RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees

Colorectal Cancer Clinical Trial

Official title:

Comparison of Study Versus Conventional Method for Performing Colonoscopy by Supervised Trainees for Colorectal Cancer Screening and Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841282
• Other study ID #: EBIRE-GI-002
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: February 10, 2009
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: East Bay Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Colonoscopy for colorectal cancer screening

• Water Infusion Colonoscopy
water infusion in lieu of air insufflation for screening colonoscopy
• Air insufflation colonoscopy
Conventional colonoscopy with air insufflation

Locations

Country	Name	City	State
United States	Sacramento VA Medical Center,	Mather	California

Sponsors (1)

Lead Sponsor	Collaborator
East Bay Institute for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increments of medications used for sedation		duration of procedure	Yes
Secondary	pain score during colonoscopy		duration of procedure	Yes
Secondary	success of cecal intubation		duration of study	No
Secondary	willingness to repeat colonoscopy		duration of study	No