Clinical trial NCT01978509
Conditions: Colonoscopy
Keywords: Colonoscopy
Sponsor: Mayo Clinic
Start date: 2013-09-01; Completion date: 2019-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing colonoscopies.

Detailed description:

Arms: arm 1: Low volume prep for colonoscopy (Prepopik) arm 2: Moderate volume prep for colonoscopy (Moviprep) arm 3: High volume prep for colonoscopy (Golytely)
Interventions: intervention 1: Low volume prep (Prepopik) intervention 2: Moderate volume prep (Moviprep) intervention 3: High volume prep (Golytely)
Intervention descriptions: intervention 1: Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy. intervention 2: Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy. intervention 3: Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.

Protocol documents:
Prot_000.pdf: 
 
 
The Affect of Low-Volume 
Bowel Preparation for 
Hospitalized Patients 
Colonoscopies 
 
NCT# 01978509  
 
December 03, 2015 


The Affect of Low-Volume Bowel Preparation for Hospitalized Patients 
Colonoscopies-Final 
 
 
Jennifer Horsley-Silva, MD; Laura Koepke, NP; Sameer Islam, MD; Kevin Ruff, MD; 
Francisco Ramirez, MD 
 
 
Colonoscopic examinations are frequently performed in hospitalized patients for a 
number of indications. There are, however, significant limitations that prevent an 
endoscopist from performing a high quality examination, necessitating delaying the 
procedure or even cancelling it. One such challenge is in the adequacy of bowel 
cleansing. Inpatient status has been shown to be a predictor of poor bowel 
preparation as these patients are older, less mobile, and have more co-morbidities 
than outpatient populations. Though studies in outpatient populations have 
demonstrated that timing and choice of cathartic medication affects the cleanliness 
of the bowel preparations, currently, no standardized (or optimized) bowel 
preparation regiment administration exists for inpatient populations undergoing 
colonoscopy.  
 
The purpose of this study is to compare the efficacy of a low-volume bowel 
preparation versus a high-volume bowel preparation for bowel cleansing on 
hospitalized patients undergoing colonoscopies.  
 
Primary Outcome: 


To determine if using a split-dose low volume prep (Prepopik ® or Moviprep ®) 
prior to colonoscopy would improve bowel preparation in hospitalized patients 
based on a Boston Bowel Prep Score (BBPS).  
 
Secondary Outcomes: 
1. Delayed colonoscopy if bowel prep deemed inadequate 
2. Procedure cancelled if bowel prep deemed inadequate  
3. Patient tolerance  
4. Able to completely finish prep 
5. Side effects of low volume preparation 
6. Cecal intubation time 
7. Withdrawal time 
8. Total time of colonoscopy 
9. Willingness to repeat colonoscopy in future 
 
Inclusion Criteria: 
1. Inpatient colonoscopies 
2. Age 18 years and older 
3. Able to give consent 
4. Split dose colonoscopies for all patients  
 
Exclusion Criteria: 
1. No consent obtained 


2. Pregnancy or lactating 
3. Renal impairment 
4. Ileus 
5. Ascites 
6. Toxic megacolon 
7. Gastrointestinal obstruction 
8. Allergy to study drug 
9. Toxic colitis 
10. Not able to split the dose 
 
Methods: 
We plan of performing a single blinded (endoscopist), prospective, randomized 
control trial on whether using a split-dose low volume bowel preparation would 
improve bowel preparation in hospitalized patients at our institution.  
 
Currently at Mayo Clinic Arizona, there are two bowel preps available in 
hospitalized patients: Golytely ® and Moviprep ®. They are 4-liter and 3-liter 
preparations taken the night prior to colonoscopy or in a split-dose fashion.  
 
After informed consent, we will randomly select patients to take the 4-liter split-
dose prep (Golytely ®) or the low volume split-dose preps (Moviprep ® or Prepopik 
®). The randomization will be carried out using a computer-generated random 
numbers, with the group assignments placed in sealed, consecutively numbered, 


opaque envelops. Instructions will be provided prior to the colonoscopy for the 
common side effects and administration instructions for both arms.  Bowel prep 
orders will be done by a Nurse Practitioner, who will not inform the endoscopists of 
which prep is being used (i.e. the endoscopists will be blinded). Additionally, the 
patients will be told to not inform the endoscopy nurse and performing 
endoscopists which bowel prep regiment they took.   
 
During the colonoscopy, various metrics will be obtained. After colonoscopy is 
completed, patients will be given a questionnaire about their experiences with the 
bowel preps.  
 
Data Collection: 
1. All enrolled patient will be asked: 
a. Details of how purging agents were used 
b. Start of bowel prep time 
c. Side effects of preparation 
d. Sleeping quality  
e. Willingness to repeat bowel preparation 
 
2. Colonoscopy demographics 
a. Prep quality, based on the Boston Bowel Prep Score 
b. Cecal intubation 
c. Terminal ileum intubation 


d. Total colonoscopy time 
e. Adenoma detection rate 
 
3. Patient demographics 
a. Sex 
b. Age 
c. BMI 
d. Primary symptoms 
e. Purgative type 
 
Confidentiality of Data 
The cases will be indexed by medical record to protect the privacy of the patients.  
All electronic data will be stored in a password-protected database. The data 
storage will be restricted to facility computers that are password protected. 
Relevant clinical information will be reported only with collective data with no 
identities revealed. 
 
 
 
 
 
 
 


 
 
 
Bowel Preparations: 
 
Prep Types 
Volume of 
Prep 
Ingredients 
Administration 
(full dose regiment) 
Golytely ® 
4 liters 
Polyethylene 
glycol, sodium 
sulfate, 
sodium 
bicarbonate, 
sodium 
chloride, 
potassium 
chloride 
3L of water and Golytely and taken in the 
evening before the colonoscopy, 1 L of 
water and Golytely taken the morning of 
the colonoscopy 
Moviprep ® 
3 liters 
Polyethylene 
glycol, sodium 
sulfate, 
sodium 
chloride, 
potassium 
chloride, 
sodium 
ascorbate and 
ascorbic acid 
 
1.5L of water and Moviprep taken in the 
evening before the colonoscopy, 1.5 L of 
water and Moviprep taken the morning of 
the colonoscopy 
Prepopik ® 
74 ounces 
(2.2 liters) 
Sodium 
picosulfate, 
magnesium 
oxide, 
anhydrous 
citric acid 
1) Drink 5-ounce cold water mixed with 
one packet of Prepopik 
2) This is followed by 5 8-ounces of water 
within the next 5 hours the night prior 
to the colonoscopy 
3) Drink second 5-ounce cold water mixed 
with packet in the morning 
4) This is followed by 3 8-ounces of water 
within the next 5 hours 
 
 
References: 
 
1. Hendry PO, Jenkins JT, Diament RH. The impact of poor bowel 
 


preparation on colonoscopy: a prospective single centre study of 10571 
 
colonoscopies. Colorectal Dis 2007;9:745–8. 
 
2. Froehlich F, Wietlisbach V, Gonvers JJ, et al. 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;61:378–84. 
 
3. Spiegel BMR, Talley J, Shekelle P, et al. Development and validation 
 
of a novel patient educational booklet to enhance colonoscopy 
 
preparation. Am J Gastroenterol 2011;106:875–83. 
 
4. Golytely ®, Moviprep ®, and Prepopik ® Prescribing Information and Patient 
Instructions.