of 50 and 75 years referred to the Forzani \& MacPhail Colorectal Cancer Screening Centre in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients will be asked to participate in the study by a nurse clinician. If they agree - final consent will be obtained by a gastroenterologist along with consent for the colonoscopy. Those not interested in participating will simply receive their physicians standard bowel preparation protocol. There will be no coercion of any sort.

Patients with acute coronary syndrome, congestive heart failure, unstable angina, known or suspected renal failure, ascites, megacolon, known or suspected bowel obstruction, or other comorbidities that may prevent colonoscopy will be excluded. Patients will also be excluded if they previously had partial or subtotal colectomy or if the colonoscopy is warranted for the evaluation of diarrhea.

Enrollment of participants will be performed with block randomizations of 8 stratified by AM versus PM procedure time using a computer-generated table, with allocation concealment maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and investigators will be blinded to allocation groups. Patients will be allocated to one of two groups: (1) 4L PEG day prior to procedure; (2) 4L of PEG split in two 2L doses

A study assistant will assign patients to their group and instruct them on the proper use of their assigned bowel preparation method. Patients will be given a tolerability questionnaire, that was modified from a previously reported questionnaire, to be completed once their bowel preparation is finished and before coming to the hospital for the colonoscopy. Patient concerns or questions regarding the preparation will be directed toward the assistant as opposed to their gastroenterologist, so as to avoid unblinding the gastroenterologist.

Outcomes

The previously validated Ottawa bowel preparation scale80 will be used to assess the quality of bowel cleanliness. Each of the right, mid and rectosigmoid colon is rated on a 5-point scale (0-4). In addition, a complete 3-point rating for overall colonic fluid is assessed resulting in an overall score range of 0 to 14. An excellent preparation with little fluid would score 0 to 1; a good preparation, 2 to 4; while scores higher than 4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11 to 14, depending on the amount of colonic fluid.

Colonoscopy will be performed in a standard fashion and endoscopists will rate the bowel-preparation quality during the procedure and record the result on a separate standardized form.

Secondary outcomes will include a previously validated tolerability questionnaire and patient and investigator reported adverse events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy Preparation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEG - 4 L

4 Litres PEG bowel preparation given the day prior to colonoscopy with a clear fluid diet

Group Type EXPERIMENTAL

Polyethylene Glycol

Intervention Type DRUG

4 Litres of polyethylene glycol bowel preparation solution

Split Dose PEG

4 Litres of Colyte given as two split doses of 2L each either the day before colonoscopy 8 hours apart in the case of an AM colonoscopy or in the case of an afternoon colonoscopy given 5PM the day before and 6:00AM the day of the colonoscopy

Group Type ACTIVE_COMPARATOR

polyethylene glycol

Intervention Type DRUG

Polyethylene glycol 4L given in two split doses of 2L each

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polyethylene Glycol

4 Litres of polyethylene glycol bowel preparation solution

Intervention Type DRUG

polyethylene glycol

Polyethylene glycol 4L given in two split doses of 2L each

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

co-lyte Go-lyte PEG PEG Co-lyte Go-lyte

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients between the age of 50 and 75 years referred to the Forzani \& MacPhail Colorectal Cancer Screening Centre in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion.

Exclusion Criteria

* patients with acute coronary syndrome,
* congestive heart failure,
* unstable angina,
* known or suspected renal failure,
* ascites,
* megacolon,
* known or suspected bowel obstruction, or
* other comorbidities that may prevent colonoscopy will be excluded. Patients will also be excluded if they previously had partial or subtotal colectomy or if the colonoscopy is warranted for the evaluation of diarrhea.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes