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

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112967
• Other study ID #: 2016-03-021
• Status: Completed
• Phase: N/A
• First received: March 30, 2017
• Last updated: August 13, 2017
• Start date: April 20, 2017
• Est. completion date: August 13, 2017

Study information

• Verified date: August 2017
• Source: Kyung Hee University Hospital at Gangdong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: August 13, 2017
• Est. primary completion date: August 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Kyung Hee University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	compliance and acceptability	proportion of patients willingness	Up to 2 months