Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution

NCT03112967 | Completed

• 1 other identifier: 2016-03-021
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will investigate the safety and efficacy of low-volume preparation (Oral Sulfate solution) compared to 4L PEG solution in bowel preparation before colonoscopy. One aim of this study was to investigate the efficacy of low-volume preparation (Oral Sulfate solution) on bowel preparation before colonoscopy.

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Efficacy in bowel preparation

  The boston bowel preparation scale The BBPS uses a 10-point (0-9) summation scale assessing bowel preparation quality, by a 3 point scoring system of 0 to 3 in 3 segments of the colon (right colon, transverse colon, and left colon), where 0 = ''unprepared colon with mucosa not seen because of solid stool,'' 1 = ''portion of colonic mucosa of the segment seen, but other areas not well seen due to staining, residual stool, and/or opaque liquid,'' 2 = ''minor amount of residual staining, stool, and/or opaque liquid, but colonic mucosa of the segment seen well,'' and 3 = ''entire colonic mucosa seen well with no residual staining, stool or opaque liquid.'' An adequate bowel preparation was defined by a total BBPS score ≥ 6 with all segment scores ≥ 2, and excellent cleansing was considered as a score of \> 7.

  Up to 2 months

Secondary Outcomes (2)

• Adverse events

  Up to 2 months

• compliance and acceptability

  Up to 2 months

Study Arms (2)

OSS(Suprep)

EXPERIMENTAL

Oral Sulfate solution (Suprep) in day before and split-dose regimens In the OSS arm: between 17:00 and 18:00 hours on the day before colonoscopy, subjects were instructed to pour one 180-ml bottle of the study medication into a provided 480-ml mixing cup and fill it with water and then drink the entire volume, followed by two additional 480 ml of water. At approximately 6:00 a.m. on the following morning, the subjects took the second dose of OSS by same formulation protocol.

Other: low-volume preparation, oral sulfate solution

4L PEG solution(Colyte)

ACTIVE COMPARATOR

4L PEG solution in day before and split-dose regimens In the 4L PEG arm: subjects had the first 2L between 18:00 and 19:00 hours (250mL every 15 minutes) in the evening before the colonoscopy. And the second 2L was given between 07:00 and 08:00 on the day of colonoscopy.

Other: large-volume preparation, 4L polyethylene glycol

Interventions

low-volume preparation, oral sulfate solution OTHER

Oral Sulfate solution (Suprep) in day before and split-dose regimens In the OSS arm: between 17:00 and 18:00 hours on the day before colonoscopy, subjects were instructed to pour one 180-ml bottle of the study medication into a provided 480-ml mixing cup and fill it with water and then drink the entire volume, followed by two additional 480 ml of water. At approximately 6:00 a.m. on the following morning, the subjects took the second dose of OSS by same formulation protocol.

Also known as: Suprep

OSS(Suprep)

large-volume preparation, 4L polyethylene glycol OTHER

4L PEG solution in day before and split-dose regimens In the 4L PEG arm: subjects had the first 2L between 18:00 and 19:00 hours (250mL every 15 minutes) in the evening before the colonoscopy. And the second 2L was given between 07:00 and 08:00 on the day of colonoscopy.

Also known as: Colyte

4L PEG solution(Colyte)

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• All participants from 65 to 75 age

You may not qualify if:

• Underwent Colorectal surgery
• CHF, Acute MI \<6 months
• ASA class III =\<
• LC, CRF, Ascite, IBD, or Severe inflammatory state
• Severe constipation (Bowel movement 3/wk \> or Taking stool softener)
• Disabled person physically or mentally
• Refuse consent

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Department of Internal Medicine, Kyung Hee University College of Medicine

Seoul, 05278, South Korea

Location

Related Publications (1)

• Kwak MS, Cha JM, Yang HJ, Park DI, Kim KO, Lee J, Shin JE, Joo YE, Park J, Byeon JS, Kim HG. Safety and Efficacy of Low-Volume Preparation in the Elderly: Oral Sulfate Solution on the Day before and Split-Dose Regimens (SEE SAFE) Study. Gut Liver. 2019 Mar 15;13(2):176-182. doi: 10.5009/gnl18214.

  PMID: 30400725 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols; Golytely

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Min Seob Kwak, MD,PhD

  KyungHee university hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 13, 2017
• Study Start: April 20, 2017
• Primary Completion: August 13, 2017
• Study Completion: August 13, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)