RCT of Air Insufflation Versus Water Infusion Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785889
• Other study ID #: EBIRE-GI-001
• Status: Completed
• Phase: N/A
• First received: November 3, 2008
• Last updated: November 13, 2008
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• 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

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

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.

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: 56
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• healthy individual 50 years or older

• eligible for colorectal cancer screening or surveillance

Exclusion Criteria:

• patients who do not understand or failed to sign informed consent

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• water infusion colonoscopy
water infusion in lieu of air insufflation for screening colonoscopy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
East Bay Institute for Research and Education

Country where clinical trial is conducted

United States, 

References & Publications (3)

Leung FW, Aharonian HS, Guth PH, Chu SK, Nguyen BD, Simpson P. Involvement of trainees in routine unsedated colonoscopy: review of a pilot experience. Gastrointest Endosc. 2008 Apr;67(4):718-22. doi: 10.1016/j.gie.2007.11.040. — View Citation

Leung FW. Water-related techniques for performance of colonoscopy. Dig Dis Sci. 2008 Nov;53(11):2847-50. doi: 10.1007/s10620-008-0259-1. Epub 2008 May 7. Review. — View Citation

Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. Review. — View Citation

Outcome

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