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

Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution vs 4L PEG Dolution

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation
• Intervention / Treatment: Other: low-volume preparation, oral sulfate solution; Other: large-volume preparation, 4L polyethylene glycol

Detailed Description

Traditionally, polyethylene glycol (PEG) solution, which requires ingestion of a large volume of liquid, has been used and now to a low-volume preparations because of its clear advantages in tolerability. The tolerability of bowel preparations is related to their volume, taste, and side effects, with this being a particular problem in the elderly. Meanwhile, a new oral sulfate solution (OSS, SUPREP, Braintree Laboratories, Braintree, Mass) formulation as an effective low-volume bowel cleansing agent, with a split-dose regimen was recently developed in 2009.

Concerned about being able to better complete ingestion of bowel cleansing agent, OSS with lower volume and improved taste features, as long as it does not sacrifice safety, shuld be a better choice than PEG. Many studies have already looked at the efficacy and safety of OSS compared to PEG in average risk population, but there are no data available in solely at the elderly population. In this context, we hypothesized that OSS could be a good alternative to a standard 4L-PEG solution in elderly patients.

In this report, we describe a multicenter, prospective, investigator-blind, randomized, controlled trial investigating OSS with 4L PEG for efficacy and safety in the elderly.

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05278
    • Department of Internal Medicine, Kyung Hee University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All participants from 65 to 75 age

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OSS(Suprep); 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; 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 Names: Suprep
ACTIVE_COMPARATOR: 4L PEG solution(Colyte); 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; 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 Names: Colyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Proportion of adverse events. Adverse events recorded on the questionnaires included nausea, vomiting, abdominal pain, bloating, sleep disturbance, numbness, weakness/faint feeling, fecal incontinence, and thirsty. Blood samples were taken at the screening visit and the day of the procedure and were analysed for serum electrolytes (sodium, potassium, chloride, calcium, phosphate and magnesium), blood urea nitrogen (BUN), creatinine and glomerular filtration rate (GFR). Incident kidney injury was defined as a 25% increase in serum creatinine levels or longitudinal significant change in estimated glomerular filtration rate.	Up to 2 months
compliance and acceptability	proportion of patients willingness	Up to 2 months

Collaborators and Investigators

• Sponsor: Kyung Hee University Hospital at Gangdong
• Investigators: Principal Investigator: Min Seob Kwak, MD,PhD, Kyunghee University Hospital at Gangdong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2017
• Primary Completion (ACTUAL): August 13, 2017
• Study Completion (ACTUAL): August 13, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 13, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2016-03-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will not share datas

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No