Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy

NCT ID: NCT01685970

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Detailed Description

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Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Conditions

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Colonoscopy

Keywords

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Bowel preparation colonoscopy polyethylene glycol picosulfate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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High volume Split-dose PEG

Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation

Group Type PLACEBO_COMPARATOR

High volume split-dose PEG

Intervention Type DRUG

High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy

2 sachets of picosulfate

Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.

Group Type ACTIVE_COMPARATOR

2 sachets of picosulfate

Intervention Type DRUG

2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy

Interventions

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High volume split-dose PEG

High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy

Intervention Type DRUG

2 sachets of picosulfate

2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy

Intervention Type DRUG

Other Intervention Names

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Polyethylene glycol(Colyte) sodium picosulfate

Eligibility Criteria

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Inclusion Criteria

* Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms

Exclusion Criteria

* pregnancy,
* breast feeding,
* prior history of surgical large bowel resection,
* severe medical condition such as severe cardiac,
* hepatic, or
* renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
* significant gastric paresis or gastric outlet obstruction or ileus,
* known or suspected bowel obstruction or perforation,
* drug addiction or major psychiatric illness,
* allergy to PEG and refusal to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Eun Hee Seo, MD

Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for aternoon colonoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Oh Kim, Ph D

Role: STUDY_DIRECTOR

Haeundae Paik Hospital, Inje University College of Medicine

Locations

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Haeundae Paik Hospital, Inje University College of Medicine

Busan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae Oh Kim, Ph D.

Role: CONTACT

Phone: 82-51-797-0658

Email: [email protected]

Eun Hee Seo, MD

Role: CONTACT

Phone: 82-51-797-0220

Email: [email protected]

Facility Contacts

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Eun Hee Seo, MD

Role: primary

Tae Oh Kim, Ph D

Role: backup

Other Identifiers

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HGI-2012-09

Identifier Type: -

Identifier Source: org_study_id