Clinical trial NCT03112967: Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution
Official title: Safety and Efficacy of Low-volume Preparation in the Elderly: Oral Sulfate Solution vs 4L PEG Dolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 193
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy in bowel preparation
timeFrame: Up to 2 months
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 2 months
measure: compliance and acceptability
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Kyung Hee University College of Medicine
Study officials:
affiliation: KyungHee university hospital at Gangdong
name: Min Seob Kwak, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.