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

Cathartic Colon Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761213
• Other study ID #: KC16MISV0004
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2016
• Last updated: October 10, 2017
• Start date: April 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cathartic Colon

Intervention

Drug:
• Oral sulfate solution (OSS)
Oral sulfate solution (OSS)
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Bo-In Lee	Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Scale (BPPS)		during colonoscopy
Primary	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	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
Secondary	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
Secondary	Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers		during colonoscopy
Secondary	Percentage of cecal intubation		during colonoscopy
Secondary	Insertion time		during colonoscopy
Secondary	Withdrawal time		during colonoscopy
Secondary	Adenoma detection rate		during colonoscopy