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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.


N/A
45 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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.


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Increments of medications used for sedation

Outcome Time Frame:

duration of procedure

Safety Issue:

Yes

Principal Investigator

Joseph Leung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sacramento VA Medical Center, GI Section

Authority:

United States: Institutional Review Board

Study ID:

EBIRE-GI-001

NCT ID:

NCT00785889

Start Date:

March 2008

Completion Date:

October 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer screening
  • optical colonoscopy
  • water method
  • sedation
  • Colorectal Neoplasms

Name

Location

Sacramento VA Medical Center, VANCHCSMather, California  95655