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Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange

D

Dalin Tzu Chi General Hospital

Status

Completed

Conditions

Adenoma

Treatments

Procedure: Water exchange
Procedure: water immersion
Procedure: Air insufflation

Study type

Interventional

Funder types

Other

Identifiers

NCT01894191
DalinTCGH-hsieh-03

Details and patient eligibility

About

Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon.

Full description

All of the procedures will be recorded and stored as digital files.

Enrollment

651 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing colonoscopy performed by the participating endoscopists

Exclusion criteria

  • obstructive lesions of the colon known before colonoscopy
  • massive ascites
  • past history of partial colectomy
  • refusal to provide written informed consent

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

651 participants in 3 patient groups

air insufflation
Active Comparator group
Description:
Air insufflation will be used throughout whole procedure of colonoscopy
Treatment:
Procedure: Air insufflation
water immersion
Active Comparator group
Description:
Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy.
Treatment:
Procedure: water immersion
water exchange
Active Comparator group
Description:
Water will be infused and removed during insertion phase of colonoscopy
Treatment:
Procedure: Water exchange

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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