Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03952611
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2017-10-23
Brief Title:
Three Arm Rand Trial of HD Light vs Reveal Cap vs Endocuff Cap for Detection of Colorectal Adenomas TRACE
Sponsor:
Midwest Biomedical Research Foundation
Organization:
Midwest Veterans Biomedical Research Foundation
Study Overview
Official Title:
Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACE
Brief Summary:
Protocol Title Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas
Hypothesis Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light HDWL colonoscopy with Reveal distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone
Design Multicenter Prospective randomized controlled study
Primary Aim To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Secondary Aims To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
To compare the detection rates for polyp subtypes including advanced adenomas serrated polyps right sided adenomas etc cecal intubation rate insertion time withdrawal time and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Hypothesis Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light HDWL colonoscopy with Reveal distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone
Design Multicenter Prospective randomized controlled study
Primary Aim To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Secondary Aims To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
To compare the detection rates for polyp subtypes including advanced adenomas serrated polyps right sided adenomas etc cecal intubation rate insertion time withdrawal time and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Detailed Description:
Hypothesis and specific aims of the Study
We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone
Primary Aim
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Secondary Aims
1 To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
2 To compare the detection rates for polyp subtypes including advanced adenomas serrated polyps right sided adenomas etc cecal intubation rate insertion time withdrawal time and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Methodology
This will be a prospective randomized controlled study Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled They will be randomized to one of 3 arms ie HDWL colonoscopy HDWL colonoscopy with Reveal cap or HDWL colonoscopy with Endocuff Vision
Enrollment
A member of the research team will approach a potential subject to discuss participation in the study including background of the proposed study inclusion and exclusion criteria benefits and risks of the procedures and follow-up If this is of interest to the subject the informed consent form is discussed and presented The subject must sign the consent form prior to enrollment This form will have prior approval of the study sites Institutional Review Board IRB Failure to obtain informed consent renders the subject ineligible for the study
Length of the study
The duration of the study is expected to be approximately 12 months Enrollment of study patients will cease when approximately 1227 patients have been enrolled
Inclusion criteria
Referral for screening or surveillance colonoscopy
Ability to provide informed consent
Exclusion criteria
Prior history of colon cancer
History of inflammatory bowel disease
Prior surgical resection of any part of the colon
Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
History of polyposis syndrome or HNPCC
Inability to give informed consent
Family history of colon cancer in a first degree relative 60 years or two first degree relatives with colorectal cancer
For three groups moderate sedation will be administered in a standard fashion with intravenous midazolam meperidine or fentanyl prior to undergoing colonoscopy
The colonoscope HDWL colonoscope or HDWL colonoscope with Reveal cap or HDWL colonoscope with Endocuff Vision will be inserted and cecum will be intubated Photo documentation of the cecum will be performed The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope
The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the insertion time
The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the withdrawal time During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned fluidsolid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds flexures and valves
All polyps detected will be documented size location and morphology using the Paris classification - Appendix A Photo documentation of the polyps will be performed
Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation each in a separate jar and labeled accordingly
The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale Appendix B Complications including any mucosal trauma from the high definition colonoscope alone or with high definition colonoscope with Reveal cap or Endocuff Vision perforation or gastrointestinal bleeding requiring intervention will be recorded for three groups
We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone
Primary Aim
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Secondary Aims
1 To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
2 To compare the detection rates for polyp subtypes including advanced adenomas serrated polyps right sided adenomas etc cecal intubation rate insertion time withdrawal time and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision
Methodology
This will be a prospective randomized controlled study Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled They will be randomized to one of 3 arms ie HDWL colonoscopy HDWL colonoscopy with Reveal cap or HDWL colonoscopy with Endocuff Vision
Enrollment
A member of the research team will approach a potential subject to discuss participation in the study including background of the proposed study inclusion and exclusion criteria benefits and risks of the procedures and follow-up If this is of interest to the subject the informed consent form is discussed and presented The subject must sign the consent form prior to enrollment This form will have prior approval of the study sites Institutional Review Board IRB Failure to obtain informed consent renders the subject ineligible for the study
Length of the study
The duration of the study is expected to be approximately 12 months Enrollment of study patients will cease when approximately 1227 patients have been enrolled
Inclusion criteria
Referral for screening or surveillance colonoscopy
Ability to provide informed consent
Exclusion criteria
Prior history of colon cancer
History of inflammatory bowel disease
Prior surgical resection of any part of the colon
Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
History of polyposis syndrome or HNPCC
Inability to give informed consent
Family history of colon cancer in a first degree relative 60 years or two first degree relatives with colorectal cancer
For three groups moderate sedation will be administered in a standard fashion with intravenous midazolam meperidine or fentanyl prior to undergoing colonoscopy
The colonoscope HDWL colonoscope or HDWL colonoscope with Reveal cap or HDWL colonoscope with Endocuff Vision will be inserted and cecum will be intubated Photo documentation of the cecum will be performed The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope
The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the insertion time
The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the withdrawal time During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned fluidsolid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds flexures and valves
All polyps detected will be documented size location and morphology using the Paris classification - Appendix A Photo documentation of the polyps will be performed
Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation each in a separate jar and labeled accordingly
The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale Appendix B Complications including any mucosal trauma from the high definition colonoscope alone or with high definition colonoscope with Reveal cap or Endocuff Vision perforation or gastrointestinal bleeding requiring intervention will be recorded for three groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None