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RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees

This study has been completed.
Sponsor:
Information provided by:
East Bay Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00841282
First received: February 9, 2009
Last updated: February 10, 2009
Last verified: February 2009

February 9, 2009
February 10, 2009
October 2008
February 2009   (final data collection date for primary outcome measure)
Increments of medications used for sedation [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00841282 on ClinicalTrials.gov Archive Site
  • pain score during colonoscopy [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]
  • success of cecal intubation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • willingness to repeat colonoscopy [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees
Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Colorectal Cancer
  • Procedure: Colonoscopy for colorectal cancer screening
  • Procedure: Water Infusion Colonoscopy
    water infusion in lieu of air insufflation for screening colonoscopy
  • Procedure: Air insufflation colonoscopy
    Conventional colonoscopy with air insufflation
  • Active Comparator: 1
    Water Infusion in lieu of Air Insufflation Colonoscopy
    Interventions:
    • Procedure: Colonoscopy for colorectal cancer screening
    • Procedure: Water Infusion Colonoscopy
  • Placebo Comparator: 2
    Air Insufflation Colonoscopy
    Interventions:
    • Procedure: Colonoscopy for colorectal cancer screening
    • Procedure: Air insufflation colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00841282
EBIRE-GI-002
Yes
Joseph Leung, MD, Section of Gastroenterology, Sacramento VA Medical Center
East Bay Institute for Research and Education
Not Provided
Not Provided
East Bay Institute for Research and Education
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP