Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection? (INWARD)

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.

Study Overview

• Status: Completed
• Conditions: Adenoma Colon; Serrated Adenoma
• Intervention / Treatment: Other: Colonic inspection

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 Type: Interventional
• Enrollment (Actual): 490
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Inspection on withdrawal; Participants colonic mucosa will be examined only during withdrawal phase of the examination.	Other: Colonic inspection; 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
ACTIVE_COMPARATOR: Inspection on insertion and withdrawal; Participants colonic mucosa will be examined during insertion and withdrawal phase of the examination	Other: Colonic inspection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Number of participants with at least one adenoma	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection rate	Number of patients with at least one polyp	8 months
Mean number of adenoma per patient	Number of adenomas divided by the number of patients in that group	8 months
Total procedure time	Time taken to complete the procedure	8 months
Advanced adenoma detection rate	Number of patients with adenoma larger than 10mm and or consists of villous histology or high grade dysplasia	8 months

Collaborators and Investigators

• Sponsor: London North West Healthcare NHS Trust
• Investigators: Principal Investigator: Rajaratnam Rameshshanker, MBBS,MRCP, London North West Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2017
• Primary Completion (ACTUAL): August 30, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (ACTUAL): August 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Adenoma; Sessile serrated adenoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: RD16/117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No