Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection? (INWARD)
Primary Purpose
Adenoma Colon, Serrated Adenoma
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Colonic inspection
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma Colon focused on measuring Adenoma, Sessile serrated adenoma
Eligibility Criteria
Inclusion Criteria:
- Participants who are referred for a bowel scope screening procedure
Exclusion Criteria:
- Patients lacking capacity to give informed consent
- Pregnant women
- Age less than 55 years
- Uncorrectable coagulopathy
- Patients who are not fit for flexible sigmoidoscopy
- Incomplete procedure
Sites / Locations
- NorthWest London Hospitals - NOrthwick park hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Inspection on withdrawal
Inspection on insertion and withdrawal
Arm Description
Participants colonic mucosa will be examined only during withdrawal phase of the examination.
Participants colonic mucosa will be examined during insertion and withdrawal phase of the examination
Outcomes
Primary Outcome Measures
Adenoma detection rate
Number of participants with at least one adenoma
Secondary Outcome Measures
Polyp detection rate
Number of patients with at least one polyp
Mean number of adenoma per patient
Number of adenomas divided by the number of patients in that group
Total procedure time
Time taken to complete the procedure
Advanced adenoma detection rate
Number of patients with adenoma larger than 10mm and or consists of villous histology or high grade dysplasia
Full Information
NCT ID
NCT03254030
First Posted
August 17, 2017
Last Updated
September 9, 2020
Sponsor
London North West Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03254030
Brief Title
Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection?
Acronym
INWARD
Official Title
Does Careful Inspection of Colonic Mucosa During Insertion and Withdrawal During Bowel Scope Improve Rate of Adenoma Detection?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective randomised controlled trial to assess an intervention of inspection during both phases of colonoscopic examination ( insertion and withdrawal) improve adenoma detection rate when compared to inspection only during withdrawal.
Detailed Description
Successful implementation of colorectal screening programmes and improvement in colonoscopic technology have resulted in significant decrease in colorectal cancer incidence and mortality. Effectiveness of colonoscopy largely depends on detection and removal of adenomas before they become cancerous. Despite the vast improvement in colonoscopy training and technology, it remains as an imperfect tool. It has been reported that the adenoma miss rate during colonoscopy varies between 6-27% in clinical practice. Adenoma Detection Rate (ADR) is a surrogate marker of efficient colonoscopy. Researchers continue to explore various methods and technologies to improve adenoma detection such as frequent position changes, routine use of antispasmodics and devices to improve the mucosal visibility (third eye retro view scope, Transparent cap, Endocuff).
However, all the techniques are focused on the withdrawal stage of the examination. Colonic examination is traditionally performed with rapid passage of colonoscope to the caecum and a careful examination of mucosa is carried out during the withdrawal phase. Polyps are removed during the withdrawal phase. It is well known from expert opinion that some polyps are detected during the insertion phase rather than withdrawal phase especially in sigmoid and transverse colon. This could be due to different anatomical configuration of colon during insertion and withdrawal.
During insertion phase colonic mucosa is stretched and the folds are splayed due to the formation of loops and angulation hence affects the visualised area of the mucosa ahead of the colonoscope. During withdrawal, the colon is shortened and the adjacent folds are brought closer to each other. On withdrawal colon is much straighter. Therefore, it may expose different portions of colonic mucosal surface on insertion and withdrawal.
Flexible sigmoidoscopy Bowel cancer screening programme (Bowel Scope) has been successfully implemented since May 2013. Initial reports suggest ADR within Bowel Scope screening varies considerably.
Therefore, we propose a simple technique to improve ADR in Bowel Scope Screening.
RATIONALE FOR CURRENT STUDY
Recent report suggests that ADR within Bowel Scope screening (BSS) varies considerably. We propose a small technical alteration to improve ADR in BSS. A recent prospective trial highlighted that if polypectomy was performed only during Withdrawal Phase (WP) when compared to performing careful inspection and polypectomy during Inspection Phase (IP) plus WP, polyps could be missed in about 7% of patients. We hypothesised that careful inspection and polypectomy during both phases would be complementary and it would increase ADR by complete visualisation of recto sigmoid mucosa during Bowel Scope.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Colon, Serrated Adenoma
Keywords
Adenoma, Sessile serrated adenoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomised to undergo the flexible sigmoidoscopy screening examination either for control or intervention group. Control group is to undergo inspection of colonic mucosa only during withdrawal phase of the examination. Intervention group will undergo the examination during which the colonic mucosa will be inspected during inspection and withdrawal phase.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspection on withdrawal
Arm Type
Placebo Comparator
Arm Description
Participants colonic mucosa will be examined only during withdrawal phase of the examination.
Arm Title
Inspection on insertion and withdrawal
Arm Type
Active Comparator
Arm Description
Participants colonic mucosa will be examined during insertion and withdrawal phase of the examination
Intervention Type
Other
Intervention Name(s)
Colonic inspection
Other Intervention Name(s)
Inspection of colonic mucosa during insertion and withdrawal
Intervention Description
Participants who are randomised to undergo the intervention will have the colonic mucosa examined during inspection and withdrawal phase of examination
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
Number of participants with at least one adenoma
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Polyp detection rate
Description
Number of patients with at least one polyp
Time Frame
8 months
Title
Mean number of adenoma per patient
Description
Number of adenomas divided by the number of patients in that group
Time Frame
8 months
Title
Total procedure time
Description
Time taken to complete the procedure
Time Frame
8 months
Title
Advanced adenoma detection rate
Description
Number of patients with adenoma larger than 10mm and or consists of villous histology or high grade dysplasia
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who are referred for a bowel scope screening procedure
Exclusion Criteria:
Patients lacking capacity to give informed consent
Pregnant women
Age less than 55 years
Uncorrectable coagulopathy
Patients who are not fit for flexible sigmoidoscopy
Incomplete procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajaratnam Rameshshanker, MBBS,MRCP
Organizational Affiliation
London North West Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthWest London Hospitals - NOrthwick park hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection?
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