NCT03254030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

August 17, 2017

Last Update Submit

September 9, 2020

Conditions

Adenoma ColonSerrated Adenoma

Keywords

AdenomaSessile serrated adenoma

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    Number of participants with at least one adenoma

    8 months

Secondary Outcomes (4)

  • Polyp detection rate

    8 months

  • Mean number of adenoma per patient

    8 months

  • Total procedure time

    8 months

  • Advanced adenoma detection rate

    8 months

Study Arms (2)

Inspection on withdrawal

PLACEBO COMPARATOR

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

Other: Colonic inspection

Inspection on insertion and withdrawal

ACTIVE COMPARATOR

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

Other: Colonic inspection

Interventions

Colonic inspectionOTHER

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
Inspection on insertion and withdrawalInspection on withdrawal

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who are referred for a bowel scope screening procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthWest London Hospitals - NOrthwick park hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Rajaratnam Rameshshanker, MBBS,MRCP

    London North West Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 18, 2017

Study Start

March 27, 2017

Primary Completion

August 30, 2018

Study Completion

December 31, 2018

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)