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Completed

NCT Number: NCT03254030

Does Inspection of Colonic Mucosa During Insertion Improve 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.

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Key information

Age range

55 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthWest London Hospitals - NOrthwick park hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colonic inspection

Other

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

Other names: Inspection of colonic mucosa during insertion and withdrawal

Primary outcomes

  1. Adenoma detection rate

    Time frame: 8 months

    Number of participants with at least one adenoma

Secondary outcomes

  1. Polyp detection rate

    Time frame: 8 months

    Number of patients with at least one polyp

  2. Mean number of adenoma per patient

    Time frame: 8 months

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

  3. Total procedure time

    Time frame: 8 months

    Time taken to complete the procedure

  4. Advanced adenoma detection rate

    Time frame: 8 months

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

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study title

Does Careful Inspection of Colonic Mucosa During Insertion and Withdrawal During Bowel Scope Improve Rate of Adenoma Detection?

Acronym: INWARD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2017
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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