Bowel Preparation for Colonoscopy in the Elderly

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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The success of colonoscopy is closely related to the quality of colonic preparation. However, data regarding colonoscopy preparations in the elderly (65 years older) are scarce. Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence is lacking in this particular group of patients. Moreover, patient tolerability is a key factor for success of bowel preparation in the aged people.

The purpose of this study is to compare the bowel cleansing efficacy and patient compliance of following bowel preparation methods prior to elective outpatient colonoscopy in the elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume \[2L\] PEG-3350 containing ascorbic acid solution.

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Detailed Description

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Conditions

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Bowel Preparation Colonoscopy

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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Standard full-volume PEG

Group Type ACTIVE_COMPARATOR

Standard full-volume PEG

Intervention Type DRUG

Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.

Split-dose full-volume PEG

Group Type EXPERIMENTAL

Split-dose full-volume PEG

Intervention Type DRUG

Subjects will be asked to take 2L of PEG-3350 solution the day prior to procedure, followed by another 2L of PEG-3350 solution on the day of the procedure.

Split-dose low-volume PEG

Group Type EXPERIMENTAL

Split-dose low-volume PEG

Intervention Type DRUG

Subjects will be asked to take 1L of PEG-3350 containing ascorbic acid solution the day prior to procedure, followed by another 1L of PEG-3350 containing ascorbic acid solution on the day of the procedure.

Interventions

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Standard full-volume PEG

Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.

Intervention Type DRUG

Split-dose full-volume PEG

Subjects will be asked to take 2L of PEG-3350 solution the day prior to procedure, followed by another 2L of PEG-3350 solution on the day of the procedure.

Intervention Type DRUG

Split-dose low-volume PEG

Subjects will be asked to take 1L of PEG-3350 containing ascorbic acid solution the day prior to procedure, followed by another 1L of PEG-3350 containing ascorbic acid solution on the day of the procedure.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* elderly people aged over 65 years
* elective outpatient colonoscopy
* informed consent

Exclusion Criteria

* patients who had bowel movements of less than 3 per week during last one month
* patients who have a history of renal dysfunction (abnormal elevation of serum creatinine and electrolyte imbalance)
* patients who have a history of alimentary tract surgery
* patients who have other gastrointestinal diseases that are not suitable for undergoing colonoscopy (gastroparesis, gastric outlet obstruction, ileus, ischemic colitis, megacolon, and toxic colitis)
* patients classified as the American Society for Anesthesiology class III or higher
* Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No