The Impact of Distraction on Adenoma Detection Rate

D

Dalin Tzu Chi General Hospital

Status

Completed

Conditions

Adenoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02978664
DalinHsieh201401

Details and patient eligibility

About

The investigators will review video-recordings of three randomized, controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi Hospital.

Full description

The investigators will review video-recordings of three randomized controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be obtained from the local Institutional Review Board (IRB) to review, analyze and report de-identified findings. Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies. Recordings will be selected for review if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection will be excluded from analysis. The included video recordings will be edited to remove the insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer uninvolved in the performance of the colonoscopies will be in charge of evaluating the selected videos, using the criteria described by Yung et al

Enrollment

500 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers.

Exclusion criteria

Patients with incomplete recordings and a history of bowel resection will be excluded from analysis.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

500 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

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems