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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01869296
First Posted: June 5, 2013
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PUTUT BAYUPURNAMA, Gadjah Mada University
  Purpose
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.

Condition Intervention Phase
Effect of Endoscope Water Pump Flow Rates Procedure: higher flow rates Procedure: lower flow rates Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effect of Endoscopy Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by PUTUT BAYUPURNAMA, Gadjah Mada University:

Primary Outcome Measures:
  • cecal intubation rate [ Time Frame: 1.5 years ]

Secondary Outcome Measures:
  • Cecal intubation time [ Time Frame: 1.5 years ]
  • Abdominal discomfort score [ Time Frame: 1.5 years ]
  • Willingness to repeat [ Time Frame: 1.5 years ]
  • Causes of unsuccessful [ Time Frame: 1.5 years ]
  • Abdominal compression [ Time Frame: 1.5 years ]
  • Position change [ Time Frame: 1.5 years ]
  • Diagnostic lesions [ Time Frame: 1.5 years ]

Enrollment: 132
Study Start Date: May 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: higher flow rates endoscope pump
higher flow rates endoscope water pump : 10.4 ml/sec
Procedure: higher flow rates
higher flow rates endoscope pump water immersion colonoscopy : 10.4 ml/sec
Experimental: lower flow rates endoscope water pump
lower flow rates endoscope water pump : 1.7 ml/sec
Procedure: lower flow rates
lower flow rates endoscope pump water immersion colonoscopy : 1.7 ml/sec

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869296


Locations
Indonesia
Dr. Sardjito General Hospital
Yogyakarta, Special Region of Yogyakarta, Indonesia, 55284
Sponsors and Collaborators
Gadjah Mada University
Investigators
Principal Investigator: Putut Bayupurnama, MD Div of Gastroenterology and Hepatology, Dept of Internal Medicine,Fac of Medicine, Gadjah Mada University/Dr.Sardjito General Hospital,Yogyakarta,Indonesia
  More Information

Responsible Party: PUTUT BAYUPURNAMA, MD, Internist-Gastroenterologist, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT01869296     History of Changes
Other Study ID Numbers: PB-02-CWUGM
First Submitted: May 26, 2013
First Posted: June 5, 2013
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by PUTUT BAYUPURNAMA, Gadjah Mada University:
unsedated
water immersion colonoscopy
endoscope water pump flow rates