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RCT of Air Insufflation Versus Water Infusion Colonoscopy

E

East Bay Institute for Research and Education

Status

Completed

Conditions

Colorectal Cancer

Treatments

Procedure: water infusion colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT00785889
EBIRE-GI-001

Details and patient eligibility

About

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.

Full 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

Enrollment

56 patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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