Effect of Endoscope Water Pump Flow Rates Clinical Trial
Official title:
The Effect of Endoscopy Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial
| Verified date | August 2016 |
| Source | Gadjah Mada University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Indonesia: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 132 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | Dr. Sardjito General Hospital | Yogyakarta | Special Region of Yogyakarta |
| Lead Sponsor | Collaborator |
|---|---|
| Gadjah Mada University |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | cecal intubation rate | 1.5 years | No | |
| Secondary | Cecal intubation time | 1.5 years | No | |
| Secondary | Abdominal discomfort score | 1.5 years | No | |
| Secondary | Willingness to repeat | 1.5 years | No | |
| Secondary | Causes of unsuccessful | 1.5 years | No | |
| Secondary | Abdominal compression | 1.5 years | No | |
| Secondary | Position change | 1.5 years | No | |
| Secondary | Diagnostic lesions | 1.5 years | No |