Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid

Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study

The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.

Study Overview

• Status: Completed
• Conditions: Cathartic Colon
• Intervention / Treatment: Drug: Oral sulfate solution (OSS); Drug: 2-L PEG/Asc

Detailed Description

High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.

Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.

In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-040
    • Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• people who receive colonoscopy
• aged : 18-80
• people who sign the consent

Exclusion Criteria:

• those aged over 80 years
• the disabled
• intestinal obstruction
• severe constipation
• previous history of bowel resection
• liver cirrhosis
• heart failure or ischemic heart disease within 6 months
• inflammatory bowel disease
• pregnant women
• severe renal insufficiency
• people who refuse to sign the consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral sulfate solution (OSS); oral sulfate solution (OSS)	Drug: Oral sulfate solution (OSS); Oral sulfate solution (OSS); Other Names: SUPREP
Active Comparator: 2-L PEG/Asc; low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc)	Drug: 2-L PEG/Asc; Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.; Other Names: COOLPREP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Bowel Preparation Scale (BPPS)		during colonoscopy
Aronchick scale	Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon.	during colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate		during colonoscopy
Tolerability by a patient questionnaire using 5-point Likert scale	to assess tolerability of each bowel preparation	on arrival at the endoscopy unit before colonoscopy
Safety by measuring hemodynamic and biochemical data	Biochemical data will be measured only in case of necessity such as weakness, mental change or numbness.	at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite
Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers		during colonoscopy
Percentage of cecal intubation		during colonoscopy
Insertion time		during colonoscopy
Withdrawal time		during colonoscopy

Collaborators and Investigators

• Sponsor: Bo-In Lee
• Collaborators: Pharmbio Korea Co., Ltd.
• Investigators: Study Director: Bo-In Lee, MD, PhD, Seoul St. Mary's Hospital

Publications and helpful links

General Publications

• Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85. doi: 10.1111/j.1572-0241.2006.00673.x. No abstract available.
• Bannas P, Bakke J, Patrick JL, Pickhardt PJ. Automated volumetric analysis for comparison of oral sulfate solution (SUPREP) with established cathartic agents at CT colonography. Abdom Imaging. 2015 Jan;40(1):11-8. doi: 10.1007/s00261-014-0186-x. Erratum In: Abdom Imaging. 2015 Aug;40(6):2066.
• Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.
• Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: May 1, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: KC16MISV0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No