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

50 Years
80 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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

Inclusion 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

Type of Study:


Study Design:

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

Outcome Measure:

Increments of medications used for sedation

Outcome Time Frame:

duration of procedure

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

February 2009

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer screening
  • Optical colonoscopy
  • Water method
  • Sedation
  • Colorectal Neoplasms



Sacramento VA Medical Center,Mather, California  95655