NCT02292563

Brief Summary

The purpose of this study is to determine whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 2, 2019

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

November 12, 2014

Last Update Submit

June 30, 2019

Conditions

PolypAdenoma

Keywords

Nurse; Colonoscopy; Polyp; Adenoma;

Outcome Measures

Primary Outcomes (2)

  • Polyp detection rate

    1.5 year

  • adenoma detection rate

    1.5 year

Secondary Outcomes (1)

  • Advanced polyp detection rate

    1.5 year

Study Arms (2)

endoscopist only

EXPERIMENTAL

Single inspection by endoscopist during colonoscopy

Procedure: Colonoscopist onlyProcedure: Experienced Endoscopy Nurse Participation

nurse participation

EXPERIMENTAL

Dual inspection by both an endoscopist and an experienced nurse during colonoscopy

Procedure: Colonoscopist onlyProcedure: Experienced Endoscopy Nurse Participation

Interventions

Colonoscopist onlyPROCEDURE

Only Colonosopist Observe during Colonoscopy (single observer)

endoscopist onlynurse participation
Experienced Endoscopy Nurse ParticipationPROCEDURE

Experienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe)

endoscopist onlynurse participation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-70 average risk screening colonoscopy

You may not qualify if:

  • GI Bleeding ;
  • history of colorectal surgery ;
  • inflammatory bowel disease ;
  • colorectal cancer,or polyposis syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

Related Publications (1)

  • Wang W, Xu L, Bao Z, Sun L, Hu C, Zhou F, Xu L, Shi D. Differences with experienced nurse assistance during colonoscopy in detecting polyp and adenoma: a randomized clinical trial. Int J Colorectal Dis. 2018 May;33(5):561-566. doi: 10.1007/s00384-018-3003-0. Epub 2018 Mar 14.

    PMID: 29541895DERIVED

MeSH Terms

Conditions

PolypsAdenoma

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • XIAOYUN DING, M.D

    Ningbo No. 1 Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

July 2, 2019

Record last verified: 2015-10

Locations

CN(1)