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Completed

NCT Number: NCT01869296

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

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.

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Key information

Conditions

Effect of Endoscope Water Pump Flow Rates

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Sardjito General Hospital

Yogyakarta, Special Region of Yogyakarta, 55284, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

higher flow rates

Procedure

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

lower flow rates

Procedure

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

Primary outcomes

  1. cecal intubation rate

    Time frame: 1.5 years

Secondary outcomes

  1. Cecal intubation time

    Time frame: 1.5 years

  2. Abdominal discomfort score

    Time frame: 1.5 years

  3. Willingness to repeat

    Time frame: 1.5 years

  4. Causes of unsuccessful

    Time frame: 1.5 years

  5. Abdominal compression

    Time frame: 1.5 years

  6. Position change

    Time frame: 1.5 years

  7. Diagnostic lesions

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 5, 2013
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.