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

August 9, 2016 updated by: PUTUT BAYUPURNAMA, Gadjah Mada University

The Effect of Endoscopy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Special Region of Yogyakarta
      • Yogyakarta, Special Region of Yogyakarta, Indonesia, 55284
        • Dr. Sardjito General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cecal intubation rate
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 26, 2013

First Submitted That Met QC Criteria

June 1, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PB-02-CWUGM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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