Adenoma ColonINWARDNCT03254030
Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection?
A study testing Colonic inspection in people with Adenoma Colon and Serrated Adenoma, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Adenoma Colon, Serrated Adenoma
- What is being tested?
- Colonic inspection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are referred for a bowel scope screening procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NorthWest London Hospitals - NOrthwick park hospital
Harrow, Middlesex, HA1 3UJ
About this study
Official title: Does Careful Inspection of Colonic Mucosa During Insertion and Withdrawal During Bowel Scope Improve Rate of Adenoma Detection?
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.
Read the 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.
- Conditions
- Adenoma Colon, Serrated Adenoma
- Being tested
- Colonic inspection
- Keywords
- Adenoma, Sessile serrated adenoma
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic inspectionOther
Also called Inspection of colonic mucosa during insertion and withdrawal
Participants who are randomised to undergo the intervention will have the colonic mucosa examined during inspection and withdrawal phase of examination
| Study group | Role | What they receive |
|---|---|---|
| Inspection on withdrawal | Placebo comparator | Participants colonic mucosa will be examined only during withdrawal phase of the examination. Receives: Other: Colonic inspection |
| Inspection on insertion and withdrawal | Active comparator | Participants colonic mucosa will be examined during insertion and withdrawal phase of the examination Receives: Other: Colonic inspection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Number of participants with at least one adenoma
Measured: 8 months
Secondary outcomes (4)
Polyp detection rate
Number of patients with at least one polyp
Measured: 8 months
Mean number of adenoma per patient
Number of adenomas divided by the number of patients in that group
Measured: 8 months
Total procedure time
Time taken to complete the procedure
Measured: 8 months
Advanced adenoma detection rate
Number of patients with adenoma larger than 10mm and or consists of villous histology or high grade dysplasia
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start27 Mar 2017
- Primary completion30 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajaratnam Rameshshanker, MBBS,MRCP, Principal investigator, London North West Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254030
- Sponsor's protocol ID
- RD16/117
- Acronym
- INWARD
- Status last verified
- Sep 2020
- First submitted
- 17 Aug 2017
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Careful Inspection of Colonic Mucosa During Insertion and Withdrawal During Bowel Scope Improve Rate of Adenoma Detection?
- ClinicalTrials.gov ID
- NCT03254030
- Acronym / sponsor ID
- INWARD / RD16/117
- Conditions
- Adenoma Colon, Serrated Adenoma
- Keywords
- Adenoma, Sessile serrated adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inspection on withdrawal | Placebo comparator | Other: Colonic inspectionParticipants colonic mucosa will be examined only during withdrawal phase of the examination. |
| Inspection on insertion and withdrawal | Active comparator | Other: Colonic inspectionParticipants colonic mucosa will be examined during insertion and withdrawal phase of the examination |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who are referred for a bowel scope screening procedure
Key exclusion criteria (6 listed)
- Patients lacking capacity to give informed consent
- Pregnant women
- Age less than 55 years
- Uncorrectable coagulopathy
- Patients who are not fit for flexible sigmoidoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic inspectionAlso: Inspection of colonic mucosa during insertion and withdrawalParticipants who are randomised to undergo the intervention will have the colonic mucosa examined during inspection and withdrawal phase of examination | Other | Inspection on insertion and withdrawal, Inspection on withdrawal |
Primary outcome
Adenoma detection rate
Time frame: 8 months
Number of participants with at least one adenoma
4 secondary outcomes
Polyp detection rate
Time frame: 8 months
Mean number of adenoma per patient
Time frame: 8 months
Total procedure time
Time frame: 8 months
Advanced adenoma detection rate
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajaratnam Rameshshanker, MBBS,MRCP principal investigator
London North West Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonic inspection in people with Adenoma Colon and Serrated Adenoma, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.