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Clinical Trials/NCT00785889
NCT00785889
Completed
Not Applicable

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.

East Bay Institute for Research and Education1 site in 1 country56 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
East Bay Institute for Research and Education
Enrollment
56
Locations
1
Primary Endpoint
Increments of medications used for sedation
Status
Completed
Last Updated
17 years ago

Overview

Brief 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.

Detailed 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

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
October 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
East Bay Institute for Research and Education

Eligibility Criteria

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

Outcomes

Primary Outcomes

Increments of medications used for sedation

Time Frame: duration of procedure

Secondary Outcomes

  • pain scores during colonoscopy(duration of procedure)
  • success with cecal intubation(during procedure)
  • willingness to repeat colonoscopy(after procedure)

Study Sites (1)

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