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Completed

NCT Number: NCT00785889

RCT of Air Insufflation Versus Water Infusion Colonoscopy

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sacramento VA Medical Center, VANCHCS

Mather, California, 95655, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water Infusion Colonoscopy

Procedure

water infusion in lieu of air insufflation for screening colonoscopy

Other names: optical colonoscopy, water infusion colonoscopy

Primary outcomes

  1. Increments of medications used for sedation

    Time frame: duration of procedure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

East Bay Institute for Research and Education

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 5, 2008
Registry last updated
Nov 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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