CClinicalTrials.gg
Status unknownNCT00920751Updated Jun 15, 2009

Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance

An interventional study of Water infusion and Air insufflation in Colorectal Cancer Screening, sponsored by East Bay Institute for Research and Education. Status unknown at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-15.

Sponsored by East Bay Institute for Research and Education · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
All
01

Study summary

Hypothesis

  1. Study method achieves lower requirement for medications
  2. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
  3. Study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy
  4. Study method improves bowel preparation and increases polyp pickup rate

Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic VA patients is being promoted (VHA directive). Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy. The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.

Methods that maintain a high success rate and good patient assessment improve overall compliance for surveillance colonoscopy. Our preliminary experience showed that patients are able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was aided by a water infusion in lieu of air insufflation method. In this group of patients, the shortened recovery time means a quick turn around of patient and a more efficient endoscopy service. Patients are able to communicate better with the staff and physician regarding their problem and discharge instructions, and not subjected to the amnesic effect of sedation. Next day follow-up of patient by telephone contact which requires commitment of staff time can be obviated.

If this randomized study confirms the success of our preliminary findings and this technique is adopted by more endoscopists, a larger number of VA patients may benefit from less sedation complications and at the same time allow for more efficient colonoscopy screening services.

02

Conditions studied

  • Colorectal Cancer Screening

Keywords

  • water infusion
  • air insufflation
  • colonoscopy
  • colorectal cancer screening
03

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

East Bay Institute for Research and Education is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult (> 50 years old), male and female patients
  • Scheduled and consented for screening or surveillance colonoscopy
  • Accept randomization to the study or the conventional method
  • Agree to complete study questionnaires will be considered for enrollment
  • Normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2

Exclusion criteria

Exclusion Criteria:

  • Patients who decline to participate, are unable to give informed consent or to complete the questionnaires due to language or other difficulties will be excluded. Excluded patients will be managed by usual procedures at the Sacramento VAMC
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Water infusion

    Water infusion in lieu of air insufflation during colonoscope insertion

    Procedure: Water infusion

  • Active comparator
    Air insufflation

    Conventional air insufflation colonoscopy

    Procedure: Air insufflation

Interventions

  • ProcedureWater infusion

    Water infusion in lieu of air insufflation during colonoscope insertion

  • ProcedureAir insufflation

    Conventional air insufflation colonoscopy

06

What researchers measure

Primary outcomes

  1. Primary outcome - success of cecal intubation without sedation

    Time frame: 1 year

Secondary outcomes

  1. Diagnostic yield, patients' current experience, willingness to repeat future colonoscopy, turn around time, and staff rating of satisfaction, and medication-related complications.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Sacramento VA Medical Center
    Mather, California 95655, United States
    Recruiting
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References and documents

Publications

  • Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020. PubMed 21184876 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00920751
Lead sponsor
East Bay Institute for Research and Education
First posted
Jun 15, 2009
Start date
Mar 2009
Last update
Jun 15, 2009

Study contacts

Joseph W Leung, MD
Contact
Joseph.Leung2@va.gov
916-366-5339

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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