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
  Purpose

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 Intervention
Colorectal Cancer
Procedure: Colonoscopy for colorectal cancer screening
Procedure: Water Infusion Colonoscopy
Procedure: Air insufflation colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance

Resource links provided by NLM:


Further study details as provided by East Bay Institute for Research and Education:

Primary Outcome Measures:
  • Increments of medications used for sedation [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00841282

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

No publications provided

Responsible Party: Joseph Leung, MD, Section of Gastroenterology, Sacramento VA Medical Center
ClinicalTrials.gov Identifier: NCT00841282     History of Changes
Other Study ID Numbers: EBIRE-GI-002
Study First Received: February 9, 2009
Last Updated: February 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by East Bay Institute for Research and Education:
Colorectal cancer screening
Optical colonoscopy
Water method
Sedation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 26, 2014