RCT of Air Insufflation Versus Water Infusion Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
East Bay Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00785889
First received: November 3, 2008
Last updated: November 13, 2008
Last verified: November 2008
  Purpose

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 Intervention
Colorectal Cancer
Procedure: water infusion colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by East Bay Institute for Research and Education:

Primary Outcome Measures:
  • Increments of medications used for sedation [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pain scores during colonoscopy [ Time Frame: duration of procedure ] [ Designated as safety issue: Yes ]
  • success with cecal intubation [ Time Frame: during procedure ] [ Designated as safety issue: No ]
  • willingness to repeat colonoscopy [ Time Frame: after procedure ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: water infusion colonoscopy
    water infusion in lieu of air insufflation for screening colonoscopy
    Other Name: optical colonoscopy, water infusion 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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: November 3, 2008
Last Updated: November 13, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 02, 2014