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

NCT ID: NCT03112967

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2017-08-13

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.

Conditions

Bowel Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

low-volume preparation, oral sulfate solution

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

large-volume preparation, 4L polyethylene glycol

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Suprep; Colyte

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: lead

Responsible Party

Min Seob Kwak

Clinical associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min Seob Kwak, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

KyungHee university hospital at Gangdong

Locations

Department of Internal Medicine, Kyung Hee University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30400725 (View on PubMed)

Other Identifiers

2016-03-021

Identifier Type: -

Identifier Source: org_study_id