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RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees

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. Identifier: NCT00841282
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : February 11, 2009
Information provided by:
East Bay Institute for Research and Education

Brief Summary:
Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Colonoscopy for colorectal cancer screening Procedure: Water Infusion Colonoscopy Procedure: Air insufflation colonoscopy Not Applicable

Detailed Description:

Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.

Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients by supervised trainees.

Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.

Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.

Limitations: Single VA site, older male population

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Water Infusion in lieu of Air Insufflation Colonoscopy
Procedure: Colonoscopy for colorectal cancer screening
Procedure: Water Infusion Colonoscopy
water infusion in lieu of air insufflation for screening colonoscopy

Placebo Comparator: 2
Air Insufflation Colonoscopy
Procedure: Colonoscopy for colorectal cancer screening
Procedure: Air insufflation colonoscopy
Conventional colonoscopy with air insufflation

Primary Outcome Measures :
  1. Increments of medications used for sedation [ Time Frame: duration of procedure ]

Secondary Outcome Measures :
  1. pain score during colonoscopy [ Time Frame: duration of procedure ]
  2. success of cecal intubation [ Time Frame: duration of study ]
  3. willingness to repeat colonoscopy [ Time Frame: duration of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Adult (> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy,
  • Accept randomization to the study or the conventional method, and agree to complete study questionnaires
  • The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2

Exclusion criteria:

  • Patients who have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded
  • Excluded patients will be managed by usual procedures

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 identifier (NCT number): NCT00841282

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United States, California
Sacramento VA Medical Center,
Mather, California, United States, 95655
Sponsors and Collaborators
East Bay Institute for Research and Education

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Responsible Party: Joseph Leung, MD, Section of Gastroenterology, Sacramento VA Medical Center Identifier: NCT00841282    
Other Study ID Numbers: EBIRE-GI-002
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by East Bay Institute for Research and Education:
Colorectal cancer screening
Optical colonoscopy
Water method
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases