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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Colonoscopy for colorectal cancer screening; Procedure: Water Infusion Colonoscopy; Procedure: Air insufflation colonoscopy

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mather, California, United States, 95655
      • Sacramento VA Medical Center,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increments of medications used for sedation	duration of procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
pain score during colonoscopy	duration of procedure
success of cecal intubation	duration of study
willingness to repeat colonoscopy	duration of study

Collaborators and Investigators

• Sponsor: East Bay Institute for Research and Education

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 10, 2009
• First Posted (Estimate): February 11, 2009

Study Record Updates

• Last Update Posted (Estimate): February 11, 2009
• Last Update Submitted That Met QC Criteria: February 10, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Sedation; Colorectal cancer screening; Optical colonoscopy; Water method
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: EBIRE-GI-002