Trial record 3 of 196 for:    Open Studies | "Drinking Water"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Gadjah Mada University
Sponsor:
Information provided by (Responsible Party):
PUTUT BAYUPURNAMA, Gadjah Mada University
ClinicalTrials.gov Identifier:
NCT01869296
First received: May 26, 2013
Last updated: June 1, 2013
Last verified: June 2013
  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 Endoscopy Water Pump Flow Rates
Procedure: higher flow rates
Procedure: lower flow rates
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Gadjah Mada University:

Primary Outcome Measures:
  • cecal intubation rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cecal intubation time [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Abdominal discomfort score [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Willingness to repeat [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Causes of unsuccessful [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Abdominal compression [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Position change [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Diagnostic lesions [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: higher flow rates endoscopy pump
higher flow rates endoscopy pump : 10.4 ml/sec
Procedure: higher flow rates
higher flow rates endoscopy pump water immersion colonoscopy : 10.4 ml/sec
Experimental: lower flow rates endoscopy pump
lower flow rates endoscopy pump : 1.7 ml/sec
Procedure: lower flow rates
lower flow rates endoscopy pump water immersion colonoscopy : 1.7 ml/sec

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869296

Contacts
Contact: Putut Bayupurnama, MD pututby@yahoo.com
Contact: Neneng Ratnasari, MD nenengratnasari@yahoo.com

Locations
Indonesia
Dr. Sardjito General Hospital Recruiting
Yogyakarta, Special Region of Yogyakarta, Indonesia, 55284
Contact: Putut Bayupurnama, MD       pututby@yahoo.com   
Principal Investigator: Putut Bayupurnama, MD         
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

No publications provided

Responsible Party: PUTUT BAYUPURNAMA, MD, Internist-Gastroenterologist, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT01869296     History of Changes
Other Study ID Numbers: PB-02-CWUGM
Study First Received: May 26, 2013
Last Updated: June 1, 2013
Health Authority: Indonesia: Ethics Committee

Keywords provided by Gadjah Mada University:
unsedated
water immersion colonoscopy
endoscopy water pump flow rates

ClinicalTrials.gov processed this record on September 18, 2014