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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01869296
Enrollment
132
Registered
2013-06-05
Start date
2013-05-31
Completion date
2015-06-30
Last updated
2016-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Endoscope Water Pump Flow Rates

Keywords

unsedated, water immersion colonoscopy, endoscope water pump flow rates

Brief summary

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.

Interventions

PROCEDUREhigher flow rates

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

PROCEDURElower flow rates

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

Sponsors

Gadjah Mada University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
cecal intubation rate1.5 years

Secondary

MeasureTime frame
Abdominal discomfort score1.5 years
Willingness to repeat1.5 years
Causes of unsuccessful1.5 years
Cecal intubation time1.5 years
Position change1.5 years
Diagnostic lesions1.5 years
Abdominal compression1.5 years

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026