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

Study Overview
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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.

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

Conditions
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Effect of Endoscope Water Pump Flow Rates

Intervention / Treatment
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* Procedure: higher flow rates
* Procedure: lower flow rates


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: higher flow rates endoscope pump<br>higher flow rates endoscope water pump : 10.4 ml/sec | Procedure: higher flow rates<br>* higher flow rates endoscope pump water immersion colonoscopy : 10.4 ml/sec<br>|
| Experimental: lower flow rates endoscope water pump<br>lower flow rates endoscope water pump : 1.7 ml/sec | Procedure: lower flow rates<br>* lower flow rates endoscope pump water immersion colonoscopy : 1.7 ml/sec<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cecal intubation rate |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation time |  | 1.5 years | 
| Abdominal discomfort score |  | 1.5 years | 
| Willingness to repeat |  | 1.5 years | 
| Causes of unsuccessful |  | 1.5 years | 
| Abdominal compression |  | 1.5 years | 
| Position change |  | 1.5 years | 
| Diagnostic lesions |  | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unsedated, water immersion colonoscopy, endoscope water pump flow rates