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RCT of Air Insufflation Versus Water Infusion Colonoscopy

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ClinicalTrials.gov Identifier: NCT00785889
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:
East Bay Institute for Research and Education

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: water infusion colonoscopy Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: 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.
Study Start Date : March 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: water infusion colonoscopy
    water infusion in lieu of air insufflation for screening colonoscopy
    Other Name: optical colonoscopy, water infusion colonoscopy


Primary Outcome Measures :
  1. Increments of medications used for sedation [ Time Frame: duration of procedure ]

Secondary Outcome Measures :
  1. pain scores during colonoscopy [ Time Frame: duration of procedure ]
  2. success with cecal intubation [ Time Frame: during procedure ]
  3. willingness to repeat colonoscopy [ Time Frame: after procedure ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785889


Locations
United States, California
Sacramento VA Medical Center, VANCHCS
Mather, California, United States, 95655
Sponsors and Collaborators
East Bay Institute for Research and Education
Investigators
Principal Investigator: Joseph Leung, MD Sacramento VA Medical Center, GI Section

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Leung, M.D., GI Section, Northern California Health Care System
ClinicalTrials.gov Identifier: NCT00785889     History of Changes
Other Study ID Numbers: EBIRE-GI-001
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by East Bay Institute for Research and Education:
Colorectal cancer screening
optical colonoscopy
water method
sedation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases