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Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection

Primary Purpose

Adenoma, Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Water exchange
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adenoma focused on measuring Adenoma, Adenoma detection rate, Colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing diagnostic colonoscopy and surveillance colonoscopy

Exclusion Criteria:

  • Contraindication for performing the endoscopic procedure.
  • Refusal to provide inform consent.
  • Past history of partial colectomy, familial adenomatous polyposis, inflammatory bowel disease, coagulopathy or thrombocytopenia.
  • Incomplete colonoscopy
  • Inadequate bowel preparation
  • Pregnant patients.

Sites / Locations

  • Denise Guimaraes

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Second Examination of the right colon

Water exchange

Arm Description

Second forward view examination of the right colon once the right colon (cecum to hepatic flexure) has been examined

Water infusion during colonoscope insertion in the right colon (from hepatic flexure to cecum) and remove water during withdrawn ("Exchange method").

Outcomes

Primary Outcome Measures

Adenoma detection rate
Proportion of individuals with at least one adenoma

Secondary Outcome Measures

Detection rate of any clinically significant lesion
Proportion of participants with at least one clinically significant lesion (adenoma, serrated or cancer)
Detection rate of serrated adenoma
Proportion of participants with at least one serrated adenoma total and per resident
Colonoscopy completion rate per resident
Proportion of complete colonoscopies per resident, independently of the senior examiner
Cecal intubation time
Time it takes from anal insertion ti the time the tip of colonoscope in the the cecum
Colonoscopy withdrawal time
time it takes to withdraw colonoscope
Boston Intestinal Preparation Scale
Proportion of participants with boston scale grade

Full Information

First Posted
January 24, 2018
Last Updated
January 24, 2018
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03416322
Brief Title
Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection
Official Title
Impact of Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
Introduction Colorectal cancer (CRC) is one of the most common cancers in the world. In Brazil, it is the second most incident tumor in women and the third in men. Colonoscopy is considered the gold standard test for colorectal cancer screening through the detection and removal of adenomas or detection of early cancers. However, this protection is not perfect and even less effective in the right colon (cecum and ascending colon) when compared to the distal colon, which leads to underdiagnosis of neoplasias and precursor lesions (eg adenomas). In this context, the performance and quality of colonoscopy play an important role in minimizing colonoscopy deficiencies. The American Society for Gastrointestinal Endoscopy (ASGE) determines three indispensable indicators for measuring the quality of colonoscopy: cecal intubation (≥95% in screening colonoscopies), adenoma detection rate (ADR) (≥25% in men and women, on screening colonoscopies) and withdrawal time (≥6 minutes on screening, negative colonoscopies). In addition, for a better detection of lesions, it is necessary that the assessed colonic segment be cleaned of residues, and, therefore, proper colonic preparation is one of the quality items of the examination. Inadequate preparation impairs the detection of polyps and flat lesions, increases the time of the examination, increases the chances of complications and the costs of colonoscopy. One way to measure the quality of bowel preparation is the Boston Intestinal Prepare Scale. This scale uses a classification from 0 to 9 evaluating the preparation in three segments (right colon, transverse colon and left colon) after cleaning maneuvers. The score ranges from 0 (poor preparation) to 9 (excellent preparation). In order to increase the quality of the colonoscopic examinations by increasing the ADR and reducing the incidence of the interval CRC, some methods have been investigated, including the Second Foward View Examination of the right-side colon (SFVE) and examination with Water Aid or Underwater colonoscopy (UW). The first method is to evaluate the right colon with air and, upon reaching the hepatic flexsure, return to the cecum and re-evaluate the colonic segment. The second method, is to evaluate the right colon by inserting the colonoscope with the device completely immersed in water and withdrawn from the colonoscope with air after complete aspiration of the water, also known as the "Exchange method". The principle is that water cleans the colon and allows an increase of the image that is visualized by the colonoscope, and in that way, would improve the visualization of the mucosa. Clark et al. demonstrated that, after performing SFVE, additional adenomas were found in 43 of 280 patients evaluated (15.4%, p <0.05) and the overall adenoma detection rate increased by 3.2% (p <0.05). The ADR in the right colon increased by 6.7% (p <0.05). A retrospective study conducted by Leung et al. demonstrated that the UW technique increased the ADR in the right colon - at least one adenoma of any size was detected in 26.8% of patients in the air-evaluated group and in 34, 9% of patients in the group evaluated with water. The two techniques showed to increase the ADR. Both are easy to carry out, do not require extra training or additional equipment, and have low cost. However, the impact of water exchange method colonoscopy on adenoma detection rate have not benn completely calrified. Further there is no evidence in the literature comparing these two techniques. During colonoscopy learning curve, objective criteria are increasingly being suggested to assess the competence of "trainees". Traditionally, this evaluation is made by the number of procedures performed by them, but recently other criteria such as quality indicators, the ADR and intubation of the cecum have been investigated as formal methods in the evaluation of a trainee or resident. During the endoscopy residency in Barretos Cancer Hospital, surveillance colonoscopies are performed by residents supervised by the senior endoscopistThere is currently no evaluation of the colonoscopy technique performed by the resident. In addition, there is no evaluation of the ADR during the learning curve of the endoscopy resident in our department. Justification The need to ensure adequate ADR among endoscopy residents. Absence of studies comparing UW and SEVF techniques of the right colon for the adenoma detection rate. Primary objective To compare the ADR between combined SEFV and UW techniques in the right colon in patients undergoing colonoscopy for high-risk screening, diagnosis and follow-up after polypectomy, performed by residents supervised by a senior endoscopist. Secondary objectives To estimate the association between withdrawal time, proportion of independent intubation of the cecum, preparation of the colon and the number of previously performed colonoscopies in the ADR in both techniques previously performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Colorectal Cancer
Keywords
Adenoma, Adenoma detection rate, Colorectal cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
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.
Allocation
Randomized
Enrollment
708 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Second Examination of the right colon
Arm Type
No Intervention
Arm Description
Second forward view examination of the right colon once the right colon (cecum to hepatic flexure) has been examined
Arm Title
Water exchange
Arm Type
Experimental
Arm Description
Water infusion during colonoscope insertion in the right colon (from hepatic flexure to cecum) and remove water during withdrawn ("Exchange method").
Intervention Type
Other
Intervention Name(s)
Water exchange
Intervention Description
Infusion and remove water during inertion and withdrawal of colonoscope
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
Proportion of individuals with at least one adenoma
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Detection rate of any clinically significant lesion
Description
Proportion of participants with at least one clinically significant lesion (adenoma, serrated or cancer)
Time Frame
up to 12 months
Title
Detection rate of serrated adenoma
Description
Proportion of participants with at least one serrated adenoma total and per resident
Time Frame
up to 12 monthas
Title
Colonoscopy completion rate per resident
Description
Proportion of complete colonoscopies per resident, independently of the senior examiner
Time Frame
up to 12 months
Title
Cecal intubation time
Description
Time it takes from anal insertion ti the time the tip of colonoscope in the the cecum
Time Frame
up to 12 months
Title
Colonoscopy withdrawal time
Description
time it takes to withdraw colonoscope
Time Frame
up to 12 months
Title
Boston Intestinal Preparation Scale
Description
Proportion of participants with boston scale grade
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing diagnostic colonoscopy and surveillance colonoscopy Exclusion Criteria: Contraindication for performing the endoscopic procedure. Refusal to provide inform consent. Past history of partial colectomy, familial adenomatous polyposis, inflammatory bowel disease, coagulopathy or thrombocytopenia. Incomplete colonoscopy Inadequate bowel preparation Pregnant patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DENISE GUIMARAES, MD, PhD
Phone
17981524444
Email
guimaraes.dp@gmail.com
Facility Information:
Facility Name
Denise Guimaraes
City
Barretos
State/Province
SÃO Paulo
ZIP/Postal Code
14783062
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DENISE GUIMARAES, PhD
Phone
551733216600
Ext
7267
Email
guimaraes.dp@gmail.com

12. IPD Sharing Statement

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Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection

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