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CompletedNCT03254030INWARDUpdated Sep 10, 2020

Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection?

An interventional study of Colonic inspection in Adenoma Colon and Serrated Adenoma, sponsored by London North West Healthcare NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 55 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-09-10.

Sponsored by London North West Healthcare NHS Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
490
Allocation
Randomized
Ages
55 Years to 79 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Adenoma Colon
  • Serrated Adenoma

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Keywords

  • Adenoma
  • Sessile serrated adenoma
03

Who can participate

Ages eligible
55 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants who are referred for a bowel scope screening procedure

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
490 participants (actual)

Study arms

  • Placebo comparator
    Inspection on withdrawal

    Participants colonic mucosa will be examined only during withdrawal phase of the examination.

    Other: Colonic inspection

  • Active comparator
    Inspection on insertion and withdrawal

    Participants colonic mucosa will be examined during insertion and withdrawal phase of the examination

    Other: Colonic inspection

Interventions

  • OtherColonic inspection

    Participants who are randomised to undergo the intervention will have the colonic mucosa examined during inspection and withdrawal phase of examination

    Also known as: Inspection of colonic mucosa during insertion and withdrawal

05

What researchers measure

Primary outcomes

  1. Adenoma detection rate

    Number of participants with at least one adenoma

    Time frame: 8 months

Secondary outcomes

  1. Polyp detection rate

    Number of patients with at least one polyp

    Time frame: 8 months

  2. Mean number of adenoma per patient

    Number of adenomas divided by the number of patients in that group

    Time frame: 8 months

  3. Total procedure time

    Time taken to complete the procedure

    Time frame: 8 months

  4. Advanced adenoma detection rate

    Number of patients with adenoma larger than 10mm and or consists of villous histology or high grade dysplasia

    Time frame: 8 months

06

Study locations

1 site
  • NorthWest London Hospitals - NOrthwick park hospital
    Harrow, Middlesex HA1 3UJ, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03254030
Lead sponsor
London North West Healthcare NHS Trust
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Mar 27, 2017
Primary completion
Aug 30, 2018
Completion
Dec 31, 2018
Last update
Sep 10, 2020

Study contacts

Rajaratnam Rameshshanker, MBBS,MRCP
principal investigator · London North West Healthcare NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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