Comparison of Clenpiq vs Golytely Bowel Preparation

The purpose of our study is to determine if a 4L bowel cleansing agent is more effective than a low volume bowel preparation, and if the time of dosing (single dose night before vs split dose) of the bowel preparation results in better bowel cleansing in participants undergoing colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy with general anesthesia will be randomized only to the single dose arms of the study. Participants will complete a questionnaire while drinking the bowel preparation to determine timing and tolerability of the bowel preparation.

• Golytely (Drug), also known as polyethylene glycol 3350 and electrolytes oral solution: bowel preparation
• Clenpiq (Drug), also known as sodium picosulfate, magnesium oxide, anhydrous citric acid: bowel preparation

Primary outcomes

• Percentage of Participants With Satisfactory Bowel Cleansing [1 day]: Bowel cleansing efficacy will be measured using the Boston Bowel Prep Scale (BBPS). The BBPS divides the colon into 3 segments (right, transverse, left); each is scored from 0-3 (0=colonic mucosa not seen due to solid stool that cannot be cleared, 1=only a portion of the mucosa of the colon segment is seen due to staining, residual stool and/or opaque liquid, 2=minor amount of residual staining, small fragments of stool and/or opaque liquid but mucosa of colon segment is seen well, and 3=entire mucosa is seen well with no residual staining, small fragments of stool or opaque liquid). A total BBPS score of 6 or greater AND 2 or greater in all segments will be defined as satisfactory bowel prep. BBPS score of less than 6 or less than 2 in any segment of the colon will be taken as unsatisfactory bowel cleansing in the final analysis.

Secondary outcomes

• Proportion of Participants Requiring a Repeat Colonoscopy [1 day]: Participants requiring a repeat procedure due to unsatisfactory bowel prep

Sex: All, ages: 18 Years to any

Inclusion Criteria:

\- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

* Creatinine clearance less than 30 ml/min
* History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
* Small bowel obstruction, ileus or bowel perforation
* Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
* Gastroparesis
* Toxic megacolon or undergoing colonoscopy for decompression
* Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
* History of prior colorectal surgery
* Allergy to any of the ingredients in Clenpiq or golytely
* if the procedure is planned in the intensive care unit (ICU)

Participant flow

Outcome results

• Percentage of Participants With Satisfactory Bowel Cleansing (Primary), Count of participants, Participants: Group A 2; Group B 2; Group C 4; Group D 2
• Proportion of Participants Requiring a Repeat Colonoscopy (Secondary), Count of participants, Participants: Group A 0; Group B 0; Group C 0; Group D 0

Adverse events

Time frame: Data were collected over the space of 9 months

• Study Protocol and Statistical Analysis Plan (PDF, 2019-03-08)

• Carol Burke, MD, Principal investigator, The Cleveland Clinic