The Effect of Endoscope Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial

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

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to compare the cecal intubation rate between two endoscopy water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy.

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Detailed Description

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Conditions

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Effect of Endoscope Water Pump Flow Rates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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higher flow rates endoscope pump

higher flow rates endoscope water pump : 10.4 ml/sec

Group Type ACTIVE_COMPARATOR

higher flow rates

Intervention Type PROCEDURE

higher flow rates endoscope pump water immersion colonoscopy : 10.4 ml/sec

lower flow rates endoscope water pump

lower flow rates endoscope water pump : 1.7 ml/sec

Group Type EXPERIMENTAL

lower flow rates

Intervention Type PROCEDURE

lower flow rates endoscope pump water immersion colonoscopy : 1.7 ml/sec

Interventions

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higher flow rates

higher flow rates endoscope pump water immersion colonoscopy : 10.4 ml/sec

Intervention Type PROCEDURE

lower flow rates

lower flow rates endoscope pump water immersion colonoscopy : 1.7 ml/sec

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult \> 18 years old with indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative of need for diagnostic colonoscopy examination

Exclusion Criteria

* Patients refuse to participate, patient with obstructive lesion in the colon distal of the cecum, patients with experienced of colon resection, hemodynamically unstable, severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure), patients with fecal obstruction (whatever the causes) so that impossible to pass the scope through the obstructed segment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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PUTUT BAYUPURNAMA

MD, Internist-Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Putut Bayupurnama, MD

Role: PRINCIPAL_INVESTIGATOR

Div of Gastroenterology and Hepatology, Dept of Internal Medicine,Fac of Medicine, Gadjah Mada University/Dr.Sardjito General Hospital,Yogyakarta,Indonesia