Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection
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|ClinicalTrials.gov Identifier: NCT03416322|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Introduction and objectives: The adenoma detection rate (ADR) has been investigated as a formal method in the evaluation of a trainee or resident physician. Several studies have suggested that water-assisted colonoscopy methods increase the ADR, especially in the right colon, when compared to air-insufflated methods alone. The objective of this study is to compare the adenoma detection rates between the techniques of the second frontal view examination and "Underwater" examination by residents, supervised by a senior endoscopist.
Patients and methods: This is a prospective, comparative and randomized clinical trial. The patients referred to the Cancer Hospital of Barretos for colonoscopy, and who agreed with the study, were divided into two groups, one with the use of water and the other only with air insufflation. The primary endpoint of this study is to compare adenoma detection rate. Secondary outcomes were withdrawal time, proportion of intubation of the cecum, preparation of the colon, and number of previously performed colonoscopies in the ADR in both techniques.
|Condition or disease||Intervention/treatment||Phase|
|Adenoma Colorectal Cancer||Other: Water exchange||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||708 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Clinical, prospective and comparative, randomized study. Patients referred to the Endoscopy Department of the Barretos Cancer Hospital from August 2017 to August 2018 will be invited to participate in the study, with an indication of performing a diagnostic colonoscopy for high-risk CCR screening (Lynch and Li Fraumeni Syndrome) or who are in post-polypectomy follow-up.
After agreeing and signing the Informed Consent Term (ICF), the included patients will be divided into two groups. The first group will be submitted to the technique of "second right frontal view of the right colon" (SEVF), which consists in reexamining the right colon after reaching the hepatic angle on colonoscope withdrawal. The second group will be submitted to the "Underwater" technique, which consists in evaluating the right colon after this segment has been cleaned with water, injected water and aspirated after. During aspiration of water, the colon will be examined.
|Masking Description:||Randomization of participants will be done in a 1:1 ratio, with the random sequence in blocks 2, 4 and 6. The sequence of treatments within the blocks and the block sequence will be randomized. For this randomization, the REDCap platform will be used.|
|Official Title:||Impact of Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection|
|Estimated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||November 1, 2018|
No Intervention: Second Examination of the right colon
Second forward view examination of the right colon once the right colon (cecum to hepatic flexure) has been examined
Experimental: Water exchange
Water infusion during colonoscope insertion in the right colon (from hepatic flexure to cecum) and remove water during withdrawn ("Exchange method").
Other: Water exchange
Infusion and remove water during inertion and withdrawal of colonoscope
- Adenoma detection rate [ Time Frame: up to 12 months ]Proportion of individuals with at least one adenoma
- Detection rate of any clinically significant lesion [ Time Frame: up to 12 months ]Proportion of participants with at least one clinically significant lesion (adenoma, serrated or cancer)
- Detection rate of serrated adenoma [ Time Frame: up to 12 monthas ]Proportion of participants with at least one serrated adenoma total and per resident
- Colonoscopy completion rate per resident [ Time Frame: up to 12 months ]Proportion of complete colonoscopies per resident, independently of the senior examiner
- Cecal intubation time [ Time Frame: up to 12 months ]Time it takes from anal insertion ti the time the tip of colonoscope in the the cecum
- Colonoscopy withdrawal time [ Time Frame: up to 12 months ]time it takes to withdraw colonoscope
- Boston Intestinal Preparation Scale [ Time Frame: up to 12 months ]Proportion of participants with boston scale grade
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416322
|Contact: DENISE GUIMARAES, MD, PhDfirstname.lastname@example.org|
|Denise Guimaraes||Not yet recruiting|
|Barretos, SÃO Paulo, Brazil, 14783062|
|Contact: DENISE GUIMARAES, PhD 551733216600 ext 7267 email@example.com|