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

Kyung Hee University

Status: Completed

Conditions: Bowel Preparation

Treatments: Other: large-volume preparation, 4L polyethylene glycol; Other: low-volume preparation, oral sulfate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03112967

2016-03-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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193 participants in 2 patient groups

OSS(Suprep)

Experimental group

Description:

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.

Treatment:

Other: low-volume preparation, oral sulfate solution

4L PEG solution(Colyte)

Active Comparator group

Description:

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.

Treatment:

Other: large-volume preparation, 4L polyethylene glycol