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Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy

A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02737514
Enrollment
371
Registered
2016-04-14
Start date
2015-12-31
Completion date
2020-02-29
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma

Keywords

adenoma detection rate, colonoscopy, water exchange

Brief summary

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

Detailed description

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

Interventions

Insufflation during colonoscopy including insertion phase

Water will infused during insertion phase and removed during withdrawal phase of colonoscopy

Water will infused and removed during insertion phase of colonoscopy

Sponsors

Dalin Tzu Chi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
adenoma detection rate in the right colonone week

Secondary

MeasureTime frameDescription
overall adenoma detection rateone week
post-procedure discomfort1 day after colonoscopypain or distention on a 0 to 10 VAS scale
30 days complication rate30 daysincidence of bleeding, perforation and unexpected admission

Countries

Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026