Clinical trial NCT02761213: Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid
Official title: Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cathartic Colon
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Pharmbio Korea Co., Ltd.
First posted: 2016-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Boston Bowel Preparation Scale (BPPS)
timeFrame: during colonoscopy
measure: Aronchick scale
timeFrame: during colonoscopy
Secondary outcomes:
measure: Tolerability by a patient questionnaire using 5-point Likert scale
timeFrame: on arrival at the endoscopy unit before colonoscopy
measure: Safety by measuring hemodynamic and biochemical data
timeFrame: at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite
measure: Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers
timeFrame: during colonoscopy
measure: Percentage of cecal intubation
timeFrame: during colonoscopy
measure: Insertion time
timeFrame: during colonoscopy
measure: Withdrawal time
timeFrame: during colonoscopy
measure: Adenoma detection rate
timeFrame: during colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Bo-In Lee, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.