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

G

Gadjah Mada University

Status and phase

Completed
Phase 2

Conditions

Effect of Endoscope Water Pump Flow Rates

Treatments

Procedure: lower flow rates
Procedure: higher flow rates

Study type

Interventional

Funder types

Other

Identifiers

NCT01869296
PB-02-CWUGM

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

132 participants in 2 patient groups

higher flow rates endoscope pump
Active Comparator group
Description:
higher flow rates endoscope water pump : 10.4 ml/sec
Treatment:
Procedure: higher flow rates
lower flow rates endoscope water pump
Experimental group
Description:
lower flow rates endoscope water pump : 1.7 ml/sec
Treatment:
Procedure: lower flow rates

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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