Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection?

NCT ID: NCT03254030

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2018-12-31

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.

Conditions

Adenoma Colon; Serrated Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Inspection on withdrawal

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

Group Type: PLACEBO_COMPARATOR

Colonic inspection

Intervention Type: OTHER

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

Inspection on insertion and withdrawal

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

Group Type: ACTIVE_COMPARATOR

Colonic inspection

Intervention Type: OTHER

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

Interventions

Colonic inspection

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

Intervention Type: OTHER

Other Intervention Names

Inspection of colonic mucosa during insertion and withdrawal

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London North West Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajaratnam Rameshshanker, MBBS,MRCP

Role: PRINCIPAL_INVESTIGATOR

London North West Healthcare NHS Trust

Locations

NorthWest London Hospitals - NOrthwick park hospital

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

RD16/117

Identifier Type: -

Identifier Source: org_study_id